Pharmacy Prior Authorization Criteria - AmeriHealth ... · Field Name Field Description Prior...

Pharmacy Prior Authorization Criteria

Field Name Field Description Prior Authorization Group Description

Ampyra

Drugs Ampyra (dalfampridine) tablets Covered Uses Medically accepted indications are defined using the following sources:

the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines.

Exclusion Criteria History of seizures. Moderate or severe renal impairment (creatinine clearance ≤ 50mL/minute)

Required Medical Information

See “other criteria”

Age Restrictions Patient must be 18 years of age or older Prescriber

Restrictions Prescriber must be a neurologist

Coverage Duration If the criteria are met, the request will be approved with a 6 month duration; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.

Other Criteria

Revision/Review Date 4/2018

Initial Authorization: • Baseline creatinine clearance (within 60 days of request) • Patient has diagnosis of multiple sclerosis (MS), patient is

ambulatory (baseline 25 foot walk was submitted with request), AND patient has walking impairment

• Documentation was submitted (consistent with pharmacy claims data, OR for new members to the health plan, consistent with chart notes) that patient is currently being treated for MS (e.g. immunomodulator, interferon, immunosuppressive), or documentation of a medical reason (intolerance, hypersensitivity) as to why patient is unable to use one of these agents to treat their medical condition

• Drug is being requested at an FDA approved dose Re-authorization:

• Documentation of improvement in 25 foot walk was submitted with request

• Documentation was submitted patient is on MS treatment (e.g. immunomodulator, interferon, immunosuppressive), or documentation of a medical reason (intolerance, hypersensitivity) as to why patient is unable to use one of these agents to treat their medical condition

• Drug is being requested at an FDA approved dose Medical Director/clinical reviewer must override criteria when, in

his/her professional judgement, the requested item is medically necessary.

ACTH AR H.P. (corticotropin) Vials: 80u/ml available in 5 ml vials

PA CRITERI A FOR APPROVAL FOR INFANTILE SPASMS (WEST SYNDROME): • Patient is < 2 years of age • The medication is being prescribed by a neurologist. • Documentation of the patient’s current weight (in kg) and height/length (in cm) or body

surface area (BSA) If all of the above conditions are met, the request will be approved for up to a 1 month duration; if all of the above criteria are not met then, the request is referred to a Medical Director/Clinical reviewer for medical necessity review.

PA CRITERIA FOR APPROVAL FOR MULTIPLE SCLEROSIS:

• Documentation was submitted that patient is having acute attack, with neurologic

symptoms and increased disability or impairments in vision, strength or cerebellar function, and has failed therapy with IV methylprednisolone, or a medical reason has been submitted why patient is unable to use IV methylprednisolone.

• The medication is being prescribed by a neurologist If all of the above conditions are met, the request will be approved for up to a 1 month duration; if all of the criteria are not met, the request will be sent to the clinical reviewer for medical necessity review.

PA CRITERI A FOR ALL OTHER FD A APPROVED CONDITIONS AND INDICATIONS:

• Documented trial and failure of IV methylprednisolone AND oral prednisone, or documented medical reason for why the patient cannot use these therapies for treatment AND

• Documentation was provided that ALL other standard therapies have been used to treat the member’s condition as described in the medical compendium (Micromedex, AHFS, Drug Points, and package insert) as defined in the Social Security Act and/or per recognized standard of care guidelines OR there is a documented medical reason (i.e. medical intolerance, treatment failure, etc.) for why all other standard therapies could not be used to treat the member’s condition.

AND • Prescriber is a specialist in the condition they are treating.

If all of the above conditions are met, the request will be approved for up to a 1 month duration, according to standard dosing based on indication. If all of the above criteria are not met then, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Revision/Review Date: 4/2018

NOTE: Clinical review er must override criteria w hen, in his/her professional

judgment, the requested item is medically necessary.

PERFORMRx PRIOR AUTHORIZATION PROTOCOL FOR INJECTABLE 5-

HYDROXYTRYPTAMINE-3 (5HT3) SEROTONIN RECEPTOR ANTAGONISTS Formulary Status: Generic Ondansetron or Granisetron Preferred ondansetron (Zofran) granisetron (Kytril) palonosetron (Aloxi) Akynzeo (palonosetron/fosnetupitant) Sustol (granisetron ER) Any other newly marketed agent

Criteria for Approval:

• The request for the medication is for an Food and Drug Administration (FDA) approved indication, and/or is used for a medical condition that is supported by the medical compendium and/or per the National Comprehensive Cancer Network (NCCN) standard of care guidelines for antiemetic therapy.

• Patients receiving an antineoplastic agent =as HIGH or MODERATE emetic risk per the ASCO Practice guidelines can receive generic palonosetron hydrochloride as a first line antiemetic agent. (See tables that follow)

• For all other patients, if the medication request is for any other 5-hydroxytryptamine-3 (5HT3) serotonin receptor antagonist other than Ondansetron or Granisetron, the patient has a documented treatment failure after receiving an adequate trial of Ondansetron or Granisetron and/or has another documented medical reason ( intolerance, hypersensitivity, contraindication, etc.) for not utilizing these medications to treat their medical condition.

• Prescribed dosing of the 5HT3 serotonin receptor antagonist is within FDA approved or NCCN standard of care guidelines.

• The medication is recommended and prescribed by a specialist in the field to treat the patient’s respective medical condition.

If all of the above conditions are met, the request will be approved for up to 6 months or as recommended by the medical compendium and/or per the NCCN standard of care guidelines; if all of the above criteria are not met, the request is referred to a Medical Director/Clinical reviewer for medical necessity review.

Revised February 2015

Na t onal Comprehensi ve Cancer Network.,

NCCN Guidelines Version 3.2018 Antiemesis

EMETOGENIC POTENTIAL OF INTRAVENOUS ANTICANCER AGENTS•

NCCN Gui dle ines Index

Table of Contents Discussion

LEVEL AGENT High emetic risk (>90% frequency of emesis)b.c

• AC combination defined as any chemotherapy regimen that contains an anthracycline and cyclophosphamide

• Carboplatin AUC 4

• Cannustine >250 mg/111' • Cisplatin • Cyclophosphamide >1,500 mg/nr • Oacarbazine • Doxorubicin 60 mg/m'

• Epirubicin >90 mginn' • Ifosfamide 2 gim' per dose • Mechlorethamine • Streptozocin

Moderate emetic risk • Aldesleukin >12-15 million IU/nr • Oactinomycin• • Melphalan (>30o/-90% frequency of emesis)b.c • Amifostine >300 mginr

• Arsenic trioxide • Azacitidine • Bendamustine • Busulfan • Carboplatin AUC <4• • Cannustine•!Q50 mginr • Clofarabine • Cyclophosphamide :S1500 mg/m' • Cytarabine >200 mginr

• Oaunorubicin° • Methotrexate• 250 mg/nr • Dual-drug liposomalencapsulation • Oxaliplatin•

of cytarabine and daunorubicin • Temozolomide • Oinutuximab • Trabectedin• • Doxorubicin• <60 mg/nr • Epirubicin°:s90 mgim' • ldarubicin •Ifosfamide" <2 g/nr per dose •Interferon alta10 millioniU/m' • lrinotecan•

Adapted with permission from: Hesketh PJ, et al. Proposalfor classifying the acute emetogenicityof cancer chemotherapy. J Clin Oncol 1997;15:103-109. Grunberg SM, Warr 0, Gralla RJ, ,et al. Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity-state of the art Support Care Cancer 2010;19:543-47.

aPotential drug interactions between antineoplastic agents/antiemetic therapies and various other drugs should atways be considered. bProportion of patients who experience emesis in the absence of effective antiemetic prophylaxis. CContinuous infusion may make an agent less emetogenic. 6rhese agents may be highly emetogenic in certain patients.

Low Emetic Risk «See AE-31 Minimal Emetic Risk « See AE-3l Oral CbtmgthtrilQ)f < Spt A f -4)

Note: Allreconvnendations are category 2A unless otherwise indicated. Clinical Trial s: NCCN beli eves that the best management of any patient with cancer isin a clinicaltrial Participation in clinical trial s is espeeially encouraged.

AE-2

LEVEL

Nat onal Comprehensive Cancer Network.,

NCCN Guidelines Version 3.2018 Antiemesis

EMETOGENIC POTENTIAL OF INTRAVENOUS ANTICANCER AGENTS•

AGENT

NCCN Giu de i nes

Index Table of Contents

Discussion

Low emetic risk (10%--30% frequency of emesis)•

• Ado-trastuzumab emtansine • Etoposide • Aldesleukin 12 million IU/m 2 • 5-Fiuorouracil (5-FU) • Amfiostine 300 mg/m 2 • Floxuridine • Atezolizumab • Gemcitabine • Belinostat · Interferon alta >5- <10 million • Blinatumomab internationalunitsfmt • Brentuximab vedotin • lrinotecan (fiposomal) • Cabazitaxel • lxabepilone • Cartilzomib • Methotrexate >50 mg/m2 - <250 mg/m2

• Cytarabine (low dose) 100-200 mg/m2 ·Mitomycin • Docetaxel • Mitoxantrone • Doxorubicin (liposomal) • Necitumumab • Eribulin • Olaratumab

• Omacetaxine • Paclitaxel • Paclitaxel-albumin • Pemetrexed • Pentostatin • Pralatrexate o Romidepsin o Talimogenelaherparepvec o Thiotepa o Topotecan o Ziv-aflibercept

Minimalemetic risk (<10% frequency of emesis)•

Adapted with permission from:

• Alemtuzumab • Avefumab ·Asparaginase • Bevacizumab ·Bleomycin • Bortezomib • Cetuximab • Cladribine • Cytarabine <100 mgJm2 • Daratumumab • Decitab ne • Denileukin diftitox • Oexrazoxane • Ourvafumab

o Elotuzumab o Fludarabine o lnterteron a pha 55 million 1Ulm2 o lpliimumab o Methotrexate 550 m g m2

o t4elarab ne o t4ivolumab o Ob nutuzumab o Ofatumumab o Panitumumab o Pegaspargase o Peg nterteron o Pembrolizumab o Pertuzumab

o Ramucirumab o Rituximab o Rituximab and

hyaluronidase human injection for SQ use

o Siltuximab o Temsirolimus o Trastuzumab o Valrubic n o Vinblastine o Vincristine o Vincristine (liposomat} o Vinorelbine

Hesketh PJ.et al. Proposal for classifying the acute emetogenicity of cancer chemothe·rapy.J Clin Oncol1997;15:103-109. Grunberg SM.Warr 0, Grana RJ,et al. Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity-state of the art.Support Care Cancer 2010;19:543-47.

High Emetic Risk fSee AE-21

apotentialdrug interactions between antineoplastic agents/antiemetic therapies and various other drugs should atways be considered. Moderate Emetic Risk « See AE-21 bProport on of patients who experience emesis in the absence of effective antiemetic prophylaxis. Ora l Ch em gth erapy r sf'f' A E-4!

Note: All recommendations are category 2A u nless oth HWise i ndicated. Cli nical Trials: NCCN believes that the best man agement of any patien t with cancer is in a clinical trial Participation i n clinical trials is especially encouraged.

AE-3

Review Date: 7/2018

Field Name Field Description

Prior Authorization Group Description ADHD Medications

Drugs Covered Uses Medically accepted indications are defined using the following

sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines.

Exclusion Criteria N/A Required Medical

Information See “other criteria”

Age Restrictions Members > 21 years old (See other Criteria) Prescriber

Restrictions N/A

Coverage Duration If the criteria are met, the request will be approved with up to a 6 month duration; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.

Other Criteria


Continuation of Therapy/Grandfathering Provision: Members with history (within the past 90 days) of a non-formulary product are not required to try a formulary agent prior to receiving the non-formulary product. Initial Authorization:

For members 21 and older:

o Appropriate diagnosis/indication for requested ADHD medication

o For use in adults for Attention Deficit Hyperactivity Disorder, the DSM-V criteria must be met: 5 symptoms are required (see attachment 1).

AND o Appropriate dose of medication based on age (i.e. elderly

populations) and indication AND o If the medication requested is for a non-preferred medication:

Documented trial and failure or intolerance with up to three preferred medications used to treat the documented diagnosis. For medications where there is only one preferred agent, only that agent must have been ineffective or not tolerated

OR o No other formulary medication has a medically accepted use

for the patient’s specific diagnosis as referenced in the medical compendia.

OR o All other formulary medications are contraindicated based on

the patient’s diagnosis, other medical conditions, or other medication therapy

OR o Member has been receiving non-preferred medication and

requires continuation of therapy with non-preferred medication

For members under 21 requesting a non-preferred ADHD medication:

o Appropriate diagnosis/indication for requested non-preferred medication

AND o Documented trial and failure or intolerance with up to three

preferred medications used to treat the documented diagnosis. For medications where there is only one preferred agent, only that agent must have been ineffective or not tolerated

AND o Appropriate dose of medication based on age (i.e. pediatric

populations) and indication

OR o No other formulary medication has a medically accepted use

for the patient’s specific diagnosis as referenced in the medical compendia.

OR o All other formulary medications are contraindicated based on

the patient’s diagnosis, other medical conditions, or other medication therapy OR

o Member has been receiving non-preferred medication and requires continuation of therapy with non-preferred medication

Re-authorization: o Appropriate dose of medication based on age (i.e. elderly

populations) and indication

Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically

necessary.

Attachment 1: DSM-V: Attention-Deficit/Hyperactivity Disorder (ADHD)


ALLERGIC CONJUNCTIVITIS AGENTS

Drugs FORMULARY STATUS Formulary, Pays at Point-of-Sale KETOTIFEN 0.025% eye drops

ALAWAY 0.025% eye drops ZADITOR 0.025% eye drops

FORMULARY STATUS Requires Step Therapy with one prior step OLOPATADINE 0.1% eye drops

PATADAY 0.2% eye drops AZELASTINE 0.05% eye drops

Note: Patient must meet criteria #1 & #2 for approval of the PA

request.

Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines.

Exclusion Criteria N/A Required Medical Information


Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration If the criteria are met, the request will be approved with up to a 12 month

duration for; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.

Other Criteria Revision/Review Date 7/2018

Initial Authorization: 1. Presumed or documented diagnosis of allergic conjunctivitis 2. Documented trial and failure or intolerance with ketotifen, Alaway

or Zaditor for a minimum of 3 weeks within past 60 days

Field Name Field Description Prior Authorization Group Desc ALPHA-1 PROTEINASE INHIBITORS (HUMAN) Drug(s) Preferred Alpha-1 Proteinase Inhibitor (s) (Human):

Prolastin-C Non-Preferred Alpha-1 Proteinase Inhibitor(s) (Human) Aralast NP Glassia Zemaira Or any other newly marketed agent

Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), and the Drug Package Insert.

Exclusion Criteria None Required Medical Information None Age Restrictions 18 years of age or older Prescriber Restrictions Prescriber must be pulmonologist

Coverage Duration The request will be approved for up to a 6 month duration; if all of the above criteria

are not met, the request is referred to a Medical Director for medical necessity review.

Other Criteria

INITIAL AUTHORIZATION: • The member is an adult (≥ 18 y/o) and has a documented diagnosis of a

congenital deficiency of alpha-1 antitrypsin (ATT) [serum level < 11uM or 80mg/dl].

• Documentation was submitted indicating the member has undergone genetic testing for ATT deficiency and is classified as phenotype PiZZ, PiSZ, PiZ(null) or Pi(null)(null) [NOTE: phenotypes PiMZ or PiMS are not candidates for treatment with Alpha1-Proteinase Inhibitors].

• Documentation was submitted (member’s pulmonary function test results) indicating airflow obstruction by spirometry [forced expiratory volume in 1 second (FEV1) in the range of 30%-65% of predicted], or provider has documented additional medical information demonstrating medical necessity

• Documentation was submitted indicating member is non-smoker or ex-smoker (eg. Smoking cessation treatment)

• Documentation of the member’s current weight • The Alpha1-Proteinase Inhibitor (human) is being prescribed at an FDA

approved dosage. If the medication request is for an Alpha1-Proteinase Inhibitor (human) product other than Prolastin®-C, the patient has a documented medical reason (intolerance, hypersensitivity, contraindication,treatment failure, etc) for not using Prolastin®-C to treat their medical condition. PA CRITERIA FOR REAUTHORIZATION: • Documentation of the member’s current weight • Documentation was submitted indicating the member has clinically benefited

from therapy (i.e. stable lung function, improved PFTs), alpha-1 antitrypsin serum level maintained above 80 mg/dL, improved quality of life).

Review Date: 2/2019

• The Alpha1-Proteinase Inhibitor (human) is being prescribed at an FDA approved dosage.

NOTE: Clinical reviewer/Medical Director must override criteria when, in his/her professional judgment, the requested item is medically necessary.

Field Name Field Description Prior Authorization Group ANDROGENIC AGENTS

Drug(s) ***If the request is for gender dysphoria, please use the gender dysphoria critera***

Formulary Status: Formulary with quantity limit Depo-Testosterone (Testosterone Cypionate) vial – QL of 4ml per 28 days Testosterone Enanthate vial – QL of 5ml per 28 days Formulary Status: Formulary, PA Required ***Preferred Products*** Axiron® (testosterone solution) (generic) Androgel 1%® (testosterone gel) (generic) Fortesta® (testosterone gel pump) (generic) *Patient must meet criteria 1 and 2

Formulary Status: Non-Formulary:

• Androgel 1.62% • Androderm • Testim • Testopel • Natesto • Striant • Aveed • Methitest • Testred • Or any newly marketed testosterone agent

*Patient must meet criteria 1-3

Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI) , and the Drug Package Insert).

Exclusion Criteria N/A Required Medical Information Prescriber must document medical reason for low testosterone, such as

Hypogonadism, copy of laboratory result required, demonstrating low testosterone. Age Restrictions None Prescriber Restrictions None

Coverage Duration If all of the conditions are met, the initial request will be approved with 3 month duration and the renewal request will be approved with a 12 month duration; if the above conditions are not met, the request will be referred to a Medical Director for medical necessity review.

Other Criteria: Review/Revision Date: 10/2018

For Initial Authorization:

1. Diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired)

2. Documented low testosterone level (s) (copy of laboratory result required)

3. Documented adequate trial and failure or intolerance with a preferred agent.

For Re-Authorization:

1. Diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).

2. Documentation that the member is benefitting from use of the medication

NOTE: Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.

Field Name Field Description Prior Authorization Group

Description ANGIOTENSIN II RECEPTOR BLOCKER AND RENIN INHIBITOR MEDICATIONS

Drugs FORMULARY STATUS: Formulary, Pays at Point-of-Sale (First Line)

• Cozaar (losartan) Tablets • Hyzaar (losartan/hydrochlorothiazide) Tablets

FORMULARY STATUS: Formulary, Requires Step Therapy (Second Line)

• Avapro (irbesartan) Tablets • Avalide (irbesartan/hydrochlorothiazide) Tablets • Benicar (olmesartan medoxomil) Tablets • Benicar HCT (olmesartan medoxomil/

hydrochlorothiazide) Tablets • Diovan (valsartan) Tablets • Diovan-HCT (valsartan/hydrochlorothiazide) Tablets • Exforge (amlodipine besylate/valsartan) Tablets • Micardis (telmisartan) Tablets

NOTE: Patient must meet criteria #1 for approval of

initial PA request. FORMULARY STATUS: Non-Formulary, Requires Prior Authorization (Third Line)

• Atacand (candesartan cilexetil) Tablets • Atacand HCT(candesartan cilexetil/

hydrochlorothiazide) Tablets • Azor (amlodipine besylate/olmesartan medoxomil)

Tablets • Edarbi (azilsartan) Tablets • Edarbyclor (azilsartan/hydrochlorothiazide) Tablets • Exforge HCT

(amlodipine/valsartan/hydrochlorothiazide) Tablets • Micardis-HCT (telmisartan/hydrochlorothiazide)

Tablets • Teveten (eprosartan mesylate) Tablets • Tribenzor (olmesartan

medoxomil/amlodipine/hydrochlorothiazide) Tablets: • Twynsta (telmisartan/amlodipine) Tablets • Tekturna (aliskiren hemifumarate) Tablets • Tekturna HCT (aliskiren/hydrochlorothiazide)

Tablets

NOTE: Patient must meet criteria #1 & #2 for approval of initial PA request.



Information


Age Restrictions N/A Prescriber Restrictions N/A


Other Criteria


PA CRITERIA FOR APPROVAL:

1. Documented adequate trial and failure or intolerance with a first line agent of at least 15 days of therapy within the previous 90 days.

2. Documented adequate trial and failure or intolerance with a second line agent of at least 15 days of therapy within the previous 90 days. .

Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested

item is medically necessary.


ANTIDIABETIC AGENTS

Drugs FORMULARY STATUS Formulary, Pays at Point-of-Sale (First Line) METFORMIN tablets

INSULIN – ADMELOG, BASAGLAR vial and syringe

FORMULARY STATUS Requires Step Therapy (Second Line) TRULICITY

VICTOZA

Note: Patient must meet criteria #1 and #2 for approval of the PA request.

FORMULARY STATUS Requires Step Therapy with two prior steps

ALOGLIPTIN ALOGLIPTIN/METFORMIN

ALOGLIPTIN/PIOGLITAZONE JANUVIA

JANUVIA XR JANUMET

JANUMET XR

Note: Patient must meet criteria #1, #2 or #3 for approval of the PA request.

FORMULARY STATUS Non-Formulary, Requires Prior Authorization ALL ROSIGLITAZONE PRODUCTS

ALL ONGLYZA (saxagliptin) SINGLE AND COMBINATION PRODUCTS

OZEMPIC (semaglutide) OR ADLYXIN (lixisenatide)

Note: Patient must meet criteria #1, 2, or 3 & #4 for approval of the PA request.




Age Restrictions N/A

Prescriber Restrictions N/A Coverage Duration If the criteria are met, the request will be approved with up to a 12 month



Initial Authorization: 1. Diagnosis of diabetes mellitus, type II. 2. Documented trial and failure or intolerance with metformin for a

minimum of three weeks of therapy within the previous 60 days 3. Documented trial and failure or intolerance with an insulin product

for a minimum of three weeks of therapy within the previous 60 days

4. Documented trial and failure or intolerance with a second line agent for at least three weeks of therapy


Agents for Atopic Dermatitis

Drugs Eucrisa® (crisaborole), Protopic® (tacrolimus), Elidel® (pimecrolimus) Dupixent®(dupilumab)




Age Restrictions N/A Prescriber

Restrictions Provider must be a pediatrician or dermatologist


Other Criteria


Initial Authorization For Elidel®: o Diagnosis of mild to moderate atopic dermatitis in non-

immunocompromised patient in whom the use of other topical prescription treatments is not advisable or in patients who have failed to respond adequately or are intolerant to formulary topical corticosteroids.

For Protopic®: o Diagnosis of moderate to severe atopic dermatitis in non-

immunocompromised patients in whom the use of other topical prescription treatments is not advisable or in patients who have failed to respond adequately or are intolerant to formulary topical corticosteroids.

For Eucrisa®: o Diagnosis of mild to moderate atopic dermatitis

AND o Trial and failure of a formulary topical corticosteroid

AND o Trial and failure of Protopic® or Elidel®

For Dupixent®: o Diagnosis of moderate to severe atopic dermatitis

AND o For moderate atopic dermatitis: Trial and failure of a fomulary

topical corticosteroid AND trial and failure of Protopic or Elidel AND trial and failure of Eucrisa OR

o For severe atopic dermatitis: Trial and failure of a formulary topical corticosteroid AND Protopic

Medical Director/clinical reviewer must override criteria when, in



Prior Authorization Group Description Topical Antiviral Treatment Prior Authorization Criteria

Drugs FORMULARY STATUS: Formulary, pays at the point of sale • Abreva® (docosanol)

FORMULARY STATUS: Non-Formulary, Prior Authorization Required

• Denavir® (penciclovir) • Xerese® (acyclovir/hydrocortisone) • Zovirax® (acyclovir) cream/ointment • or any newly marketed topical antiviral agent

Covered Uses Medically accepted indications are defined using the following sources:





Restrictions N/A


Other Criteria


Initial Authorization For the treatment of herpes labialis (cold sores): • Documented trial and failure or intolerance to a preferred oral

antiviral, such as acyclovir or valcyclovir tablet. OR For the treatment of venereal herpes: • Documented trial and failure or intolerance to a preferred oral

antiviral, such as acyclovir or valcyclovir tablet.


necessary.


BANZEL

Drugs FORMULARY STATUS Formulary, Pays at Point-of-Sale (First Line) LAMOTRIGINE

CARBAMAZEPINE GABAPENTIN

LEVETIRACETAM

FORMULARY STATUS Requires Step Therapy with one prior step (Second Line)

BANZEL TABLETS BANZEL ORAL SUSPENSION


request.







1. Presumed or documented diagnosis of epilepsy or seizure disorder, as evident by provision of one of the following ICD-10 codes: (G40.811, G40.812, G40.813, G40.814)

2. Documented trial and failure or intolerance with a formulary anticonvulsant for a minimum of 3 weeks within past 60 days

3. Members with history of Banzel in the previous 90 days are not required to try a first line agent and will be approved.


Prior Authorization Group Description

Botulinum Toxins A&B

Drugs OnabotulinumtoxinA (Botox®), IncobotulinumtoxinA (Xeomin®), AbobotulinumtoxinA (Dysport™), RimabotulinumtoxinB (Myobloc®), or any newly marketed agent



Information N/A


Prescriber Restrictions None Coverage Duration If all of the conditions are met, the request will be approved for 12

month duration. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria **The use of these medications for cosmetic purposes is NOT a covered benefit under the Medical Assistance program.**

For Approval:

• Xeomin and Dysport are the preferred products for their

respective FDA approved indications

• The request is for a FDA approved indication and dose or is supported by compendia or standard of care guidelines

• Documentation was submitted, that the patient had an adequate trial (consistent with pharmacy claims) of standard first line therapy for their disease state and/or has a documented medical reason (intolerance, hypersensitivity, contraindication, etc) for not taking first line therapy to treat their medical condition.

• If the diagnosis is Chronic Migraines (≥15 days per month with headache lasting 4 hours a day or longer), the patient has a documented adequate trial (consistent with pharmacy claims data) of beta blockers (e.g. propranolol), Depakote, and topiramate, or a medical reason was submitted (intolerance, hypersensitivity, contraindication, etc) why patient is not able to utilize these therapies .

• If the diagnosis is Overactive Bladder, the patient has a

1

documented adequate trial (consistent with pharmacy claims data) of at least 2 formulary medications (e.g. oxybutynin)


Physician/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.

2


Brand Name Medication Criteria

Covered Uses All medically accepted indications. Medically accepted indications are defined using the following compendia resources: the Food and Drug Administration (FDA) approved indication(s) (Drug Package Insert), American Hospital Formulary Service Drug Information (AHFS-DI), and DRUGDEX Information System. The reviewer may also reference disease state specific standard of care guidelines.

Scope Requests for Brand Name medications when an equivalent generic product is on the plan’s formulary ***Narrow Therapeutic Index drugs do not require a prior authorization review and will pay at the point of sale***

Criteria • The provider either verbally or in writing has submitted a medical or member specific reason why the brand name drug is required based on the member’s condition or treatment history.

AND • The provider has completed and submitted an FDA MedWatch

form to justify the member’s need to avoid a generic product. The new MedWatch form, or a previously submitted MedWatch form must also be included with the prior authorization request. (Not applicable for ACLA)

Form FDA 3500 - Voluntary Reporting

Medical Director/clinical reviewer may override criteria when, in his/her professional judgement, the requested item is medically necessary.

Coverage Duration 12 months Revision/Review Date

10/2018

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf


Description Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonists

Drugs Preferred Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist: Emgality Non-Preferred Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist(s): Aimovig (erenumab) Ajovy (fremanezumab) and any newly marketed drug in the class


Exclusion Criteria Request for indication of cluster headaches Required Medical


Age Restrictions According to package insert Prescriber Restrictions Prescribed or in consultation with a neurologist or a headache specialist

Coverage Duration If the criteria are met, the initial authorization request will be approved for 3 months. Reauthorization may be approved for 6 months.

Other Criteria


Criteria for Initial Authorization for Migraine Headache Prophylaxis: Diagnosis of migraine headache. Patient must have at least 4

migraine days per month or one or more severe migraines lasting for greater than 12 hours despite use of abortive therapy (e.g. triptan or NSAIDs) AND

Documented trial and failure (or a medical justification for not using e.g. hypersensitivity, baseline bradycardia or hypotension, adverse events experienced from previous trial, etc.) with at least one drug from two categories below for at least 4 weeks EACH, at minimum effective doses: 1. Beta-adrenergic blockers 2. Topiramate or divalproex ER or DR 3. Amitriptyline or venlafaxine 4. Frovatriptan, zolmitriptan or naratriptan (for menstrual migraine

prophylaxis) AND

• If the medication request is for a Calcitonin Gene-Related Peptide Receptor Antagonist other than Emgality, the patient has a documented medical reason (intolerance, hypersensitivity, contraindication, treatment failure etc) for using Emgality to treat their medical condition.

Criteria for Re-Authorization: Documentation supporting re-evaluation of patient and one of the following:

• A reduction in the average number of headache days per month by at least 1 day from baseline.

• A reduction in severity or duration of migraines from baseline. If the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review. Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.


CHRONIC DRY EYE AGENTS

Drugs FORMULARY STATUS Formulary, Pays at Point-of-Sale ARTIFICIAL TEARS (Glycerin-Peg) 1 %-0.3 % Eye Drops

POLYVINYL ALCOHOL 1.4 % eye drops ISOPTO TEARS 0.5 % Eye Drops

REFRESH TEARS 0.5 % Eye Drops

FORMULARY STATUS Requires Step Therapy with one prior step XIIDRA 5% EYE DROPS

RESTASIS 0.05% EYE DROPS

Note: Patient must meet criteria #1 & #2 for approval of the PA request.







Initial Authorization: 1. Presumed or documented diagnosis of chronic dry eye 2. Documented trial and failure or intolerance with a formulary

artificial tears product for a minimum of 3 weeks within past 60 days


Cholbam™

Drugs Cholbam™ (cholic acid)


Exclusion Criteria N/A




Prescriber Restrictions MD is a gastroenterologist OR hepatologist

Coverage Duration If all of the conditions are met, the request will be approved for a 3 month duration for the first year of therapy, and then for a 6 month duration after one year of treatment. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria

Initial authorization: • Patient has a confirmed diagnosis of:

Bile acid synthesis disorder due to single enzyme defect (SEDs) OR

peroxisomal disorders (PDs) including Zellweger spectrum disorders in patients that exhibit manifestations of liver disease, steatorrhea or complications from decreased fat soluble vitamin absorption

• Current labs (within 30 days of request) have been submitted for the following:

ALT/AST GGT (serum gamma glutamyltransferase) ALP (Alkaline phosphatase) Bilirubin INR

Re-authorization:

• Documentation has been submitted indicating clinical benefit/ liver function has improved since beginning treatment*

• For reauthorization after the first 3 months of treatment, lab results must show an improvement in liver function and there must be no evidence of biliary obstruction or cholestasis

• Current labs (within 30 days of request) have been submitted for the

following: ALT/AST GGT (serum gamma glutamyltransferase) ALP (Alkaline phosphatase) Bilirubin INR


Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.

Prior Authorization Group Description Ciprodex

Drugs Ciprodex® (0.3% ciprofloxacin, 0.1% dexamethasone) Otic Suspension: 7.5mL

Covered Uses

Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines.


Information See “Other Criteria”


Restrictions N/A

Coverage Duration

If criteria are met, the request will be approved for up to a 3 month duration. If the below conditions are not met, the request will be referred to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria


Acute otitis externa: • Documented trial and failure, contraindication, or intolerance to two of the following: ofloxacin otic, Acetic acid 2% ear solution, or neomycin/polymixin B/hydrocortisone otic drops. OR • Prescribing provider is an ear, eye, nose and throat (EENT) physician Acute otitis media in patients with tympanostomy tubes: • Documented trial and failure, contraindication, or intolerance to ofloxacin otic drops AND • Approvable for a diagnosis of acute otitis media with tympanostomy tubes OR • Prescribing provider is an ear, eye, nose and throat (EENT) physician

NOTE: Medical Director/Clinical Reviewer must override criteria when, in his/her professional judgment, the

requested item is medically necessary

Field Name Field Description Prior Authorization Group Description Crinone®

Drugs Crinone® (micronized progesterone) Covered Uses Medically accepted indications are defined using the following


Exclusion Criteria Diagnosis or treatment of infertility




Coverage Duration If the criterion is met, the request will be approved for 30 single use applicators per 30 days until the end of pregnancy if the diagnosis is the prevention of spontaneous preterm delivery (singleton pregnancy and no prior preterm birth; short cervix), or for up to 6 single dose applicators if the diagnosis is secondary amenorrhea;. If the criterion is not met, the request will be referred to a Clinician for medical necessity review.

Other Criteria


Initial Authorization:

• Documented ultrasound of transvaginal cervical length (TVCL<20mm if less than 24 weeks of gestation OR therapy may begin at 16 to 24 weeks (regardless of cervical length.

• Patient has a diagnosis of short cervix (i.e. singleton pregnancy with no prior preterm birth for the prevention of spontaneous preterm delivery)

OR

• Patient has diagnosis of secondary amenorrhea • Patient has tried and failed or has a documented medical

allergy/intolerance to oral progestin therapy (e.g. medroxyprogesterone acetate or norethindrone acetate tablets)


necessary.


Danocrine® (danazol)

Drugs danazol (Danocrine) capsules


Exclusion Criteria Pregnancy- see “other criteria” Required Medical


Age Restrictions N/A Prescriber Restrictions See “other criteria”

Coverage Duration If the criteria are met, the request will be approved with a 6 month duration for generic medication; if the criteria are not met, the request will be referred to a Medical Director for medical necessity review.

Other Criteria

Revision/Review Date

10/2018

ENDOMETRIOSIS • Diagnosis of endometriosis

AND • Documented trial and failure, intolerance or documented

medical reason for not using first line therapy of oral contraceptive therapy.

AND • Prescribing physician is a gynecologist. • AND • Negative pregnancy test

FIBROCYSTIC BREAST PAIN DISEASE • Diagnosis of fibrocystic breast disease.

AND • Documented trial and failure, intolerance or documented

medical reason for not using first line therapy of analgesics including acetaminophen and NSAIDs.

AND • Prescribing physician is a gynecologist. • AND • Negative pregnancy test

HEREDITARY ANGIOEDEMA:

• Diagnosis of hereditary angioedema. • AND • Negative pregnancy test



DDAV ® P

Drugs DDAVP® (desmopressin) Tablets & Nasal Spray/Nasal Solution (Rhinal Tube) Covered Uses Medically accepted indications are defined using the following sources: the

Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines.




Coverage Duration If the conditions are met, the request will be approved with a 12 month duration. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria Revision/Review 01/2018

Tablets

• Diagnosis of primary nocturnal enuresis in children 5 years of age and older.

OR • Diagnosis of central cranial (neurogenic) diabetes insipidus.

Note: Tablet formulation will process at the point-of-sale for members > 6 years old.

Nasal Spray and Rhinal Tube (nasal solution):

• Diagnosis of central cranial (neurogenic) diabetes insipidus.



Diclegis®

Drugs Diclegis® (doxylamine/pyridoxine HCL)





Age Restrictions According to package insert

Prescriber Restrictions Prescriber must be an obstetrician/gynecologist

Coverage Duration If the above conditions are met, the request will be approved for up to 6 (six) months. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria


Initial authorization: • The indicated diagnosis of nausea and vomiting due to

pregnancy. AND • The member has had an adequate trial and failure with one

(1) of the following agents o Ondansetron, pyridoxine(vitamin B6), metoclopramide




Dificid® (fidaxomicin)

Drugs Dificid® (fidaxomicin)

Covered Uses

Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of

Exclusion Criteria Requests for therapy to treat an initial Clostridium difficile infection


Diagnosis of Clostridium difficile infection. Patient must have documented trial and failure or intolerance/contraindication with oral vancomycin for manage Clostridium difficile infection


Prescriber Restrictions N/A

Coverage Duration If the criteria are met, the request will be approved for up to 10-day duration.

Other Criteria


If the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.



DONEPEZIL

Drugs FORMULARY STATUS Formulary, Pays at Point-of-Sale DONEPEZIL TABLETS AND DISINTEGRATING TABLETS 5MG

AND 10MG

FORMULARY STATUS Requires Step Therapy with one prior step DONEPEZIL 23MG TABLET


request.




Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration If the criteria are met, the request will be approved with up to 12 month



Initial Authorization: 1. Presumed or documented diagnosis of dementia or Alzheimer

disease 2. Documented trial and failure or intolerance with donepezil

disintegrating or non-disintegrating 5 or 10mg tablet for a minimum of 3 weeks within past 60 days




Emflaza

Drugs Emflaza (deflazacort) Covered Uses Medically accepted indications are defined using the following


Exclusion Criteria Required Medical


Age Restrictions Patient must be 5 years of age or older

Prescriber Restrictions Prescriber must be a neurologist Coverage Duration If all of the conditions are met, the approval will be for a 6 month

duration. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria

For Approval: • Confirmed diagnosis of Duchenne Muscular Dystrophy

(documented mutation of dystrophin gene genetic sequencing indicating mutations attributed to Duchene Muscular Dystrophy, OR muscle biopsy indicating absence of dystrophin protein), and copies of testing were submitted with request

• Patient has onset of weakness before 5 years of age • Patient has had a baseline eye examination • Patient has had a baseline bone mineral density (BMD)

screening completed • Patient is or will be taking adequate calcium and vitamin D

supplementation if dietary intake is less than recommended for age according to Institute of Medicine Guidelines

• If patient has been previously established on deflazacort before available in the U.S., provider has submitted detailed chart notes including dates of therapy and response

• Patient has trial and failure with prednisone or prednisolone for at least 6 months, or have a contraindication or intolerance to prednisone/prednisolone (e.g. significant weight gain or behavioral changes)

• The request is for an FDA approved dose Reauthorization:

• Physician attests that the patient is receiving clinical benefit since starting treatment

• Patient’s claim history shows consistent therapy (monthly fills)


• Physician attests patient has had repeat eye and BMD screenings as appropriate

• The request is for an FDA approved dose

Physician/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.



Eosinophilic Asthma Agents

Drugs Nucala (mepolizumab), Fasenra (Benralizumab), Cinqair (Reslizumab), Dupixent (dupilumab) or any newly marketed agents


Exclusion Criteria When being used for relief of acute bronchospasm or status asthmaticus, or for the treatment of other eosinophilic conditions. When used in combination with another monoclonal antibody for the treatment of asthma



Age Restrictions Dupixent, Fasenra, Nucala: Member must be 12 years of age or older Cinqair: Member must be 18 years of age or older

Prescriber Restrictions Prescriber must be an allergist or pulmonologist Coverage Duration If the above conditions are met, the initial request will be approved with a 3

month duration. All subsequent requests will be approved with a 6 month duration. If the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.

Other Criteria


Initial Authorization: 1. Confirmed diagnosis of eosinophilic asthma 2. Drug is appropriate for member (e.g. age) as indicated in package

insert or clinical care guidelines. 3. For Nucala, Fasenra, or Cinqair: Documentation has been provided

(within the last year of request) with of an eosinophil count ≥ 300 cells/mcL or member has eosinophils in treatment range per package insert if level was taken less than 1 year of request.

4. The patient has a documented baseline FEV1 < 80% of predicted with evidence of reversibility by bronchodilator response.

5. Documentation has been provided indicating patient still is having symptoms or ≥ 2 exacerbations in the previous 12 months requiring additional medical treatment, (e.g. oral systemic steroids, emergency room visits, hospital admissions) while compliant on a high-dose inhaled corticosteroid with a long-acting B2 agonist ± a leukotriene receptor antagonist OR theophylline. If the patient has not utilized these therapies, a documented medical reason must be provided why patient is unable to do so.

6. The prescribed dose is within FDA approved dosing guidelines Re-Authorization:

1. Documentation submitted indicates the member has clinically benefited from the medication (FEV1, reduced exacerbations, etc.)

2. The prescribed dose is within FDA approved dosing guidelines Medical Director/clinical reviewer must override criteria when, in his/her

professional judgement, the requested item is medically necessary.

Field Name Field Description Prior Authorization Group Description Entocort EC®

Drugs Entocort EC® (budesonide) Covered Uses Medically accepted indications are defined using the following





Age Restrictions N/A Prescriber Restrictions Gastroenterologist

Coverage Duration If the criteria are met, the request will be approved for up to a 6 month duration; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.

Other Criteria



• Diagnosis of mild to moderate active or remissive Crohn’s disease involving the ileum and/or the ascending colon.

AND

• Documented trial and failure with 16 weeks of therapy at therapeutic doses of at least one first- line therapies of sulfasalazine, or prednisone.

Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item

is medically necessary.

Prior Authorization Group Description Erythropoiesis-Stimulating Agents (ESAs)

Drugs

Procrit (epoetin alfa): non-formulary Epogen (epoetin alfa): non-formulary Retacrit (epoetin alfa-epbx): non-formulary (Preferred) Aranesp (darbepoetin alfa-polysorbate 80): non-formulary Mircera (methoxy peg-epoetin beta): non-formulary

Covered Uses





Coverage Duration If criteria are met, the request will be approved for up to 1 month if the member is deficient in iron, vitamin B12 or folate, and up to 3 months for all other requests.

Other Criteria


Criteria for authorization of existing ESA users who are NEW to the plan: • Documentation of current dose • Documented (submitted lab result dated within 30 days of request) hemoglobin <12

g/dL

Criteria for approval of ALL NEW REQUESTS: • The following lab results (drawn within 30 days of the request date) must be submitted:

o Hemoglobin, hematocrit, serum ferritin level (normal is greater than 100ng/ml), transferrin saturation (TSAT) (normal is greater than 20%), vitamin B12 level, folate level, and erythropoietin level (for HIV-related anemia)

• For any request that indicates a member has low levels of vitamin B12, folate, or iron, the member MUST be receiving appropriate supplementation or the member is beginning therapy to correct deficiency.

• The medication is being prescribed at an FDA appropriate dose as indicated in compendia or standard of care guidelines.

• If the request is for ribavirin-induced anemia then the member MUST currently be receiving ribavirin therapy and documentation submitted indicates a dosage reduction of ribavirin was attempted but the member remains anemic.

• Retacrit is the preferred ESA. For requests for all other ESAs, documentation must be provided as to why Retacrit is not medically appropriate for the member.

Additional Requirements: New requests for anemia of chronic kidney disease: • Hemoglobin less than 10 g/dl for treatment naïve members OR if the member is new to

the health plan and was receiving therapy previously, the member has a documented (submitted lab result dated within 30 days of request) hemoglobin <12 g/dL.

New requests for anemia related to chemotherapy in cancer patients: • Member must have a documented cancer diagnosis for which they are receiving

myelosuppressive therapy for palliative treatment (members receiving myelosuppressive therapy with curative intent should not receive ESAs) AND documented symptomatic anemia with Hb <11 g/dl or > 2 g/dl below baseline

• OR Member must have symptomatic anemia related to myelodysplastic syndrome AND documented serum erythropoietin level < 500 mU/ml

New requests for anemia related to myelofibrosis: • Member must have documented diagnosis of non-transfusion-dependent, myelofibrosis-

associated anemia AND documented serum erythropoietin level < 500 mU/mL despite treatment of coexisting causes (e.g. bleeding; iron, B12 or folate deficiency; hemolysis).

New requests for zidovudine-related anemia: • If the request is for anemia due to zidovudine-treatment in members with HIV then the

member MUST currently be receiving highly active antiretroviral therapy (HAART) • Documentation has been submitted that the member has an erythropoietin level < 500

mU/mL (lab dated within 30 days prior to request date). • Documentation of current weight. Epoetin dose must not exceed 300 U/kg/dose.

New requests for members undergoing surgery to reduce the need for allogenic blood transfusion: • Perioperative hemoglobin must be less than 13g/dl and greater than 10g/dl. • The member must have normal iron stores or will be receiving adequate iron

supplementation. • The member is scheduled for an elective, non-cardiac, nonvascular surgery.

Reauthorization: • Repeat labs are required since the previous authorization • If hemoglobin is ≥ 12 g/dL, the request will be denied. • If the member has been receiving therapy and hemoglobin is less than 12 g/dL the

following should apply (as applicable): o The ordered dose has been reduced by 25% of previous dose if the rate of Hb

increase was greater than 1g/dL over a two week period o The ordered dose has been increased from the previous dose if the member’s

Hb improved less than 1g/dL over a 4 to 6 week period and iron stores were adequate.

o An increase in dose by 25% has not occurred more than once per month • For ribavirin-induced anemia: the member is currently receiving ribavirin therapy.

If the request is for anything other than Retacrit, documentation must be provided as to why Retacrit is not medically appropriate for the member For requests that fall outside of these parameters, or if the criteria are not met, the request will be referred to a Medical Director/clinical reviewer for medical necessity review.


Exondys 51

Drugs Exondys 51 (eteplirsen) Covered Uses Medically accepted indications are defined using the following




Age Restrictions Patient must be a male

Prescriber Restrictions Prescriber must be a neurologist. Coverage Duration If all of the conditions are met, the request will be approved for a 6

month duration. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria


For Approval: • Member has confirmed diagnosis of Duchenne Muscular

Dystroph y (DMD) and lab test was submitted confirming the mutation of dystrophin gene amenable to exon 51 skipping

• Documentation is provided that patient is on a stable dose of corticosteroids unless contraindicated

• A baseline standardized assessment of motor function by a neurologist with experience treating Duchenne Muscular Dystroph y


• Based on the prescriber’s assessment the member continues to have clinical benefit from Exondys 51 .

• The request is for an FDA approved dose Physician/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessar y.

396 Revised April 2014


Daraprim®

Drugs Daraprim® (pyrimethamine)


Exclusion Criteria Patients with documented megaloblastic anemia due to folate deficiency.


• If diagnosis is toxoplasmosis, and request is for PRIMARY PROPHYLAXIS, a medical reason was provided as to why patient is not able to use trimethoprim-sulfamethoxazole

• If diagnosis is toxoplasmosis, request is for TREATMENT and will be used in combination with a sulfonamide. If patients are allergic to sulfa, densitization should be attempted or another preferred regimen can be used

• If request is for CHRONIC MAINTENANCE treatment of toxoplasmosis, and patient was NOT TREATED with a pyrimethamine regimen, a medical reason was provided why patient is not able to continue with alternative regimen for maintenance

• If diagnosis is TREATMENT OF isosporiasis in an HIV patient, a medical reason was provided why patient is not able to use trimethoprim-sulfamethoxazole to manage their condition

• If diagnosis is TREATMENT OF pneumocystis pneumonia in an HIV patient, documentation was submitted with a medical reason for not utilizing trimethoprim-sulfamethoxazole or dapsone to manage their condition

• If diagnosis is prophylaxis of malaria-documentation was submitted with a medical reason as to why patient is not able to use all other first line malaria agents, as resistance to pyrimethamine is prevalent worldwide, and it is not suitable as a prophylactic agent for travelers to most areas.


Prescriber Restrictions Prescriber must be an appropriate specialist or documentation has been provided that prescriber has consulted with an appropriate specialist (i.e. infectious disease, OB/GYN)

Coverage Duration If all of the conditions are met, PRIMARY PROPHYLAXIS requests will be approved for 3 months, TREATMENT requests will be approved for 6 weeks, and CHRONIC MAINTANENCE requests will be approved for 3 months at a time.. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria


N/A




Endari

Drugs Endari (L-Glutamine) Covered Uses Medically accepted indications are defined using the following



Information “see other criteria”


Prescriber Restrictions Prescriber must be a hematologist Coverage Duration If all of the conditions are met, requests will be approved for a 12

months. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria


Initial: • Member has diagnosis of sickle cell • Documentation was provided that the patient had 2 or more

crises in the last 12 months • Documentation was provided the member has been on

hydroxyurea at the maximum tolerated dose and was compliant within the last 6 months (or a medical reason was provided why patient is unable to use hydroxyurea)

• Request is for an FDA approved dose Reauthorization:

• Prescriber attests member had reduction in number of sickle cell crises

• Request is for an FDA approved dose Physician/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.


Agents to Treat Gaucher’s Disease

Drugs Cerdelga® (Eliglustat Tartrate), Cerezyme ® (Imiglucerase), Vpriv®

(velaglucerase alfa), Elelyso® (taliglucerase alfa), Zavesca® (miglustat) Covered Uses Medically accepted indications are defined using the following sources:

the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), and the Drug Package Insert (PPI).

Exclusion Criteria None Required Medical


Age Restrictions See “Other Criteria” Prescriber

Restrictions MD is a specialist in treatment of Gaucher’s Disease (hematologist or geneticist), or is in consultation with a specialist including endocrinologists, hematologists, and geneticists.

Coverage Duration If all of the conditions are met, the request will be approved with 6- month duration. If all of the criteria are not met, the request is referred to a clinical reviewer for medical necessity review.

Other Criteria Initial Authorization: Cerezyme®, Vpriv®, or Elelyso® initial authorization:

• Patient has a confirmed diagnosis of Gaucher’s disease, type 1 (GD1)

• Request is for an FDA approved dose Zavesca® initial authorization:

• Patient has a confirmed diagnosis of Gaucher’s disease, type 1 (GD1)

• Documentation has been provided with medical reason why patient is unable to use Cerezyme®, Vpriv®, or Elelyso® to manage their medical condition

• Request is for an FDA approved dose Cerdelga® initial authorization:

• Patient is 18 years of age or older. • Patient has a confirmed diagnosis of Gaucher’s disease, type

1 (GD1) and is a CYP2D6 extensive metabolizer (EM), intermediate metabolizer (IM) or poor metabolizer (PM), as detected by an FDA-approved test.

• Patient is not concomitantly taking a moderate or strong CYP3A inhibitor (e.g. ketoconazole, fluconazole) or a Class IA or Class III antiarrhythmic.

• Patient has no pre-existing cardiac disease or long QT syndrome.

• The patient has a documented (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) adequate trial (including dates and doses) of Cerezyme®, Vpriv®, or Zavesca®, or has a documented medical reason for not utilizing these therapies to manage their condition.

Re-Authorization criteria for all agents:

• Documentation has been provided that patient has obtained clinical benefit from medication (e.g. increased platelet count, improvement in anemia, PFT’s, improvement in radiographic scans, improved quality of life,)

• Request is for an FDA approved dose Revision/Review

Date 4/2018


necessary.


FARESTON

Drugs FORMULARY STATUS Formulary, Pays at Point-of-Sale TAMOXIFEN TABLETS 10MG AND 20MG

FORMULARY STATUS Requires Step Therapy with one prior step FARESTON 60MG TABLET


request.







Initial Authorization: 1. Presumed or documented diagnosis of metastatic breast cancer in

postmenopausal female patient 2. Documented trial and failure or intolerance with tamofixen 10 or

20mg tablet for a minimum of 3 weeks within past 60 days


Description GONADOTROPIN RELEASING HORMONE AGONISTS (GNRH)**IF DIAGNOSIS IS GENDER DYSPHORIA, USE GENDER DYSPHORIA CRITERIA**

Drug(s) Preferred GNRH Agonists for their respective indications: Zoladex (goserelin acetate), Lupron Depot (leuprolide acetate), Lupron Depot-Ped (leuprolide acetate) Non- Preferred GNRH Agonists: Supprelin LA (histrelin acetate), Vantas (histrelin acetate), Leuprolide acetate (Lupron), Eligard (leuprolide acetate), Synarel (nafarelin acetate), Trelstar (triptorelin pamoate), Triptodur (triptorelin pamoate), Lupaneta Pack (leuprolide acetate/norethindrone acetate), and any newly marketed GnRH agonist.

Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), and/or per the National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology (ASCO), the American College of Obstetricians and Gynecologists (ACOG), or the American Academy of Pediatrics (AAP) standard of care guidelines.

Exclusion Criteria N/A Required Medical Information See “Other Criteria”

Age Restrictions According to package insert if not detailed in “Other Criteria” Prescriber Restrictions See “Other Criteria”

Coverage Duration If all of the conditions are met, the request will be approved for up to 12 months if

diagnosis is cancer or central precocious puberty, and up to 3-6 months as indicated below for other indications as recommended per FDA approved indications and/or as defined by the medical compendium or standard of care guidelines. If the conditions are not met, the request will be sent to a Medical Director/Clinical Reviewer for medical necessity review.

Other Criteria

INITIAL AUTHORIZATION for ALL REQUESTS: • The medication is being requested by a specialist in the field to treat the

member’s condition. • The medication is being prescribed for an FDA approved/ standard of care

guideline indication and within FDA approved/standard of care dosing guidelines.

AND the member meets the following for the respective diagnosis: Central precocious puberty (CPP) • Onset of secondary sexual characteristics occurred when member was aged less

than 8 years for females or aged less than 9 years for males • Diagnosis is confirmed by a pubertal response to a GnRH stimulation test and/or

measurement of gonadotropins (FSH/LH), and bone age advanced beyond chronological age.

If basal levels of LH are markedly elevated [e.g. more than 0.3mlU/ml (where IU- International units)] in a child with precocious puberty, then a diagnosis of Gonadotropin Dependent Precocious Puberty (GDPP) can be made without proceeding to a GnRH stimulation test. Patients with low or intermediate basal levels of LH should have a GnRH stimulation test to clarify the diagnosis.

• Brain magnetic resonance imaging (MRI) has been performed for all boys with CPP and for girls with onset of secondary sexual characteristics before the age of six years of age to rule out a tumor.

• If the request is for any agent other than Lupron Depot-Ped the member has had a documented trial and failure with Lupron Depot-Ped or a documented medical reason (e.g. intolerance, hypersensitivity, contraindication) was submitted why the member is not able to use Lupron Depot-Ped

Endometriosis • Member is ≥ 18 years of age with a confirmed diagnosis (e.g.

laparoscopy, etc.) • Documentation has been provided that patient has had an adequate trial

and failure with conservative treatment (e.g. nonsteroidal anti-inflammatory drugs (NSAIDs), oral contraceptives) or a medical reason was provided why member is unable to use these therapies (e.g. contraindication, intolerance, hypersensitivity)

• Documentation has been provided that patient has had an adequate trial and failure with Orilissa (elagolix), or a medical reason was provided why the member is unable to use this therapy (e.g. contraindication, intolerance, hypersensitivity)

• Approval is 6 months Uterine leiomyomas (Fibroids) • Member is ≥ 18 years of age and is anemic due to vaginal bleeding from

fibroids (hemoglobin < 10.2 g/dl or hematocrit <30%), and patient has had a trial of at least one month with oral iron (e.g. iron sulfate), or a medical reason (e.g. contraindication, hypersensitivity, intolerance) was provided why patient is not able to use iron to treat the anemia OR

• The patient requires the medication to decrease uterine volume as a result of uterine fibroids to manage symptoms (e.g. pelvic pressure, urinary frequency or urgency, cramping, constipation, etc.) for shrinkage of size to allow surgical intervention. • If the request is for any agent other than Lupron Depot the member

has had a documented trial and failure with Lupron Depot or a documented medical reason (e.g. intolerance, hypersensitivity,

contraindication) was submitted why the member is not able to use Lupron Depot

• Approval is 3 months Endometrial thinning • Documentation indicates patient is scheduled for endometrial ablation for

dysfunctional uterine bleeding. • If the request is for any agent other than Zoladex the member has had

a documented trial and failure with Zoladex or a documented medical reason (e.g. intolerance, hypersensitivity, contraindication) submitted why the member is not able to use Zoladex

• Approval is 3 months REAUTHORIZATION for all requests: • The medication is being requested by a specialist in the field to treat the

member’s condition. • The medication is being prescribed for an FDA approved/ standard of care

guideline indication and within FDA approved/standard of care dosing guidelines.

• • Documentation was provided supporting continued treatment (e.g. patient

still has symptoms), and medication is being continued as recommended in package insert or standard of care guidelines.

AND meets the following per diagnosis: Central precocious puberty (CPP) • If the medication reauthorization is for central precocious puberty, the

child is male and < 12 years or female and < 11 years of age OR a documented medical reason to continue treatment was provided with request, and includes current height and bone age

Endometriosis • MD has evaluated patient for osteoporosis (e.g. Dexascan), and patient is

receiving “add back” hormonal therapy (norethindrone acetate 5 mg daily or conjugated estrogen therapy) or an oral bisphosphonate AND calcium and vitamin D supplementation.

• The patient has not received cumulative doses of the GnRH agonist greater than 12 months of therapy.

Fibroids • The patient has not received cumulative doses of the GnRH agonist

greater than 6 months of therapy, and documentation that the drug is being used prior to surgery.

Review Date 2/2019

NOTE: Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.


Gender Dysphoria Medications if Prior Authorization is required

Drugs Formulary anti-androgens, progestins, GnRH agonists, estrogens, testosterone medications if prior authorization is required **See table that follows***




Age Restrictions Requests for members under the age of 12 must be sent to the Medical Director for review.


Coverage Duration If all of the conditions are met, requests will be approved for a 12 months. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria


• The prescriber has submitted information that indicates (in accordance with World Professional Association for Transgender Health (WPATH)) Standards of Care that: Member has persistent, well-documented gender

dysphoria Member has capacity to make a fully informed decision

and to consent for treatment For minors, consent provided by parents/legal

guardians. When parental/legal guardian consent cannot be obtained, exceptions are reviewed on a case by case basis and in conjunction with a behavioral health provider.

If significant medical or mental health concerns are present, they must be reasonably well-controlled OR are being managed concurrently with gender dysphoria treatment.

• If request is for a non-formulary agent, documentation of a medical reason (e.g. intolerance, hypersensitivity, contraindication) was submitted with request why the member is not able to use two formulary alternatives

• If the member is under 12 years of age, the request must be sent to the Medical Director for clinical review.

• Dosing is within the recommended range


***Recommended dosing next page

2

Hormone regimens in adult transsexual persons

Estrogen Oral: estradiol (17β-estradiol valerate) 2 to 6 mg/day Transdermal: estradiol patch 0.025-0.2 mg/24 hours, changed once or twice

weekly depending on product Parenteral: estradiol valerate 5 to 30 mg IM every two weeks estradiol cypionate 2 to 10 mg IM every week Antiandrogens Oral: spironolactone 100 to 400 mg/daily GnRH agonists Leuprolide 3.75 to 7.5 mg IM depot monthly OR 11.25 mg

IM depot every 3 months. Testosterone Parenteral: testosterone enanthate or cypionate 50 to 100 mg IM every week

OR 100 mg to 200 mg IM every two weeks

Transdermal: testosterone gel 1%

2.5 to 10 grams of gel per day (equivalent to 25 to 100 mg/day testosterone)

testosterone patch 2.5 to 7.5 mg/day • Dose of estrogen should be adjusted according to serum 17β-estradiol levels (i.e., 100 to 200 pg/mL) and

effect. Lower doses of estradiol are generally sufficient for feminization goals when combined with an anti-androgen, GnRH agonist, or after gonadectomy. Anti-androgen therapy is discontinued after gonadectomy. Synthetic estrogens, e.g. ethinyl estradiol, are not recommended due to elevated risk of thromboembolic disease, cardiovascular mortality and inability to regulate dose by measurement of serum levels.

• Doses of testosterone should be adjusted according to serum testosterone levels (i.e., normal male range 320 to 1000 ng/dL) and effect. Time to onset of effect of parenteral preparations may be less than with transdermal preparations.

Data from:

1. Tangpric ha, V. Treatment of transsexualism. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. (Accessed on July 6, 2018)

2. Hembree WC, Cohen-Kettenis P, Gooren L, et al. Endocrine treatment of gender-dysphoric/gender-incongruent persons: An Endocrine Society* clinical practice guideline. J Clin Endocrinol Metab 2017; 102:1.

3. Gooren LJ. Clinical practice. Care of transsexual persons. N Engl J Med 2011; 364:1251. 4. Spack NP. Management of transgenderism. JAMA 2013; 309:478. 5. Knezevich EL, Viereck LK, Drincic AT. Medical management of adult transsexual persons. Pharmacotherapy 2012;

32:54.

PRIOR AUTHORIZATION PROTOCOL FOR HEPATITIS C TREATMENT

MAVYRET™ (Glecaprevir/Pibrentasvir)-PREFERRED AGENT VOSEVI ™ (sofosbuvir/ velpatasvir/voxilaprevir) EPCLUSA® (sofosbuvir/velpatasvir) ZEPATIER® (elbasvir/grazoprevir) HARVONI™ (ledipasvir/sofosbuvir) DAKLINZA™ (Daclatasvir) TECHNIVIE™ (Ombitasvir, paritaprevir, ritonavir) VIEKIRA PAK™/VIEKIRA XR™ (Ombitasvir/paritaprevir/ritonavir/dasabuvir) OLYSIO™ (simeprivir) SOVALDI ™ (sofosbuvir) PEG-INTRON™/ PEGASYS ™ (peginterferon alfa-2a) RIBAVIRIN tablets or capsules OR ANY OTHER NEWLY MARKETED AGENT for treatment of Hepatitis C

Where applicable and appropriate: MAVYRET (Glecaprevir/Pibrentasvir) is the PREFERRED AGENT for Hepatitis C requests unless a documented medical reason has been provided (intolerance, hypersensitivity, contraindication, etc.) why the member is not able to use Mavyret. Initial requests must meet ALL of the following requirements:

1. Request must be for an appropriate FDA approved/AASLD guideline recommended indication, at an approved dose and duration, and for appropriate member (e.g. age/weight).

2. Provider attests that member does not have limited life expectancy of less than 12 months due to non-liver related comorbid conditions.

3. Provider attests that they have documentation of the following: • A complete Hepatitis B immunization series OR • Hepatitis B screening (sAb, sAg and cAb)

AND • Quantitative HBV DNA results if positive for hepatitis B sAg

AND • If there is detectable HBV DNA, a treatment plan for Hepatitis B consistent with AASLD

recommendations AND

• If negative for Hepatitis B sAb, a hepatitis B immunization plan or counseling to receive the hepatitis B immunization series

4. Provider attests that they have documented HIV screening (HIV Ag/Ab) and if confirmed positive by HIV-1/HIV-2 differentiation immunoassay:

• Is being treated for HIV OR

• Is not being treated for HIV and the medical record documents the rationale for not being treated

5. Provider attests that all potential drug interactions with concomitant medications have been addressed (including discontinuation of the interacting drug, dose reduction, or counseling of the member of the risks associated with the use of both medications).

6. Provider attests that member does not have current issues with compliance. 7. Provider attests if member is actively abusing alcohol or IV drugs, or has a history of abuse that

they have counseled member regarding the risks of alcohol or IV drug abuse, and an offer of

referral for substance abuse disorder treatment has been made. 8. Provider attests that member is committed to treatment plan, including lab monitoring and

SVR12 lab testing will be completed and submitted to health plan. 9. Member’s treatment history and response has been provided with request. 10. Member’s fibrosis level has been provided with request. 11. The following lab testing is required before treatment (copies of labs required):

• Genotype (and subtype if provided) • RASs (resistance-associated substitutions, previously called RAVs) testing for Zepatier 1a

requests or as indicted in treatment guidelines • Detectable HCV RNA viral load • CBC (within 3 months only if regimen contains ribavirin and hemoglobin must be at least

10g/dL) • Pregnancy test (within 1 month for regimens that contain ribavirin and the member is a

female of child bearing age) 12. If member is cirrhotic, documentation of Child Turcotte Pugh Class (Class A, Class B, Class C). 13. The member will be referred to participate in Hepatitis C education and counseling program

provided by the health plan. 14. All approvals are for 28 days supply (see treatment summary that follows), and will be consistent

with labeling or current guidelines, and are subject to change as guidelines are updated.

TREATMENT SUMMARY Treatment Naive

Genotype

Treatment Option

Duration No Cirrhosis Compensated

Cirrhosis (Child-Pugh A)

1,2,3,4,5 or 6 Mavyret 8 weeks 12 weeks

1,2,3,4,5 or 6 Epclusa * *ONLY if medical reason provided that

member is unable to use Mavyret

12 weeks 12 weeks

Treatment Experienced

Genotype

Failed Regimen

Treatment Option

Duration No

Cirrhosis Compensated

Cirrhosis (Child-Pugh A)

Genotype 1,2, 4, 5 or 6

Peg/Riba Mavyret 8 weeks 12 weeks

Genotype 3 Peg/Riba Mavyret OR Vosevi

16 weeks 12 weeks

16 weeks

12 weeks Genotype 1 Peg/Ribavirin with Olysio,

Incivek or Victrelis OR Sovaldi/Olysio

Mavyret

12 weeks 12 weeks

Genotype 1 or 2 Sovaldi/Peg/Ribavirin OR Sovaldi/Ribavirin

Mavyret 12 weeks 12 weeks

ALL GENOTYPES Any other DAA regimen other than those specifically listed above

Vosevi 12 weeks 12 weeks

Patients with mild, moderate or severe renal impairment, including those requiring hemodialysis

Genotype

Treatment Option

Duration No Cirrhosis Compensated Cirrhosis

(Child-Pugh A) 1,2,3,4,5 or 6 Mavyret 8 weeks-16 weeks

Dependent on treatment history, GT-refer to package

insert/AASLD guidelines

12 weeks-16 weeks Dependent on treatment

history, GT-refer to package insert/AASLD guidelines

1 or 4 Zepatier* RAV testing required for

GT1a *ONLY if medical reason provided that member is

unable to use Mavyret

12 weeks-16** **Dependent on RAV testing

and previous treatment history-refer to package insert/AASLD guidelines

12 weeks-16** **Dependent on RAV testing

and previous treatment history-refer to package insert/AASLD

guidelines

Unique patient populations (e.g. Decompensated Cirrhosis, Post-Transplant,

etc. not addressed in previous tables) Decompensated Cirrhosis Refer to current AASLD guidelines @ http://www.hcvguidelines.org/

http://www.hcvguidelines.org/

(Child-Pugh B or C) NOTE: If Mavyret is a recommended treatment option it is preferred unless medical reason provided that member is unable to use Mavyret

Post-Transplant Refer to current AASLD guidelines @ http://www.hcvguidelines.org/ NOTE: If Mavyret is a recommended treatment option it is preferred unless medical reason provided that member is unable to use Mavyret

Hepatocellular Carcinoma NOTE: Refer to current AASLD guidelines @ http://www.hcvguidelines.org/ *If Mavyret is a recommended treatment option it is preferred unless medical reason provided that member is unable to use Mavyret

Pediatrics Refer to current AASLD guidelines @ http://www.hcvguidelines.org/ *If Mavyret is a recommended treatment option it is preferred unless medical reason provided that member is unable to use Mavyret

Review/Revision Date: 10/2018




Field Name Field Description Prior Authorization Group Growth Hormone

Drug(s) Preferred Growth Hormone: Humatrope (somatropin) Non-Preferred Growth Hormones: Genotropin Cartridge Genotropin MiniQuick, Norditropin FlexPro, Nutropin AQ NuSpin, Omnitrope, Saizen, Saizen Click Easy, Zomacton and any newly marketed growth hormone agent


Exclusion Criteria Treatment of idiopathic short stature (ISS)-not a covered benefit and will not be approved Required Medical Information See other criteria

Age Restrictions According to package insert Prescriber Restrictions MD is an endocrinologist or specialist in diagnosis being treated

Coverage Duration

If all of the conditions are met, the initial request will be approved for 12 months. If all of the above criteria are not met, the request is referred to a Clinical Reviewer/Medical Director for medical necessity review.

Other Criteria

1. If diagnosis is for growth failure associated with chronic kidney disease (CKD), documentation that: either pretreatment height is < -1.88 standard deviations (SD) below the mean for age or a height velocity for age < 3rd percentile that persists beyond 3 months AND epiphyses are open

2. If Diagnosis is for growth failure associated with Prader-Willi Syndrome, Noonan Syndrome Turner’s Syndrome or short stature homeobox-containing gene(SHOX) documentation of confirmation by genetic testing

3. If diagnosis is adult growth hormone (GH) deficiency Documentation of either: a. Insulin Growth Factor (IGF-1) deficiency (e.g. < 10 mcg/L) in a patient with organic pituitary

disease; OR b. If IGF-1 test result is equivocal, than GH level in response to one additional stimulatory test (e.g.

insulin tolerance test [ITT] , glucagon, arginine, clonidine, arginine/L-DOPA or macimorelin

Other Criteria Revision Date 2/2019

OR medical reason was provided why only one test was completed (e.g. member has significant structural abnormality such as pituitary stalk agenesis or empty stella panhypopituitarism, etc.) If diagnosis is pediatric GH deficiency documentation of either: a. Moderate to severe IGF-1 and insulin-like growth factor binding protein-3 (IGFBP-3) deficiency (< -1.3 SD) with severe clinical/auxological features; OR b. Mild to moderate IGF-1 and IGFBP-3 deficiency (0 to -1.3 SD) and either severe clinical/auxiological features OR GH level in r3esponse to an additional stimulatory test (e.g. ITT, glucagon, arginine, clonidine, arginine/L-DOPA); AND c. Provider attests that MRI or CT has been completed to exclude possibility of a pituitary tumor; AND d. Provider attests that member’s epiphyses are open; AND

e . If the member is ≥17 years old, documentation was provided that indicates

GH therapy is still medically necessary (IGF-1 retesting after a minimum 1 month of therapy discontinuation reveals continued GH deficiency).

4. If the request is not for Humatrope, the provider submitted a documented medical reason (i.e. intolerance) why it is medically necessary to use another agent.

Medical Director/clinical reviewer must override criteria when, in his/her

professional judgment, the requested item is medically necessary.


Hepsera®

Drugs Hepsera® (adefovir) Covered Uses Medically accepted indications are defined using the following sources:




Age Restrictions N/A Prescriber Restrictions

N/A

Coverage Duration If the above conditions are met, the request will be approved with a 12 month duration; If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria

Revision/Review 1/2018

Initial authorization:

• Diagnosis of hepatitis B. AND • Submitted current laboratory values indicating evidence of active

viral replication. AND • Submitted current laboratory values indicating persistent elevations

in ALT or AST or histologically active disease. AND • Documented treatment failure with or contraindication to

Baraclude® (entecavir) therapy. AND • Patient under the care of a gastroenterologist or an infectious disease

specialist.


necessary.

Prior Authorization Group Description Treatment of Hereditary Angioedema

Drugs Cinryze, Berinert, Kalbitor, Firazyr, Ruconest, Haegarda, Takhzyro

Covered Uses




Age Restrictions N/A Prescriber Restrictions Immunologist, Allergist or Hematologist

Coverage Duration

If criteria are met, the request will be approved for the standard FDA approved dosing per treatment episode with 5 refills for acute treatment and for 3 month duration for prophylaxis treatment for both initial and reauthorization. If the below conditions are not met, the request will be referred to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria


Continuation of Therapy/Grandfathering Provision: Members with history (within the past 90 days) of a non-formulary product are not required to try a formulary agent prior to receiving the non-formulary product. All requests M UST meet the following requirements:

• Confirmed diagnosis of hereditary angioedema (HAE) with measurement of C1-INH antigenic level, C1-INH functional level, and C4 level

• The patient is not taking ACE inhibitors or estrogen replacement • Documentation submitted indicates the medication is being prescribed f or

an FDA approved indication at FDA approved dose. For acute treatment:

• If all of the above conditions are met, the request will be approved for the standard FDA approved dosing per treatment episode, with 5 refills.

For prophylaxis treatment:

• The patient has a history of at least two severe attacks/month with s welling of the face, throat, or GI tract, and chart notes have been submitted indicating the date and severity of attack.

• The patient has tried and failed and/or has a documented medical reason (intolerance or contraindication) f or not using danazol or oxandrolone.

If all of the above conditions are met, the request will be approved for three month duration. If all of the above criteria are not met, the request is referred to a Medical Director/Clinical reviewer f or medical necessity review. Renewal Criteria:

• Documentation was submitted that the patient has clinically benefited from medication in an acute attack, or documentation was submitted that the patient has clinically benefited with reduced attack s, if using as

prophylaxis. • Documentation submitted indicates the medication is being prescribed f or

an FDA approved indication at FDA approved dose. • Approval duration for acute treatment is the FDA approved dosing per

treatment episode, with 5 refills. • Approval duration for prophylaxis treatment is 3 months.

If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.

NOTE: Medical Director/Clinical Reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary


Hyaluronic Acid Derivatives

Drug(s) Preferred Hyaluronic Acid Derivative EUFLEXXA Non-Preferred Hyaluroic Acid Derivatives: Gel-One, Gelsyn-3, GenVisc 850, Hyalgan, Monovisc, Orthovisc, Supartz FX, TriVisc, Synvisc One, Synvisc, Durolane, Visco-3, Hymovis, or any newly marketed agent

Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), and/or per standard of care guidelines.

Exclusion Criteria N/A Required Medical Information See “Other Criteria”

Age Restrictions According to Package Insert Prescriber Restrictions N/A

Coverage Duration If all of the criteria are met, the request will be approved for one complete course of treatment (based on the FDA labeled dose of the drug requested). If all of the criteria are not met, the request is referred to a Medical Director for medical necessity review.

Other Criteria Review/Revision Date 2/2019

Initial Authorization: • A diagnosis of Osteoarthritis (OA)/Degenerative joint disease (DJD) of the knee. • Documentation (in claim history or provider statement) that the member has had adequate trials on simple analgesics (e.g., acetaminophen containing products) & two different Nonsteroidal anti-inflammatory drugs (NSAIDs) at prescription strength on a continuous basis without success or has a medical reason (intolerance, hypersensitivity, contraindication, etc.) for not being able to utilize these therapies to treat their condition. • Documentation has been provided that member has tried and failed a steroid injection, per affected, knee or the member has a medical reason for not being able to utilize steroid injections. • If the request is for any other product other than Euflexxa, the member has a documented medical reason (intolerance, hypersensitivity, contraindication, etc) for not using Euflexxa to treat their medical condition.

Reauthorization: • Documentation was submitted that the member had a response to the treated knee (s) (e.g. decreased joint pain or stiffness, improved knee range of motion, etc.), and last injection lasted approximately 6 months • Documentation was submitted that the member has a return of symptoms of osteoarthritis that has not responded to analgesics or NSAIDs, or has a medical reason (intolerance, hypersensitivity, contraindication, etc) for not being able to utilize these therapies. • If the request is for any other product other than Euflexxa, the member has a documented medical reason (intolerance, hypersensitivity, contraindication, etc) for not using Euflexxa to treat their medical condition.



HYPERLIPIDEMIA AGENTS

Drugs FORMULARY STATUS Formulary, Pays at Point-of-Sale SIMVASTATIN TABLETS LOVASTATIN TABLETS

ATORVASTATIN TABLETS ROSUVASTATIN TABLETS

NIACIN IR TABLETS NIACIN ER TABLETS

FORMULARY STATUS Requires Step Therapy with one prior step

PRAVASTATIN


FORMULARY STATUS Requires Step Therapy with one prior step

FLUVASTATIN LESCOL XL


request. Covered Uses Medically accepted indications are defined using the following sources:







Initial Authorization: 1. Presumed or documented diagnosis of hypercholesterolemia and/or

hyperlipidemia 2. Documented trial and failure or intolerance with atorvastatin or

simvastatin for a minimum of three weeks of therapy within the previous 60 days

3. Documented trial and failure or intolerance with atorvastatin, pravastatin, lovastatin or simvastatin for a minimum of three weeks of therapy within the previous 60 days

PERFORMRx PRIOR AUTHORIZATION CRITERIA for Idiopathic Pulmonary Fibrosis (IPF)

PREFERRED STATUS: REQUIRE Prior Authorization Ofev® (Nintedanib Esylate): 100mg,150mg capsules Esbriet® (Pirfenidone): 267mg capsule

INITIAL CRITERIA FOR IDIOPATHIC PULMONARY FIBROSIS: Patient is 18 years of age or older Confirmed diagnosis of Idiopathic Pulmonary Fibrosis as demonstrated by a High Resolution CT

scan with “honeycombing” or “ground glass opacities” or lung biopsy, and other known causes of interstitial lung disease have been excluded

MD is a pulmonologist or lung transplant specialist Pulmonary function test indicate patient has Forced Vital Capacity (%FVC) greater than or equal

to 50% within 30 days of request Baseline ALT, AST, and bilirubin has been submitted within 30 days of request Provider attests that they have reviewed patient’s other medication, and has addressed all

potential drug interactions Documentation has been provided that the patient does not smoke

If all of the above conditions are met, the request will be approved for a 6 month duration; if all of the above criteria are not met, the request is referred to a Medical/clinical reviewer for medical necessity review.

REAUTHORIZATION CRITERIA FOR IDIOPATHIC PULMONARY FIBROSIS: MD is a pulmonologist or lung transplant specialist Repeat ALT, AST and bilirubin within 90 days of request Documentation submitted indicates that the member has obtained clinical benefit from the

medication Documentation has been provided that the patient does not smoke

If all of the above conditions are met, the request will be approved for a 6 month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review.

NOTE: Medical Director/Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.


PerformRx Prior Authorization Criteria for Immunoglobulins (IVIG)

ALL REQUESTS MUST HAVE A CONFIRMED DIAGNOSIS BY A SPECIALIST

FOR ALL INDICATIONS: Patient has documented trial and failure of all other standard of care therapies as defined per recognized guidelines, or have a documented medical reason why patient is not able to utilize other standard of care therapy.

IVIG will be considered for the following indications provided the required information is present:

1. Primary immunodeficiency 2. Thrombocytopenia purpura, Idiopathic and chronic immune 3. Kawasaki disease 4. Chronic B- cell lymphocytic leukemia 5. Bone marrow transplantation 6. Pediatric HIV 7. Multifocal motor neuropathy 8. Chronic inflammatory demyelinating neuropathy 9. Guillain-Barre syndrome 10. Other medically accepted indications

If criteria is met, the request will be approved for the duration listed below, if criteria is not met, the request is referred to a Medical Director/Clinical reviewer for medical necessity review.

Primary immunodeficiency Congenital agammaglobulinemia Hypogammaglobulinemia (Common Variable

Immunodeficiency, CVID) Severe combined immunodeficiency (SCID) Wiskott-Aldrich syndrome X-linked agammaglobulinemia or Bruton’s Hypergammaglobulinemia X-linked Hyper IgM syndrome

• Documentation submitted includes patient’s IgG

level and is below normal level for indication

• Clinically significant deficiency of humoral immunity as evidenced by ONE of the following:

Documented inability to produce an adequate immunologic response to specific antigens.

Patient has history of recurrent infections despite prophylactic antibiotics

• Dose is within range per product and indication and consistent with standard of care

If criteria is met, approve for 6 months.

Idiopathic Thrombocytopenia Purpura, acute and chronic

Acute : (active bleeding, patients requiring an urgent invasive procedure, to defer splenectomy, or platelet counts < 20,000/ul at risk for intra-cerebral hemorrhage or has life threatening bleeding)

• Dose does not exceed 1g/kg daily for up to 2 days, or 400mg/kg daily for 5 days

Chronic:

• Duration of illness of greater than 6 months

• Patient has documented trial and failure of corticosteroids and splenectomy, or has a documented medical reason why they are not able to use corticosteroids or patient is at high risk for post-splenectomy sepsis.


• If criteria is met, approve for up to 5 days.

Kawasaki disease • IVIG is being given with high dose aspirin • Requested dose does not exceed a single 2g/kg dose

or a dose of 400mg/kg for five consecutive days

If criteria is met, approve for up to 5 days.

Chronic B-cell lymphocytic leukemia • Patient’s IgG level has been provided, and is < 500mg/dL

• The patient has history of severe bacterial infections • Dose does not exceed 400mg/kg every 3-4 weeks


Bone marrow transplantation • Confirmed bone marrow transplant within last 100 days.

• Patient’s IgG level has been provided, and is < 400mg/dL

• Dose does not exceed 500mg/kg/wk for the first 100 days post- transplant


Pediatric HIV • Diagnosis of HIV • Patient is < 13 years of age • Patient’s IgG level has been provided, and is

< 400mg/dL OR

• Clinically significant deficiency of humoral immunity as evidenced by ONE of the following:

Documented inability to produce an adequate immunologic response to specific antigens.

Patient has history of recurrent bacterial infections despite prophylactic antibiotics

• Dose does not exceed 400mg/kg/dose every 14 days


Multifocal motor neuropathy (MMN) • Duration of symptoms has been at least 1 month with disability.

• Documentation submitted includes nerve conduction studies were completed to rule out other possible conditions, and confirms the diagnosis of MMN.


Chronic inflammatory demyelinating neuropathy (CIDP)

• Duration of symptoms has been at least 2 months with disability.

• Documentation submitted includes nerve conduction studies were completed or nerve biopsy to rule out other possible conditions, and confirms the diagnosis of CIDP.

• Patient has documented trial and failure of

corticosteroids, or has a documented medical reason why they are not able to use corticosteroids to treat the condition. In addition, if documentation is provided that patient has severe and fulminant CIDP, IVIG can be approved as initial therapy

• Dose does not exceed 2g/kg over a five day period or 1g/kg every 3 weeks for maintenance treatment.

If criteria is met, approve for up to 5 days for 3 months.

Guillain-Barre syndrome • Documentation submitted indicates severe disease with the inability to walk without aid

• Onset of symptoms within the last 4 weeks • Dose does not exceed 2g/kg/month


Any other medically accepted indication

Review/Revision Date 10/2018

• For any other indication, medical recommendation must have a I, IIa or IIb recommendation, and be used for a medical condition that is supported by the medical compendium (Micromedex, American Hospital Formulary Service, Drug Points, and Drug Package Insert) as defined in the Social Security Act 1927, and/or per recognized standard of care guidelines.

• Patient has documented trial and failure of all other standard of care therapies as defined per recognized guidelines, or has a documented medical reason why patient is not able to utilize other standard of care therapy.

If criteria is met, approve for 3 months


Injectable/Infusible Osteoporosis Agents

Drugs Boniva® Injection (Ibandronate), Forteo® (teriparatide), Prolia™ (denosumab), Reclast® (zoledronic acid), Tymlos (abaloparatide) or any other newly marketed agent



Information “See other criteria”


Prescriber Restrictions N/A Coverage Duration If all of the conditions are met, requests will be approved for a 1 year.

***FORTEO/TYMLOS REQUESTS WILL ONLY BE APPROVED FOR A TOTAL DURATION OF 24 MONTHS***If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria

For all requests: • The member has a documented (consistent with pharmacy

claims) adequate trial of an oral bisphosphonate or has a medical reason (e.g. intolerance, hypersensitivity, contraindication, etc.) for not using an oral bisphosphonate

• The member is taking calcium and vitamin D • The medication is FDA approved for indication and is being

requested at an FDA approved dose If diagnosis is osteoporosis

• Documentation was submitted indicating member is postmenopausal woman or a male member with a bone mineral density (BMD) value consistent with osteoporosis (T-scores equal to or less than –2.5) OR has had an osteoporotic fracture, OR member is over age of 50 with a T-score between -1 and -2.5 at the femoral neck or spine, and a 10 year hip fracture probability >3% or a 10 year major osteoporosis-related fracture probability >20%, based on the US-adapted WHO absolute fracture risk model

• If request is for Forteo (teriparatide) or Tymlos (abaloparatide), the member has not exceeded a total of 24 months of therapy AND one of the following applies to member: member has documented trial and failure of Boniva

(Ibandronate) injection, Reclast (zoledronic acid) or Prolia (denosumab) or has a medical reason (e.g.


intolerance, contraindication, etc.) why these therapies are not suitable to be used

has SEVERE osteoporosis (T-Score -3.5 or below, or T-Score of -2.5 or below plus a fragility fracture)

• If request is for Forteo, a medical reason why member is unable to use Tymlos if appropriate based on diagnosis

If diagnosis is Paget’s disease • Documentation (within 60 days of request) was submitted

including member’s serum alkaline phosphatase level of ≥ two times the upper limit of normal, the member is symptomatic OR there is documentation of active disease

If the diagnosis is glucocorticoid-induced osteoporosis: • Documentation for adequate trial of oral bisphosphonate for either

prevention or treatment of glucocorticoid-induced osteoporosis • Documentation that the member is currently utilizing glucocorticoid

therapy for a minimum of 6 months. • Documentation that the dosage of the glucocorticoid therapy is

equivalent to a dose greater than 7.5 mg of prednisone daily • Member is 40 years of age or older • Member has a moderate to high risk of fracture based on ONE of the

following: o History of osteoporotic fracture o BMD less than or equal to -2.5 at the hip or spine o FRAX 10-year risk for major osteoporotic fracture greater than

or equal to10% (with glucocorticoid adjustment) o FRAX 10-year risk for hip fracture greater than 1% o Glucocorticoid dose greater than or equal to the equivalent of 30

mg/day of prednisone and cumulative dose of at least 5 grams in the past year

o If the request is for Forteo (teriparatide) or Tymlos (abaloparatide), the patient has not exceeded a total of 24 months of therapy AND member has documented trial and failure of Reclast (zoledronic acid) or Prolia (denosumab) or has a medical reason (e.g. intolerance, contraindication, etc.) as to why these therapies are not suitable to be used



Prior Authorization Group Injectable Osteoclast Inhibitors for Skeletal Related Events

Drugs Preferred: Pamidronate disodium (Aredia®), Zoledronic Acid (Zometa ®), Nonpreferred: Denosumab (Xgeva®)

Covered Uses The request is for an FDA approved indication or for a medically accepted indications as defined or as supported by the medical compendium (Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI) , Drug Package Insert) as defined in the Social Security Act 1927, or per the National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology (ASCO), or the National Institutes of Health (NIH) Consensus Panel standard of care guidelines.


See “Other Criteria”

Age Restrictions According to package insert Prescriber Restrictions Prescriber is an oncologist Coverage Duration 6 months Other Criteria


• The request is for an approved/accepted indication at an approved dose

• Documentation has been provided that patient has a creatinine clearance (CrCl) > 30mL/min for requests for zoledronic acid or for pamidronate

Documentation has been provided that the patient is being treated with calcium and vitamin D, unless contraindicated (e.g. history of recurrent renal stones) • If the request is for a brand name agent, the patient has a

documented trial and failure of generic Pamidronate (Aredia) OR zoledronic acid (Zometa) that is consistent with claims history, or has a documented medical reason (intolerance, hypersensitivity, contraindication, etc) for not utilizing one of these agents to manage their medical condition

• If the request is for denosumab (Xgeva) for treating Giant cell tumor of bone, documentation has been submitted that the tumor is unresectable or that surgical resection is likely to result in morbidity (e.g denosumab therapy is being used to aide in the possibility of resection with tumor shrinkage)

If these conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.

PERFORMRx PRIOR AUTHORIZATION CRITERIA for Juxtapid® PREFERRED STATUS: Non-Preferred- REQUIRE Prior Authorization Juxtapid® (lomitapide)

INITIAL CRITERIA FOR JUXTAPID®: • Request is appropriate for member (e.g. age) as indicated in package labeling or standard of

care guidelines • Prescriber must be cardiologist or specialist in treatment of lipid disorders. • Patient has tried and failed atorvastatin 40mg-80mg or rosuvastatin 20-40mg (consistently for 3

months via claim history or chart notes). If patient is not able to tolerate atorvastatin or rosuvastatin, documentation was provided that patient is taking another statin at the highest tolerated dose, or a medical reason was provided why the member is not able to use these therapies.

• If prescriber indicates member is “statin intolerant”, documentation was provided including description of the side effects, duration of therapy, “wash out”, re-trial, and then change of agents.

• Patient has tried and failed ezetimibe at a maximal tolerated dose or documentation has been provided that the patient is not able to tolerate ezetimibe

• Documentation was provided indicating provider has counseled member on smoking cessation and following a “heart healthy diet”.

• Documentation was provided of current LDL level • Documentation of a diagnosis of homozygous familial hypercholesterolemia (H0FH) via either:

o Genetic confirmation of two mutant alleles at the LDL receptor, ApoB, PCSK9 or ARH adaptor protein gene locus; OR

o A clinical diagnosis of HoFH which includes: untreated LDL-C >500 mg/dL (>13 mmol/L) or treated LDL‐C ≥300 mg/dL (>8 mmol/L), AND Cutaneous or tendon xanthoma before age 10 years, OR Elevated LDL-C levels consistent with heterozygous FH in both parents.

• Member has documented trial and failure with PCSK9 inhibitor for at least 3 months, or a medical reason has been provided, why member is unable to use a PCSK9 inhibitor to manage their condition.

If all of the above conditions are met, the request will be approved for up to a 3 month duration; if all of the above criteria are not met, the request is referred to a Clinical reviewer for medical necessity review.

REAUTHORIZATION CRITERIA: • Prescriber must be cardiologist or a specialist in the treatment of lipid disorders. • Documentation submitted indicates that the member has obtained clinical benefit from the

medication o For first reauthorization request only: repeat fasting lipid panel lab report which shows

improvement in LDL from previous request. • The patient’s claim history shows consistent therapy (monthly fills)


NOTE: Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested items medically necessary.



LEVALBUTEROL

Drugs FORMULARY STATUS Formulary, Pays at Point-of-Sale VENTOLIN HFA 90MCG/ACTUATION ALBUTEROL

2.5MG/3ML INHALATION SOLUTION

FORMULARY STATUS Requires Step Therapy with one prior step LEVALBUTEROL HFA 45MCG/ACTUATION AEROSOL

INHALER







Other Criteria Revision/Review Date

Initial Authorization: 1. Presumed or documented diagnosis of dyspnea 2. Documented trial and failure or intolerance with an inhalation form

of albuterol for a minimum of 3 weeks within past 60 days

7/2018

Field Name Field Description Prior Authorization Group Description Lyrica®

Drugs Lyrica® (pregabalin) capsule Covered Uses Medically accepted indications are defined using the following






Prescriber Restrictions N/A Coverage Duration If the criteria are met, the request will be approved with up to a 12

month duration; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.

Other Criteria Initial Authorization:

Partial-Onset Seizures for Lyrica® • Documented diagnosis of partial-onset seizures. • Patient currently receiving another anticonvulsant medication at a therapeutic dosage. • Documented trial and failure, intolerance or contraindication to gabapentin.

Postherpetic Neuralgia for Lyrica® and Lyrica® CR

• Documented diagnosis of postherpetic neuralgia. • Documented trial and failure, intolerance or contraindication

of two formulary alternatives* (Gabapentin- , amitriptyline, nortriptyline, desipramine)

Neuropathic Pain Associated with Diabetic Peripheral Neuropathy for Lyrica® and Lyrica® CR

• Documented diagnosis of peripheral neuropathy.

66

Neuropathic Pain Associated with Spinal Cord Injury for Lyrica®

• Documented diagnosis of neuropathic pain associated with spinal cord injury

• Trial and failure, intolerance or contraindication of one formulary alternative* ( i.e. gabapentin, amitriptyline)


Fibromyalgia for Lyrica®: • Documented diagnosis of fibromyalgia.

• Trial and failure, intolerance or contraindication of two formulary alternatives* (i.e. gabapentin, duloxetine, amitriptyline, Savella®)

Trigeminal Neuralgia Pain for Lyrica®:

• Documented diagnosis of trigeminal neuralgia. • Documented trial and failure, intolerance or contraindication to at least three of the following*: baclofen, carbamazepine, gabapentin, lamotrigine, oxcarbazepine, phen ytoin

*= Trial and failure of maximum tolerated doses

Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is

medically necessary.


RETINOIDS (DERMATOLOGIC)

Drugs FORMULARY STATUS Requires Prior Authorization, Generically Available Agents Preferred:

• Claravis (isotretinoin) • Myorisan (isotretinoin) • Zenatane (isotretinoin) • Amnesteem (isotretinoin)

FORMULARY STATUS Requires Prior Authorization, Non-Preferred: • Absorica (isotretinoin) • Or any newly marketed oral retinoid product





Restrictions N/A


Other Criteria


Initial Authorization

1. Diagnosis of moderate to severe recalcitrant nodular acne AND

2. Documented treatment with a therapeutic trial and failure or intolerance to one or more first line topical therapies (e.g. topical antibiotics or topical retinoids) AND one or more first line oral therapies (e.g. doxycycline, tetracycline or minocycline)for at least 4 weeks (28 days) of therapy in the previous 180 days.



Field Name Field Description Prior Authorization Group KUVAN® Drug(s) Kuvan® (Sapropterin Dihydrochloride) Covered Uses *Medically accepted indications are defined using the following sources: the

Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI) , and the Drug Package Insert).

Exclusion Criteria None Required Medical Information See “Other Criteria” Age Restrictions None Prescriber Restrictions Specialist experienced in treating PKU

Coverage Duration Initial: If the criterion is met, the request will be approved for a duration of 1 month; if the above conditions are not met, the request will be referred to a clinical reviewer for medical necessity review. 1st Reauthorization: If the criteria is met, the request will be approved for a duration of 1 month for patients who require a dose increase to 20 mg/kg/day due to non-responsiveness and for all other patients the request will be approved for a duration of 3 months; if the above conditions are not met, the request will be referred to a clinical reviewer/Medical Director for medical necessity review. 2nd Reauthorization and Thereafter: If the criterion is met, the request will be approved for a duration of 4 months; if the above conditions are not met, the request will be referred to a clinical reveiwer/Medical Director for medical necessity review.

Other Criteria INITIAL AUTHORIZATION: • Documentation of a confirmed diagnosis of Phenylketonuria (PKU) by a specialist experienced in treating PKU • Documentation of the patient’s baseline blood Phe level. (within 30 days of the request) • Documentation consistent with order forms OR receipts (within 30 days of request) that the patient is currently utilizing a Phe restricted diet with Phe-free medical products/foods in conjunction with dietician or nutritionist. (Examples include Phenyl-Free® (phenylalanine free diet powder), Loplex, Periflex, Phlex-10, PKU 2, PKU 3, XPhe Maxamaid, XPhe Maxamum,) • Documentation of the patient’s current weight. • The medication is being prescribed at a dose no greater than the FDA approved maximum initial dose of 10 mg/kg/day-20mg/kg/da y.

PA CRITERIA FOR 1st REAUTHORIZATION: Patients that were dosed at 20mg/kg/day (initial auth) and did not have a decrease in Phe level of at least 30% from baseline, are considered NON RESPONDERS and NO ADDITIONAL TREATMENT will be authorized.

• Documentation of the patient’s current weight.

• Documentation of at least two separate blood Phe level results after initiation of therapy (within 30 days of request). • The medication is being prescribed at an FDA approved dosage.

PA CRITERIAFOR 2nd REAUTHORIZATIONAND THEREAFTER: • Documentation of the patient’s current weight.

• Documentation of at least two separate blood Phe level results (within 60 days of request). • The medication is being prescribed at an FDA approved dosage

If the above conditions are met, the request will be approved for a duration of 4 months; if the above conditions are not met, the request will be referred to a clinical reviewer/Medical Director for medical necessity review.

Last review: 4/2018

NOTE: Clinical reviewer/Medical Director must override criteria when, in his/her professional judgment, the requested item is medically necessary.


Prior Authorization Group LEMTRADA® Drug(s) Lemtrada® Covered Uses Medically accepted indications are defined using the following sources: the Food and

Drug Administration (FDA), Micromedex (DrugPoint or DRUGDEX), American Hospital Formulary Service (AHFS – accessed via Lexicomp), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), and the Drug Package Insert.

Exclusion Criteria Patients that are infected with HIV (Human Immunodeficiency Virus) Required Medical Information See “Other Criteria” Age Restrictions Patients must be 17 years age or older Prescriber Restrictions Prescriber must be a neurologist Coverage Duration If all of the criteria are met, the initial request will be approved for 5 vials (60mg).

For continuation of therapy, if all criteria are met, the request will be approved for 3 vials (36mg). If all of the above criteria are not met, the request is referred to a Clinical Reviewer for medical necessity review.

Other Criteria Review Date 10/2018

INITIAL AUTHORIZATION: The patient is ≥ 17 years old with a clinical diagnosis of a relapsing form of multiple

sclerosis (MS). Documentation of the following lab values have been submitted within 30 days of

request: -HIV testing -Thyroid function tests -Complete blood count with differential -Serum creatinine -Urinalysis with cell counts -baseline skin exam (for melanoma)

The member has a documented trial of glatiramer AND Aubagio AND Gilenya or has a documented medical reason (intolerance, hypersensitivity, etc) for not utilizing these therapies.

Documentation has been provided that the patient will be taking formulary anti- herpetic

prophylaxis for a minimum of 60 days beginning day one of treatment. Lemtrada® is being prescribed at an FDA approved dosage

PA CRITERIA FOR REAUTHORIZATION: The patient is ≥ 17 years old with a clinical diagnosis of a relapsing form of MS. A period of 12 months has elapsed since previous treatment. Documentation of the following labs values have been submitted with request:

-HIV testing (within 30days of request) -Thyroid function tests (every 90 days of request) -Complete blood count with differential (within 30 days of request) -Serum creatinine (within 30 days of request) -Urinalysis with cell counts (within 30 days of request) -annual skin exam (for melanoma)

Documentation has been provided that the patient will be taking formulary anti- herpetic prophylaxis for a minimum of 60 days beginning day one of treatment.

Lemtrada® is being prescribed at an FDA approved dosage

Continuation of Therapy/Grandfathering Provision:

Members with any history of Lemtrada are not required to try a formulary agent prior to receiving Lemtrada.

NOTE: Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.


Lidoderm®

Drugs Lidoderm® (lidocaine) Covered Uses Medically accepted indications are defined using the following sources:





Restrictions N/A


Other Criteria



• Diagnosis of postherpetic neuralgia AND

• Documented trial and failure (maximum tolerated dose) or

intolerance to one of the following medications: amitriptyline, nortriptyline, desipramine or gabapentin




Prior Authorization Group Long Acting Injectable Antipsychotics

Drug(s) risperidone (Risperdal Consta®), paliperidone palmitate (Invega Sustenna™, Invega Trinza™), olanzapine pamoate monohydrate (Zyprexa Relprevv®), aripiprazole monohydrate (Abilify Maintena®), aripiprazole lauroxil (Aristada™), or any newly marketed long acting injectable antipsychotic

*Risperdal Consta®, Invega Sustenna™ and Invega Trinza™ are preferred agents for this class

Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), and the Drug Package Insert).


Required Medical Information Initial approval:

• If documentation was provided (claim history or chart notes with dosage and treatment dates) indicating the member has been stable on a long acting antipsychotic other than the preferred agents, the request can be approved as continuation of therapy.

• Member has claims history or physician attestation that member has had prior use of an oral atypical antipsychotic

• Member has demonstrated tolerability to the oral agent of the drug that is being requested without side effects

• If the request is for any other product other than the preferred agents, the member has a documented trial (consistent with pharmacy claims or chart notes including 3 months or more of therapy) with one of the preferred agents, OR has a documented medical reason such as intolerance, hypersensitivity, contraindication, etc. OR documentation was provided indicating member was previously established on a non-preferred agent and prescriber feels changing patient to one of the preferred long acting agents would cause detriment or patient decompensation.

• If request is for Invega Trinza™, documentation has been provided that the member has been stable on Invega Sustenna™ for 4 months, and at the same dose for the last 2 months

• Request is for FDA approved or a medically accepted indication at an approved dose

Reauthorization:

• Member has been compliant with filling their medication OR

documentation was provided indicating why member missed dosing • Documentation was provided that member is stable on medication • Request is for FDA approved or a medically accepted indication at an

approved dose

Age Restrictions Member must be 18 years of age or older.

Prescriber Restrictions Prescriber is a psychiatrist or in consultation with a psychiatrist.

Coverage Duration If all of the conditions are met, the initial request will be approved for 6 month duration; reauthorization requests will be approved for 12 months. If the above conditions are not met, the request will be referred to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria

Review Date: 4/2018

N/A

NOTE: Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.



Hydroxyprogesterone caproate

Drug(s) Hydroxyprogesterone caproate IM vial (generic preferred) Makena® Makena® Autoinjector

Covered Uses *Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), or the Drug Package Insert (PPI).

Exclusion Criteria Patients pregnant with multiples, history of thrombosis or thromboembolic disorders, history of breast cancer or other hormone sensitive cancer, cholestatic jaundice of pregnancy, liver tumors or active liver disease, uncontrolled hypertension, or abnormal vaginal bleeding

Required Medical Information See other criteria

Age Restrictions Patient must be 16 years of age or older

Prescriber Restrictions Prescriber must be an obstetrician

Coverage Duration If all of the criteria is met, the request will be approved for up to 21 weeks

Other Criteria

Review Date 10/2018

***Generic hydrooxyprogesterone caproate vials are preferred*** • The patient has a history of preterm birth before 37 weeks gestation • The patient has a singleton pregnancy (is pregnant with one fetus) • Documentation that drug is being used for FDA approved indication

(begin treatment between 16 weeks gestation and continued weekly until week 37 gestation) at an FDA approved dose.

• If the request is for the brand Makena® vial or Makena® autoinjector, prescriber must provide a documented medical justification for not using the generic hydroxyprogesterone caproate IM vials.

If all of the criteria is not met, the request is referred to a Medical Director

or clinical reviewer for medical necessity review.

Field Name Field Description Prior Authorization Group Description Mepron®

Drugs Mepron® (atovaquone) suspension Covered Uses Medically accepted indications are defined using the following



Information




Other Criteria



• Diagnosis of mild to moderate Pneumocystis jirovecii pneumonia (PCP) or diagnosis with the need to prevent PCP infection.

AND • Documented trial and failure with therapeutic doses or

intolerance to trimethoprim- sulfamethoxazole (TMP-SMX) (first line therapy).

AND • Documented trial and failure with therapeutic doses or

intolerance to dapsone

Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is

medically necessary.


SELF INJECTABLE DISEASE MODIFYING IMMUNOMODULATORS FOR MULTIPLE SCLEROSIS (MS)

Drugs Interferon beta-1a (Avonex®, Rebif®), Interferon beta-1b (Betaseron®, Extavia™), Glatiramer Acetate (Copaxone®, Glatopa™), Peginterferon beta-1a (Plegridy®),


Exclusion Criteria Patients with primary progressive MS Required Medical


Age Restrictions Patient must be age appropriate per package label. Prescriber


Coverage Duration If all of the criteria are met, the request will be approved for 12 months. If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review

Other Criteria

Revision/Review

Date 10/2018

INITIAL AUTHORIZATION: • The patient is ≥ appropriate age (per label) with a clinical diagnosis

of a relapsing form of multiple sclerosis • If the request is for any agent other than glatiramer, then the

member must have a documented trial of glatiramer AND Aubagio AND Gilenya, or has a documented medical reason (intolerance, hypersensitivity, etc.) for not utilizing these therapies

• The medication is bei.ng prescribed by a neurologist at an FDA approved dose

PA CRITERIA FOR REAUTHORIZATION: • The patient is ≥ 17 years old with a clinical diagnosis of a relapsing

form of multiple sclerosis • Documentation indicating the member has clinically benefited from

therapy • The medication is being prescribed by a neurologist at an FDA

approved dose

Continuation of Therapy/Grandfathering Provision: Members with history (within the past 90 days) of a non-formulary product are not required to try a formulary agent prior to receiving the non-formulary product.



Field Name Field Description Prior Authorization Group Description Multaq®

Drugs Multaq® (dronedarone) Covered Uses Medically accepted indications are defined using the following


Exclusion Criteria Pregnancy Required Medical

Information


Age Restrictions N/A Prescriber Restrictions Request must be from a cardiologist or electrophysiologist.

Coverage Duration If the criteria are met, the request will be approved with up to a 12 month duration; if the criteria are not met, the request will be referred to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria



• Diagnosis of parox ysmal or persistent atrial fibrillation

(AF) or atrial flutter (AFL) • Must not have NYHA Class IV heart failure or

symptomatic heart failure with recent decompensation requiring hospitalization or referral to a specialized heart failure clinic

• Must have AF that can be cardioverted into normal sinus rhythm

• Female patients age <50 years old have a negative pregnancy test result within previous 30 days of request or have a documented medical reason that a pregnancy test is not warranted (i.e hysterectomy)


necessary.


Description Natpara®

Drugs Natpara® (parathyroid hormone)


Exclusion Criteria Patients with hypoparathyroidism caused by calcium-sensing receptor mutations or in patients with acute postsurgical hypoparathyroidism.


Serum calcium and serum 25-hydroxyvitamin D levels

Age Restrictions Patient is 18 years of age or older

Prescriber Restrictions MD is an endocrinologist Coverage Duration If all of the conditions are met, the request will be approved for a 3 month duration.

If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria


• Documentation has been submitted that the patient has a diagnosis of chronic hypoparathyroidism who cannot maintain stable serum and urinary calcium levels with calcium and vitamin D

• Documentation has been submitted (with dates of therapy) that the patient has had an adequate trial with calcium and vitamin D

• Documentation has been submitted that the patient will take Natpara® in combination with calcium and vitamin D

• Patient is NOT currently taking alendronate • Current labs (within 60 days of request) have been submitted for the

following: Serum calcium (must be above 7.5mg/dL to start therapy) Vitamin D level (must be greater than or equal to 30ng/mLto start therapy)

If these conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.


1


ORAL AGENTS FOR MULTIPLE SCLEROSIS (MS)

Drugs AUBAGIO® (teriflunomide), GILENYA® (fingolimod hcl), TECFIDERA® (dimethyl fumarate), or any other newly marketed oral MS Agent


Exclusion Criteria Patients with primary progressive MS Required Medical


Age Restrictions Patient must be age appropriate per package insert Prescriber


Coverage Duration If all of the criteria are met, the request will be approved for 12 months. If all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.

Other Criteria


• The patient is age appropriate per package insert with a clinical diagnosis of a relapsing form of multiple sclerosis

• If the request is for any agent other than Aubagio OR Gilenya, then the member must have a documented trial of glatiramer AND Aubagio AND Gilenya, or has a documented medical reason (intolerance, hypersensitivity, etc.) for not utilizing these therapies.

• New members to the health plan stable on Gilenya OR Tecfidera will be permitted to continue therapy if requested by provider

• The medication is being prescribed by a neurologist at an FDA approved dose

Continuation of Therapy/Grandfathering Provision: Members with history (within the past 90 days) of a non-formulary product are not required to try a formulary agent prior to receiving the non-formulary product. Medical Director/clinical reviewer must override criteria when, in



Non-Formulary/Prior Authorization Required Medications Criteria ***Please Note: If the request is for a non-formulary brand with an A-rated generic, refer to Criteria for Brand Medications When An A-Rated Generic is Available***

Drugs Covered Uses Medically accepted indications are defined using the following







Coverage Duration If the criterion is met, the request will approved for up to a 12 month duration (depending on the diagnosis and usual treatment duration). If criterion is not met, the request will be referred to a Clinician for medical necessity review.

Other Criteria



• Appropriate diagnosis/indication for requested non- preferred/prior authorization required medication.

• Appropriate dose of medication based on age (i.e. pediatric and elderly populations) and indication.

And patient meets one of the three following criteria:

• Documented trial and failure or intolerance with up to

three formular y medications used to treat the documented diagnosis. For medications where there is only one preferred agent, only that agent must have been ineffective or not tolerated.

• No other formular y medication has a medically accepted use for the patient’s specific diagnosis as referenced in the medical compendia.

• All other formulary medications are contraindicated based on the patient’s diagnosis, other medical conditions, or other medication therapy.

Medical Director/clinical reviewer must override criteria

when, in his/her professional judgement, the requested item is me872dically necessary.


Hemophilia Factor VIII Deficiency

Drugs Novoeight®- PREFERRED PRODUCT Advate, Adynovate, Afstyla, Alphanate, Eloctate, Helixate FS, Hemofil M, Humate P, Koate-DVI, Kogenate®FS, Kovaltry®, Monoclate-P , Nuwiq, Obizur, Recombinate, Xyntha and any newly marketed recombinant factor VIII product




Age Restrictions Patient must be age appropriate per package insert Prescriber

Restrictions Prescriber must be a Hematologist

Coverage Duration If all of the criteria are met, the request will be approved for 1 month. Other Criteria


• Patient has a diagnosis of Hemophilia and the type of deficiency has

been provided • The drug is being used for an FDA-approved indication at an FDA

approved dose or the indication/dose are otherwise supported by treatment guidelines.

• If the request is for any drug other than Noveoeight, the member has a trial and failure of Novoeight or has a medical reason for not utilizing Novoeight if appropriate based on the member’s diagnosis

If all of the above criteria are not met, the request is referred to a

Medical Director/Clinical Reviewer for medical necessity review.


necessary.

Prior Authorization Group Description Oral Cystic Fibrosis Agents Drug(s) Kalydeco®, Kalydeco Granules® (ivacaftor), Orkambi®

(Lumacaftor/Ivacaftor), or any newly marketed oral agent to treat cystic fibrosis


Exclusion Criteria See “Other Criteria” Required Medical Information See “Other Criteria”

Age Restrictions See “Other Criteria” Prescriber Restrictions MD is pulmonologist

Coverage Duration If all of the conditions are met the initial request will be 6 months. Reauthorization requests will be 12 months. If all of the criteria are not met, the request is referred to a Medical director/clinical reviewer for medical necessity review.


Initial criteria: • Documentation provided includes a copy of the FDA-cleared

cystic fibrosis (CF) mutation test OR documentation from the National Cystic Fibrosis Registry (e.g. screen shot) with member’s genetic mutations

• The request is for an FDA approved indication for the member’s genotype and within dosing guidelines

• The request is appropriate for member (e.g. age/weight) based on FDA-approved package labeling, peer reviewed medical literature and nationally-recognized compendia.

• Baseline forced expiratory volume in 1 second (FEV1)were submitted with request* Not required for kids <6 years old

• Baseline liver transaminase levels were submitted with request (within 90 days of request)

• If request is for Orkambi, baseline bilirubin levels were submitted with request (within 90 days of request)

Reauthorization:

• Based on prescriber’s assessment, patient continues to benefit from therapy

• The request is within FDA dosing guidelines • MD attests that liver function testing/monitoring has been

completed per the package labeling


Revised April 2014


Inhaled Cystic Fibrosis Agents

Drug(s) Cayston® (Aztreonam lysine), Pulmozyme® (dornase alfa), Tobi®, Tobi Podhaler®, Bethkis, Kitabis (tobramycin), or any newly marketed inhalation for treatment of cystic fibrosis


Exclusion Criteria See “Other Criteria” Required Medical Information • Request is for an FDA approved indication and

within dosing guidelines • The request is appropriate for member (e.g

age/weight) based on FDA-approved package labeling, peer reviewed medical literature and nationally-recognized compendia.

• If the request is for a brand name tobramycin product, documentation has been provided why member is unable to use generic tobramycin

Age Restrictions See “Other Criteria”

Prescriber Restrictions MD is pulmonologist Coverage Duration If all of the conditions are met the request will be approved

for 12 months. If all of the criteria are not met, the request is referred to a Medical director/clinical reviewer for medical necessity review.


N/A Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.

Opioid Dependence Agents Prior Authorization Criteria

Formulary Agents: Buprenorphine/Naloxone sublingual tablets – Formulary with QL Vivitrol®- Formulary with QL Naltrexone tablet- Formulary Non-Formulary Agents: Zubsolv® Buprenorphine Bunavail® Suboxone® Sublocade Probuphine® Or any newly marketed opioid dependence agent

Initial Request for oral opioid dependence agents:

1. Diagnosis is for opioid dependence and/or opioid addiction (requests for pain will be denied)

2. If member is female of child bearing age, provider attests that a pregnancy test was completed within 30 days of the request - if positive, buprenorphine generic or buprenorphine/naloxone sublingual tablets will be approved.

a. If member is pregnant, up to 24mg buprenorphine per day will be allowed b. Duration of approval will be up to 1 month after estimated delivery date

3. Provider confirms that the risks of using buprenorphine/naloxone with alcohol or benzodiazepines have been explained to the member

4. For a non-preferred oral Opioid Dependence Agent, provider has documented with medical charts or claims history shows therapeutic failure, contraindication or intolerance of buprenorphine/naloxone sublingual tablets

5. For buprenorphine products above 16mg per day, Zubsolv above 11.4mg/2.9mg per day or Bunavail film above 8.4mg/1.4mg per day

a. Criteria #1-4 have been met and additionally, the following criteria are met: b. Provider has documented medical necessity and dose requested is

supported by clinical treatment guidelines c. Documentation of an evaluation by a licensed drug and alcohol provider or

a single county authority to determine recommended level of care d. Participation with a licensed drug and alcohol or behavioral health provider

at the recommended level of care until successful completion of the program

6. If criteria has been met, the request will be approved for up to 6 months

Renewal Request: 1. If member is female of child bearing age, provider attests that a pregnancy test

was completed within 30 days of the request - if positive, buprenorphine generic or buprenorphine/naloxone sublingual tablets will be approved.

2. Provider confirms that the risks of using buprenorphine/naloxone with alcohol or benzodiazepines have been explained to the member

3. For a non-preferred oral Opioid Dependence Agent, provider has documented with medical charts or claims history shows therapeutic failure, contraindication or intolerance of buprenorphine/naloxone sublingual tablets

4. For buprenorphine products above 16mg per day, Zubsolv above 11.4mg/2.9mg per day or Bunavail film above 8.4mg/1.4mg per day

a. Criteria #1-3 have been met and additionally, the following criteria are met: b. The requested dose is a medically accepted prescribing practice and is

standard of care c. Participation with a licensed drug and alcohol or behavioral health provider

at the recommended level of care until successful completion of the program

5. If criteria has been met, the request will be approved for up to 12 months

Requests for Sublocade or Probuphine: 1. Agent being requested is being prescribed for the treatment of a condition that is

FDA approved or a medically accepted indication and is consistent with package labeling

2. If criteria has been met, the request will be approved for up to 6 months for initial and up to 12 months for renewal


Oral Antipsychotic Agents

Drugs For antipsychotic medications that require PA for members less than 18 years of age






Prescriber Restrictions Prescription is written by a specialist or appropriate consultation with a specialist has occurred. Specialists may include Pediatric Neurologist, Child and Adolescent Psychiatrist, Child development Pediatrician, or General Psychiatrist for recipients 14 or older.

Coverage Duration If the criteria are met, the request will be approved with up to a 12 week duration for initial authorization and up to 12 month duration for reauthorization; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.

Other Criteria Initial Authorization: 1. Documentation of severe behavioral problems related to

psychotic or neuro-developmental disorders (such as but not limited to autism, intellectual disability, conduct disorder, bipolar disorder, tic disorder (including Tourette’s syndrome), transient encephalopathy or schizophrenia Documentation of a comprehensive patient evaluation including baseline monitoring of all of the following:

a. Weight/BMI b. Blood pressure c. Glucose d. Lipids e. Extrapyramidal symptoms (EPS) using the abnormal

involuntary movement scale (AIMS) 2. Documentation of a trial of non-pharmacologic therapies (such

as but not limited to behavior, cognitive or family based therapies)

Re-Authorization:

1. Documentation of improvement of target symptoms 2. Documentation of follow up monitoring of all of the following:

a. Weight/BMI (at least quarterly) b. Blood pressure (after 3 months of therapy and annually

thereafter) c. Glucose (after 3 months of therapy and annually

thereafter) d. Lipids (after 3 months of therapy and annually

thereafter) e. Extrapyramidal symptoms (EPS) using the abnormal

involuntary movement scale (AIMS) (after 3 months of

therapy and annually thereafter) 3. Clinical rationale for continued use or plan for discontinuation

of therapy

Duplicate Antipsychotic Criteria Duplicate antipsychotic use will be approved when one of the following criteria is met:

1. Documentation member is being titrated to or tapered from a drug in the same class

2. Documentation of peer reviewed literature or national treatment guidelines that support the use of the regimen requested


necessary.



CHELATING AGENTS

Drugs FORMULARY STATUS Specialty Tier (PA required) • Exjade® (Deferasirox) Tablet for Oral Suspension

• Jadenu® (Deferasirox) Tablet, Granule Pack




Age Restrictions See “other criteria” Prescriber

Restrictions N/A

Coverage Duration If the above conditions are met, the request will be approved with a 6 month duration; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.

Other Criteria Chronic iron overload due to blood transfusions: For Pediatric Population:

• Patient must be > 2 years old and < 21 years old and

• Diagnosis of chronic iron overload due to blood transfusions and

• Patient receiving blood transfusions on a regular basis/participating in blood transfusion program and

• Serum Ferritin concentration is consistently > 1000 mcg/L. If the serum ferritin levels fall consistently below 500 mcg/L, Exjade or Jadenu must be discontinued and

• The medication requested is being prescribed at an FDA approved dose

For Adult Population: • Patient must be > 21 years old and

• Diagnosis of chronic iron overload due to blood transfusions and

• Patient receiving blood transfusions on a regular

basis/participating in blood transfusion program and

• Serum Ferritin concentration is consistently > 1000 mcg/L. If the serum ferritin levels fall consistently below 500 mcg/L, Exjade or Jadenu must be discontinued and

• Documented patient is unable to use deferoxamine (Desferal) parenterally and


Chronic iron overload in non-transfusion dependent thalassemia Syndromes:

• Patient must be ≥ 10 years old and

• Diagnosis of thalassemia syndrome and

• Liver iron content (LIC) by liver biopsy of ≥ 5 mg Fe/g dry weight and

• Serum ferritin level on ≥ 2 measurements one month apart of > 300mcg/L and


Revision/Review

Date 7/2018


necessary.

Proprotein Convertase Subtilisin/kexin 9 (PCSK9) PA Criteria All PCSK9’s Require Prior Authorization

Repatha® (evolocumab)- Repatha® - PREFERRED AGENT Praluent ® (alirocumab)

All initial requests for diagnosis of Familial Hypercholesterolemia (FH) must meet and include the following information:

• Request is appropriate for member as indicated in package labeling or standard of care guidelines • Prescriber must be cardiologist or specialist in treatment of lipid disorders. • Patient has tried and failed atorvastatin 40mg-80mg or rosuvastatin 20-40mg (consistently for 3 months via

claim history or chart notes). If patient is not able to tolerate atorvastatin or rosuvastatin, documentation was provided that patient is taking another statin at the highest tolerated dose, or a medical reason was provided why the member is not able to use these therapies.




• Documentation was provided including one fasting lipid panel lab report with abnormal low density lipoprotein (LDL) levels ≥190 for Familial Hypercholesterolemia (FH) in adults or ≥160 for FH in children.

• ONE of the following also applies: o Has first degree relative with confirmed FH o Has premature coronary artery disease (CAD) o Has positive genetic testing for LDL raising gene defect or autosomal-recessive FH (copy of lab

required) o Has an LDL > 400mg/dL with aortic valve disease OR xanthoma at <20 years of age

• If the request is for Praluent, documentation was provided of trial and failure, or a medical reason has been provided, why member is unable to use Repatha to manage their condition.

If the above criteria are met for familial hypercholesterolemia, the request will be approved for up to a 3 month duration; if all of the above criteria are not met, the request is referred to a Physician reviewer for medical necessity review.

All initial requests for primary hyperlipidemia OR secondary hyperlipidemia with atherosclerotic cardiovascular disease must meet and include the following information:

• Request is appropriate for member(e.g. age) as indicated in package labeling or standard of care guidelines • Prescriber must be cardiologist or specialist in treatment of lipid disorders. • Documentation was provided 1) if member has atherosclerotic cardiovascular disease (ASCVD),2) if member

has elevations of LDL-C >190mg/dL OR 3) if the member has diabetes and is age 40-75 years old OR 4) if the member does not have diabetes, is age 40-75 years old, and has a 10 year ASCVD risk of 7.5% or greater

• Patient has tried and failed atorvastatin 40mg-80mg or rosuvastatin 20-40mg (consistently for 3 months via claim history or chart notes). If patient is not able to tolerate atorvastatin or rosuvastatin, documentation was provided that patient is taking another statin at the highest tolerated dose, or a medical reason was provided why the member is not able to use these therapies.




AND

• Documentation was provided including two fasting lipid panel lab reports within the last 12 months with abnormal low density lipoprotein (LDL) levels >70 mg/dL on maximal tolderated status plus ezetimibe with additional documentation for one of the following:

o Patient has a history of stable or unstable coronary artery disease o Patient has a history of ischemic stroke or transient ischemic attack o Patient has a history of peripheral arterial disease

OR Documentation was provided including two fasting lipid panel lab reports within the last 12 months with abnormal low density lipoprotein (LDL) levels >= 50 mg/dL on maximal tolderated statin plus ezetimibe with additional documentation for one of the following:

o Acute coronary syndrome within the past year o Diabetes o Chronic kidney disease stages 3, 4, and 5 o Recurrent atherosclerotic CVD event or need for revascularization while on a statin o Polyvascular disease o History of premature ASCVD (<55 years of age for males or <65 years of age for females)

If the request is for Praluent, documentation was provided of trial and failure, or a medical reason has been provided, why member is unable to use Repatha to manage their condition

If the above criteria are met for primary or secondary hyperlipidemia, the request will be approved for up to a 3 month duration; if all of the above criteria are not met, the request is referred to a Physician reviewer for medical necessity review.

Criteria for reauthorization for FH, primary or secondary hyperlipidemia:

• Prescriber must be cardiologist or a specialist in the treatment of lipid disorders. • Documentation submitted indicates that the member has obtained clinical benefit from the medication

o For first reauthorization request only: repeat fasting lipid panel lab report which shows improvement in LDL from previous request.

• The patient’s claim history shows consistent therapy (i.e. monthly fills)

If the above criteria are met, the reauthorization request will be approved for up to a 12 month duration; if all of the above criteria are not met, the request is referred to a Physician reviewer for medical necessity review.

NOTE: Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.

Review/Update: 2/2019

Field Name Field Description Prior Authorization Group Description Sleep Disorder Stimulants

Drugs Formulary status: Non-formulary, prior authorization required • modafinil (Provigil) tablets • armodafinil (Nuvigil) tablets



Required Medical Information See “other criteria”

Age Restrictions Patient must be 18 years of age or older. Prescriber Restrictions N/A


Other Criteria


10/2018

Authorization: • Appropriate diagnosis/indication for requested medication • Medication is being prescribed at an FDA approved dose

Continuation of Therapy/Grandfathering Provision: Members with history (within the past 90 days) of a non-formulary product are not required to try a formulary agent prior to receiving the non-formulary product. Medical Director/clinical reviewer must override criteria when, in



Quantity Limit Exception Criteria


Scope Requests for formulary drugs exceeding the health plan’s published quantity limits

Criteria • The member must have a documented treatment failure with the

drug prescribed at the health plan’s quantity limit OR the member requires a dose within prescribing guidelines that exceeds the plan’s quantity limit.

AND • The provider has submitted a medical reason why the plan’s

quantity limit will be inadequate based on the member’s condition and treatment history.

AND • The dose requested is supported by the Medical Compendia or

current treatment guidelines.


Coverage Duration 12 Months Revision/Review Date

10/2018


Prior Authorization Exception Criteria


Scope Requests for exception to the drug’s prior authorization criteria requirements

Criteria • The provider either verbally or in writing has submitted a medical or member specific reason why prior authorization criteria all or in part is not applicable to the member.

o Medical reasons may include but are not limited to: Criteria requirements are not applicable to the

member based on the uniqueness of the member’s condition or other physical characteristics of the member’s condition.

OR

o Member specific reasons may include but are not limited to: Mental and/or physical characteristics of the

member which may inhibit the provider from obtaining all necessary prior authorization criteria requirements.


Coverage Duration 12 months

Revision/Review date: 10/2017


Injectable/Specialty Medications Without Specific Prior Authorization Protocol

Drugs Any injectable or specialty medication that does not have criteria specific to the drug***PLEASE NOTE FOR ONCOLOGY MEDICATIONS there is either specific criteria or follow the ONCOLOGY WITHOUT SPECIFIC CRITERIA POLICY***





Prescriber Restrictions N/A Coverage Duration If all of the conditions are met, requests will be approved for up to 6 months.

If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria


• Appropriate diagnosis according to covered uses section • For Non-Formulary agents documentation has been provided that

patient has tried and failed the formulary agents as indicated in covered uses OR a medical reason has been provided as to why these agents are unable to be used to treat the patient’s condition (e.g. intolerance, contraindication, etc.)

• Dosing is appropriate Physician/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.

Field Name Field Description Prior Authorization Group Description PEDICULICIDES

Drugs FORMULARY STATUS Formulary, Pays at Point-of-Sale • Permethrin OTC: Lotion / cream rinse and liquid • Pyrethrins/Piperonyl Butoxide OTC: Shampoo • Sklice (ivermectin): Lotion

FORMULARY STATUS Non-Formulary, Requires Prior Authorization (Second Line)

• Eurax (crotamiton): Cream and Lotion • Lindane: Shampoo • Lycelle: Gel • Ovide (malathion): Lotion • Natroba (spinosad): Topical Suspension • Or any newly marketed pediculicide

Note: Patient must meet criteria #1& #2 for approval of

initial PA request. Covered Uses Medically accepted indications are defined using the following



Required Medical Information See “other criteria”


Coverage Duration If the criterion is met, the request will be approved for initial authorization. For re – authorization, a maximum of 2 treatments in a 30 day period will be approved. If the criterion is not met, the request will be referred to a Clinician for medical necessity review.

Other Criteria



1. Diagnosis of pediculus capitus (head lice and its eggs) 2. Documented intolerance or hypersensitivity to a first line agent OR Documented trial and failure of a first line agent within the previous 45 days, but no earlier than 7 days after the original fill.

Re - Authorization:

• Natroba can be approved for a second treatment if live lice are present 7 days after the initial treatment.

• Ovide can be approved for a second treatment if live lice are present 7-9 days after the initial treatment.


when, in his/her professional judgement, the requested item is medically necessary.


PROTON PUMP INHIBITORS (PPIs)

Drugs FORMULARY STATUS Formulary, Pays at Point-of-Sale • PRILOSEC (omeprazole) capsule; tablet (generic OTC only) • PRILOSEC (omeprazole) packet for oral suspension (for

members <8 years old only) • PROTONIX (pantoprazole) tablet

FORMULARY STATUS Formulary, Requires Step Therapy

• PREVACID/PREVACID 24HR OTC (lansoprazole) capsule: • ZEGERID OTC (omeprazole/sodium bicarbonate) capsule • NEXIUM 24HR OTC (esomeprazole) capsule

Note: Patient must meet criteria #1 & # 2 for approval of the PA

request.

FORMULARY STATUS Non-Formulary, Requires Prior Authorization • ACIPHEX • ACHIPHEX SPRINKLES • DEXILANT (dexlansoprazole) • NEXIUM (esomeprazole) capsules & packet for oral

suspension • PRILOSEC OTC (omeprazole) • PREVACID (lansoprazole) solutabs • Omeprazole Magnesium capsule (generic OTC) • PROTONIX (pantoprazole) packet for oral suspension • ZEGERID (omeprazole/sodium bicarbonate)

Note: Patient must meet criteria #1, # 2 & #3 for approval of the PA

request.




Age Restrictions N/A Prescriber N/A

Restrictions Coverage Duration If the criteria are met, the request will be approved with up to a 12


Other Criteria



1. Presumed or documented diagnosis of duodenal ulcer, H.pylori, gastritis, gastric ulcer, GERD, erosive esophagitis, Barrett’s disease or hypersecretory disease.

2. Documented trial and failure or intolerance with omeprazo or pantoprazole tablets for a minimum of 3 weeks of thera within the previous 60 days.

3. Documented trial and failure or intolerance with Prevacid 24 HR or Zegerid OTC once daily for a minimum of 3 weeks of therapy.

Doses Greater Than Once Daily After Meeting Criteria For PPI:

1. Confirmed diagnosis of GERD, erosive esophagitis, H. pylori or hypersecretory disease. OR

2. Evaluation made by gastroenterologist and / or otolaryngologist recommending higher doses of PPI.


necessary.

p


Prior Authorization Group Description Pulmicort® Respules (budesonide)

Drugs Pulmicort® Respules (budesonide) inhalation suspension Covered Uses Medically accepted indications are defined using the following sources:



Information



Restrictions N/A

Coverage Duration If the above conditions are met, the request will be approved with a 12 month duration. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria


• Diagnosis of chronic asthma for patients of ages 12 months to 8

years will process at the point of sale without prior authorization required if dosed within appropriate dosing guidelines as follows:

o 0.25mg/2mL once daily o 0.5mg/2mL once daily or twice daily o 1.0mg/2mL once daily

• A dose of 0.25mg/2mL twice daily will be approved if prescriber indicates that once daily dosing is not efficacious and determines that increasing the dose (i.e. 0.5mg/2mL once daily) is not appropriate for the patient.



Pulmonary Arterial Hypertension (PAH) PA Criteria

Drugs Adcirca® (tadalafil), Letairis™ (ambrisentan), Revatio® (sildenafil), Tracleer® (bosentan), Opsumit ® (macitentan), Orenitram™ (Treprostinil Diolamine), Adempas ® (riociguat), Uptravi® (selexipag), Flolan® (epoprostenol), Remodulin® (Treprostinil), Tyvaso® (Treprostinil), Ventavis ® (Iloprost) and any other newly marketed PAH treatment agents.





Restrictions Prescriber must be pulmonologist or cardiologist

Coverage Duration If all of the above conditions are met, the request will be approved for 6 month duration, with the exception of Orenitram™ Uptravi® Tyvaso®, Adempas® or Ventavis® requests. Orenitram™ and Uptravi® requests will be initially approved for 28 days (approve Uptravi® for an initial 200mcg bottle of #140 for 28 days, subsequent refill with Titration Pack for 28 days or documentation that patient has achieved highest tolerated dose. Orenitram™ and Adempas® requests should be approved for 28 days using dose the proper tablets required according to the titration schedule). Tyvaso® requests should be approved for the 28 day starter kit followed by the refill kit. Ventavis® requests should be approved for up to 28 days. Once patient has achieved maintenance dosing, further refills can be approved for 6 month duration. Patients new to the plan would be approved for 6 months with documentation patient is stable on dose. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria


• Documentation of a confirmed diagnosis of pulmonary arterial hypertension (PAH) World Health Group (WHO Group I), and functional class Or Persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (WHO Group 4) after surgical treatment or inoperable CTEPH to improve WHO functional class and to delay clinical worsening (ADEMPAS only)

• Medication is being used for an FDA approved functional class at a

dose that is within FDA approved guidelines or supported by nationally recognized compendia or peer reviewed medical literature.

• Documentation that the patient has undergone acute vasoreactivity testing and whether or not the results were favorable (required for WHO group 1 patients only). For those patients who demonstrated a favorable response to the acute vasoreactivity testing (defined as a fall in mean pulmonary arterial pressure [PAPm] of at least 10 mm Hg to < 40 mm Hg with an increased or unchanged cardiac output), then documentation that his/her pulmonary hypertension has progressed despite maximal medical treatment with a calcium channel blocker, or documentation has been provided of medical reason why patient is not able to use a calcium channel blocker.

• Documentation of the patient’s current weight (for epoprostenol injection, treprostinil injection or Tracleer requests).

• If the request is for Revatio® oral suspension, documentation has been submitted as to why patient is unable to use sildenafil or tablets (e.g. difficulty swallowing)

• If the request is for Opsumit® or Tracleer® the patient must have a documented trial and failure or intolerance to Letairis™.

• If the provider is requesting combination therapy with two agents then documentation must be submitted as to why patient is unable to be treated with monotherapy, or a medical reason was provided why monotherapy is not appropriate.. (e.g. worsening of the symptoms of dyspnea or fatigue, decline in functional class by at least one class or in 6-minute walk test (6MWD) by greater than 30meters)

• If the provider is requesting combination therapy with three agents then documentation must be submitted of an adequate trial of therapy with two agents of different mechanism, documentation that the patient has been compliant with the dual therapy agents, and documentation that the patient has clinically deteriorated, or a medical reason was provided why dual therapy is not appropriate (e.g. worsening of the symptoms of dyspnea or fatigue, decline in functional class by at least one class or in 6-minute walk test (6MWD) by greater than 30 meters) while on dual therapy.

• For Orenitram™ Uptravi® Tyvaso®, Adempas® and Ventavis® requests, documentation of current dosing and titration schedule is required.

• If the request is for Tyvaso®, Ventavis® or Uptravi®, and the patient has functional class II or III, documentation has been provided that the patient has tried and failed an adequate trial (3 months) of a


phosphodiesterase-5 inhibitor (e.g. sildenafil) in combination with an endothelin receptor antagonist (e.g. Letairis) or a medical reason has been submitted why the patient is not able to use BOTH of these therapies before starting Tyvaso®, Ventavis® or Uptravi®.

Re-authorization:

• Documentation has been submitted indicating the clinical benefit of therapy (e.g. improvement in functional class, improvement in 6-minute walk test, exercise capacity, or hemodynamics).

• If dosing is being increased, documentation of the medical necessity to increase the dosage is provided.

• For Orenitram™ and Uptravi® Tyvaso®, Adempas®, and Ventavis® requests, documentation of current dosing and titration schedule is required.

• The medication is being recommended and prescribed by a pulmonologist or a cardiologist at a dose that is within FDA approved guidelines or supported by nationally recognized compendia or peer reviewed medical literature.

Members with history of a Pulmonary Arterial Hypertension agent in the previous 90 days are not required to try a formulary Pulmonary Arterial Hypertension agent and will be approved for that same agent as a continuation of therapy.

Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically

necessary.


SEDATIVE HYPNOTICS

Drugs FORMULARY STATUS Formulary, Pa ys at Point-of-Sale (First Line)

• Ambien (zolpidem) • Sonata (zaleplon)

FORMULARY STATUS: Formular y, Requires Step Therap y (Second Line)

• • Lunesta (eszopiclone) tablet

Note: Patient must meet #1 & #2 criteria for approval of initial PA

request FORMULARY STATUS Non-Formulary, Requires Prior Authorization (Second Line)

• Ambien CR (zolpidem) extended-release tablet • Edular (zolpidem) sublingual tablet • Rozerem (ramelteon) tablet • Intermezzo (zolpidem) sublingual tablet • Zolpimist (zolpidem) oral solution

Note: Patient must meet criteria #1, #2 & #3 for approval of initial

PA request.





Restrictions N/A


Other Criteria PA CRITERIA FOR APPROVAL: 1. Diagnosis of insomnia.

2. Documented trial and failure or intolerance to Ambien (zolpidem) or Sonata (zaleplon) for at least 2 weeks (14 days) of therapy. 3. Documented trial and failure or intolerance to Lunesta (eszopiclone) for at least 2 weeks (14 days) of therap y.

NOTE: Rozerem can be approved as a first line agent if there is a

history of substance abuse.



necessary.


SEROTONIN RECEPTOR AGONISTS (TRIPTANS)

Drugs FORMULARY STATUS Formulary, Pays at Point-of-Sale (First Line) Patient must meet #3 to pay at point of sale

• Imitrex (sumatriptan) • Maxalt & Maxalt- MLT (rizatriptan)

FORMULARY STATUS Non-Formulary, Requires Prior Authorization (Second Line)

• Amerge (naratriptan) • Axert (almotriptan) • Frova (frovatriptan) • Relpax (eletriptan) • Sumavel Dosepro (sumatriptan) • Treximet (sumatriptan/naproxen) • Zomig (zolmitriptan) • Zomig-ZMT(zolmitriptan) • Zembrace™ SymTouch (sumatriptan) • Any other newly marketed serotonin receptor agonists

(triptans) treatment agents. Patients must meet #1 or 2 and and 4 for approval





Restrictions N/A

Coverage Duration If the above conditions are met, the request will be approved with a 12 month duration for quantities not to exceed 12 tablets per 30 days, 2 injections kits (4 injections) per 30 days, and 6 nasal spray units (1 box) per 30 days; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.

Other Criteria Initial Authorization: 1. Diagnosis of migraine headaches. 2. Diagnosis of cluster headaches (sumatriptan injection only). 3. An automatic approval for sumatriptan (generic) or rizatriptan at the point-of-sale will occur if the quantities prescribed do not exceed 12 tablets per 30 days, 2 injection kits (4 injections) per 30 days, and 6 nasal spray units (1 box) per 30 days. 4. Documented trial and failure at therapeutic doses or intolerance to sumatriptan or rizatriptan.

Quantities Greater Than Allowed Per 30 Days: If the patient requires doses greater than the set limits after meeting approval, the request will be referred to a Medical Director/clinical reviewer for medical necessity review.

Revision/Review

Date 4/2018 Medical Director/clinical reviewer must override criteria when, in


PRIOR AUTHORIZATION CRITERIA RITUXAN® (rituximab) & RITUXAN HYCELA (rituximab and hyaluronidase)

RITUXAN® WILL BE APPROVED IF THE FOLLOWING PRIOR AUTHORIZATION CRITERIA IS MET:

PA CRITERIA FOR INITIAL APPROVAL FOR USE IN RHEUMATOID ARTHRITIS: • The medication is being recommended and prescribed by a rheumatologist. • The patient is an adult (≥18 y/o) and has a documented clinical diagnosis of rheumatoid arthritis. • The patient has a documented (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) adequate trial (including dates and doses) of 3 months or more of therapy) of

® methotrexate AND then leflunomide (generic Arava ) and/or another disease-modifying antirheumatic treatment option (i.e. combination therapy - methotrexate + sulfasalazine and/or hydroxychloroquine) or has another documented medical reason (e.g. intolerance, hypersensitivity) for not utilizing any of these therapies to manage their medical condition. • The patient has a documented (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) adequate trial (including dates, doses) of all preferred biologics indicated for rheumatoid arthritis, or has documented medical reason (intolerance, hypersensitivity, etc.) for not taking ALL of these therapies to manage their medical condition. • Documentation indicating that Rituxan® is being used concurrently with methotrexate. • Documentation indicating that the patient has been screened for HBV (hepatitis B virus) prior to initiation of treatment. • Rituxan® is being prescribed at an FDA approved dosage.

If all of the above conditions are met, the request will be approved for up to a 1 month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review.

PA CRITERIA FOR RE-AUTHORIZATION FOR USE IN RHEUMATOID ARTHRITIS • The member has been receiving Rituxan® and documentation is provided that a rheumatologist has reevaluated the member and recommends continuation of therapy. • Documentation was provided indicating that the patient had clinical benefit from receiving Rituxan® therapy. • At least 16 weeks (4 months) has elapsed since the previous course of Rituxan® therapy. • Documentation indicating that Rituxan® is being used concurrently with methotrexate. • Rituxan® is being prescribed at an FDA approved dosage.


PA CRITERIA FOR INITIAL APPROVAL FOR USE IN NON-HODGKIN’S LYMPHOMA (NHL) AND CHRONIC LYMPHOCYTIC LEUKEMIA (CLL): • The medication is being recommended and prescribed by an oncologist. • If the medication request is for Non-Hodgkin Lymphoma, documentation was submitted of confirmed diagnosis of CD20-positive B-cell NHL • If the medication request is for Chronic Lymphocytic Leukemia, documentation was submitted of confirmed diagnosis of CD20-positive CLL and Rituxan® is being using in concurrently with fludarabine and cyclophosphamide (FC) • Documentation indicating that the patient has been screened for HBV (hepatitis B virus) prior to initiation of treatment. • Rituxan® is being prescribed at a dose that is within FDA approved guidelines and/or is supported by the medical compendium as defined by the Social Security Act and/or the National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) standard of care guidelines.


PA CRITERIA FOR RE-AUTHORIZATION FOR USE IN NON-HODGKIN’S LYMPHOMA (NHL) AND CHRONIC LYMPHOCYTIC LEUKEMIA (CLL):

• The medication is being recommended and prescribed by an oncologist. • Rituxan® is being prescribed at a dose that is within FDA approved guidelines and/or is supported by the medical compendium as defined by the Social Security Act and/or per the NCCN or ASCO standard of care guidelines.


PA CRITERIA FOR INITIAL APPROVAL FOR USE IN GRANULOMATOSIS WITH POLYANGIITIS (GPA) (WEGENER’S GRANULOMATOSIS) AND MICROSCOPIC POLYANGIITIS (MPA): • The medication is being recommended and prescribed by a rheumatologist or nephrologist.. • The patient is an adult (≥18 y/o) and has a documented clinical diagnosis of granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) or microscopic polyangiitis (MPA). • The patient has a documented (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) adequate trial (including dates, doses) of glucocorticoid

® (i.e. prednisone) AND methotrexate, OR glucocorticoid AND cyclophosphamide (Cytoxan ) OR documentation includes a medical reason (intolerance, hypersensitivity, etc.) why patient is not able to use these therapies to manage their medical condition. • Documentation indicating that Rituxan® is being used concurrently with glucocorticoids. • Documentation indicating that the patient has been screened for HBV (hepatitis B virus) prior to initiation of treatment. • Rituxan® is being prescribed at an FDA approved dosage.


PA CRITERIA FOR RE-AUTHORIZATION FOR USE IN GRANULOMATOSIS WITH POLYANGIITIS (GPA) (WEGENER’S GRANULOMATOSIS) AND MICROSCOPIC POLYANGIITIS (MPA): • The medication is being recommended and prescribed by a rheumatologist or nephrologist. • Rituxan is being prescribed at an FDA approved dose.


RITUXAN® HYCELA WILL BE APPROVED IF THE FOLLOWING PRIOR AUTHORIZATION CRITERIA IS MET:

PA CRITERIA FOR INITIAL USE IN CHRONIC LYMPHOCYTIC LEUKEMIA (CLL), FOLLICULAR LYMPHOMA (FL), OR DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL): • The medication is being recommended and prescribed by an oncologist. • The patient is an adult (≥18 y/o) and documentation was submitted that the patient has received at least one full dose of a rituximab product by intravenous infusion. • If the medication is for CLL, the patient has a confirmed diagnosis of malignant CD20-positive CLL and Rituxan® Hycela is being used concurrently with fludarabine and cyclophosphamide (FC) • If the medication is for FL, the patient has a confirmed diagnosis of malignant FL • If the medication is for DLBCL, the patient has a confirmed diagnosis of previously untreated malignant DLBCL and Rituxan® Hycela is being used concurrently with cyclophosamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimen. • Documentation indicating that the patient has been screened for HBV (hepatitis B virus) prior to initiation of treatment. • Rituxan® is being prescribed at a dose that is within FDA approved guidelines and/or is supported by the medical compendium as defined by the Social Security Act and/or per the NCCN or ASCO standard of care guidelines.


PA CRITERIA FOR RE-AUTHORIZATION FOR USE IN CHRONIC LYMPHOCYTIC LEUKEMIA (CLL), FOLLICULAR LYMPHOMA (FL), OR DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL): • The medication is being recommended and prescribed by an oncologist. • Rituxan® is being prescribed at a dose that is within FDA approved guidelines and/or is supported by the medical compendium as defined by the Social Security Act and/or per the NCCN or ASCO standard of care guidelines.


PA CRITERIA FOR INITIAL AUTHORIZATION FOR USE IN OTHER MEDICALLY ACCEPTED INDICATIONS • The medication is prescribed for a non-FDA approved indication but is considered to be a medically accepted use of the medication per the medical compendia (Micromedex, American Hospital Formulary Service (AHFS), DrugPoints, the Drug Package Insert as defined in the Social Security Act and/or per the National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology (ASCO) or the American Academy of Pediatrics (AAP) standard of care guidelines and has a Class I or IIa recommendation. • The medication is prescribed at a medically accepted dose per the medical compendia as defined above. • The medication is recommended and prescribed a specialist in the field to treat the member’s respective medical condition.

• Documentation indicating that the patient has been screened for HBV (hepatitis B virus) prior to initiation of treatment. • Documentation was submitted indicating that the member has a documented (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) adequate trial (including dates, doses of medications) of ALL first line medical therapies as recommended by the medical compendia and standard care guidelines and/or has another documented medical reason (e.g. intolerance, contraindications, etc.) for not receiving or trying all first line medical treatment(s).

If all of the above conditions are met, the request will be approved for up to a 3 month duration. If all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review.

PA CRITERIA FOR RE-AUTHORIZATION FOR USE IN OTHER MEDICALLY ACCEPTED INDICATIONS • The medication is prescribed at a medically accepted dose per the medical compendia • The medication is recommended and prescribed a specialist in the field to treat the member’s respective medical

condition. • Documentation from medical chart was submitted indicating that the member has significantly clinically benefited from the medication.


NOTE: Physician/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.



Safety Edit Exception Criteria


Scope Requests for formulary drugs and for previously approved non-formulary drugs:

• Exceeding the Food and Drug Administration (FDA) or compendia max dose recommendations

• Exceeding the FDA dosing or compendia administration frequency recommendations

• Exceeding the FDA or compendia duration of therapy recommendations

• Duplication of therapy error at Point of Service (POS) • (including ADHD medications, Benzodiazepines, SSRI, SNRI,

Antipsychotics, Nitrates and PDE-5 inhibitors, Opioid dependence agents and Opioids, Warfarin and factor 10a inhibitors)

• Age Restriction error at POS Criteria Exceeding the FDA or compendia maximum dose, administration

frequency or duration of therapy recommendations.

• The member must have a documented treatment failure with the drug at the maximum tolerated dose or maximum dose (whichever is the lesser dose), administration frequency or duration of therapy.

AND • The provider must submit a medical reason why the maximum

dose, administration frequency or duration of therapy needs to be exceeded based on the member’s condition or treatment history.

Duplication of therapy

Transition from one agent to another

• If a provider has outlined a plan to transition a member to a similar drug or provided a dose titration schedule, the requested drug is approved for one month*.

Concurrent Therapy with two similar agents

• The provider must submit a medical reason why treatment with more than one drug in the same class is required based on the member’s condition and treatment history.

OR • The provider must submit disease state specific standard of care

guidelines supporting concurrent therapy. Age Restriction

• The provider must submit a medical reason why the drug is needed for a member whose age is outside of the plan’s minimum or maximum age limit.

AND • The indication and dose requested is supported by the Medical

Compendia or current treatment guidelines.


Coverage Duration *One month approval for Duplication of therapy when transitioning from one agent to another. All Other Scenarios: 12 months



Second Generation Antihistamines PA Criteria

Drugs FORMULARY STATUS Formulary, Pays at Point-of-Sale (First Line)

CLARITIN® (loratadine) (generic) tablets, ZYRTEC® (cetirizine) (generic) tablets, oral solution XYZAL® (levocetirizine) tablets FORMULARY STATUS Formulary, Requires Step Therapy (Second

Line) ALLEGRA® (fexofenadine) (generic) oral suspension and 180 mg tablets only CLARITIN® (loratadine) (generic) 10 mg orally disintegrating tablets, oral solution, capsules ZYRTEC® (cetirizine) (generic) orally disintegrating tablets, capsules ZYRTEC-D® 12 HOURS (cetirizine/pseudoephedrine) (generic)

*Patient must meet criteria #1 and #2 for approval

FORMULARY STATUS Non-Formulary, Requires Prior Authorization (Third Line)

ALLEGRA® (fexofenadine) 30mg and 60 mg tablets ALLEGRA-D® 12 HOUR (fexofenadine/pseudoephedrine) ALLEGRA-D® 24 HOUR (fexofenadine/pseudoephedrine) CLARITIN® (loratadine) (generic) 5 mg orally disintegrating tablets CLARITIN-D® 12 HOUR (loratadine/pseudoephedrine) (generic) CLARITIN-D® 24 HOUR (loratadine/pseudoephedrine) (generic) CLARINEX® (desloratadine) CLARINEX-D® 12 HOUR (desloratadine/pseudoephedrine) SEMPREX-D (pseudoephedrine/acrivas) XYZAL® (levocetirizine) oral solution ZYRTEC® (cetirizine) (generic) chewable tablets,

*Patient must meet criteria #1, #2 and #3 for approval Covered Uses Medically accepted indications are defined using the following sources:





Restrictions N/A

Coverage Duration If the above conditions are met, the request will be approved with a 12 month duration; If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria


PA CRITERIA FOR APPROVAL:

1. Diagnosis of seasonal allergic rhinitis with or without nasal congestion, perennial allergic rhinitis with or without nasal congestion, or urticaria.

2. Documented trial and failure or intolerance to a first line agent 3. Documented trial and failure or intolerance to a second line

agent



PERFORMRX SEROSTIM PRIOR AUTHORIZATION CRITERIA

• For patients newly initiating Serostim therapy:Prescriber must be an HIV or Infectious disease specialist

• The patient has been receiving optimal highly active antiretroviral therapy (HAART) therapy for at least 3 months prior to initiation of Serostim,

• Prescriber attests that the patient has been evaluated for other possible etiologies leading to wasting/cachexia (e.g. malignancies) or fat redistribution (e.g. diabetes mellitus, lipodystrophy, etc.)

• The request is for an FDA approved/Medically accepted dosing

If the diagnosis is anything other than HIV wasting or cachexia, and the above conditions are met, the request will be approved for up to a 12 week duration.

AND If the diagnosis is HIV wasting or cachexia (all of the following apply as well):

• Baseline and repeat evaluation of patient’s weights (over last 6 months), BMI (in kg/ m2), and lean body mass (LBM) by dual energy X-ray absorptionmetry (DEXA /DXA) were provided with request

• Documentation provided demonstrates an involuntary weight loss >10% of baseline body weight associated with either chronic diarrhea (two or more loose stools per day for ≥1 month) or chronic weakness and documented fever for ≥1 month that is not due to HIV

• The patient has tried a 2 month or more course of therapy with megestrol acetate, dronabinol or cyproheptadine for appetite stimulation or has medical reason for not using one of these agents

• The patient has tried a 2 month course of therapy with anabolic steroids (e.g., Oxandrin) or has a medical reason for not using one of these agents

If the above conditions are met, the request will be approved for up to a 12 week duration. If all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review.

Patients already receiving Serostim must meet the following criteria for authorization::

• Prescriber must be an HIV or Infectious disease specialist • The patient is receiving optimal highly active antiretroviral therapy (HAART) therapy • The provider has provided documentation of clinical benefit/response.

If the above conditions are met, the request will be approved for up to a 12 week duration. If all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review.



Soliris (eculizumab)

Drugs Soliris (eculizumab)

Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, the Drug Package Insert, and/or per the standard of care guidelines





Prescriber Restrictions Prescriber must be a hematologist nephrologist, or neurologist.

Coverage Duration If the criteria are met, the initial request will be approved for up to 1 month duration; reauth requests will be approved for up to 3 months. If the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.

Other Criteria


4/2018

Initial: Requests for Myasthenia Gravis (gMG):

• Patient has a positive serologic test for anti-AChR antibodies • Patient has a Myasthenia Gravis Foundation of America (MGFA) clinical classification of

class II,III or IV at initiation of therapy • Patient has a Myasthenia Gravis-specific Activities of Daily Living scale (MG-ADL) total

score > 6 at initiation of therapy • Failed treatment over 1 year or more with 2 or more immunosuppressive therapies (ISTs)

either in combination or as monotherapy • OR • Failed at least 1 IST and required chronic plasmapheresis or plasma exchange or

intravenous immunoglobulin • OR • Has a documented history of contraindications or intolerance to ISTs

•

Requests for all other indications:

• The patient has a confirmed diagnosis that is indicated in the FDA approved package insert OR is a medically-accepted indication.

• The request is age appropriate according to FDA approved package labeling or nationally recognized compendia

• The request is for a dose that is FDA approved or in nationally recognized compendia in accordance with the patient’s diagnosis, age and concomitant medical conditions.

• Provider confirms patient has received appropriate vaccinations as recommended in the package insert unless contraindicated

• The following lab results were submitted with request (within

30 days of request):

Complete blood count with differential Lactase dehydrogenase level (LDH) Serum creatinine Aspartate Amino Transferase (AST) Urinalysis

• Reauth:

• Provider has submitted documentation of clinical response to therapy (e.g. improvement in lab values)



PERFORMRx PRIOR AUTHORIZATION CRITERIA for Specialty Biological Agents for Crohn’s Disease

PREFERRED BIOLOGICAL AGENTS: HUMIRA® (adalimumab) RENFLEXIS™ (infliximab-abda) ) NON-PREFERRED BIOLOGICAL AGENTS:- REMICADE® (infliximab) INFLECTRATM (infliximab-dyyb) CIMZIA® (certolizumab) ENTYVIO® (vedolizumab) STELARA® (ustekinumab) TYSABRI™ (natalizumab) Or any newly marketed agent PA CRITERIA FOR APPROVAL FOR CROHN’S DISEASE: • The member has a diagnosis of severe/fulminant Crohn’s disease OR • The member has mild-to-moderate/low risk or moderate-to-severe Crohn’s disease AND has had an

adequate trial of sulfasalazine, Uceris, azathioprine, 6-mercaptupurine, Pentasa or methotrexate consistent with pharmacy claims/medical record data/chart notes/physician attestation OR

• The member has a di agnosis of perianal/fistulizing Crohn’s disease AND has had an adequat e trial of azathioprine, 6-mercaptopurine, or tacrolimus consistent with pharmacy claims/medical record data/ chart notes/physician attestation

OR • Member has a doc umented medical reason (e.g. allergy, intolerance, contraindication) for not using

conventional oral therapy to manage their condition. • The medication is being recommended or prescribed by a gastroenterologist • If the request is for a non-preferred agent, documented (consistent with pharmacy claims data, OR for new

members to the health plan consistent with medical chart history) adequate trial of a preferred biological agent

If all of the above conditions are met, the request will be approved for up to a 12 -month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. PA CRITERIA FOR RE-AUTHORIZATION FOR CROHN’S DISEASE: • The medication is being recommended and prescribed by a gastroenterologist at an FDA-approved dosage. • For members who require Humira 40 mg SC weekly, documentation must be submitted indicating that the

member was compliant (consistent with pharmacy claims) with receiving at least 16 weeks of continuous Humira therapy every other week prior to the request for weekly dosing of Humira.

If all of the above conditions are met, the request will be approved for a 12 month duration; if all of the above criteria are not met, the request is referred to a Medical Director/Clinical reviewer for medical necessity review.


• Members with history (within the past 90 days) of a non-preferred biological agent are not required to try a preferred biological agent or the above mentioned conventional therapies prior to receiving the non-preferred agent.

• Members with history (within the past 90 days) of a preferred biological agent are not required to try the above mentioned conventional therapies prior to receiving the preferred biological agent.

NOTE: Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. Revision/Review Date: 02/2019

PERFORMRx PRIOR AUTHORIZATION CRITERIA for Specialty Biological Agents for Ulcerative Colitis

PREFERRED BIOLOGICAL AGENTS: HUMIRA® (adalimumab) RENFLEXIS™ (infliximab-abda) NON-PREFERRED BIOLOGICAL AGENTS:REMICADE® (infliximab) SIMPONI® (golimumab) ENTYVIO® (vedolizumab) XELJANZ® (tofacitinib) XELJANZ XR® (tofacitinib) INFLECTRA™ (infliximab-dyyb) Or any newly marketed agent PA CRITERIA FOR APPROVAL FOR ULCERATIVE COLITIS: • The member has a diagnosis of ulcerative colitis AND the medication is being prescribed at an appropriate FDA

approved dose (for age and weight) • The member has an adequate trial of conventional therapy (e.g. sulfasalazine, mesalamine, azathioprine, 6-

mercaptopurine, or oral corticosteroids) and is consistent with pharmacy claims/medical record data/chart notes/physician attestation,

OR

• Member has a documented medical reason (e.g. allergy, intolerance, contraindication) for not using conventional therapy to manage their condition.

• The medication is recommended or prescribed by a gastroenterologist. • If the request is for a non-preferred agent, documented (consistent with pharmacy claims/medical record

data/chart notes/physician attestation) adequate trial of a preferred biologic agent. If all of the above conditions are met, the request will be approved for up to a 12 -month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. PA CRITERIA FOR RE-AUTHORIZATION FOR ULCERATIVE COLITIS: • The medication is being recommended or prescribed by a gastroenterologist for an FDA-approved indication at

an FDA-approved dosage. • The member has been receiving the medication and documentation was provided that the prescriber has

evaluated the member and recommends continuation of therapy (clinical benefit). If all of the above conditions are met, the request will be approved for a 12 month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review.



• Members with history (within the past 90 days) of a preferred biological agent are not required to try the above mentioned conventional therapies prior to receiving the preferred biological agent.

NOTE: Medical Director/Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. Revision/Review Date: 02/2019

PERFORMRx PRIOR AUTHORIZATION CRITERIA for Specialty Biological Agents for Psoriasis

PREFERRED BIOLOGICAL AGENTS: ENBREL® (etanercept) HUMIRA® (adalimumab) RENFLEXIS™ (infliximab-abda) COSENTYX® (secukinumab) TALTZ® (ixekizumab) NON-PREFERRED BIOLOGICAL AGENTS:REMICADE® (infliximab) OTEZLA® (apremilast) CIMZIA® (certolizumab pegol) STELARA® (ustekinumab) TREMFYA™ (guselkumab) ILUMYA® (tildrakizumab-asmn) SILIQ™™ (brodalumab) INFLECTRA™ (infliximab-dyyb) Or any newly marketed agent

PA CRITERIA FOR APPROVAL FOR PSORIASIS: • Member has a diagnosis of plaque psoriasis AND the medication is being prescribed at an appropriate FDA

approved dose (for age and weight) The member has an adequate trial of (and is consistent with pharmacy claims/medical record data/chart notes/physician attestation) of 3 of the following: o Topical steroids o Topical tacrolimus or pimecrolimus o Dovonex (calcipotriene) Tazorac (tazarotene), anthralin or a coal tar preparation that is indicated o Methotrexate o Cyclosporine o Soriatane (acitretin) o UVB phototherapy or PUVA (psoralen-oral or topical methoxsalen plus UVA therapy)

OR • Member has a documented medical reason (e.g. allergy, intolerance, contraindication) for not using 3 of

these therapies to manage their condition. • The medication is being recommended or prescribed by a dermatologist. • If the request is for a non-preferred agent, documented (consistent with pharmacy claims/medical record

data) adequate trial of at least two preferred products with different mechanisms of action or medical reason as to why patient is unable to utilize the preferred products.

If all of the above conditions are met, the request will be approved for up to a 12 month duration. If all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. PA CRITERIA FOR RE-AUTHORIZATION FOR PSORIASIS: • The medication is being recommended or prescribed by a dermatologist at an FDA-approved dosage. • The member has been receiving the medication and documentation was provided that the prescriber has

evaluated the member and recommends continuation of therapy (clinical benefit).

If all of the above conditions are met, the request will be approved for a 12 month duration. If all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review.


• Members with history (within the past 90 days) of a non-preferred biological agent are not required to try a two preferred biological agents or the above mentioned conventional therapies prior to receiving the non-preferred agent.

• Members with history (within the past 90 days) of a preferred biological agent are not required to try the above mentioned 3 therapies prior to receiving the preferred biological agent.


PERFORMRx PRIOR AUTHORIZATION CRITERIA for Specialty Biological Agents for Polyarticular Juvenile Idiopathic Arthritis

PREFERRED BIOLOGICAL AGENTS: ENBREL® (etanercept) HUMIRA® (adalimumab) NON-PREFERRED BIOLOGICAL AGENTS:ACTEMRA® (tocilizumab) ORENCIA® (abatacept) Or any newly marketed agent PA CRITERIA FOR APPROVAL FOR POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS: • Has a diagnosis of polyarticular juvenile idiopathic arthritis AND • The medication is being prescribed at an appropriate FDA approved dose (for age and weight) The member has an adequate trial with one disease modifying anti-rheumatic drug (DMARD) (e.g.

methotrexate) or leflunomide or sulfasalazine AND a non-steroidal anti-inflammatory drug (NSIAD) (e.g. naproxen, celecoxib) and is consistent with pharmacy claims/medical record data/chart notes/physician attestation

OR


• The medication is being recommended or prescribed by a rheumatologist. • If the request is for a non-preferred agent, documented (consistent with pharmacy claims/medical

record data/chart notes.physician attestation) adequate trial of a preferred biological agent.

If all of the above conditions are met, the request will be approved for up to a 12 -month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review.

PA CRITERIA FOR RE-AUTHORIZATION FOR POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS: • The medication is being recommended or prescribed by a rheumatologist at an FDA-approved dosage. • The member has been receiving the medication and documentation was provided that the prescriber

has evaluated the member and recommends continuation of therapy (clinical benefit). If all of the above conditions are met, the request will be approved for a 12 month duration. If all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review.



• Members with history (within the past 90 days) of a preferred biological agent are not required to try the above mentioned therapies prior to receiving the preferred biological agent.


PERFORMRX PRIOR AUTHORIZATION CRITERIA for Specialty Biological Agents for Systemic Juvenile Idiopathic Arthritis

PREFERRED BIOLOGICAL AGENTS: ENBREL® (etanercept) HUMIRA® (adalimumab) NON-PREFERRED BIOLOGICAL AGENTS:ACTEMRA® (tocilizumab) ORENCIA® (abatacept) ILARIS® (canakinumab) Or any newly marketed agent

PA CRITERIA FOR APPROVAL FOR SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS: • Member has a diagnosis of systemic juvenile idiopathic arthritis AND • The medication is being prescribed at an appropriate FDA approved dose (for age and weight) • The member has an adequate trial with a formulary NSAID and is consistent with pharmacy claims/medical

record data/chart notes/physician attestation OR


• The medication is being recommended or prescribed by a rheumatologist • If the request is for a non-preferred agent, documented (consistent with pharmacy claims/medical record data)

adequate trial of a preferred biological agent. If all of the above conditions are met, the request will be approved for a 12-month duration. If all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review.

PA CRITERIA FOR RE-AUTHORIZATION FOR SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS: • The medication is being recommended and prescribed by a rheumatologist at an FDA-approved dosage. • The member has been receiving the medication and documentation was provided that the

prescriber has evaluated the member and recommends continuation of therapy (clinical benefit).

If all of the above conditions are met, the request will be approved for a 12 month duration. If all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. Continuation of Therapy/Grandfathering Provision:

• Members with history (within the past 90 days) of a non-preferred biological agent are not required to try a preferred biological agent or NSAID therapy prior to receiving the non-preferred agent.

• Members with history (within the past 90 days) of a preferred biological agent are not required to try formulary NSAID therapy prior to receiving the preferred biological agent.

NOTE: Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the

requested item is medically necessary. Revision/Review Date: 02/2019

PERFORMRx PRIOR AUTHORIZATION CRITERIA for Specialty Biological Agents for FDA (if no indication specific criteria) and NON-FDA Approved Medically

Accepted Indications

PREFERRED BIOLOGICAL AGENTS: ENBREL® (etanercept) HUMIRA® (adalimumab) RENFLEXIS™ (infliximab-abda) COSENTYX® (Secukinumab) KEVZARA® (sarilumab) TALTZ® (Ixekizumab) NON-PREFERRED BIOLOGICAL AGENTS:ACTEMRA® (tocilizumab) CIMZIA® (certolizumab) KINERET® (anakinra) ORENCIA® (abatacept) SIMPONI® (golimumab) STELARA® (ustekinumab) ENTYVIO® (Vedolizumab) OTEZLA® (Apremilast) REMICADE® (infliximab) ILARIS® (canakinumab) TREMFYA™™ (guselkumab) SILIQ™™ (brodalumab) TYSABRI™ (natalizumab) XELJANZ® (tofacitinib) XELJANZ XR® (tofacitinib) ILUMYA® (tildrakizumab-asmn) OLUMIANT® (baricitinib) INFLECTRA™ (infliximab-dyyb) Or any newly marketed agent PA CRITERIA FOR AUTHORIZATION FOR OTHER FDA or NON-FDA APPROVED MEDICALLY ACCEPTED INDICATIONS: • Request has a medically accepted use per the medical compendia or standard of care guidelines for

member (e.g. age/weight) at recommended dose • The member has an adequate trial of all first line therapies as recommended by the medical compendia or

standard of care guidelines and is consistent with pharmacy claims/medical record data/chart notes/physician attestation (including dates and dosing of all first line therapies),

OR

• Member has a documented medical reason (e.g. allergy, intolerance, contraindication) for not using all first line therapies to manage their condition.

• The medication is recommended and prescribed by a specialist in the field to treat the member’s respective medical condition. • If the request is for a non-preferred biological agent, documented (consistent with pharmacy

claims/medical record data) adequate trial of at least three preferred products with different mechanisms of action or medical reason as to why patient is unable to utilize the preferred products (


PA CRITERIA FOR RE-AUTHORIZATION FOR OTHER NON-FDA APPROVED MEDICALLY ACCEPTED INDICATIONS: • The medication is recommended and prescribed by a specialist in the field to treat the member’s

respective medical condition. • Documentation submitted indicates that the member has obtained clinical benefit from the medication. If all of the above conditions are met, the request will be approved for a 6-month duration. If all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review.


• Members with history (within the past 90 days) of a non-preferred biological product are not required to try three preferred biological agents or first line therapies prior to receiving the non-preferred agent.

• Members with history (within the past 90 days) of a preferred biological agent are not required to try all first line therapies as recommended by the medical compendia or standard of care guidelines prior to receiving the preferred biological agent.

NOTE: Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the

requested item is medically necessary. Revision/Review Date: 02/2019

PERFORMRx PRIOR AUTHORIZATION CRITERIA for Specialty Biological Agents for Rheumatoid Arthritis

PREFERRED BIOLOGICAL AGENTS: ENBREL® (etanercept) HUMIRA® (adalimumab) RENFLEXIS™ (infliximab-abda) KEVZARA® (sarilumab) NON-PREFERRED BIOLOGICAL AGENTS:REMICADE® (infliximab) ACTEMRA® (tocilizumab) CIMZIA® (certolizumab) KINERET® (anakinra) ORENCIA® (abatacept) SIMPONI® (golimumab) XELJANZ® (tofacitinib) XELJANZ XR® (tofacitinib) OLUMIANT® (baricitinib) INFLECTRA™ (infliximab-dyyb) Or any newly marketed agent

PA CRITERIA FOR APPROVAL FOR RHEUMATOID ARTHRITIS: • The member has a diagnosis of rheumatoid arthritis AND • The medication is being prescribed at an appropriate FDA approved dose (for age and weight) • The member has an adequate trial with methotrexate AND another disease modifying anti-rheumatic drug

(DMARD) (e.g. leflunomide, sulfasalazine or hydroxychloroquine) and is consistent with pharmacy claims/medical record data/chart notes/physician attestation

OR

• Member has a documented medical reason (e.g. allergy, intolerance, contraindication) for not using methotrexate AND another disease modifying anti-rheumatic drug (DMARD) (e.g. leflunomide, sulfasalazine or hydroxychloroquine) to manage their condition.

• The medication is being recommended or prescribed by a rheumatologist at an FDA-approved dosage. • If the request is for a non-preferred biological agent, documented (consistent with pharmacy

claims/medical record data) adequate trial of at least twopreferred products with different mechanisms of action or medical reason as to why patient is unable to utilize the preferred products .

If all of the above conditions are met, the request will be approved for up to a 12 -month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. PA CRITERIA FOR RE-AUTHORIZATION FOR RHEUMATOID ARTHRITIS: • The medication is being recommended or prescribed by a rheumatologist at an FDA-approved dosage. • The member has been receiving the medication and documentation was provided that the prescriber

has evaluated the member and recommends continuation of therapy (clinical benefit). • For members who require Humira 40 mg SC weekly documentation must be submitted indicating that the

member was compliant (consistent with pharmacy claims) with receiving at least 16 weeks of continuous Humira therapy every other week, AND the member has a medical reason (e.g. intolerance, hypersensitivity, contraindication) for not receiving concomitant methotrexate.



• Members with history (within the past 90 days) of a non-preferred biological product are not required to try two preferred biological agents or methotrexate AND then another DMARD prior to receiving the non-preferred agent.

• Members with history (within the past 90 days) of a preferred biological agent are not required to try methotrexate AND then another DMARD prior to receiving the preferred biological agent.

NOTE: Medical Director/Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. Revision/Review Date: 02/2019

PERFORMRx PRIOR AUTHORIZATION CRITERIA for Specialty Biological Agents for Ankylosing Spondylitis

PREFERRED BIOLOGICAL AGENTS:ENBREL® (etanercept) HUMIRA® (adalimumab) RENFLEXIS™ (infliximab-abda) COSENTYX (secukinumab) NON-PREFERRED BIOLOGICAL AGENTS:CIMZIA® (certolizumab) SIMPONI® (golimumab) REMICADE® (infliximab) Or any newly marketed agent

PA CRITERIA FOR ANKYLOSING SPONDYLITIS • The member has a diagnosis of ankylosing spondylitis AND • The medication is being prescribed at an appropriate FDA approved dose (for age and weight) • The member has an adequate trial with two different nonsteroidal anti-inflammatory drugs (NSAIDs) and is

consistent with pharmacy claims/medical record data/chart notes/physician attestation OR

• Member has a documented medical reason (e.g. allergy, intolerance, contraindication) for not using two NSAIDs to manage their condition.

• The medication requested is being recommended or prescribed by a rheumatologist. • If the request is for a non-preferred biological agent, documented (consistent with pharmacy claims/medical

record data) adequate trial of at least two preferred products with different mechanisms of action or medical reason as to why patient is unable to utilize the preferred products .

If all of the above conditions are met, the request will be approved for up to a 12-month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. PA CRITERIA FOR RE-AUTHORIZATION FOR ANKYLOSING SPONDYLITIS: • The medication is being recommended or prescribed by a rheumatologist at an FDA-approved dosage. • The member has been receiving the medication and documentation was provided that the prescriber has

evaluated the member and recommends continuation of therapy (clinical benefit). If all of the above conditions are met, the request will be approved for a 12 month duration. If all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review.


• Members with history (within the past 90 days) of a non-preferred biological product are not required to try twopreferred biological agents prior to receiving the non-preferred agent.

• Members with history (within the past 90 days) of a preferred biological agent are not required to try two different NSAIDs prior to receiving the preferred biological agent.


PERFORMRx PRIOR AUTHORIZATION CRITERIA for Specialty Biological Agents for Psoriatic Arthritis (PsA)

PREFERRED BIOLOGICAL AGENTS:ENBREL® (etanercept) HUMIRA® (adalimumab) RENFLEXIS™ (infliximab-abda) COSENTYX (Secukinumab)

TALTZ® (ixekizumab) NON-PREFERRED BIOLOGICAL AGENTS:CIMZIA® (certolizumab) SIMPONI® (golimumab REMICADE® (infliximab) OTEZLA® (Apremilast) STELARA® (ustekinumab) ORENCIA® (abatacept) XELJANZ® (tofacitinib) XELJANZ XR® (tofacitinib) INFLECTRA™ (infliximab-dyyb) Or any newly marketed agent

PA CRITERIA FOR PSORIATIC ARTHRITIS (PsA): • The member has a diagnosis of psoriatic arthritis AND • The medication is being prescribed at an appropriate FDA approved dose (for age and weight) • The member has an adequate trial with nonsteroidal anti-inflammatory drugs (NSAIDs) or a

cyclooxygenase-2 (COX-2) inhibitor and then a conventional DMARD (e.g. leflunomide, methotrexate or sulfasalazine) and is consistent with pharmacy claims/medical record data/chart notes/provider attestation

OR

• Member has axial symptoms/disease or enthesitis (i.e involving the plantar fascia and Achilles tendon insertion) and has tried and failed NSAID therapy

OR

• Member has a documented medical reason (e.g. allergy, intolerance, contraindication) for not using NSAIDS, then a DMARD to manage their condition.

• The medication is being recommended or prescribed by a rheumatologist or a dermatologist. • If the request is for a non-preferred biological agent, documented (consistent with pharmacy claims/medical

record data/chart notes/provider attestation) adequate trial of ot least two preferred products with different mechanisms of action or medical reason as to why patient is unable to utilize the preferred products .

If all of the above conditions are met, the request will be approved for up to a 12 -month duration; if all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. PA CRITERIA FOR RE-AUTHORIZATION FOR PSORIATIC ARTHRITIS (PsA): • The medication is being recommended or prescribed by a rheumatologist or dermatologist at an FDA-approved

dosage. • The member has been receiving the medication and documentation was provided that the prescriber has

evaluated the member and recommends continuation of therapy (clinical benefit). If all of the above conditions are met, the request will be approved for a 12 month duration. If all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review.


• Members with history (within the past 90 days) of a non-preferred biological product are not required to try twopreferred biological agents prior to receiving the non-preferred agent.

• Members with history (within the past 90 days) of a preferred biological agent are not required to try the required NSAIDs/DMARDs prior to receiving the preferred biological agent.

NOTE: Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. Revision/Review Date 02/2019

PERFORM RX PRIOR AUTHORIZATION SYNAGIS CRITERIA SYNAGIS (palivizumab): 50mg vial, 100mg vial

All requests require documentation of the following

• Child’s gestational age at birth, chronological age, and current weight • Pertinent medical risk factors

Approval requires that Synagis is ordered for the FDA approved indication of Respiratory Syncytial Virus (RSV) infection prophylaxis in high risk patients and that it is requested at the FDA approved dose of 15mg/kg/dose every 30 days.

PLEASE NOTE: Synagis prophylaxis is NOT recommended for otherwise healthy infants born after

29 weeks, 0 days gestation, OR for patients greater than 24 months old.

If an infant or child who is receiving Synagis immunoprophylaxis experiences a breakthrough RSV infection, monthly prophylaxis should be discontinued.

Synagis requests are approvable if the patient meets one of the following:

If child has a chronological age of < 12 months old:

1. The child was born prematurely with a gestational age of 28 weeks & 6 days or less, and the child’s current chronological age is less than or equal to 1 year at the beginning of RSV season (November 1st).

2. The child was born with a Gestational Age (GA) of <32 weeks, 0 days and required > 21%

oxygen for at least 28 days after birth, AND has confirmed diagnosis of chronic lung disease of prematurity (CLD) a.k.a. bronchopulmonary dysplasia (BPD), (ICD10: P27.1)

3. The child was born with significant heart disease requiring medication to control CHF,

moderate to severe pulmonary hypertension, or cyanotic heart disease (see Table 1 & 2) that could be complicated by pulmonary disease.

4. The child will be undergoing cardiac transplantation during the RSV season.

5. The child will be profoundly immunocompromised during the RSV season (see Table 3).

6. The child has a congenital abnormality of the airway or a neuromuscular disease that compromise

handling of respiratory secretions during the first year of life.

If child has a chronological age of 12 to 24 months old:

1. The child was born with a Gestational Age (GA) of <32 weeks, 0 days and required > 21 % oxygen for at least 28 days after birth, AND has confirmed diagnosis of chronic lung disease of prematurity (CLD) a.k.a. bronchopulmonary dysplasia (BPD), (ICD10: P27.1), AND continues to require medical treatment with either supplemental oxygen, chronic corticosteroids, or diuretic treatment within 6 months of the start of or during the current RSV season.

2. The child will be profoundly immunocompromised during the RSV season (see Table 3).

3. The child will be undergoing cardiac transplantation during the RSV season.

If the patient meets criteria, the request will be approved with a quantity sufficient to provide coverage fro m November 1st through March 31st (a maximum quantity of 5 doses). If all of the above criteria are not met then, based on professional judgment, the Clinical reviewer will issue a denial for the medication requested.

FDA INDICATIONS: Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus(RSV) in pediatric patients at high risk of RSV disease.

DOSAGE AND ADMINISTRATION: The recommended dose of Synagis is 15 mg/kg of body weight, and patients should receive monthly doses throughout the RSV season. The first dose should be administered prior to commencement of the RSV season if possible.

**MAXIMUM APPROVABLE DOSES** ALL PATIENTS will receive Synagis treatment for a maximum of 5 doses per RSV season. There are no valid clinical reasons for a 6th dose of Synagis and, therefore, all requests for a 6th dose will be denied.

Table 1.

EXAMPLES OF SIGNIFICANT AND APPROVABLE CARDIAC CONDITIONS

Examples of significant hemodynamic cyanotic congenital heart disease: Tetralogy of Fallot, Transposition of the great vessels, Ebstein’s anomally, Tricuspid atresia, Total anomalous pulmonary venous return, Truncus arteriosus, Hypoplastic left heart syndrome

Table 2.

NON-APPROVABLE CARDIAC CONDITIONS

Insignificant hemodynamic heart disease (and therefore are NOT approvable indications):

Indications in which patients are NOT at an increased risk for RSV (and therefore are NOT approvable indications)

Secundum atrial septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, patent ductus arteriosus

• Lesions adequately corrected by surgery (unless the patient continues to require medications for CHF)

• Mild cardiomyopathy who are NOT receiving medical therapy

Table 3.

EXAMPLES OF SEVERE IMMUNODEFICIENCIES/IMMUNOSUPPRESSION:

HIV positive, Transplant, Chemotherapy, Severe Combined Immunodeficiency (SCID)


NOTE: Medical Director/Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary


Tardive Dyskinesia Criteria

Drugs Ingrezza™ (valbenazine), Austedo® (deutetrabenazine) or any other newly marketed agent






Prescriber Restrictions Prescriber must be a neurologist or a psychiatrist.

Coverage Duration If the criteria are met, the initial request will be approved for up to 6 month duration, and renewal requests will be approved for 12 months. If the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.

Other Criteria

Revision/Review Date: 11/2017 PARP: 2/26/2018

Initial: • Provider attests that member has a diagnosis of moderate to

severe tardive dyskinesia using the Abnormal Involuntary Movement Scale (AIMS) with a score >10, OR has an AIMS score of less than 10 with significant impact to member’s daily function or activities of daily living. >

• Documentation was provided that patient has had a trial and failure with tetrabenazine, or a medical reason was provided (e.g. intolerance or contraindication) why patient is unable to use tetrabenazine to treat their condition.

• MD attests that patient has had a baseline electrocardiogram (EKG) and is aware of the possible risk of QT prolongation.

• Dose is within FDA approved limits.

Reauthorization: • For initial reauthorization, provider attests to improvement in

AIMS score from baseline. For all other reauthorization requests, provider attests that patient’s condition has stabilized/improved while on therapy.

• Dose is within FDA approved limits.


necessary.


Triamcinolone Intranasal

Drugs FORMULARY STATUS Formulary, Pays at Point-of-Sale FLUTICASONE NASAL SPRAY (50mcg/actuation)

FORMULARY STATUS Requires Step Therapy with one prior step TRIAMCINOLONE NASAL SPRAY


request.






Other Criteria Revision/Review Date

Initial Authorization: 1. Presumed or documented diagnosis of allergic rhinitis 2. Documented trial and failure or intolerance with a formulary

fluticasone intranasal formulation for a minimum of 3 weeks within past 60 days

7/2018

Field Name Field Description Prior Authorization Group Description Transderm-Scop®

Drugs Transderm-Scop® (scopolamine) Covered Uses Medically accepted indications are defined using the following






Coverage Duration If the criteria are met, the request will be approved for the treatment of motion sickness or post-operative nausea and vomiting prophylaxis for a one (1) month duration and for the treatment of sialorrhea for a 12 month duration; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.

Other Criteria


Initial Authorization: Motion Sickness

• Diagnosis of nausea and vomiting associated with motion sickness

• Documented trial and failure at therapeutic doses, intolerance or contraindication to meclizine, diphenhydramine and dimenhydrinate.

Post-operative nausea and vomiting (PONV) prophylaxis • Request is indicated for PONV prophylaxis • Patient must have a medical reason for not using

ondansetron, i.e. known intolerance, or previous therapeutic failure.

Sialorrhea

• Documented trial and failure at therapeutic doses, intolerance or contraindication to glycopyrrolate.


when, in his/her professional judgement, the requested item is medically necessary.


TRAVOPROST

Drugs FORMULARY STATUS Formulary, Pays at Point-of-Sale LATANOPROST 0.005% EYE DROPS

FORMULARY STATUS Requires Step Therapy with one prior step TRAVOPROST 0.004% EYE DROPS


request.







Initial Authorization: 1. Presumed or documented diagnosis of glaucoma 2. Documented trial and failure or intolerance with latanoprost for a

minimum of 3 weeks within past 60 days


TYSABRI®

Drugs Tysabri® (natalizumab) Covered Uses Medically accepted indications are defined using the following sources:


Exclusion Criteria Member does not have a history of progressive multifocal leukoencephalopathy (PML) or have a compromised immune system. Documentation consistent with pharmacy claims data was submitted indicating the patient is not currently using any antineoplastic, immunosuppressant, or immunomodulating medications



Age Restrictions Patients must be 18 years age or older Prescriber

Restrictions Prescriber must be a neurologist if diagnosis is multiple sclerosis. ***If diagnosis is Crohn’s, please use the Specialty Biological Agents for Crohn’s Disease PA Criteria***

Coverage Duration If all of the criteria are met, the initial request will be approved for 3 months. For continuation of therapy the request will be approved for 6 months. If all of the above criteria are not met, the request is referred to a Clinical Reviewer for medical necessity review.

Other Criteria


PA CRITERIA FOR INITIAL AUTHORIZATION FOR USE IN MULTIPLE SCLEROSIS (MS):

• The member has a clinical diagnosis of a relapsing form of multiple sclerosis and Tysabri is being prescribed at an FDA approved dose.

• The member has a documented trial of glatiramer AND Aubagio AND Gilenya or has a documented medical reason (intolerance, hypersensitivity, etc) for not utilizing these therapies.

• Tysabri is being prescribed by a neurologist.

PA CRITERIA FOR RE-AUTHORIZATION FOR MS: • The medication is being recommended or prescribed by a

neurologist at an FDA-approved dosage. Documentation was provided that the prescriber has evaluated the member and recommends continuation of therapy (clinical benefit). Continuation of Therapy/Grandfathering Provision: Members with history (within the past 90 days) of a non-formulary product are not required to try a formulary agent prior to receiving the non-formulary product.


necessary.

Field Name Field Description Prior Authorization Group Description Vfend®

Drugs Vfend®(vorizonazole) tablets and oral suspension Covered Uses Medically accepted indications are defined using the following





Age Restrictions FDA recommends use in patients 12 years of age and older. Prescriber Restrictions N/A

Coverage Duration If the above conditions are met, the request will be approved with up to a 3 month duration depending upon the severity of the infection; if the above conditions are not met, the request will be referred to a clinical reviewer for medical necessity review. .

Other Criteria



• For a diagnosis of invasive aspergillosis or a serious fungal infection caused by Scedosporium apiospermum and Fusarium species. OR

• For a diagnosis of esophageal candidiasis, candidemia (nonneutropenics) and disseminated candidiasis in the skin, abdomen, kidney bladder all and wounds o Documented trial and failure with a formulary treatment option (i.e. fluconazole or nystatin) or documented reason (i.e. recent discharge from hospital on PO Vfend) for not using a formulary treatment option for relevant indications.

Medical Director/clinical reviewer must override criteria when, in his/her professional judgement, the requested item

is medically necessary.

PerformRx Prior Authorization Criteria for Xolair (omalizumab) Xolair (omalizumab) Formulary Status: Non Formulary

• For all initial authorizations for Xolair for asthma:Provider is a pulmonologist or allergist, or provider

has consulted with one of these specialists (provide documentation of consult) • Patient has history ≥ 1 year of moderate to severe asthma, and drug is indicated for age of patient at an

approved dose For all patients who are newly initiating Xolair for asthma: • The patient has a documented baseline FEV1 < 80%o f predicted or FEV1/FVC that has been reduced

by at least 5% of normal for the patient age range (see Table 1 below). • Patient has at least ONE of the following:

Daily use of inhaled short acting B 2 agonist Daily or continual symptoms Limited physical activity due to asthma exacerbations Nighttime symptoms > once per week

• Patient continues to have significant symptoms (e.g. hospital admission, emergency room visits, and/or the severe of asthma exacerbations) AND IS COMPLIANT on the following (or has medical reason for not utilizing) ALL of the following agents: High-dose inhaled corticosteroid with long-acting B 2 agonist A leukotriene receptor antagonist OR theophylline

• The patient has a positive documented immediate response on RAST test and/or skin prick test to at least 1 common allergen (e.g. dermatophagoides farinae, dermatop hagoides pteronyssinus, dog, cat, or cockroach) and is an asthma trigger (copy of results required). Pre-treatment serum IgE levels must be between greater than or equal to 30IU/mL

• The patient is not currently receiving medication that could cause bronchospasm (e.g. beta blocker or NSAIDs), or a medical reason was provided that the medication is not causing worsening in asthma symptoms.

For all initial authorizations for Xolair for urticarial: • Drug is indicated for age of patient at an approved dose • Provider is a pulmonologist or allergist, immunologist or dermatologist, or provider has consulted with

one of these specialists (provide documentation of consult)

Initial PA Criteria for Chronic Idiopathic Urticaria: For all patients who are newly initiating Xolair for urticarial:

• The patient has a documented history of urticaria for at least 3 months • The patient requires oral corticosteroids to control symptoms • The patient remains symptomatic despite adequate trials (or has medical reason for not utilizing) ALL

of the following: ONE formulary H1 antihistamines (1st generation-e.g. hydroxyzine, cyproheptadine and 2nd

generation –loratidine, cetirizine) ONE formulary H2 antihistamine (e.g. famotidine, ranitidine) Montelukast

If all of the above conditions are met per indication, the request will be approved with a 4-month duration; if all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.

Re-Authorization PA Criteria for Both Indications: • Prescriber has re-evaluated member and recommends continuation of therapy • Documentation submitted indicates that the member has significantly benefited from medication (e.g.

decrease exacerbations, reduction in use of oral steroids)

If all of the above conditions are met per indication, the request will be approved with a 6-month duration; if all of the above criteria are not met, the request is referred to a Medical Director/Clinical Reviewer for medical necessity review.

Table 1: Normal FEV1/FVC Patient Age Normal Value

8-19 85% 20-39 80% 40-59 75% 60-80 70%

Review/Revision Date: 7/2018


Xyrem®

Drugs Xyrem® (sodium oxybate) Covered Uses Medically accepted indications are defined using the following


Exclusion Criteria Medication is being taken along with sedative hypnotics


“See Other Criteria”

Age Restrictions Patient must be 7 years of age or older.

Prescriber Restrictions MD is a neurologist or sleep specialist, or documentation has been provided that provider has consulted with a neurologist or sleep specialist.

Coverage Duration If all of the conditions are met, the request will be approved for a 3 month duration. If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria


Initial: • If patient has a history of substance abuse, documentation has

been provided that provider has referred the patient for substance abuse disorder treatment.

• Patient has documented trial and failure of modafinil and a formulary stimulant medication (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history), or a documented medical reason for not utilizing these medications.

• For patients with cataplexy: Patient also has a documented trial and failure with a formulary tricyclic or SSRI AND venlafaxine, or has a documented medical reason (contraindication/intolerance) for not utilizing a formulary tricyclic or SSRI AND venlafaxine.

• Medication is being prescribed at an FDA approved dose. Continuation: • Documentation has been submitted indicating patient has

clinically benefited from treatment (i.e. improvement on Epworth Sleepiness Score)

• Medication is being prescribed at an FDA approved dose. • For patients with cataplexy: Documentation has been provided

that there has been a reduction in frequency of cataplexy attacks.


Zyvox

Drugs Zyvox® (linezolid) Covered Uses Medically accepted indications are defined using the following



Information




Other Criteria


Initial Authorization • Diagnosis of vancomycin-resistant enterococcus faecium

infection, nosocomial pneumonia, complicated skin and skin structure infection (including diabetic foot infections, without concomitant osteomyelitis), uncomplicated skin and skin structure infection, methicillin-resistant Staphylococcus aureus infection, or community-acquired pneumonia.

And patient meets one of the two following criteria: • Documented history of treatment with Zyvox IV (continuation of

therapy, IV to PO conversion). • Documentation that the infection is susceptible to Zyvox AND

the patient has failed treatment or is contraindicated to treatment with antibiotics to which the organism is susceptible.

Medical Director/clinical reviewer must override criteria when,

in his/her professional judgement, the requested item is medically necessary.


WHITE BLOOD CELL STIMULATORS

Drugs FORMULARY STATUS Specialty Tier (PA required) • Zarxio™ (Filgrastim-sndz) • Neupogen® (Filgrastim) • Neulasta® (Pegfilgrastim) • Mozobil® (Plerixafor) • Leukine® (Sargramostim)





Restrictions Prescriber must be a hematologist, an oncologist or an infection disease specialist

Coverage Duration The request will be approved for up to 12 weeks. Re-authorization for all indications except chronic neutropenia: 12 weeks. For chronic neutropenia: 24 weeks. If all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria • For Leukine® requests ONLY: Documentation is submitted of the patient’s current diagnosis, current bodyweight, body surface area and absolute neutrophil count (within 30 days of the request). For Fulphila requests ONLY: For requests for patients in outpatient setting, with expected chemotherapy cycle duration of at least 14 days, request will be approved • For Neulasta® requests ONLY: The patient has a documented treatment failure (i.e. failure to reach and/or maintain target ANC, prolonged febrile neutropenia or infection requiring prolonged anti- infection use) with the use of Fulphila. (and/or has another documented medical reason (intolerance, hypersensitivit y, stem cell collection, etc.) for not using Fulphila to treat their medical condition.) • For Neupogen® requests that are less than 180mcg, Neupogen® can be approved. For all other requests for Neupogen® or Neulasta®: the patient has a documented treatment failure {i.e. failure to reach and/or maintain target ANC, prolonged febrile neutropenia, unplanned hospitalization, infection requiring prolonged anti-infectives} , with an adequate trial (including dates, doses of therapy) of Zarxio™ and/or has another documented medical reason (intolerance, hypersensitivity, or , stem cell collection, etc.) for not using Zarxio™ to treat their medical condition. For Granix® requests ONLY: The patient has a documented treatment failure {i.e. failure to reach and/or maintain target ANC, prolonged

Revision/Review

Date 7/2018

febrile neutropenia, unplanned hospitalization or infection requiring prolonged anti-infective use} with an adequate trial (including dates, doses of therap y) of Zarx io™ and/or has another documented medical reason (intolerance, hypersensitivit y, stem cell collection, etc.) for not using Zarx io™ to treat their medical condition. • For Mozobil® requests ONLY: documentation must be submitted that the patient is using Mozobil® in combination with a granulocyte-colony stimulating factor (G-CSF) agent (i.e. Zarxio™) • Patients ANC (absolute neutrophil count) has been submitted with request and prescribed dosing of medication is within FDA approved dosing.


necessary.


Prior Authorization Group Oncology without specific criteria to be used with an oncology diagnosis

Drugs Oral and Injectable Oncology Medications (specialty or non- specialty) without medication specific Criteria with an oncology diagnosis

Covered Uses Medically accepted indications are defined using the following sources: the Food and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI) , and the Drug Package Insert, and/or per the National Comprehensive Cancer Network (NCCN)




Age Restrictions N/A Prescriber Restrictions Prescriber is an oncologist Coverage Duration If the criteria are met, the request will be approved for up to 6


Other Criteria


All of the following criteria must be met: • Requested indication must be supported by NCCN

Category 1 or 2A level of evidence. If the request is for a Category 2B recommendation then medical documentation has been provided as to why member is unable to utilize a treatment regimen with a higher level of evidence (e.g. allergic reaction, contraindication).

• Documentation provided of results of genetic testing where required per drug package insert.

• Documentation provided of results of all required laboratory values and patient specific information (e.g. weight, ALT/AST, Creatinine Kinase, etc.) when recommended/required per drug package insert.

• The medication is being prescribed at a dose that is within FDA approved/NCCN guidelines.

Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.




Ocaliva®

Drugs Ocaliva® (obeticholic acid) Covered Uses Medically accepted indications are defined using the following


Exclusion Criteria N/A Required Medical Information See “other criteria”

Age Restriction 18 and older Prescriber Restrictions Hepatologist or Gastroenterologist

Coverage Duration If the criteria are met, the request will be approved for 5 mg once daily for a 3 month duration for initial authorization and up to 10mg once daily for up to a 6 month duration for reauthorization; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review. ***If member has moderate or severe hepatic impairment, 5mg once weekly will be approved for initial and 5mg twice weekly or 10mg twice weekly will be approved for reauthorization.***

Other Criteria

Initial Authorization: 1. Diagnosis of primary biliary cholangitis (PBC) with

confirmation of diagnosis by the following tests: a) Positive antimitochondrial antibody test b) Elevated serum alkaline phosphatase level

AND

2. Ocaliva is being requested in addition to ursodeoxycholic acid (UDCA) due to patient having an inadequate response to UDCA monotherapy for at least 1 year OR

3. Patient is unable to tolerate UDCA and is taking Ocaliva as

monotherapy AND

4. If patient has moderate or severe hepatic impairment, requested dose is for 5mg once weekly AND

5. Submission of the following test results within 30 days of

2


request: a) Serum alkaline phosphatase b) Total bilirubin

Reauthorization:

1. Provider attests that the patient has not developed complete

biliary obstruction 2. Submission of lab tests confirming a decrease in serum alkaline

phosphatase (ALP) and total bilirubin since beginning therapy

3. If patient has moderate or severe hepatic impairment, requested dose is for 5mg twice weekly or 10mg twice weekly.


necessary.

Revised April 2014


Description Spinraza

Drugs Spinraza (nusinersen) Covered Uses Medically accepted indications are defined using the following sources: the Food

and Drug Administration (FDA), Micromedex, American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information for the Healthcare Professional (USP DI), the Drug Package Insert (PPI), or disease state specific standard of care guidelines.



Age Restrictions According to package insert

Prescriber Restrictions Prescriber must be a neurologist

Coverage Duration If all of the conditions are met, the initial request will be approved for 5 doses (4 loading doses and 1st maintenance dose). Reauthorizations will be approved for 3 additional maintenance doses . If the conditions are not met, the request will be sent to a Medical Director/clinical reviewer for medical necessity review.

Other Criteria


For Approval: • Member has confirmed diagnosis of spinal muscular atrophy (SMA) types

I, II or III, and the molecular genetic test with mutation analysis was submitted that is positive for the genetic deletion of the exon 7 of the survival motor neuron (SMN1) gene

• Baseline motor function or motor milestone achievement was submitted with request [e.g. CHOP Infant Test of Neuromuscular Disorders (CHOP-INTEND) for Type 1 or Hammersmith Functional Motor Scale Expanded Scores (HFMSE) or Hammersmith Infant Neurological Examination (HINE) for Type II and Type III]


• Documentation of clinical response based on the prescriber’s assessment was submitted with request (e.g. improvement in motor function/motor milestone achievement scores using CHOP-INTEND, HFMSE or HINE . improvement in more categories of motor milestones than worsening), patient remains permanent ventilation free)


Physician/clinical reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.



Huntington’s Disease Criteria

Drugs Austedo (deutetrabenazine), Xenazine (tetrabenazine), or any other newly marketed agent






Prescriber Restrictions Prescriber must be a neurologist

Coverage Duration If the criteria are met, the request will be approved for up to 6 month duration; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.


Other Criteria


Initial: • Patient must have diagnosis of moderate to severe

Huntington’s with chorea, with documented baseline evaluation with one of the following scoring tools: Total Maximal Chorea (TMC) score ≥ 8, or Total Functional Capacity (TFC) score ≥ 5.

• Documentation was provided that patient has had a trial and failure with following: Rilutek (riluzole) for Xenazine requests OR Rilutek and Xenazine for Austedo requests, or medical reason was provided (e.g. intolerance or contraindication) why patient is unable to use these therapies to manage condition

• MD attests that patient has had a baseline electrocardiogram (EKG) and is aware of the possible risk of QT prolongation

• Dose is within FDA approved limits

Reauth:

• Documentation was provided that demonstrates improvement in TMC or TFC scores

• Dose is within FDA approved limits



2


Opioid Containing Products

Drugs ***If the member has cancer, sickle cell or is on hospice please automatically authorize for up to 12 months (member must meet

non-formulary criteria if request is for non-formulary medication)***

1. Opioids >90 Morphine Milligram Equivalents (MME) per day. 2. Opioids > 5 days for adults (21 years of age and older). 3. Opioids >3 days for children (0-20 years of age). 4. All long acting opioid products regardless of dose or day

supply Covered Uses Medically accepted indications are defined using the following


Exclusion Criteria Members taking buprenorphine-containing products for opioid dependence.




Restrictions The following specialties are required for requests >90MME per day: Pain Specialist, Oncologist, Hospice Physician, Hematologist, Surgeon, or attestation that the requesting prescriber is working in consultation with or has consulted with one of the above specialty types. If the prescriber is not one of the above specialties and is unable to consult with one of the above specialties, provider has attested that an attempt has been made to refer and/or transition patient to one of the above specialties.

Coverage Duration If the criteria are met, the request will be approved with up to six months duration; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review. ***If a member does not meet the criteria but is actively tapering off of opioids and the prescriber has explained medical necessity, the request should be approved for 6 months***

Other Criteria Revision/Review

Date 7/2018

***If the member has cancer, sickle cell or is on hospice please automatically authorize for up to 12 months (member must meet

non-formulary criteria if request is for non-formulary medication)***

Initial Authorization for Opioid Containing Products: 1. The diagnosis is pain. For long-acting products, the diagnosis

is chronic pain that requires daily, around the clock, opioid medication.

2. Prescriber has assessed the patient’s cause of pain and documented the anticipated duration of therapy

3. The patient has tried and failed non-pharmacologic treatment and two non-opioid containing pain medications (ex. acetaminophen, NSAIDs, selected antidepressants, anticonvulsants). **If the request is for a long acting opioid product, patient has also tried and failed a short acting opioid product first**

4. The prescriber has justified medical necessity for dosing above the current MME limit (i.e active tapering) and/or above the day supply limit.

5. Member is not taking concurrent benzodiazepines. If member is taking benzodiazepines, prescriber has provided documentation as to why and has discussed risks of using opioids and benzodiazepines concurrently and has outlined plan for tapering if appropriate.

6. Member is not taking concurrent muscle relaxants. If member is taking muscle relaxants, prescriber has provided documentation as to why and has discussed risks of using opioids and muscle relaxants concurrently and has outlined plan for tapering if appropriate.

7. If patient has a high-risk condition stated in the CDC guidelines (ex. sleep apnea or other causes of sleep-disordered breathing, patients with renal or hepatic insufficiency, older adults, pregnant women, patients with depression or other mental health conditions, and patients with alcohol or other substance use disorders) prescriber attests to discussing heightened risks of opioid use and has educated patient on naloxone use and has considered prescribing naloxone.

8. Prescriber attests urine drug screens will be completed at baseline and every 6 months and if illicit drugs are found, the patient will be identified as high risk and the heightened risk of overdose will be explained to the patient.

9. Prescriber attests to checking the Pennsylvania PDMP. 10. Prescriber attests to discussing with the patient the level of risk

for opioid abuse/overdose with the dose/duration prescribed to the patient.

11. Prescriber attests to discussing concomitant psychological disease and risks associated with opioid overdose/abuse.

12. Prescriber attests to discussing history of substance abuse and the risks associated with opioid overdose/abuse.

13. Prescriber has the patient’s signature on file acknowledging

education regarding the risks of opioid therapy as listed in items 9, 10 and 11 above.

14. Prescriber has provided a copy of a pain management agreement, either one provided in criteria below or one of their choosing. (Members in a facility are exempt from this requirement)

15. If the request is for a non-formulary opioid, patient must meet criteria 1-13 AND one of the following conditions:

a. Documented trial and failure or intolerance with up to three formulary medications used to treat the documented diagnosis. For medications where there is only one preferred agent, only that agent must have been ineffective or not tolerated.

b. No other formulary medication has a medically accepted use for the patient’s specific diagnosis as referenced in the medical compendia.

c. All other formulary medications are contraindicated based on the patient’s diagnosis, other medical conditions, or other medication therapy.

Reauthorization for Opioid Containing Products:

1. The prescriber has explained medical necessity for continued dosing above the current MME limit and/or above the day supply limit and if the dose is not being titrated, has provided medical justification explaining why the dose cannot be decreased

2. The provider has submitted documentation of member’s response to the requested medication (ex. Improvement in severity level of pain, improvement in ADL’s, etc.)

3. Member is not taking concurrent benzodiazepines. If member is taking benzodiazepines, prescriber has provided documentation as to why and has discussed risks of using opioids and benzodiazepines concurrently and has outlined plan for tapering if appropriate.

4. Member is not taking concurrent muscle relaxants. If member is taking muscle relaxants, prescriber has provided documentation as to why and has discussed risks of using opioids and muscle relaxants concurrently and has outlined plan for tapering if appropriate.

5. Urine drug screen dates have been submitted every 6 months. If illicit drugs are found, prescriber has attested to identifying patient as high risk and explained heightened risk of overdose to patient. If opioids are not found on urine drug screen, prescriber attests to why member needs to continue therapy.

6. Prescriber attests to checking the Pennsylvania PDMP. 7. If patient has a high-risk condition stated in the CDC

guidelines (ex. sleep apnea or other causes of sleep-disordered breathing, patients with renal or hepatic insufficiency, older adults, pregnant women, patients with depression or other mental health conditions, and patients with alcohol or other substance use disorders) prescriber attests to discussing heightened risks of opioid use and has educated patient on naloxone use and has considered prescribing naloxone


necessary. Example of a Pain Treatment Agreement I understand that I have a right to comprehensive pain management. I wish to enter a treatment agreement to prevent possible chemical dependency. I understand that failure to follow any of these agreed statements might result in Dr. ongoing care for me.

I, management by Dr.

not providing

, agree to undergo pain . My diagnosis is

following statements:

I will not accept any narcotic prescriptions from another doctor.

. I agree to the

I will be responsible for making sure that I do not run out of my medications on weekends and holidays, because abrupt discontinuation of these medications can cause severe withdrawal syndrome.

I understand that I must keep my medications in a safe place.

I understand that Dr. the prescriptions of medications that I may lose.

If my medications are stolen, Dr.

will not supply additional refills for

will refill the prescription one time only if a copy of the police report of the theft is submitted to the physician's office.

I will not give my prescriptions to anyone else.

I will only use one pharmacy. I will keep my scheduled appointments with Dr. notice of cancellation 24 hours in advance.

unless I give

I agree to refrain from all mind/mood altering/illicit/addicting drugs including alcohol unless authorized by Dr. .

Continued My treatment plan may change based on outcome of therapy, especially if pain medications are ineffective. Such medications will be discontinued.

My treatment plan includes:

Medications

Physical therapy/exercise

Relaxation techniques

Psychological counseling

I understand that Dr. Bill of Rights."

You have the right to:

believes in the following "Pain Patients

• Have your pain prevented or controlled adequately. • Have your pain and medication history taken. • Have your pain questions answered. • Know what medication, treatment or anesthesia will be given. • Know the risks, benefits, and side effects of treatment. • Know what alternative pain treatments may be available. • Ask for changes in treatments if your pain persists. • Receive compassionate and sympathetic care. • Receive pain medication on a timely basis. • Refuse treatment without prejudice from your physician. • Include your family in decision-making.

Sample Termination Clauses

A. The doctor may terminate this agreement at any time if he/she has cause to believe that I am not complying with the terms of this agreement, or to believe that I have made a misrepresentation or false statement concerning my pain or my compliance with the terms of this agreement. B. I understand that I may terminate this agreement at any time.

If the agreement is terminated, I will not be a patient of Dr. strongly consider treatment for chemical dependency if clinically indicated.

and would

Patient Signature Date

Physician Signature Date

Witness Signature Date WebMD Medical Reference Reviewed by Jennifer Robinson, MD on August 27, 2015

Sources SOURCES:

American Academy of Pain Management: "Opioid Agreements & Contracts."

American Academy of Family Physicians: "Improving Patient Care: A Tool for Safely Treating Chronic Pain."



VASCULAR ENDOTHELIAL GROWTH FACTOR (VEGF) INHIBITORS

Drugs FORMULARY STATUS:

Specialty Tier (PA required)

• LUCENTIS (ranibizumab) • EYLEA (afibercept) • Any newly marketed agent in this class





Age Restrictions Approvable for adults 18 years of age and older only

Prescriber Restrictions

Ophthalmologist

Coverage Duration If the above conditions are met, the request will be approved with a 3 month duration for initial and 12 months for renewal; if the criteria are not met, the request will be referred to a clinical reviewer for medical necessity review.

Other Criteria

For Lucentis:

Only FDA-approved dosing will be approved For Eylea:

Only FDA-approved dosing will be approved Documented trial and failure with Lucentis for all approved


indications OR: a medical justification for not using Lucentis (e.g. experienced a severe ADR such as hypersensitivity, arterial thromboembolism, cerebrovascular accident, raised intraocular pressure, retinal detachment, etc. while on Lucentis).

For patients who have previously tried intravitreal bevacizumab, request for Eylea will not require trial of Lucentis.


www.amerihealthcaritaspa.comwww.amerihealthcaritasnortheast.comACPA_18160104

Pharmacy Prior Authorization Criteria - AmeriHealth ... · Field Name Field Description Prior...

Documents

Transcript of Pharmacy Prior Authorization Criteria - AmeriHealth ... · Field Name Field Description Prior...