14395 Formulary MSOFL PA Web File v2 PCP...Decrease in blood transfusion or Hgb increase by 1 g/dL...

Prior Authorization Criteria 2014 MSOFL for Preferred Care Partners Last Updated: 04/01/2014

ABRAXANE Products Affected Abraxane

PA Criteria Criteria Details

Covered Uses All medically accepted indications not otherwise excluded from Part D.

Exclusion Criteria

N/A

Required Medical Information

Metastatic breast cancer: Diagnosis of metastatic breast cancer. Failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy. One of the following: Prior therapy includes an anthracycline [eg, Adriamycin (doxorubicin), Cerubidine (daunorubicin)], or contraindication to anthracycline [eg, Adriamycin (doxorubicin), Cerubidine (daunorubicin)]. Non-Small Cell Lung Cancer (NSCLC): Diagnosis of locally advanced or metastatic non-small cell lung cancer. Received in combination with carboplatin. Patient is not a candidate for either curative surgery or radiation therapy. Metastatic breast cancer and Non-Small Cell Lung Cancer (NSCLC): chart documentation of a previous hypersensitivity reaction despite premedication to one of the following: Onxol (paclitaxel) or Taxotere (docetaxel), or chart documentation of contraindication to one of the following standard premedication used to prevent hypersensitivity reactions with Onxol (paclitaxel) or Taxotere (docetaxel): H1 blocker [eg, Benadryl (diphenhydramine)], Decadron (dexamethasone), or H2 antagonist [eg, Pepcid (famotidine), Tagamet (cimetidine), Zantac (ranitidine)].

Age Restrictions N/A

Prescriber Restrictions

Metastatic breast cancer and NSCLC: prescribed or recommended by an oncologist.

Coverage Duration

12 months

Other Criteria Approve for continuation of prior therapy.

1

ACTEMRA Products Affected Actemra INJ 162MG/0.9ML,

200MG/10ML



Exclusion Criteria

N/A


Rheumatoid Arthritis (Initial): Diagnosis of moderate-to-severe RA. Systemic Juvenile Idiopathic arthritis (SJIA) (Initial): Diagnosis of active SJIA. Polyarticular Juvenile Idiopathic Arthritis (PJIA) (Initial): Diagnosis of active PJIA (eg, swollen, tender joints with limited range of motion). RA and SJIA (Reauthorization): Documentation of positive clinical response to Actemra therapy. PJIA (Reauthorization): Documentation of positive clinical response to Actemra therapy. Patient is not receiving Actemra in combination with a Biologic Disease Modifying Antirheumatic Drug (DMARD) [eg, Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] or Janus kinase inhibitor [eg, Xeljanz (tofacitinib)].



RA, SJIA, PJIA (Initial): Prescribed or recommended by a rheumatologist.

Coverage Duration

12 months

Other Criteria RA: Failure, contraindication, or intolerance (F/C/I) to 1 DMARD (eg, methotrexate, leflunomide, sulfasalazine). SJIA: F/C/I to NSAIDs or corticosteroids. PJIA: F/C/I to MTX. ALL: Patient is not receiving Actemra in combination with a biologic Disease Modifying Antirheumatic Drug (DMARD) [eg, Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] or Janus kinase inhibitor [eg, Xeljanz (tofacitinib)].

3

ACTHAR HP Products Affected Acthar Hp



Exclusion Criteria

N/A


Infantile Spasm (West Syndrome): Diagnosis of infantile spasms (West Syndrome). Multiple Sclerosis (MS): Acute exacerbations of MS. Rheumatic disorders: As adjunctive therapy for short-term administration in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis. Collagen diseases: During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematous, systemic dermatomyositis (polymyositis). Dermatologic diseases: Severe erythema multiforme, Stevens-Johnson syndrome. Allergic states: Serum sickness. Ophthalmic diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: keratitis, iritis and iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation. Respiratory diseases: Symptomatic sarcoidosis. Edematous state: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.

Age Restrictions Infantile spasms: less than 2 years old


Infantile Spasm, MS: neurologist. Rheumatic disorder, collagen disease: rheumatologist. Dermatologic: dermatologist. Allergic state: allergist, immunologist. Ophthalmic disease: optometrist, ophthalmologist. Respiratory diseases: pulmonologist. Edematous state: nephrologist, rheumatologist.

Coverage Duration

All: 12 months

Other Criteria All indications except for infantile spasms: History of failure, contraindication, or intolerance to conventional therapy including corticosteroids.

4

ADCIRCA Products Affected Adcirca



Exclusion Criteria

N/A


Pulmonary arterial Hypertension (PAH): Diagnosis of PAH which is symptomatic.



N/A

Coverage Duration

12 months

Other Criteria N/A

5

ADEMPAS Products Affected Adempas



Exclusion Criteria

N/A


Pulmonary arterial hypertension (PAH) (initial): Diagnosis of PAH which is symptomatic. Chronic thromboembolic pulmonary hypertension (CTEPH) (initial): Diagnosis of inoperable or persistent/recurrent CTEPH which is symptomatic. PAH, CTEPH (Reauthorization): Documentation of positive clinical response to therapy.



N/A

Coverage Duration

Initial: 12 months. Reauthorization: 24 months

Other Criteria N/A

6

AFINITOR Products Affected Afinitor Disperz Afinitor



Exclusion Criteria

N/A


N/A



Advanced Neuroendocrine Tumors of Pancreatic Origin (PNET), Subependymal Giant Cell Astrocytoma (SEGA) with tuberous sclerosis (TS): Prescribed by an oncologist or neuro-oncologist. Renal Angiomyolipoma with tuberous sclerosis complex (TSC): Prescribed by a nephrologist. All other uses: Prescribed by an oncologist.

Coverage Duration

5 months

Other Criteria Approve for continuation of prior therapy. Renal cell carcinoma (RCC): History of failure, contraindication, or intolerance to at least one prior tyrosine kinase inhibitor therapy [eg, Nexavar (sorafenib), Sutent (sunitinib)]. Breast cancer: Patient has previously been treated with a non-steroidal aromatase inhibitor [e.g., Arimidex (anastrozole), Femara (letrozole)]. Used in combination with Aromasin (exemestane).

7

ALIMTA Products Affected Alimta INJ 500MG



Exclusion Criteria

N/A


Non-Small Cell Lung Cancer (NSCLC): Confirmed diagnosis of locally advanced or metastatic nonsquamous NSCLC. Prior history of first-line chemotherapy treatment for NSCLC (Avastin [bevacizumab] in combination with chemotherapy, or platinum-based combination chemotherapy), or used in combination with cisplatin or carboplatin, or tumor response or stable disease after 4 cycles of first-line platinum-based chemotherapy, or used as first-line monotherapy in patients 70 years of age or greater, or used as first-line monotherapy in patients less than 70 and not eligible for platinum-based chemotherapy (eg, poor performance status or comorbidities).



N/A

Coverage Duration

12 months


8

ALPHA-1 PROTEINASE INHIBITORS Products Affected Prolastin-c Aralast Np INJ 400MG Zemaira Glassia



Exclusion Criteria

N/A


Alpha-1 antitrypsin (ATT) deficiency: Diagnosis of congenital ATT. Serum ATT level less than or equal to 11 uM/L or less than or equal to 80 mg/dL. Clinical demonstration of emphysema.

Age Restrictions Age greater than or equal to 18 years.


N/A

Coverage Duration

12 months

Other Criteria N/A

9

AMPYRA Products Affected Ampyra



Exclusion Criteria

N/A


Multiple Sclerosis (initial): Diagnosis of multiple sclerosis. Physician confirmation that patient has difficulty walking (eg, timed 25 foot walk test). One of the following: expanded disability status scale (EDSS) score less than or equal to 7, or not restricted to using a wheelchair (if EDSS is not measured). (Reauthorization): Physician confirmation that the patient's walking improved with Ampyra therapy. One of the following: EDSS score less than or equal to 7, or not restricted to using a wheelchair (if EDSS is not measured).

Age Restrictions Age greater than or equal to 18 years.


N/A

Coverage Duration

Initial: 6 months. Reauthorization: 1 year.

Other Criteria N/A

10

APOKYN Products Affected Apokyn



Exclusion Criteria

N/A


Advanced Parkinson's disease diagnosis. Unable to control “off” symptoms with adequate combinations of conventional oral therapy [eg, Comtan (entacapone), Mirapex (pramipexole), Requip (ropinirole), Sinemet (carbidopa/levodopa), Stalevo (carbidopa/levodopa/entacapone), Symmetrel (amantadine), Tasmar (tolcapone)].



N/A

Coverage Duration

12 months

Other Criteria Apokyn will only be approved for intermittent subcutaneous injection.

11

ARANESP Products Affected Aranesp Albumin Free INJ

100MCG/0.5ML, 100MCG/ML, 150MCG/0.3ML, 200MCG/0.4ML, 200MCG/ML, 25MCG/0.42ML, 25MCG/ML, 300MCG/0.6ML, 300MCG/ML, 40MCG/0.4ML, 40MCG/ML, 500MCG/ML, 60MCG/0.3ML, 60MCG/ML



Exclusion Criteria

Anemia in cancer patients on chemotherapy: Patient is not receiving cancer chemotherapy. Off-label uses (except Anemia in Myelodysplastic Syndrome (MDS): Hgb greater than 10 g/dL or Hct greater than 30%.

Required Anemia due to Chronic Kidney Disease (CKD) (Initial): Diagnosis of Medical CKD. Anemia by lab values (Hct less than 30% or Hgb less than 10 g/dL) Information within 30 days of request.(Reauth): Diagnosis of CKD. Most recent or

average (avg) Hct over 3 mo is 33% or less OR most recent or avg Hgb over 3 months is 11 g/dL or less. Decrease in blood transfusion or Hgb increase by 1 g/dL or more from pre-treatment level. Anemia w/ chemo (Initial): Other causes of anemia ruled out. Anemia w/ labs (Hct less than 30%, Hgb less than 10 g/dL) within prior 2 weeks of request. Cancer is non-myeloid malignancy. Patient is concurrently on chemo, or will receive concomitant chemo for minimum of 2 months, or anemia caused by cancer chemo. (Reauth): Anemia by labs (Hgb less than 10 g/dl or Hct less than 30%) collected within the prior 2 weeks of request. Decrease in blood transfusion or Hgb increased by 1 g/dL or more from pre-tx level. Patient is concurrently on chemo, or will receive concomitant chemo for mininum of 2 months, or anemia is caused by cancer chemo. Anemia in MDS (Init): Diagnosis of MDS. Serum erythropoietin 500 mU/mL or less, or tranfusion dependent MDS. (Reauth): Most recent or avg Hct over 3 months was 36% or less, OR most recent or avg Hgb over 3 months is 12 g/dl or less. Decrease in blood transfusion or Hgb 1 g/dL or more from pre-treatment level. All uses:Verify Fe eval for adequate Fe stores.



N/A

12

Coverage CKD (Init): 6 mo. CKD (reauth): 12 mo. Chemo(init, reauth): 3 mo. MDS Duration (init): 3 mo,(reauth) 12 mo.

Other Criteria Subject to Part B vs. Part D review.

13

ARCALYST Products Affected Arcalyst



Exclusion Criteria

N/A


Diagnosis of CAPS (Cryopyrin-Associated Periodic Syndromes) as confirmed by one of the following: NLPR-3 [nucleotide-binding domain, leucine rich family (NLR), pyrin domain containing 3] gene (also known as Cold-Induced Auto-inflammatory Syndrome-1 [CIAS1]) mutation or overproduction of interleukin-1.

Age Restrictions 12 years and older


N/A

Coverage Duration

12 months

Other Criteria N/A

14

ARZERRA Products Affected Arzerra INJ 100MG/5ML



Exclusion Criteria

N/A


N/A



N/A

Coverage Duration

24 weeks

Other Criteria Approve for continuation of prior therapy. Chronic lymphocytic leukemia (CLL): Relapsed or refractory to two prior CLL regimens containing one or more of the following agents: Leustatin (cladribine), Campath (alemtuzumab), Treanda (bendamustine), Leukeran (chlorambucil), Cytoxan (cyclophosphamide), Fludara (fludarabine), Nipent (pentostatin), or Rituxan (rituximab).

15

AUBAGIO Products Affected Aubagio



Exclusion Criteria

N/A


Multiple Sclerosis: Diagnosis of a relapsing form of multiple sclerosis (MS) (eg, relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses).



N/A

Coverage Duration

12 months

Other Criteria N/A

16

AVASTIN Products Affected Avastin INJ 100MG/4ML



Exclusion Criteria

Non-Small Cell Lung Cancer: Squamous cell histology. History of hemoptysis.


Colorectal Cancer: Diagnosis of metastatic colorectal cancer. Used in combination with 5-FU, or oxaliplatin plus capecitabine, or capecitabine. Non-Small Cell Lung Cancer (NSCLC): Diagnosis of unresectable locally advanced recurrent or metastatic NSCLC. Used in combination with paclitaxel and carboplatin. Performance status 0 to 1. Renal Cell Cancer: Diagnosis of metastatic renal cell cancer. Used in combination with interferon-alpha. Age-related Macular Degeneration (ARMD): Diagnosis of age-related macular degeneration. Macular Edema: Diagnosis of macular edema following retinal vein occlusion. Glioblastoma: Relapsed, refractory, or disease progression on one of the following: radiation therapy, temozolomide, nitrosurea, combination PCV, or platinum-based regimen.



ARMD, Macular Edema: Prescribed or recommended by ophthalmologist.

Coverage Duration

Colorectal Cancer,Renal Cell Cancer,Breast Cancer,ARMD,Glioblastoma,Macular Edema:12 mo, NSCLC:6 mo


17

AVONEX Products Affected Avonex



Exclusion Criteria

N/A


Multiple Sclerosis: Diagnosis of a relapsing form of multiple sclerosis (MS) (eg, relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses), or patient has had a first clinical episode with MRI features consistent with MS.



N/A

Coverage Duration

12 months

Other Criteria N/A

18

BENLYSTA Products Affected Benlysta INJ 120MG



Exclusion Criteria

N/A


Systemic Lupus Erythematosus (SLE): (Initial): Diagnosis of active SLE. Autoantibody positive (ie, anti-nuclear antibody [ANA] titer greater than or equal to 1:80 or anti-dsDNA level greater than or equal to 30 IU/mL). Currently receiving at least one standard of care treatment (eg, antimalarials [eg, Plaquenil (hydroxychloroquine)], corticosteroids [eg, prednisone], or immunosuppressants [eg, methotrexate, Imuran (azathioprine), CellCept (mycophenolate mofetil)]) . (Reauthorization): Documentation of positive clinical response to Benlysta therapy.



SLE (initial): Prescribed or recommended by a rheumatologist

Coverage Duration

SLE: 6 months

Other Criteria N/A

19

BETASERON Products Affected Betaseron



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A

20

BOSULIF Products Affected Bosulif



Exclusion Criteria

N/A


Diagnosis of Philadelphia chromosome-positive chronic myelogenous/myeloid leukemia (Ph+CML)



Prescribed by a hematologist/oncologist

Coverage Duration

Ph+CML Initial: 3 months (Reauthorization): 12 months

Other Criteria Approve for continuation of prior therapy. Ph+CML: History of failure, contraindication, or intolerance to one of the following: Gleevec (imatinib), Sprycel (dasatinib), or Tasigna (nilotinib), or post allogeneic hematopoietic stem cell transplantation (HSCT).

21

BOTOX Products Affected Botox INJ 100UNIT



Exclusion Criteria

N/A

Required Cervical dystonia (CD):(Init)Diagnosis (dx) of CD(aka spasmodic Medical torticollis) Urinary Incontinence (UI):(init)DSD with spinal cord injury Information (SCI) or neurogenic detrusor overactivity associated with a neurologic

condition (eg SCI, multiple sclerosis).Cervical Dystonia (CD)/UI(Reauth) Confirmed improvement in sx with initial Botox tx and at least 3 mos since last tx w/ Botox.Primary Axillary Hyperhidrosis(HH):(Init)Score of 3 or 4 on the Hyperhidrosis Disease Severity Scale (HDSS) or skin maceration with secondary infx.(Reauth)At least 2-point improvement in HDSS and at least 4-6 mos since last series of injections.Migraine:(Init)Dx of chronic migraines (15 or more migraine headache days/month with headache lasting 4 hours/day or longer).Submission of chart notes documenting complete evaluation of patient (may include, but not limited to, nature, frequency and duration of headache, length of dz, and medication use history).(Reauth)Reduction in headache frequency and intensity.Submission of chart notes documenting decreased utilization of pain meds(eg narcotic analgesics, NSAIDs) or triptans, or a reduction in number of ER visits.Achalasia:(Init)High risk of complication from pneumatic dilation or surgical myotomy, or failure to prior pneumatic dilation or prior surgical myotomy, or prior dilation caused esophageal perforation, or patient has increased risk of dilation-induced perforation due to epiphrenic diverticulum or hiatal hernia.(Reauth)Documentation of improvement or reduction in sx of achalasia (ie, dysphagia, regurgitation, chest pain).At least 4-6 mos since last series of injections.Anal Fissure:(Init)Dx of chronic anal fissure.(Reauth)Incomplete healing of fissure or recurrence of fissure. Improved sx with prior tx with Botox.At least 4-6 mos since last series of injections.CBP:(Init)Dx of low back pain greater than or equal to six months duration.(Reauth)Confirmed improvement in sx with initial Botox tx.At least 4-6 mos since the last series of injections.

Age Restrictions Chronic Back Pain (CBP), UI: 18 years or older. VII cranial nerve disorders: 12 years or older.

22


Migraine (Initial): Prescribed by a neurologist or pain specialist. CBP (Initial): Prescribed by a neurologist, neurosurgeon, orthopedist, or pain specialist. UI: Prescribed by a neurologist, neurosurgeon, or urologist.

Coverage Duration

CD:90days(1dose up to 300units)HH:1tx.CBP:1 tx(series of injxs)UI:3mo(1 dose,200units)Other:6mo

Other Criteria HH: Failure, contraindication, or intolerance (F/C/I) to topical prescription strength drying agents [eg Drysol, Hypercare, Xerac AC (aluminum chloride hexahydrate)].Migraine: F/C/I to at least two prophylactic therapies (beta-blockers, TCA, CCB, cyproheptadine, divalproex sodium, topiramate) each given for a trial of at least 2 months.Anal Fissure: F/C/I to two or more conventional therapies (bulk forming laxative, sitz baths, emollient suppositories, topical analgesics, topical nitrates, oral or topical calcium channel blockers).CBP: Failure (at least 3 months)/C/I to at least one oral NSAID and at least one oral opioid. Failure or inadequate response to physical therapy or nonpharmacologic therapy (eg, spinal manipulation, massage therapy, transcutaneous electrical nerve stimulation (TENS), acupuncture/acupressure, and surgery).UI: F/C/I to two oral anticholinergic (antispasmodic or antimuscaranic) agents [eg Bentyl (dicyclomine), Donnatal (atropine/ scopolamine/ hyoscyamine/ phenobarbital), Levsin/Levsinex (hyoscyamine), Ditropan (oxybutynin), Enablex (darifenacin), or Vesicare (solifenacin)].

23

CAYSTON Products Affected Cayston



Exclusion Criteria

N/A


Cystic Fibrosis (CF): Diagnosis of CF and lung infection with positive culture demonstrating Pseudomonas aeruginosa infection.



N/A

Coverage Duration

12 months (6 active 28-day courses)

Other Criteria N/A

24

CELLCEPT (IV)

Products Affected Cellcept Intravenous



Exclusion Criteria

N/A


Transplant: Patient received a renal (kidney), cardiac (heart), or hepatic (liver) transplant. Patient is unable to take oral formulations of mycophenolate. Lupus nephritis: Diagnosis of lupus nephritis. Patient is unable to take oral formulations of mycophenolate.



N/A

Coverage Duration

12 months

Other Criteria Subject to Part B vs. Part D review (not limited to new starts only). Approve for continuation of prior therapy if Part D.

25

CELLCEPT (ORAL)

Products Affected Mycophenolate Mofetil Cellcept



Exclusion Criteria

N/A


Graft vs. host disease: Patient received a renal (kidney), cardiac (heart), hepatic (liver) , or bone marrow/stem cell transplant. Lupus nephritis: Diagnosis of lupus nephritis. Obliterative Bronchiolitis: Diagnosis of obliterative bronchiolitis following lung transplantation.



N/A

Coverage Duration

12 months

Other Criteria Subject to Part B vs. Part D review (not limited to new starts only). Approve for continuation of prior therapy if Part D.

26

CEREZYME Products Affected Cerezyme INJ 200UNIT



Exclusion Criteria

N/A


Gaucher's disease: Diagnosis of Type 1 Gaucher's disease. Patient has evidence of symptomatic disease (eg, moderate to severe anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly).



N/A

Coverage Duration

12 months

Other Criteria N/A

27

CESAMET Products Affected Cesamet



Exclusion Criteria

N/A


Nausea and Vomiting Associated with Cancer Chemotherapy: Patient is receiving cancer chemotherapy.



N/A

Coverage Duration

CINV: 6 months

Other Criteria Subject to Part B vs. Part D review. CINV: Approve for continuation of therapy for treatment covered under Part B and when patient is receiving cancer chemotherapy. Failure, contraindication, or intolerance (F/C/I) to 5HT-3 receptor antagonist (eg, Anzemet [dolasetron], Kytril [granisetron], or Zofran [ondansetron]). F/C/I to one agent from at least one of the following drug classes: antihistamines (Compazine [prochlorperazine], Phenergan [promethazine]), corticosteroids (Decadron [dexamethasone]), prokinetic agents (Reglan [metoclopramide]), antipsychotic agents (Haldol [haloperidol], Zyprexa [olanzapine]), benzodiazepines (Ativan [lorazepam]).

28

CHORIONIC GONADOTROPIN Products Affected Pregnyl W/diluent Benzyl Chorionic Gonadotropin Alcohol/nacl Novarel



Exclusion Criteria

Used to promote fertility.


Prepubertal Cryptorchidism: Diagnosis of prepubertal cryptorchidism not due to anatomical obstruction. Male Hypogonadotropic Hypogonadism. Diagnosis of male hypogonadism secondary to pituitary deficiency, and low testosterone and low LH or FSH.



N/A

Coverage Duration

Prepubertal Cryptorchidism: 6 months. Male Hypogonadotropic Hypogonadism: 12 months.

Other Criteria N/A

29

CIALIS Products Affected Cialis ORAL TABS 2.5MG, 5MG



Exclusion Criteria

For the treatment of erectile dysfunction.


Benign prostatic hyperplasia (BPH): Diagnosis of BPH. Male Gender.



N/A

Coverage Duration

BPH: 12 months

Other Criteria BPH: Failure/contraindication/intolerance to two formulary alpha blockers. Cialis 2.5mg strength: Patient has renal insufficiency.

30

CIMZIA Products Affected Cimzia



Exclusion Criteria

N/A


Reauthorization for Crohn's Disease (CD): Demonstrated remission or significant clinical response to therapy. Reauthorization for Rheumatoid Arthritis (RA): Documentation of clinical improvement from ongoing therapy. Reauthorization for Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS): Documentation of positive clinical response to Cimzia therapy. Patient is not receiving Cimzia in combination with a biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] or Janus kinase inhibitor [eg, Xeljanz (tofacitinib)].



Crohn's: Prescribed or recommended by a gastroenterologist. RA, AS: Prescribed or recommended by a rheumatologist. PsA: Prescribed or recommended by a dermatologist or rheumatologist.

Coverage Duration

All uses: 12 months

31

Other Criteria Crohn's Disease: Failure, contraindication, or intolerance (F/C/I) to one of the following conventional therapies: aminosalicylates (eg, mesalamine, sulfasalazine, olsalazine), immunomodulators (eg, 6-mercaptopurine, azathioprine, methotrexate), corticosteroids [eg, prednisone, methylprednisone, budesonide]). Rheumatoid Arthritis: Failure, contraindication, or intolerance to one disease-modifying anti-rheumatic drug (DMARD) (eg, methotrexate, leflunomide, sulfasalazine). PsA: F/C/I to 1 DMARD (eg, MTX, leflunomide, sulfasalazine). Patient is not receiving Cimzia in combination with a biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] or Janus kinase inhibitor [eg, Xeljanz (tofacitinib)]. AS: F/C/I to 2 NSAIDs. Patient is not receiving Cimzia in combination with a biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] or Janus kinase inhibitor [eg, Xeljanz (tofacitinib)].

32

CINRYZE Products Affected Cinryze



Exclusion Criteria

N/A


Hereditary Angioedema (HAE): For the long term prevention of HAE attacks.



HAE: Prescribed by an immunologist, allergist or rheumatologist

Coverage Duration

HAE: 12 months

Other Criteria HAE: Failure, intolerance or contraindication to danazol or one alkylated androgen.

33

CNS STIMULANTS Products Affected Amphetamine/dextroamphetamine Dexmethylphenidate Hcl Dextroamphetamine Sulfate ORAL

TABS

Dextroamphetamine Sulfate Er

Metadate Er

Methamphetamine Hcl

Methylphenidate Hcl

Methylphenidate Hcl CD ORAL CPCR 10MG, 50MG, 60MG

Methylphenidate Hcl Er ORAL CP24 Methylphenidate Hcl Er ORAL

TBCR 18MG, 20MG, 27MG, 36MG, 54MG

Methylphenidate Hydrochloride Vyvanse



Exclusion Criteria

N/A


N/A



N/A

Coverage Duration

12 months

Other Criteria Approve for continuation of therapy.

34

COMETRIQ Products Affected Cometriq ORAL KIT 0, 0, 20MG



Exclusion Criteria

N/A


Diagnosis of progressive, metastatic medullary thyroid cancer.



Prescribed by an oncologist and/or hematologist.

Coverage Duration

11 months


35

COPAXONE Products Affected Copaxone INJ 20MG/ML



Exclusion Criteria

N/A





N/A

Coverage Duration

12 months

Other Criteria N/A

36

CYCLOSET Products Affected Cycloset



Exclusion Criteria

N/A


branded bromocriptine



N/A

Coverage Duration

12 months

Other Criteria Diabetes Mellitus: Failure, contraindication, or intolerance to two of the following: metformin/metformin ER, a sulfonylurea, a thiazolidinedione, insulin, or an incretin mimetic.

37

DALIRESP Products Affected Daliresp



Exclusion Criteria

N/A


Chronic Obstructive Pulmonary Disease (COPD): (Initial) Diagnosis of severe COPD. Patient has chronic bronchitis. (Reauthorization): Documentation of positive clinical response to Daliresp therapy.



N/A

Coverage Duration

12 months

Other Criteria COPD: (Initial) Failure/contraindication/intolerance to one prior therapy for COPD.

38

DEGARELIX Products Affected Firmagon



Exclusion Criteria

N/A


Prostate Cancer: For palliative treatment of advanced prostate cancer.



N/A

Coverage Duration

12 months


39

DIFICID Products Affected Dificid



Exclusion Criteria

N/A


Clostridium difficle-associated diarrhea (CDAD): Diagnosis of CDAD. One of the following: mild-moderate CDAD with history of failure, contraindication or intolerance to oral Vancocin (vancomycin), or severe CDAD.



N/A

Coverage Duration

CDAD: 10 days

Other Criteria CDAD: Approve for continuation of prior therapy.

40

DRUGS TO AVOID IN THE ELDERLY Products Affected Atropine Sulfate INJ 0.05MG/ML,

0.1MG/ML

Benztropine Mesylate

Combipatch

Cyproheptadine Hcl TABS

Digoxin TABS 0.25MG

Diphenhydramine Hcl INJ

Estradiol ORAL TABS

Hydroxyzine Hcl

Hydroxyzine Pamoate

Ketorolac Tromethamine INJ 15MG/ML, 30MG/ML

Lanoxin TABS 0.25MG Methyldopa Phenadoz Promethazine Hcl ORAL TABS Promethazine Hcl RECTAL SUPP Promethegan RECTAL SUPP 25MG,

50MG Trihexyphenidyl Hcl



Exclusion Criteria

N/A


N/A

Age Restrictions No PA required if less than 65 yo.


N/A

Coverage Duration

12 months

Other Criteria N/A

41

EGRIFTA Products Affected Egrifta



Exclusion Criteria

N/A


HIV-associated lipodystrophy (Initial): Waist-circumference greater than or equal to 95 cm (37.4 inches) in men, or greater than or equal to 94 cm (37 inches) for women. Waist-to-hip ratio greater than or equal to 0.94 for men, or greater than or equal to 0.88 for women. Body mass index (BMI) greater than 20 kg/m2. Fasting blood glucose (FBG) levels less than or equal to 150 mg/dL (8.33 mmol/L). Patient has been on a stable regimen of antiretrovirals (eg, NRTIs, NNRTI, Protease Inhibitors, Integrase Inhibitors) for at least 8 weeks. (Reauth): Documentation of clinical improvement (eg, improvement in VAT, decrease in waist circumference, belly appearance).



N/A

Coverage Duration

6 months

Other Criteria N/A

42

ELELYSO Products Affected Elelyso



Exclusion Criteria

N/A


Gaucher's disease: Diagnosis of Type 1 Gaucher's disease. Patient has evidence of symptomatic disease (eg, moderate to severe anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly.)



N/A

Coverage Duration

12 months

Other Criteria N/A

43

ELIGARD Products Affected Eligard



Exclusion Criteria

N/A


Prostate Cancer: Palliative treatment of advanced prostate cancer.



N/A

Coverage Duration

12 months

Other Criteria Prostate Cancer: History of failure, contraindication, or intolerance to Lupron Depot. Approve for continuation of prior therapy.

44

ELIQUIS Products Affected Eliquis



Exclusion Criteria

N/A


Reduction in risk of stroke and systemic embolism in non valvular atrial fibrillation (AF): Confirmed diagnosis. Patient does not have any of the following conditions: a mechanical prosthetic heart valve OR a bioprosthetic heart valve. Treatment of acute venous thromboembolism (VTE): confirmed diagnosis of acute VTE (ie, acute symptomatic deep venous thrombosis (DVT) of legs or pulmonary embolism). Prophylaxis of VTE: Completion of total knee or total hip replacement surgery. Extended VTE Treatment: Previous diagnosis of acute VTE (ie, acute symptomatic deep venous thrombosis (DVT) of legs or pulmonary embolism) which requires extended therapy.



N/A

Coverage Duration

Stroke, systemic emb AF:12 mo. VTE prophy, Hospital dc:35 days. Acute VTE:6 mo. Extended VTE:18 mo

Other Criteria Approve for continuation of therapy upon hospital discharge. Extended VTE Treatment: Patient must have been treated with Eliquis for at least 3 months prior to request.

45

EMCYT Products Affected Emcyt



Exclusion Criteria

N/A


N/A



Prescribed by an oncologist.

Coverage Duration

12 months


46

EMEND Products Affected Emend ORAL CAPS



Exclusion Criteria

N/A


Acute Chemotherapy-induced Nausea and Vomiting (CINV): Patient is currently receiving moderately or highly emetogenic chemotherapy. Patient is concurrently on both corticosteroid [eg, Decadron (dexamethasone)] and 5-HT3 receptor antagonist [eg, Aloxi (palonosetron), Anzemet (dolasetron), Kytril (granisetron), Zofran (ondansetron)]. Delayed Chemotherapy-induced Nausea and Vomiting Prevention: Patient is currently receiving highly emetogenic chemotherapy and corticosteroid [eg, Decadron (dexamethasone)], or patient is receiving an anthracycline [eg, Adriamycin (doxorubicin), Ellence (epirubicin)] and Cytoxan (cyclophosphamide), or patient is currently receiving moderately emetogenic chemotherapy and was given Emend (oral or IV) on day 1 of chemotherapy. Postoperative Nausea and Vomiting (PONV): For the prevention of postoperative nausea and vomiting when administered prior to the induction of anesthesia.



N/A

Coverage Duration

Acute CINV, Delayed CINV: 12 months. PONV: 6 months


47

ENBREL Products Affected Enbrel



Exclusion Criteria

N/A


Rheumatoid Arthritis (RA): diagnosis of moderate to severe active RA. Juvenile Idiopathic Arthritis (JIA): diagnosis of moderate to severe polyarticular juvenile idiopathic arthritis. Psoriatic Arthritis (PsA): diagnosis of active PsA. Plaque psoriasis: diagnosis of moderate to severe chronic plaque psoriasis. Ankylosing Spondylitis (AS): diagnosis of AS. Reauthorization for all uses: demonstration of clinical improvement from ongoing therapy with Enbrel.



RA (Initial), JIA (Initial), AS (Initial): Prescribed or recommended by a rheumatologist. PsA: Prescribed or recommended by a rheumatologist or dermatologist. Plaque Psoriasis (Initial): Prescribed or recommended by a dermatologist.

Coverage Duration

All uses (initial, reauthorization): 12 months

Other Criteria Rheumatoid Arthritis (RA): Failure, contraindication, or intolerance (F/C/I) to 1 disease-modifying anti-rheumatic drug (DMARD) (eg, methotrexate (MTX), leflunomide, sulfasalazine). Juvenile Idiopathic Arthritis (JIA): F/C/I to MTX. Ankylosing Spondylitis (AS): F/C/I to 2 or more NSAIDs.

48

EPOETIN ALFA Products Affected Procrit Epogen



Exclusion Criteria

Anemia in cancer patients on chemotherapy: Patient is not receiving cancer chemotherapy. Off-label uses (except Anemia in MDS): Hgb greater than 10 g/dL or Hct greater than 30%.

Required Anemia due to Chronic Kidney Disease (CKD) (Initial): Diagnosis (dx) of Medical CKD. Anemia by lab values (Hct less than 30% or Hgb less than 10 g/dL) Information within 30 days of request. (Reauth): Diagnosis of CKD. Most recent or

average (avg) Hct over 3 months is 33% or less OR most recent or avg Hgb over 3 months is 11 g/dL or less. Decrease in blood transfusion or Hgb increase by 1 g/dL or more from pre-treatment level. Anemia w/ HIV (Initial): Anemia by labs (Hgb less than 12 g/dL or Hct less than 36%) within 30 days of request. Receiving zidovudine therapy or dx of HIV. (Reauth): Most recent or avg Hct over 3 months is below 36% or most recent or avg Hgb over 3 months is below 12 g/dl. Decrease in blood transfusion or Hgb increase by 1 g/dL or more from pre-treatment level. Anemia with chemo (Initial):Other causes of anemia ruled out. Anemia with labs (Hct less than 30%, Hgb less than 10 g/dL) within prior 2 weeks of request. Cancer is non-myeloid malignancy. Patient is concurrently on chemo, or will receive concomitant chemo for mininum of 2 mos, or anemia caused by cancer chemo. (Reauth): Anemia by labs (Hgb less than 10 g/dl or Hct less than 30%) collected within the prior 2 wks of request. Decrease in blood transfusion or Hgb increased by 1 g/dL or more from pre-treatment level. Patient is concurrently on chemo, or will receive concomitant chemo for mininum 2 months, or anemia is caused by cancer chemo.



N/A

Coverage Duration

CKD,HIV(Init):6mo. CKD,HIV(reauth):12mo. Chemo,HCV(all):3mo. MDS(init):3mo,(reauth)12mo. Preop:1mo.

49

Other Criteria Subject to Part B vs. Part D review. Preoperative for reduction of allogeneic blood transfusion: Approved based on all of the following: Patient is scheduled to undergo elective, non-cardiac, non-vascular surgery, Hgb is greater than 10 and less than 13 g/dL, patient is at high risk for perioperative transfusions, and patient is unwilling or unable to donate autologous blood pre-operatively. Anemia in HCV-infected pts due to ribavirin in combination with interferon or peg-interferon (Initial): Diagnosis of HCV infection. Anemia by labs (Hct less than 30% or Hgb less than 10 g/dL) within 30 days of request. Patient is receiving ribavirin and one of the following: interferon alfa or peginterferon alfa. (Reauth): Most recent or avg Hct over 3 months was 36% or less, OR most recent or avg Hgb over 3 months is 12 g/dl or less. Decrease in blood transfusion or Hgb 1 g/dL or more from pre-treatment level. If patient has demonstrated response to therapy, authorization will be issued for the full course of ribavirin therapy. Anemia in MDS (Initial): Diagnosis of MDS. Serum erythropoietin 500 mU/mL or less, or tranfusion dependent MDS. (Reauth): most recent or avg Hct over 3 months is 36% or less, OR most recent or avg Hgb over 3 months is 12 g/dl or less. Decrease in blood transfusion or Hgb 1 g/dL or more from pre-treatment level. All uses: Verify Fe evaluation for adequate Fe stores.

50

ERBITUX Products Affected Erbitux INJ 100MG/50ML



Exclusion Criteria

N/A


Head and Neck Cancer: Diagnosis of locally or regionally advanced squamous cell head and neck cancer and used in combination with radiation therapy, or diagnosis of recurrent or metastatic squamous cell head and neck cancer with 1 of the following: after failure of platinum-based chemotherapy, or used in combination with cisplatin, or used in combination with either cisplatin plus 5-FU or carboplatin plus 5-FU. Colorectal Cancer: Diagnosis of metastatic carcinoma of the colon or rectum. One of the following: Used in combination with either FOLFOX or FOLFIRI, or intolerance to either irinotecan-based chemotherapy or intensive therapy (eg, FOLFOX or FOLFIRI), or failure of irinotecan or oxaliplatin-based chemotherapy regimens, or used as monotherapy in patients not appropriate for intensive therapy. Tumor expresses wild-type KRAS gene. NSCLC: diagnosis of recurrent or metastatic non-small cell lung cancer (NSCLC) stage IIIB or IV. Used in combination with vinorelbine and cisplatin. ECOG performance status 0-2. Epidermal growth factor receptor (EGFR) expression by immunohistochemistry.



Prescribed by or in consultation with an oncologist

Coverage Duration

Head and Neck Cancer, Colorectal Cancer, NSCLC: 6 months.


51

ERIVEDGE Products Affected Erivedge



Exclusion Criteria

N/A


Metastatic basal cell carcinoma (BCC): Diagnosis of metastatic basal cell carcinoma. Advanced basal cell carcinoma: Diagnosis of locally advanced basal cell carcinoma. One of the following: Cancer has recurred following surgery, Patient is not a candidate for surgery, or Patient is not a candidate for radiation.



Metastatic and Advanced BCC: Prescribed by or in consultation with a dermatologist or oncologist

Coverage Duration

10 months


52

EXJADE Products Affected Exjade



Exclusion Criteria

N/A


Chronic Iron Overload due to Blood Transfusions (Initial): Diagnosis of chronic iron overload (eg, sickle cell anemia, thalassemia, etc.) due to blood transfusion. Patient has blood transfusion of at least 100 mL/kg of packed red blood cells (eg, at least 20 units of packed red blood cells for a 40-kg person or more in individuals weighing more than 40 kg) prior to initiation of treatment with Exjade. Patient has serum ferritin levels consistently greater than 1000 mcg/L prior to initiation of treatment with Exjade. Unable to comply or adhere to parenteral Desferal (deferoxamine mesylate) therapy (Reauthorization): Documentation of positive clinical response to Exjade therapy. Chronic Overload in non-transfusion dependent thalassemia syndromes (initial): Diagnosis of chronic iron overload in non-transfusion dependent thalassemia syndrome. Patient has liver iron (Fe) concentration (LIC) levels consistently at least 5 mg Fe per gram of dry weight prior to initiation of treatment with Exjade. Patient has serum ferritin levels consistently more than 300 mcg/L prior to initiation of treatment with Exjade. (Reauthorization): Documentation of positive clinical response to Exjade therapy.



Prescribed by a hematologist/oncologist or hepatologist.

Coverage Duration

12 months

Other Criteria N/A

53

EXTAVIA Products Affected Extavia



Exclusion Criteria

N/A


MS: Diagnosis of a relapsing form of multiple sclerosis (MS) (eg, relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses), or patient has had a first clinical episode with MRI features consistent with MS.



N/A

Coverage Duration

12 months

Other Criteria N/A

54

FENTANYL Products Affected Fentanyl Citrate Oral Transmucosal



Exclusion Criteria

N/A


Cancer pain: for the management of breakthrough cancer pain. Demonstrated tolerance to opioids.



Prescribed by an oncologist or pain specialist.

Coverage Duration

12 months

Other Criteria N/A

55

FENTANYL (BRAND)

Products Affected Subsys SUBLINGUAL LIQD Abstral 100MCG, 200MCG, 400MCG,

600MCG, 800MCG Actiq

Fentora



Exclusion Criteria

N/A


Cancer pain: for the management of breakthrough cancer pain. Demonstrated tolerance to opioids.



Prescribed by an oncologist or pain specialist.

Coverage Duration

12 months

Other Criteria Cancer Pain: Failure to generic fentanyl.

56

FERRIPROX Products Affected Ferriprox



Exclusion Criteria

N/A


Transfusional iron overload due to thalassemia syndromes when current chelation therapy [eg, Desferal (deferoxamine), Exjade (deferasirox)] is inadequate



Prescribed by a hematologist/oncologist or hepatologist

Coverage Duration

12 months

Other Criteria Serum ferritin levels consistently greater than 1000 mcg/L prior to initiation of treatment with Ferriprox. Reauthorization: documentation of positive clinical response to Ferriprox therapy

57

FIRAZYR Products Affected Firazyr



Exclusion Criteria

N/A


N/A



Prescribed by an immunologist, allergist or rheumatologist

Coverage Duration

12 months

Other Criteria N/A

58

FOLOTYN Products Affected Folotyn INJ 40MG/2ML



Exclusion Criteria

N/A


Peripheral T-cell lymphoma (PTCL): Diagnosis of relapsed or refractory PTCL. Verification that patient is receiving folic acid and vitamin B12 supplementation.



N/A

Coverage Duration

12 months


59

FORTEO Products Affected Forteo



Exclusion Criteria

N/A


Postmenopausal Osteoporosis or men with primary or hypogonadal osteoporosis: bone mineral density (BMD) T score of -3.5 or less [based on BMD measurements from lumber spine, hip (femoral neck, total hip), or radius (one-third radius site or forearm)] OR Both of the following: BMD T-score between -2.5 and -3.5 [based on BMD measurements from lumber spine, hip (femoral neck, total hip), or radius (one-third radius site or forearm)] and either history of one of the following fractures (fx) resulting from minimal trauma (vertebral compression, hip, or distal radius fx) or failure, contraindication, or intolerance (F/C/I) to one bisphosphonate (BP) [eg Fosamax (alendronate)] OR Both of the following: History of one of the following fx resulting from minimal trauma (vertebral compression, hip, or distal radius fx) and F/C/I to one BP [eg Fosamax (alendronate)] Glucocorticoid-Induced Osteoporosis: history of prednisone or equivalent at a dose of 5mg/day or greater for 3 months or greater.



N/A

Coverage Duration

12 months, max 2 yrs of therapy.

60

Other Criteria Treatment duration has not exceeded a total of 24 months during the patient's lifetime. Glucocorticoid-Induced Osteoporosis: BMD T score of -2.0 or less [based on BMD measurements from lumber spine, hip (femoral neck, total hip), or radius (one-third radius site or forearm)] OR Both of the following: BMD T score between -1.0 and -2.0 [based on BMD measurements from lumber spine, hip (femoral neck, total hip), or radius (one-third radius site or forearm)] and either history of one of the following fx resulting from minimal trauma (vertebral compression, hip, or distal radius fx) or F/C/I to one BP [eg Fosamax (alendronate)] OR Both of the following: history of one of the following fx resulting from minimal trauma (vertebral compression, hip, or distal radius fx) and F/C/I to one BP [eg Fosamax (alendronate)]

61

GABLOFEN Products Affected Gablofen INJ 10000MCG/20ML,

40000MCG/20ML, 50MCG/ML



Exclusion Criteria

N/A


N/A



N/A

Coverage Duration

12 months


62

GAMASTAN Products Affected Gamastan S/d



Exclusion Criteria

Hepatitis A: not indicated in persons with clinical manifestations of hepatitis A or those exposed more than 2 weeks previously. Measles: Do not give at the same time as measles vaccine.


Hepatitis A: For prophylaxis before or soon after exposure to Hepatitis A. Measles: For use in susceptible individuals exposed to measles fewer than 6 days previously. Varicella: For passive immunization against varicella in immunosuppressed patients. Rubella: For pregnant women who will not consider a therapeutic abortion.



N/A

Coverage Duration

12 months

Other Criteria N/A

63

GATTEX Products Affected Gattex



Exclusion Criteria

N/A


(Initial) Diagnosis of short bowel syndrome. Patient is dependent on parenteral nutrition/intravenous (PN/IV) support for at least 12 consecutive months. (Reauthorization): Documentation of positive clinical response to Gattex therapy.



N/A

Coverage Duration

Initial: 6 months. Reauthorization: 12 months.

Other Criteria N/A

64

GILENYA Products Affected Gilenya



Exclusion Criteria

N/A


Multiple Sclerosis: Diagnosis of a relapsing form of multiple sclerosis (MS) (eg, relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses).



N/A

Coverage Duration

12 months

Other Criteria N/A

65

GILOTRIF Products Affected Gilotrif



Exclusion Criteria

N/A


Non-small cell lung cancer (NSCLS): Diagnosis of NSCLC. One of the following: 1) tumors are positive for epidermal growth factor receptor (EGFR) exon 19 deletions OR 2) tumors are positive for exon 21 (L858R) substitution mutations.



NSCLC: Prescribed by an oncologist

Coverage Duration

11 months


66

GLEEVEC Products Affected Gleevec



Exclusion Criteria

N/A


Chronic Myelogenous/Myeloid Leukemia (CML): Diagnosis of Philadelphia chromosome positive CML (Ph+CML). Acute Lymphoblastic Leukemia/Acute Lymphoblastic Lymphoma (ALL): Diagnosis of Philadelphia chromosome positive ALL (Ph+ALL)/ acute lymphoblastic lymphoma. Myelodysplastic/myeloproliferative diseases (MDS/MPD): Diagnosis of MDS/MPD associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements. Aggressive systemic mastocytosis (ASM): Diagnosis of ASM. Patient is without the D816V c-Kit mutation or c-Kit mutational status unknown. Hypereosinophilic syndrome (HES) and chronic eosinophilic leukemia (CEL): Diagnosis of at least one of the following: HES or CEL. Dermatofibrosarcoma protuberans (DFSP): Diagnosis of DFSP. Gastrointestinal Stromal Tumors (GIST): Diagnosis of GIST. Desmoid tumors/aggressive fibromatosis: Diagnosis of desmoid tumors/aggressive fibromatosis.




Coverage Duration

12 months


67

GRANIX Products Affected Granix



Exclusion Criteria

N/A


Primary prophylaxis of febrile neutropenia (FN): Patient is receiving chemotherapy regimen associated with more than 20% incidence of febrile neutropenia, or patient is receiving chemotherapy regimen associated with 10-20% incidence of febrile neutropenia and has 1 or more risk factors associated with chemotherapy-induced infection, FN, or neutropenia. Secondary prophylaxis of FN: For patients receiving myelosuppressive anticancer drugs associated with neutropenia (ANC less than or equal to 500 cells/m3). Patient has a history of febrile neutropenia during a previous course of chemotherapy.



Prescribed by a hematologist/ oncologist

Coverage Duration

3 months or duration of treatment.

Other Criteria N/A

68

GROWTH HORMONES Products Affected Genotropin Genotropin Miniquick Humatrope INJ 12MG, 24MG, 6MG Humatrope Combo Pack Norditropin Flexpro Norditropin Nordiflex Pen Nutropin

Nutropin Aq Nuspin 5 Nutropin Aq Pen Omnitrope Saizen INJ 5MG Saizen Click.easy Tev-tropin


Covered Uses All medically accepted indications not otherwise excluded from Part D. Transition Phase Adolescent Patients (TPAP)

Exclusion Criteria

N/A

69

Required PGHD(initial):less than 4mo w/GD,or hx neonatal hypoglycemia assoc Medical w/pituitary dz,or panhypopituitarism dx,or all of the following: PGHD dx Information [confirmed by ht below 3rd percentile for age and gender on grwth charts

related to ht documented(doc) by ht more than 1.5SD below midparental ht or more than 2SD below population(pop) mean,or grwth velocity more than 2SD below mean for age and gender,or delayed skeletal maturation more than 2SD below mean for age and gender (eg delayed more than 2yrs compared w/chronological age)], and doc male w/bone age less than 17yrs or female w/bone age less than 15yrs. PWS(reauth):evidence of positive response to tx (eg incr in total LBM, decr in fat mass),or ht incr at least 2cm/yr over previous yr of tx(doc by previous ht and date and current ht and date) and expctd adult ht not attained and doc of expctd adult ht goal. GFSGA(initial):SGA dx based on catchup grwth failure in 1st 24mo of life using 0-36mo grwth chart confirmed by birth wt or length below 3rd percentile for gestational age(more than 2SD below pop mean) or ht remains at or below 3rd percentile (more than 2SD below pop mean).TS,NS(initial):dx of ped grwth failure assoc w/TS w/doc female w/bone age less than 15yrs or NS w/doc male w/bone age less than 17yrs or female w/bone age less than 15yrs, and ht below 5th percentile on grwth charts for age and gender.SHOX(initial):dx of ped grwth failure w/SHOX gene deficiency confirmed by genetic testing and doc male w/bone age less than 17yrs or female w/bone age less than 15yrs.GFCRI(initial):dx of ped grwth failure assoc w/CRI and male w/bone age less than 17yrs or female w/bone age less than 15yrs. ISS(initial):ISS dx, diagnostic eval excluded other causes assoc w/short stature (eg GHD,chronic renal insufficiency), doc ht at or below -2.25SD score below corresponding mean ht for age and gender, doc grwth velocity less than 25th percentile for bone age, and doc male w/bone age less than 17 yrs or female w/bone age less than 15 yrs



PGHD (initial), TS/NS (initial), SHOX (initial), AGHD (initial), TPAP (initial), IGHDA (initial), ISS (initial): prescribed by endocrinologist. GFCRI: prescribed by endocrinologist or nephrologist

Coverage Duration

12 months

70

Other Criteria AGHD (initial): dx of AGHD due to childhood-onset GHD, or adult-onset GHD w/hormone deficiency due to hypothalamic-pituitary dz from organic or known causes (eg, damage from surgery, cranial irradiation, head trauma, subarachnoid hemorrhage) and pt has 1 GH stim test (insulin tolerance test, arginine/GHRH, glucagon, arginine) to confirm adult GHD w/corresponding peak GH values ([ITT at or below 5mcg/L], [GHRH+ARG at or below 11mcg/L if BMI less than 25kg/m2, at or below 8mcg/L if BMI at or above 25 and below 35kg/m2, or at or below 4mcg/L if BMI at or above 30kg/m2], [glucagon at or below 3mcg/L], [Arg at or below 0.4mcg/L]) or documented deficiency of 3 anterior pituitary hormones (prolactin, ACTH, TSH, FSH/LH) and IFG-1/somatomedin-C level is below age and gender adjusted normal range as provided by physician’s lab.AGHD, IGHDA (reauth): evidence of ongoing monitoring as demonstrated by documentation within past 12 mo of IGF-1/somatomedin C level.TPAP (initial): adult GH dosing used as defined by PI/AACE tx GL, pt attained expected adult ht or closed epiphyses on bone radiograph, and documentation of high risk of GHD due to GHD in childhood (from embryopathic/congenital defects, genetic mutations, irreversible structural hypothalamic-pituitary dz, panhypopituitarism, or deficiency of 3 anterior pituitary hormones: ACTH,TSH,prolactin,FSH/LH) w/IGF-1/somatomedin-C below age and gender adj nrml range as provided by physician’s lab or pt does not have low IGF-1/somatomedinC level or at low risk of severe GHD(eg d/t isolated and/or idiopathic GHD), d/c GH tx for at least 1 mo, and pt has 1 GH stim test (ITT, GHRH+ARG, ARG, glucagon) after d/c of tx for at least 1 mo w/corresponding peak GH value [ITT at or below 5mcg/L], [GHRH+ARG at or below 11mcg/L if BMI less than 25kg/m2, at or below 8mcg/L if BMI at or above 25 and below 35kg/m2, or at or below 4mcg/L if BMI at or above 30kg/m2], [glucagon at or below 3mcg/L], [Arg at or below 0.4mcg/L].TPAP (reauth): evidence of positive response to therapy (eg, incr in total LBM, exercise capacity or IGF-1 and IGFBP-3).IGHDA (initial): documented GHD by failure to produce peak serum GH greater than 5 mcg/L after 2 provocative pharmacol stim tests (insulin,L-ARG,glucagon)ISS (initial): ISS dx, diagnostic evaluation excluded other causes assoc w/short stature (eg GHD, chronic renal insufficiency), documentation of ht at or below -2.25 SD score below corresponding mean ht for age and gender, documentation of growth velocity less than 25th percentile for bone age, and documentation pt is male w/bone age less than 17 yrs or female w/bone age less than 15 yrs.PGHD, GFSGA, TS/NS, SHOX, GFCRI, ISS (reauth): growth incr of at least 2 cm/yr over previous yr of tx (documented by previous ht and date and current ht and date) and expected adult ht not attained and documentation of expected adult ht goal

71

HALAVEN Products Affected Halaven



Exclusion Criteria

N/A


Breast Cancer: Diagnosis of recurrent or metastatic breast cancer.



Prescribed by an oncologist and/or hematologist.

Coverage Duration

12 months

Other Criteria Approve for continuation of prior therapy. Breast Cancer: Previous treatment with both of the following: an anthracycline and a taxane.

72

HERCEPTIN Products Affected Herceptin



Exclusion Criteria

N/A


N/A



N/A

Coverage Duration

12 months


73

HEXALEN Products Affected Hexalen



Exclusion Criteria

N/A


Diagnosis of ovarian cancer, cancer has progressed or recurred following first-line treatment with a cisplatin or alkylating agent-based combination.



Prescribed by an oncologist

Coverage Duration

12 months


74

HUMIRA Products Affected Humira Pen-crohns Diseasestarter Humira



Exclusion Criteria

N/A


Reauthorization for all uses except Crohn's disease (CD) and Ulcerative Colitis (UC): Demonstration of clinical benefit from ongoing therapy. Reauthorization for CD: Demonstrated remission or significant clinical response to Humira therapy. Reauthorization for UC: Demonstrated remission or significant clinical benefit to Humira therapy.



RA, AS, JIA: Prescribed or recommended by a rheumatologist. PsA: Prescribed or recommended by a rheumatologist or dermatologist. Plaque Psoriasis: Prescribed or recommended by a dermatologist. CD, UC: Prescribed or recommended by a gastroenterologist.

Coverage Duration

Initial Auth: 12 months for all except UC: 12 weeks. Reauth for all 12 mo.

Other Criteria Rheumatoid Arthritis (RA): Failure contraindication, or intolerance (F/C/I) to 1 disease-modifying anti-rheumatic drug (DMARD) [eg, methotrexate (MTX), leflunomide, sulfasalazine]. Juvenile Idiopathic Arthritis (JIA): F/C/I to MTX. Ankylosing Spondylitis (AS): F/C/I to 2 NSAIDs. Crohn's Disease (CD): F/C/I to one conventional therapy (corticosteroids [eg, prednisone, methylprednisolone, budesonide], immunomodulators [eg, 6-mercaptopurine, azathioprine, methotrexate], aminosalicylates [eg, mesalamine, sulfasalazine, olsalazine]) or history of failure (ie, lost response) or intolerance to Remicade (infliximab). Ulcerative colitis: F/C/I to corticosteroids (eg, prednisone, methylprednisolone) or immunomodulators (eg, 6-mercaptopurine, azathioprine)

75

ILARIS Products Affected Ilaris



Exclusion Criteria

N/A


Systemic Juvenile Idiopathic Arthritis (SJIA) (Initial)): Dx of active SJIA (eg, fever, serositis, rash, arthritis). SJIA (Reauth): Documentation of positive clinical response to Ilaris therapy. Patient is not receiving concomitant treatment with either of the following: Tumor necrosis factor (TNF) inhibitors [eg, Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab)] or Interleukin-1 inhibitors [eg, Arcalyst (rilonacept), Kineret (anakinra)]



SJIA (initial): Prescribed or recommended by a rheumatologist.

Coverage Duration

12 months

Other Criteria SJIA (initial): Failure, contraindication, or intolerance to NSAIDs or corticosteroids. Patient is not receiving concomitant treatment with either of the following: Tumor necrosis factor (TNF) inhibitors [eg, Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab)] or Interleukin-1 inhibitors [eg, Arcalyst (rilonacept), Kineret (anakinra)]

76

IMBRUVICA Products Affected Imbruvica



Exclusion Criteria

N/A


MCL: Diagnosis of mantle cell lymphoma (MCL) and patient has received at least one prior therapy for MCL (eg, Rituxan [rituximab]). CLL/SLL: Diagnosis of one of the following: Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) and patient has received at least one prior therapy for CLL or SLL (eg, Cytoxan [cyclophosphamide], Fludara [fludarabine], Rituxan [rituximab]). WM/LPL: Diagnosis of Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma and patient has received at least one prior therapy for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma (eg, Rituxan [rituximab])




Coverage Duration

MCL, CLL/SLL, WM/LPL: 12 months


77

IMMUNE GLOBULIN Products Affected Gammaplex INJ 10GM/200ML

Carimune Nanofiltered INJ 3GM Gamunex-c INJ 1GM/10ML

Gammagard Liquid Privigen INJ 20GM/200ML



Exclusion Criteria

MG: IVIG will not be approved for chronic maintenance therapy.


Idiopathic Thrombocytopenic Purpura (ITP): For patients with ITP who require a rapid temporary increase in platelet count or to control excessive bleeding. B-cell Chronic Lymphocytic Leukemia (CLL): Documented hypogammaglobulinemia (IgG less than 600mg/dL) or history of bacterial infections associated with B-cell CLL. Bone Marrow Transplant (BMT): Confirmed allogeneic BMT within the last 100 days. Documented severe hypogammaglobulinemia (IgG less than 400 mg/dL). HIV: Documented hypogammaglobulinemia (IgG less than 400 mg/dL). Guillain-Barre Syndrome (GBS): Diagnosis of GBS. Patients with severe disease requiring aid to walk. Onset of muscle weakness within the last 4 weeks. Myasthenia Gravis (MG): Diagnosis of acute myasthenia gravis with myasthenic exacerbation, defined by either difficulty swallowing, acute respiratory failure, or major functional disability responsible for the discontinuation of physical activity. Multiple Sclerosis (MS): Diagnosis of relapsing remitting form of MS. Stiff Person Syndrome: Diagnosis of stiff-person syndrome.



MG: Prescribed by a neurologist.

Coverage Duration

Cov duration: KD: 1 mo. MG, GBS: 3 mo. ITP:6 mo. Other uses:12mo.

78

Other Criteria Subject to Part B vs. Part D review. Dermatomyositis and Polymyositis: Failure, contraindication, or intolerance to immunosuppressive therapy (eg, corticosteroids, methotrexate, azathioprine, cyclophosphamide). MS: Failure, contraindication, or intolerance to two of the following: Aubagio (teriflunomide), Betaseron (interferon beta-1b), Avonex (interferon beta-1a), Copaxone (glatiramer acetate),Rebif (interferon beta-1a), Tysabri (natalizumab), Tecfidera (dimethyl fumarate), Extavia (interferon beta-1b), Gilenya (Fingolimod).

79

INCIVEK Products Affected Incivek



Exclusion Criteria

N/A


Hepatitis C: Diagnosis of chronic hepatitis C genotype 1 infection. Used in combination with peginterferon alfa and ribavirin.



N/A

Coverage Duration

Hepatitis C: 12 weeks

Other Criteria Patient does not have failure with a previous treatment regimen that includes Incivek or other HCV NS3/4A protease inhibitor (ie, Victrelis (boceprevir)).

80

INFERGEN Products Affected Infergen



Exclusion Criteria

N/A


Hep C - Treatment Naive Patients: Diagnosis of chronic hepatitis C, patient without decompensated liver disease, patients who have not previously been treated with interferon, and used in combination with ribavirin or contraindication or intolerance to ribavirin. Hep C - Retreatment: Patients with previous treatment failure (ie, nonresponder) to non-pegylated interferon with or without ribavirin or peginterferon with or without ribavirin, diagnosis of chronic hepatitis C, patient without decompensated liver disease, and used in combination with ribavirin or contraindication or intolerance to ribavirin.



N/A

Coverage Duration

Hep C-TxNaive: 48 weeks. HepC-Retreatment: one 48 week course per lifetime.

Other Criteria N/A

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INLYTA Products Affected Inlyta



Exclusion Criteria

N/A


Advanced Renal Cell Carcinoma: Diagnosis of advanced renal cell cancer. HIstory of failure, contraindication or intolerance to of the following: Cytokine-based therapy [eg, Interleukin (IL)-2], Kinase inhibitor therapy [eg, Nexavar (sorafenib), Sutent (sunitinib), Votrient (pazopanib)], Avastin (bevacizumab) in combination with Interferon (IFN)-alfa therapy, or Mammalian target of rapamycin (mTOR) inhibitor therapy [eg, Torisel (temsirolimus)].



N/A

Coverage Duration

7 months


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INSULIN-LIKE GROWTH FACTOR Products Affected Increlex



Exclusion Criteria

N/A


Initial therapy: IGF-1 deficiency: Diagnosis of severe primary IGF-1 deficiency. Height standard deviation score of -3.0 or less. Basal IGF-1 standard deviation score of -3.0 or less. Normal or elevated growth hormone (GH). Documentation of open epiphyses on last bone radiograph. The patient will not be treated with concurrent GH therapy. GH gene deletion: Diagnosis of growth hormone gene deletion who have developed neutralizing antibodies to GH. Documentation of open epiphyses on last bone radiograph. The patient will not be treated with concurrent GH therapy. Reauthorization: Growth increase of at least 2 cm/year over the previous year of treatment as documented by both of the following: (1) Previous height and date obtained and (2) Current height and date obtained AND Both of the following: (1) Expected adult height is not obtained and (2) Documentation of expected adult height goal



N/A

Coverage Duration

12 months

Other Criteria N/A

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INTRON-A Products Affected Intron-a W/diluent INJ 10MU Intron-a INJ 6000000UNIT/ML



Exclusion Criteria

N/A

Required Hepatitis B - HBeAg positive: Chronic hepatitis B infection (HBsAg Medical positive for at least 6 months), evidence of active virus replication (HBV Information DNA level greater than 20,000 IU/mL), patients without decompensated

liver disease, and evidence of active liver disease as demonstrated by one of the following: persistent elevation in serum ALT (at least 2 x upper limit of normal, (ULN)) or evidence of significant liver disease (eg, moderate to severe hepatitis, fibrosis, or necroinflammation on biopsy) or evidence of icteric ALT flare ups. Hepatitis B - HBeAg negative: Chronic hepatitis B infection (HBsAg positive for at least 6 months), HBV DNA level greater than or equal to 2000 IU/mL, patients without decompensated liver disease, and evidence of active liver disease as demonstrated by one of the following: persistent elevation in ALT (at least 2 x ULN) or evidence of significant liver disease (eg, moderate to severe hepatitis, fibrosis, or necroinflammation on biopsy) or evidence of icteric ALT flare ups. Hepatitis C - Treatment Naive Patients (monotherapy): Diagnosis of chronic hepatitis C, patient without decompensated liver disease, patients who have not previously been treated with interferon, and contraindication or intolerance to ribavirin. Hepatitis C - Treatment Naive Patients (in combination with ribavirin): Diagnosis of chronic hepatitis C, patient without decompensated liver disease, patients who have not previously been treated with interferon, and used in combination with ribavirin. Diagnoses Other than Hepatitis: One of the following: Malignant Melanoma, Hairy cell leukemia (HCL), Stage III or IV follicular Non-Hodgkin's Lymphoma (NHL), condylomata acuminata (genital or perianal), AIDS-related Kaposi's sarcoma, as maintenance therapy for the treatment of Multiple Myeloma. Renal cell carcinoma (RCC): Diagnosis of metastatic RCC and used in combination with Avastin (bevacizumab). Acute Hepatitis C (HC): Patients with acute hepatitis C.


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RCC: Prescribed by an oncologist.

Coverage Duration

HBeAG(++):16wk.HBeAG(-):48wk. HepC TxNaive:48wk.HCL,Kaposi,RCC:6mo.Wart:6wk.Other:1yr. AcuteHC:12wk.

Other Criteria Approve for continuation of prior therapy for neoplastic diseases.

85

INTUNIV Products Affected Intuniv



Exclusion Criteria

N/A


N/A



N/A

Coverage Duration

12 months

Other Criteria One of the following: Concurrently taking a formulary ADHD stimulant, OR history of failure, intolerance or contraindication to a formulary stimulant.

86

ISOTRETINOIN Products Affected Absorica



Exclusion Criteria

N/A


(initial): Diagnosis of acne. One of the following: 1) prescribed by a dermatologist or 2) history of failure, contraindication or intolerance to an adequate trial (at least 6 weeks) on both a) topical retinoid or retinoid-like agent [eg, Retin-A/Retin-A Micro (tretinoin),] and b) combination therapy with benzoyl peroxide and one of the following: oral antibiotic [eg, Ery-Tab (erythromycin), Minocin (minocycline)] or if oral antibiotics not indicated a topical antibiotic [eg, Cleocin-T (clindamycin), erythromycin, BenzaClin (benzoyl peroxide/clindamycin), Benzamycin (benzoyl peroxide/erythromycin)]. (Reauthorization): One of the following: After more than 2 months off therapy, persistent or recurring severe recalcitrant nodular acne is still present, OR the total cumulative dose is less than 150 mg/kg (there is little therapeutic benefit to be gained by increasing the cumulative dose beyond 150 mg/kg).



N/A

Coverage Duration

Initial: 5 months Reauth: up to 5 months

Other Criteria N/A

87

ISTODAX Products Affected Istodax



Exclusion Criteria

N/A


N/A



N/A

Coverage Duration

12 months

Other Criteria Approve for continuation of prior therapy. Cutaneous T-Cell Lymphoma: Failure to one systemic therapy [eg, Ontak (denileukin diftitox), Targretin (bexarotene), Cytoxan (cyclophosphamide)]. Peripheral T-cell lymphoma (PTCL): Failure, contraindication or intolerance to one PTCL therapy [eg, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), CHOEP (cyclophosphamide, doxorubicin, vincristine, etoposide, prednisone), Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin), HyperCVAD (cyclophosphamide, vincristine, doxorubicin, dexamethasone) alternating with high-dose methotrexate and cytarabine].

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JAKAFI Products Affected Jakafi



Exclusion Criteria

N/A


Myelofibrosis: One of the following: Primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.



Myelofibrosis: Prescribed by a hematologist/oncologist

Coverage Duration

Myelofibrosis: 6 months

Other Criteria Myelofibrosis: Approve for continuation of prior therapy.

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JEVTANA Products Affected Jevtana


Covered Uses All medically accepted

14395 Formulary MSOFL PA Web File v2 PCP...Decrease in blood transfusion or Hgb increase by 1 g/dL...

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