2013 First Health Premier Prior Authorization Criteria - Coventry

2013 Prior Authorization Criteria

Table of Contents

ABILIFY DISCMELT .........................................................................................................................................8

ABILIFY MAINTENA........................................................................................................................................ 9

ADAGEN ......................................................................................................................................................10

ADCIRCA......................................................................................................................................................11

AFINITOR.....................................................................................................................................................12

ALDURAZYME..............................................................................................................................................13

ALIMTA........................................................................................................................................................14

ALPHA1‐PROTEINASE INHIBITORS ..............................................................................................................15

AMITIZA.......................................................................................................................................................16

AMPYRA ......................................................................................................................................................17

ANDROGEL ..................................................................................................................................................18

ANDROXY ....................................................................................................................................................19

APOKYN.......................................................................................................................................................20

ARCALYST ....................................................................................................................................................21

AVASTIN ......................................................................................................................................................22

AVONEX.......................................................................................................................................................23

BANZEL........................................................................................................................................................24

BENLYSTA ....................................................................................................................................................25

BLEOMYCIN SULFATE ..................................................................................................................................26

Last updated 10/22/2013

BOSULIF.......................................................................................................................................................27


BUPHENYL ...................................................................................................................................................28

BYETTA ........................................................................................................................................................29

CANCIDAS....................................................................................................................................................30

CAPRELSA ....................................................................................................................................................31

CEREZYME ...................................................................................................................................................32

CHANTIX ......................................................................................................................................................33

CINRYZE.......................................................................................................................................................34

COMETRIQ...................................................................................................................................................35

COPAXONE ..................................................................................................................................................36

CYSTAGON...................................................................................................................................................37

DACOGEN....................................................................................................................................................38

DIAZEPAM ...................................................................................................................................................39

DICYCLOMINE HCL ......................................................................................................................................40

ELAPRASE ....................................................................................................................................................41

ELELYSO.......................................................................................................................................................42

ELITEK..........................................................................................................................................................43

ENBREL ........................................................................................................................................................44

ENOXAPARIN SODIUM................................................................................................................................45

ERIVEDGE ....................................................................................................................................................46

ETOPOSIDE ..................................................................................................................................................47

EXJADE ........................................................................................................................................................48

FABRAZYME ................................................................................................................................................49

FANAPT .......................................................................................................................................................50

FASLODEX....................................................................................................................................................51

FENTANYL CITRATE ORAL TRANSMUCOSAL ...............................................................................................52


FOMEPIZOLE ...............................................................................................................................................53

FONDAPARINUX SODIUM ...........................................................................................................................54

FORTEO .......................................................................................................................................................55

FOSCARNET SODIUM ..................................................................................................................................56

GEMCITABINE .............................................................................................................................................57

GILOTRIF......................................................................................................................................................58

GLEEVEC ......................................................................................................................................................59

HERCEPTIN ..................................................................................................................................................60

HUMIRA.......................................................................................................................................................61

ICLUSIG........................................................................................................................................................63

ILARIS ..........................................................................................................................................................64

INCIVEK .......................................................................................................................................................65

INCRELEX.....................................................................................................................................................66

INLYTA .........................................................................................................................................................67

INTERFERON BETA‐1B .................................................................................................................................68

INTRON‐A ....................................................................................................................................................69

INTUNIV.......................................................................................................................................................70

INVEGA........................................................................................................................................................71

ITRACONAZOLE ...........................................................................................................................................72

IXEMPRA .....................................................................................................................................................73

JAKAFI..........................................................................................................................................................74

KADCYLA......................................................................................................................................................75

KUVAN.........................................................................................................................................................76

LEUKINE.......................................................................................................................................................77

LEUPROLIDE ................................................................................................................................................79


LINZESS........................................................................................................................................................80

LOTRONEX...................................................................................................................................................81

LYRICA .........................................................................................................................................................82

MEKINIST.....................................................................................................................................................83

MEPRON......................................................................................................................................................84

MESNEX.......................................................................................................................................................85

NAGLAZYME................................................................................................................................................86

NEUMEGA ...................................................................................................................................................87

NEUPOGEN..................................................................................................................................................88

NEXAVAR.....................................................................................................................................................90

NITROFURANTOIN.......................................................................................................................................91

NOXAFIL ......................................................................................................................................................92

NULOJIX.......................................................................................................................................................93

NUVIGIL.......................................................................................................................................................94

OCTREOTIDE ACETATE ................................................................................................................................95

OMNITROPE ................................................................................................................................................96

ONDANSETRON IV.......................................................................................................................................98

ONFI ............................................................................................................................................................99

ORENCIA....................................................................................................................................................100

ORFADIN ...................................................................................................................................................101

OXANDROLONE.........................................................................................................................................102

PACLITAXEL ...............................................................................................................................................103

PEGASYS ....................................................................................................................................................104

PERJETA.....................................................................................................................................................106

PHENOBARBITAL .......................................................................................................................................107


POMALYST.................................................................................................................................................108

POTIGA ......................................................................................................................................................109

PRENATAL VITAMINS ................................................................................................................................110

PROCRIT ....................................................................................................................................................111

PROLIA.......................................................................................................................................................112

PROMACTA ...............................................................................................................................................113

QUALAQUIN ..............................................................................................................................................114

REBIF .........................................................................................................................................................115

REGRANEX.................................................................................................................................................116

RELISTOR ...................................................................................................................................................117

REMICADE .................................................................................................................................................118

REVLIMID...................................................................................................................................................119

RIBAVIRIN..................................................................................................................................................120

RILUTEK .....................................................................................................................................................122

RITUXAN....................................................................................................................................................123

SABRIL .......................................................................................................................................................124

SAMSCA.....................................................................................................................................................125

SENSIPAR...................................................................................................................................................126

SEROSTIM..................................................................................................................................................127

SIMVASTATIN 80MG .................................................................................................................................128

SOLTAMOX................................................................................................................................................129

SOMATULINE DEPOT.................................................................................................................................130

SOMAVERT................................................................................................................................................131

SPRYCEL.....................................................................................................................................................132

STIVARGA ..................................................................................................................................................133


SUBOXONE ................................................................................................................................................134

SUCRAID ....................................................................................................................................................135

SUTENT......................................................................................................................................................136

SYLATRON .................................................................................................................................................137

SYMBYAX...................................................................................................................................................138

SYMLIN ......................................................................................................................................................139

SYNAREL ....................................................................................................................................................140

SYNRIBO ....................................................................................................................................................141

TAFINLAR...................................................................................................................................................142

TARCEVA ...................................................................................................................................................143

TARGRETIN................................................................................................................................................144

TASIGNA....................................................................................................................................................145

TAXOTERE .................................................................................................................................................146

TESTRED ....................................................................................................................................................147

THALOMID.................................................................................................................................................148

TOPOTECAN ..............................................................................................................................................149

TRACLEER ..................................................................................................................................................150

TRETINOIN.................................................................................................................................................151

TRISENOX ..................................................................................................................................................152

TYGACIL .....................................................................................................................................................153

TYKERB ......................................................................................................................................................154

VANCOCIN HCL..........................................................................................................................................155

VELCADE....................................................................................................................................................156

VENTAVIS ..................................................................................................................................................157

VIDAZA ......................................................................................................................................................158


VORAXAZE.................................................................................................................................................159

VOTRIENT..................................................................................................................................................160

XALKORI ....................................................................................................................................................161

XENAZINE ..................................................................................................................................................162

XOLAIR.......................................................................................................................................................163

XTANDI ......................................................................................................................................................164

YERVOY......................................................................................................................................................165

ZALTRAP ....................................................................................................................................................166

ZAVESCA....................................................................................................................................................167

ZELBORAF..................................................................................................................................................168

ZOLINZA ....................................................................................................................................................169

ZOMETA ....................................................................................................................................................170

ZYTIGA.......................................................................................................................................................171

ZYVOX........................................................................................................................................................172


Prior Authorization Group

ABILIFY DISCMELT

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Abilify is not approved for the treatment of patients with dementia-related psychosis.

Required Medical Documentation of past therapies and outcomes. Diagnosis for use: treatment of acute manic or mixed episodes associated with bipolar disorder (with or without psychotic features), maintenance treatment of bipolar I disorder, both as monotherapy and as an adjunct to lithium or valproate, treatment of schizophrenia, major depressive disorder (adjunctive therapy in patients also on antidepressants), autistic disorder.

Age Restrictions: Autistic disorder: Pediatrics 6-17 years old only

Prescriber Restrictions:

Coverage Duration: Remainder of contract year

Other Criteria: Abilify Discmelt is not covered for patients that can swallow Abilify tablets. Requests for new starts are covered in patients with schizophrenic and bipolar disorders following a trial and documented failure of Seroquel XR and risperidone (unless these are otherwise contraindicated). Requests for new starts are covered in patients with major depressive disorder with documentation of an inadequate response of at least a 4-6 week course of antidepressant therapy (consistent with the shortest clinical trial of antidepressants). Requests for new starts are covered in patients with autistic disorder following a trial of risperidone (unless risperidone is otherwise contraindicated).



ABILIFY MAINTENA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D.

Exclusion Criteria:

Not covered for patients not already established on Abilify/aripiprazole tablets prior to Abilify Maintena administration.

Required Medical: Documentation of past therapies and outcomes. Diagnosis for use: treatment of schizophrenia.

Age Restrictions:


Coverage Duration: Remainder of contract year.

Other Criteria:

Requests for new starts will be covered with documentation of trial and failure or contraindication to both Invega Sustenna AND Risperdal Consta AND documentation of a contraindication to continued use of oral Abilify/aripiprazole tablets.



ADAGEN

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Adenosine deaminase deficiency - Severe combined immunodeficiency disease.

Age Restrictions: Not approved for use in adults


Coverage Duration: 6 months

Other Criteria: If this medication is administered by a physician incident to a physician’s visit it would be covered by Medicare Part B



ADCIRCA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Efficacy and safety have not been established in the following and are therefore excluded from coverage when there is concomitant use with organic nitrates (e.g. isosorbide, nitroglycerin). Adcirca is not covered for the diagnosis of ED/impotence.

Required Medical Documentation of past therapies and outcomes. Diagnosis for use. Documentation to support that the patient is WHO Group 1.

Age Restrictions: Adults: 18 years and older.

Prescriber Restrictions: Cardiologist or Pulmonologist

Coverage Duration: Initial approval: 4 months. Extended approval: Annually based on therapeutic response

Other Criteria: Requests for Adcirca will be covered following a trial of calcium channel blockers (CCB) unless the member is not a candidate for CCB therapy or CCBs are contraindicated.



AFINITOR

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Documentation of previous therapies and outcomes if applicable.

Age Restrictions:

Prescriber Restrictions: Oncology


Other Criteria: For renal cell carcinoma: Requests for new starts are covered following a trial and failure of either Nexavar or Sutent (unless both are otherwise contraindicated).



ALDURAZYME

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Mucopolysaccharidosis, Type I (Hurler and Hurler-Scheie forms) and Scheie form with moderate to severe symptoms.

Age Restrictions:


Coverage Duration: 1 year

Other Criteria: If this medication is administered by a physician incident to a physician’s visit it would be covered by Medicare Part B. Not covered for mildly affected patients with the Scheie form.



ALIMTA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical For the following diagnosis: Malignant mesothelioma of pleura in combination with cisplatin in patients who are not candidates for surgical resection, OR for non-small cell lung cancer, locally advanced or metastatic, after prior chemotherapy, OR for non-small cell lung cancer as initial therapy in combination with cisplatin for locally advanced or metastatic disease, OR as maintenance therapy for patients whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.




Other Criteria: If this medication is administered by a physician incident to a physician’s visit it would be covered by Medicare Part B. Requests for new starts are covered with Malignant mesothelioma of pleura in combination with cisplatin in patients who are not candidates for surgical resection. Requests for new starts are covered with non-small cell lung cancer, locally advanced or metastatic, only after prior chemotherapy, OR for non-small cell lung cancer as initial therapy in combination with cisplatin for locally advanced or metastatic disease, OR as maintenance therapy for patients whose disease has not progressed after four cycles of platinum-based first-line chemotherapy



ALPHA1PROTEINASE INHIBITORS

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Not covered for patients who DO NOT have a diagnosis of Alpha 1 Antitrypsin Deficiency or have a contraindication to use of a alpha1-proteinase inhibitor product. Subjects with the PiMZ or PiMS phenotypes of alpha 1 -antitrypsin deficiency should not be considered for such treatment as they appear to be at small risk for panacinar emphysema.

Required Medical Diagnosis for use. Age Restrictions: Adults: 18 years and older.



Other Criteria:



AMITIZA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical

Diagnosis for use: For the treatment of irritable bowel syndrome with constipation (IBS-C) in females OR for the treatment of chronic idiopathic constipation. Covered for the diagnosis of Opioid-Induced Constipation in Adults With Chronic, Non-cancer Pain

Age Restrictions:



Other Criteria: Requests for chronic idiopathic constipation will be covered following a trial and failure or contraindication to both polyethylene glycol AND lactulose. Requests for Opioid induced Constipation in Adults With Chronic, Non-cancer Pain will be covered following a trial and failure or contraindication to both polyethylene glycol AND lactulose.



AMPYRA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Patients with history of seizures. Patients with moderate to severe renal impairment (physicians should be notified of potential risk for increased seizures in patients with mild renal impairment: CrCl between 51 and 80ml/min). Non-ambulating patients (patients that cannot complete a Timed 25-Foot Walk Test in 45 seconds).

Required Medical Diagnosis for use. Renal function labs. Results of two Timed 25 Foot-Walk Test.


Prescriber Restrictions: Neurologist

Coverage Duration: Initial: 6 months. Re-authorization every 6 months w/ evidence of improvement.

Other Criteria: Max dose to not exceed 10mg taken twice daily. Evidence of improvement is defined as at least a 20% improvement in walking speed while on Ampyra as compared to baseline.



ANDROGEL

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Testosterone levels within normal range (range for the lab doing the testing).

Female patients. Men with carcinoma of the breast or suspected carcinoma of the prostate. Use for muscle building purposes.

Required Medical Diagnosis for use. For members initiating testosterone replacement therapy: Testosterone levels (total or free). Require either ONE low total testosterone level OR ONE low free testosterone level. (normal ranges as provided by office or clinic performing labs). Note: Members that are already stabilized on Androgel will not be required to provide labs and can be approved as continuation of therapy.

Age Restrictions:


Coverage Duration: 2 years

Other Criteria: Higher quantities will require failure of recommended doses per day.



ANDROXY

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use: Indicated for delay in sexual development AND/OR puberty, and hypogonadotropic hypogonadism and l and primary hypogonadism and for adjunct palliative treatment of breast cancer. Testosterone levels (total and free), LH, and FSH levels (normal ranges as provided by office or clinic performing labs).

Age Restrictions:


Coverage Duration: Initial approval: 3 months

Other Criteria:



APOKYN

Covered Uses: All FDA-approved indications not otherwise excluded from Part D, restless leg syndrome.

Exclusion Criteria: Required Medical Documentation of previous therapies. Diagnosis for use: Restless leg syndrome, Parkinson's disease- medical history that documents patient experiences motor fluctuations despite an optimized oral drug regimen which includes levodopa: and the patient is compliant with current Parkinson’s disease drug therapy (taking at least 75% of medication doses).

Age Restrictions:


Coverage Duration: Initial approval: 3 months. Extended approval: Annual review will be based on response to therapy.

Other Criteria: Requests for restless leg syndrome are covered following trial and failure of both pramipexole and ropinirole (unless both are contraindicated). Requests for Parkinson's disease are covered following an appropriate trial of a levodopa-containing regimen.



ARCALYST

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Age Restrictions:



Other Criteria: If this medication is administered by a physician incident to a physicians visit, this would be covered by Medicare Part B. Arcalyst is not covered when the member is participating in a non-approved clinical trial using Arcalyst as part of the drug therapy. Arcalyst is not covered for off-label conditions, including gout.



AVASTIN

Covered Uses: All FDA-approved indications not otherwise excluded from Part D, renal cell carcinoma, and recurrent glioblastoma multiforme.

Exclusion Criteria: Required Medical Diagnosis for use. Documentation of previous therapies and outcomes if applicable.

Age Restrictions:

Prescriber Restrictions: Oncologist


Other Criteria: If this medication is administered by a physician incident to a physicians visit, this would be covered by Medicare Part B. Avastin is not covered when the member is participating in a non-approved clinical trial using Avastin as part of the drug therapy. Not indicated for disease progression following anthracycline and taxane chemotherapy administered for metastatic breast cancer. Avastin, in combination with intravenous 5-fluorouracil-based chemotherapy, is indicated for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum. Avastin®, used in combination with intravenous 5-FU-based chemotherapy, is administered as an intravenous infusion (5 mg/kg or 10 mg/kg) every 14 days. The recommended dose of Avastin®, when used in combination with bolus-IFL, is 5 mg/kg. The recommended dose of Avastin®, when used in combination with FOLFOX4, is 10 mg/kg. Avastin®, in combination with carboplatin and paclitaxel, is indicated for first line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer. The recommended dose of Avastin® is 15 mg/kg, as an IV infusion every 3 weeks. Note: Avastin® should not be initiated until at least 28 days following major surgery. The surgical incision should be fully healed prior to initiation of Avastin®



AVONEX

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis of definite or probable relapsing-remitting MS, secondary progressive MS with relapses, or progressive relapsing MS. Direct statement from a neurologist that diagnosis is a relapsing form of MS, or a first MS attack with documented MRI scan abnormalities characteristic of MS. OR Evaluation documenting EITHER: history of at least two focal neurological deficits (e.g. loss of vision, double vision , localized numbness or weakness), in which the first resolved and the second followed after a period of at least 6 months, OR History of one focal neurological deficit which has resolved, and an MRI suggestive of MS: At least 3 total lesions, each at least 5mm: At least one lesion with contrast enhancement: At least 2 out of 3 lesions in either, Periventricular white matter OR Brain stem (e.g., cerebellar peduncle, pons) OR (3) Spinal cord. Lack of statement that lesions are consistent with ischemic disease.

Age Restrictions:


Coverage Duration: Initial approval: 1 year. Extended approval: Reviewed annually

Other Criteria: Documentation of effective therapy may include that treatment has decreased relapses or diminished number of lesions on MRI AND for patients previously treated with mitoxantrone, documentation that prior treatment with requested drug was successful in decreasing relapses or diminishing the number of lesions on MRI AND dosage does not exceed the FDA approved dose



BANZEL

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Banzel is not covered for members with the diagnosis of Familial Short QT syndrome

Required Medical Documentation of previous therapies. Documented diagnosis of Lennox- Gastaut syndrome.

Age Restrictions:



Other Criteria: Requests for new starts are covered following a trial and failure of lamotrigine (unless lamotrigine is otherwise contraindicated).



BENLYSTA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use: For the treatment of active, autoantibody-positive, systemic lupus erythematosus (SLE) in combination with standard therapy.







BLEOMYCIN SULFATE







BOSULIF


Documentation of past therapies and outcomes. Diagnosis for use. For the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy with at least 1 tyrosine kinase inhibitor [Gleevec (imatinib), Sprycel (dasatinib) and/or Tasigna (nilotinib)]. Use of Bosulif should continue until disease progression, patient intolerance, or death.

Age Restrictions:

Adults: 18 years and older.


Oncologist

Coverage Duration: Remainder of the contract



BUPHENYL




Other Criteria: Cycle disorders: As adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamoyl phosphate synthetase (CPS), ornithine transcarbamoylase (OTC) or argininosuccinic acid synthetase (AAS). In all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life).In patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. It is important that the diagnosis is made early and treatment initiated immediately to improve survival. Any episode of acute hyperammonemia should be treated as a life-threatening emergency.



BYETTA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Not covered when used concomitantly with prandial insulins Required Medical Documentation of previous or current therapies. Diagnosis for use. Current hemoglobin A1c test (therapy failure is defined as an A1c above goal (6.5%) despite adequate trial of Victoza)




Other Criteria: Not covered for patients with Type 1 diabetes. Only covered in combination with metformin, sulfonylureas, and TZDs (not covered with DPP-IVs, nateglinide, Prandin, acarbose, Symlin, or Welchol). Not covered for weight- loss. Not covered in patients either at or below A1c goal (6.5%). Requests are covered following documentation of a trial and failure or contraindication to Victoza.



CANCIDAS



Coverage Duration: Up to 6 weeks

Other Criteria: If this medication is administered by a physician incident to a physician’s visit this would be covered by Medicare Part B.



CAPRELSA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use: Treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.

Age Restrictions:

Prescriber Restrictions: Oncologist or Endocrinologist


Other Criteria:



CEREZYME

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Gaucher disease: Long-term enzyme replacement therapy for patients with a confirmed diagnosis of Type 1 Gaucher disease that results in one or more of the following conditions: anemia, thrombocytopenia, bone disease, hepatomegaly, splenomegaly.

Age Restrictions:






CHANTIX

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical List of previous therapies and documentation of response to previous smoking cessation therapies.




Other Criteria: Requests for Chantix will be approved for smoking cessation treatment in patients who have documented failure with nicotine replacement therapy, AND who have had failure on a therapeutic course of Bupropion (7-9 weeks), or have a contraindication to its use. Patients should be treated with CHANTIX for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with CHANTIX is recommended to further increase the likelihood of long-term abstinence. Patients who do not succeed in stopping smoking during 12 weeks of initial therapy, or who relapse after treatment, should be encouraged to make another attempt once factors contributing to the failed attempt have been identified and addressed



CINRYZE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. For hereditary angioedema: Documented failure of danazol and discontinuation of medications known to cause edema where

Age Restrictions:

Prescriber Restrictions: Immunologist or Rheumatologist

Coverage Duration: Initial approval: 6 months. Extended approval: Annual review will be based on response to therapy

Other Criteria: If this medication is administered by a physician incident to a visit this would be covered by Medicare Part B. Not covered for indications other than hereditary angioedema such as acquired angioedema.



COMETRIQ

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria:

Required Medical

Documentation of past therapies and outcomes. Diagnosis for use. Treatment of patients with progressive, metastatic medullary thyroid cancer (MTC).

Age Restrictions: Adults: 18 years and over


Oncologist


Other Criteria:



COPAXONE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis of definite or probable relapsing-remitting MS, secondary progressive MS with relapses, or progressive relapsing MS. Direct statement from a neurologist that diagnosis is a relapsing form of MS, or a first MS attack with documented MRI scan abnormalities characteristic of MS.OR evaluation documenting EITHER: history of at least two focal neurological deficits (e.g. loss of vision, double vision , localized numbness or weakness), in which the first resolved and the second followed after a period of at least 6 months, OR History of one focal neurological deficit which has resolved, and an MRI suggestive of MS: At least 3 total lesions, each at least 5mm: At least one lesion with contrast enhancement: At least 2 out of 3 lesions in either, Periventricular white matter OR Brain stem (e.g., cerebellar peduncle, pons) OR (3) Spinal cord. Lack of statement that lesions are consistent with ischemic disease.

Age Restrictions:



Other Criteria:



CYSTAGON

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Nephropathic cystinosis management in children and Age Restrictions:



Other Criteria:



DACOGEN







DIAZEPAM

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documentation of previous/current therapy and outcomes. Diagnosis for use: For seizure disorder, alcohol withdrawal syndrome, anxiety, and skeletal muscle spasms

Age Restrictions:



Other Criteria: Requests for the treatment of anxiety are covered following trial and failure of both alprazolam and buspirone or contraindication to both alprazolam and buspirione. Requests for the treatment of skeletal muscle spasms are covered following a trial and failure or a documented contraindication to tizanidine



DICYCLOMINE HCL

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Age Restrictions: 65 years and older



Other Criteria: Require a supporting statement from prescriber of medical necessity of product and that benefits outweigh risks



ELAPRASE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Age Restrictions: At least 5 years and older.


Coverage Duration: Initial approval: 6 months Extended approval: Annual review will be based on response to therapy

Other Criteria: If this medication is administered by a physician incident to a physician’s visit this would be covered by Medicare Part B. Elaprase is dosed at 0.5mg/kg and administered over 1 hour every week as an intravenous infusion. Note: Because of the potential for severe infusion reactions, appropriate medical support should be readily available when Elaprase is administered.



ELELYSO


This medication is not approved for Type II or III Gaucher’s disease and therefore not covered for those patients.

Required Medical

Diagnosis for use. Long-term enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of Type 1 Gaucher’s disease.




Other Criteria: If administered incident to a Physicians office visit, this medication would be covered under Medicare Part B.



ELITEK

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Rasburicase is indicated for the initial management of plasma uric acid levels in pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving chemotherapy expected to cause tumor lysis and subsequent increased plasma uric acid levels, OR in adults as prophylaxis and treatment of hyperuricemia with hematologic malignancies or high-risk solid tumors who had or were at high risk of developing tumor lysis syndrome, AND pretreatment screening has been performed for patients at a higher risk for glucose-6-phosphate dehydrogenase (G6PD) deficiency (eg, patients of African or Mediterranean ancestry)Monitor plasma uric acid levels: Obtain other markers/assessments of tumor lysis syndrome (eg, serum creatinine, serum electrolytes): Monitor for signs and symptoms of a severe allergic reaction (eg, bronchospasm, chest pain and tightness, dyspnea, hypoxia, hypotension, shock, and/or urticaria)

Age Restrictions:


Coverage Duration: One time for course of therapy (1 to 7 days).

Other Criteria: If this medication is administered by a physician incident to a physician’s visit this would be covered by Medicare Part B. Lyophilized rasburicase (unreconstituted vials) and the diluent for reconstitution should be stored at 2 to 8 degrees C (36 to 46 degrees F) and protected form light. Freezing should be avoided. Reconstituted vials of rasburicase must be used within 24 hours. Reconstituted or diluted solutions can be stored for up to 24 hours at 2 to 8 degrees C



ENBREL

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. For moderately to severely active polyarticular-course juvenile rheumatoid arthritis: Require documentation of an inadequate response to methotrexate (MTX) alone unless MTX is contraindicated. For moderately to severely active rheumatoid arthritis: Require documentation of an inadequate response to MTX and at least one (1) other disease-modifying anti-rheumatic drug (DMARD) or tumor necrosis factor inhibitor (TNF-I), unless MTX is contraindicated, then Enbrel is covered after failure of respond to at least two (2) other DMARDs. For psoriatic arthritis: Require documentation of an inadequate response to either MTX or other DMARD. For moderate to severe chronic (greater than one year in duration) plaque psoriasis: Require documentation of at least two (2) non-biologic therapies, such as phototherapy or systemic therapies. For ankylosing spondylitis: Require documentation of inadequate response to maximum tolerated doses of at least (2) non-steroidal anti-inflammatory drugs (NSAIDs).

Age Restrictions:

Prescriber Restrictions: Rheumatologist, Dermatologist

Coverage Duration: 12 weeks for plaque psoriasis. 6 months for other indications. Extended approval: annually

Other Criteria:



ENOXAPARIN SODIUM

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use: Age Restrictions:


Coverage Duration: 21 days, except hip surgery 35 days, DVT in cancer patient 6 months

Other Criteria:



ERIVEDGE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use- Treatment of metastatic basal cell carcinoma or in patients with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery or radiation

Age Restrictions: Adults: 18 years of age and older



Other Criteria:



ETOPOSIDE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Small cell carcinoma of lung, in combination therapy with other approved chemotherapeutic agents as first-line therapy OR Testicular cancer, refractory (as combination therapy with other approved chemotherapeutic agents in patients who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy). Documentation of previous therapies and outcomes if applicable.

Age Restrictions:






EXJADE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Exjade (deferasirox) is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older such as when the patient is receiving transfusions of approximately 100 mL/kg of packed red blood cells (approximately 20 units for a 40 kg patient) and has a serum ferritin consistently above 1000 mcg/L. In patients not adequately controlled with doses of 30 mg/kg (e.g. serum ferritin levels persistently above 2500 mcg/L and not showing a decreasing trend over time), doses of up to 40 mg/kg may be considered. Doses above 40 mg/kg are not recommended. After commencing therapy, it is recommended that serum ferritin be monitored every month and the dose adjusted if necessary every 3 to 6 months based on serum ferritin trends. If the serum ferritin falls consistently below 500 mcg/L, consideration should be given to temporarily interrupt therapy with Exjade.

Age Restrictions: Covered for members 2 years of age and older with chronic iron overload due to blood transfusions.


Coverage Duration: Initial- 3 months. Can be extended in three month increments if benefit is demonstrated

Other Criteria:



FABRAZYME

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Fabry disease: For use in patients with Fabry disease. Agalsidase beta reduces globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types.

Age Restrictions:






FANAPT

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Fanapt is not approved for the treatment of patients with dementia-related psychosis.

Required Medical Documentation of past therapies and outcomes. Diagnosis for use: Schizophrenia




Other Criteria: Requests for new starts in patients with schizophrenia are covered in patients following a trial and documented failure of Seroquel XR and risperidone (unless both are otherwise contraindicated).



FASLODEX

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Breast cancer: Treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Age Restrictions:






FENTANYL CITRATE ORAL TRANSMUCOSAL

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: The drug is not indicated in the management of acute or post-operative pain. This medication must not be used in opioid non-tolerant patients. Not covered for patients with pain not associated with cancer.

Required Medical For the management of breakthrough cancer pain in patients with malignancies already receiving and tolerant to opioid therapy for their underlying cancer pain.

Age Restrictions: Patients 16 years old or older

Prescriber Restrictions: Oncologists and pain specialists who are experienced in the use of Schedule II opioids to treat cancer pain.


Other Criteria:



FOMEPIZOLE


Age Restrictions:


Coverage Duration: 1 week

Other Criteria: Fomepizole is administered in an ER or hospital and would be covered by Medicare Part B



FONDAPARINUX SODIUM

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documentation of the one of the following indications for use: for the prophylaxis of a DVT in patients undergoing hip fracture or replacement surgery, in patients undergoing knee replacement surgery, and in patients undergoing abdominal surgery who are at risk for thromboembolic complications. Additionally, fondaparinux is approved as treatment of acute DVT when used in combination with warfarin and as treatment of acute PE when used in combination with warfarin when initial therapy is administered in the hospital.

Age Restrictions:


Coverage Duration: 21 days, except hip fracture/surgery for 35 days, DVT in cancer patient for 6 months

Other Criteria:



FORTEO

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Coverage of Forteo treatment may not be considered medically necessary when: The patient is not a postmenopausal woman with osteoporosis who is at high risk for fracture, OR the patient is not a man with primary or hypogonadal osteoporosis who is at high risk for fracture OR the patient does not have glucocorticoid induced osteoporosis.

Required Medical Documentation of past therapies and outcomes (failure defined as loss of BMD OR has fragility fracture(s) after a treatment with a first-line pharmacologic treatment – bisphosphonate, Evista, or calcitonin). Diagnosis for use. Fracture history. Documentation of high risk for fracture for postmenopausal women, high risk defined with the presence of two of the following: low BMD scores (T-score less than or equal to -2.5 at the spine or hip or both), age greater than 70, or positive family history for osteoporosis in a 1st degree relative.

Age Restrictions:



Other Criteria: For postmenopausal women with osteoporosis at high risk for fracture and men with primary or hypogonadal osteoporosis, require documentation of trial and failure on at least one first-line therapy (alendronate, Evista, Boniva, or Actonel) or documentation of intolerance to at least two first-line therapies. For patients with glucocorticoid induced osteoporosis, require documentation of trial and failure to either alendronate or Actonel or documented intolerance to both alendronate and Actonel.



FOSCARNET SODIUM



Coverage Duration: Initial approval: 3 weeks. Extended approval: 6 months with documentation of response.

Other Criteria: If this medication is administered by a physician incident to a physician’s visit this would be covered by Medicare Part B. Foscarnet is NOT indicated for patients who are immunocompetent.



GEMCITABINE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Age Restrictions: Adults: 18 years and older.






GILOTRIF Covered Uses:

All FDA-approved indications not otherwise excluded from Part D

Exclusion Criteria:

Use in patients whose tumors have EGFR mutations other than EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

Required Medical

Diagnosis for use: Diagnosis of metastatic non-small cell lung cancer (NSCLC) and expression of the epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by a US Food and Drug Administration-approved test (e.g. therascreen® EGFR29 RGQ PCR Kit.

Age Restrictions:


Oncologist

Coverage Duration:

Duration of coverage year

Other Criteria:



GLEEVEC


Age Restrictions:



Other Criteria:



HERCEPTIN

Covered Uses: All FDA-approved indications not otherwise excluded from Part D, HER2- positive gastric cancer, and HER2-positive esophageal cancer

Exclusion Criteria: Required Medical Left ventricular function test. HER2-protein expression test (require positive or equivocal HER2 over-expression). Diagnosis for use: As part of a regimen for the adjuvant treatment of HER2-overexpressing, breast cancer. As first- line therapy for metastatic HER2 positive breast cancer in combination with paclitaxel. As a single agent, for the adjuvant treatment of HER2- overexpressing node-negative (ER/PR negative or with one high-risk feature) or node positive breast cancer, following multi-modality anthracycline based therapy. As a single agent for the treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. As a single agent for the treatment of HER2- overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. As part of a regimen for HER2-positive esophageal or gastric cancer. As first line treatment for HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma in combination with cisplatin and either capecitabine (Xeloda) or 5-FU.

Age Restrictions:



Other Criteria: This medication is administered by a physician incident to a physician’s visit and would be covered by Medicare Part B. Left ventricular function should be evaluated in all patients prior to and during treatment. Discontinuation of Herceptin treatment should be strongly considered in patients who develop a clinically significant decrease in left ventricular function.



HUMIRA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documentation of past therapies and outcomes. Diagnosis for use. For the treatment of adult patients with moderate to severe chronic plaque psoriasis: Require the body surface area (BSA) involvement equal to or greater than 10%.

Age Restrictions: For Patients with JIA: Humira 20MG/0.4ML Injection: 4-17 years old.

Prescriber Restrictions: Rheumatologist, Dermatologist, Gastroenterologist

Coverage Duration: 12 weeks for plaque psoriasis, 6 months for other indications. Then annual review.

Other Criteria: For moderately to severely active rheumatoid arthritis in adult patients: Require documentation of an inadequate response to MTX and at least one (1) other disease-modifying anti-rheumatic drug (DMARD) or tumor necrosis factor inhibitor (TNF-I) for the appropriate treatment period, unless MTX is contraindicated, then Humira is covered after failure to respond to at least two (2) other DMARDs. For moderately to severely active polyarticular juvenile idiopathic arthritis: Require documentation of an inadequate response to methotrexate (MTX) alone for the appropriate treatment period unless MTX is contraindicated. For reducing signs and symptoms of active arthritis in patients with psoriatic arthritis: Require documentation of an inadequate response to either MTX or other DMARD for the appropriate treatment period. For reducing signs and symptoms in patients with active ankylosing spondylitis: Require documentation of inadequate response to maximum tolerated doses of at least (2) non-steroidal anti-inflammatory drugs (NSAIDs). For reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy: Require documentation that the patient has failed to respond to at least ONE conventional therapy for an appropriate trial period or the patient has lost response to or is intolerant to infliximab (Remicade) therapy. For the treatment of adult patients with moderate to severe chronic


plaque psoriasis: Documentation of trials of at least two (2) non-biologic therapies, such as phototherapy or systemic therapies. For Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP): Require documentation that the patient has failed to respond to two (2) immunosuppressant therapies for an appropriate trial period unless contraindicated



ICLUSIG


Required Medical

Diagnosis for use. Documentation of previous therapies and outcomes. Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy OR Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy.



Oncologist


Other Criteria:



ILARIS


Diagnosis for use: treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) For the diagnosis of JIA documentation of a trial and failure of two preferred formulary TNF agents or contraindication to both.

Age Restrictions: Patient must be at least 4 years of age


Coverage Duration: Initial approval for 6 months




INCIVEK

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Not covered as monotherapy, nor for non-Genotype 1 Hepatitis C infections, nor for pregnant patients, nor for patients who are currently taking a drug(s) that are contraindicated for coadministration, nor in patients who have previously failed HCV protease therapy.

Required Medical Diagnosis for use. Concomitant medications to be used. Genotype identification. Most current RNA titer prior to therapy (level and date). Most current hemoglobin and/or hematocrit levels (level and date). Most current white blood cell count (level and date). History of past therapies and response (include dates and therapies tried). Documentation of presence of cirrhosis or compensated liver disease (date of biopsy or other equivalent test). For all continuation requests after initial approval the plan will require viral RNA titers at Treatment Week 4, 12, and 24 of therapy.



Coverage Duration: Initial: 5 weeks. Continuation: See Other Criteria

Other Criteria: Not covered in patients co-infected with HIV or HBV. For all continuation requests after initial approval the plan will require viral RNA titers at Treatment Week 4, 12, and 24 of therapy. At Week 12, if the RNA titer is at or greater than 1000IU/ml then all treatment should be discontinued. At Week 24, if viral RNA is detected then all treatment should be discontinued. For Continuation Requests in Peg/Riba Treatment Naïve Patients, Relapsed Patients, or Partial Responding Patients with or without cirrhosis: When requesting after 4 weeks of combination therapy, if the RNA titer at Treatment Week 4 is less than 1000IU/ml then an additional 8 weeks of Incivek should be approved, if at or greater than 1000IU/ml than all therapy should be discontinued.



INCRELEX

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Increlex is contraindicated in patients with allergies to mecasermin or any component of the Increlex formulation, for growth promotion in patients with closed epiphyses, for IV administration, in patients with active or suspected neoplasia. Increlex should be discontinued if neoplasia develops while on therapy.

Required Medical Increlex (mecasermin [rDNA origin] injection) is indicated for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Child has one of the following conditions: Severe primary IGF-1 deficiency, OR Growth hormone gene deletion with developed neutralizing antibodies to growth hormone, OR Genetic mutation of GH receptor (i.e. Laron Syndrome), AND Child has severe growth retardation with height standard deviation score (SDS) more than 3 SDS below the mean for chronological age and sex, AND Child with IGF-1 level greater than or equal to 3 standard deviations below normal based on lab reference range for age and sex, AND Child with normal or elevated growth hormone (GH) levels based on at least one growth hormone stimulation test, AND Evidence of open epiphyses.

Age Restrictions:

Prescriber Restrictions: Pediatric or Endocrinologist


Other Criteria:



INLYTA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documentation of previous therapies. Diagnosis for use. For the treatment of advanced renal cell cancer after failure of 1 prior systemic therapy.

Age Restrictions: Adults: 18 years of age and older



Other Criteria: For renal cell carcinoma: Requests for new starts are covered following a trial and failure of one (1) prior systemic therapy. Examples include but are not limited to Nexavar, Sutent, Avastin, Votrient and Afinitor.



INTERFERON BETA1B

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis of definite or probable relapsing-remitting MS, secondary progressive MS with relapses, or progressive relapsing MS. Direct statement from a neurologist that diagnosis is a relapsing form of MS, or a first MS attack with documented MRI scan abnormalities characteristic of MS. Or evaluation documenting EITHER: history of at least two focal neurological deficits (e.g. loss of vision, double vision , localized numbness or weakness), in which the first resolved and the second followed after a period of at least 6 months, OR History of one focal neurological deficit which has resolved, and an MRI suggestive of MS: At least 3 total lesions, each at least 5mm: At least one lesion with contrast enhancement: At least 2 out of 3 lesions in either, Periventricular white matter OR Brain stem (e.g., cerebellar penducle, pons) OR (3) Spinal cord. Lack of statement that lesions are consistent with ischemic disease.

Age Restrictions:



Other Criteria: Requests for new starts are covered following a trial and failure of Rebif.



INTRONA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Hairy-cell leukemia: Malignant melanoma: Adjuvant to surgical treatment with malignant melanoma who are free of disease but are at high risk for systemic recurrence within 56 days of surgery. Initial treatment of clinically aggressive follicular non-Hodgkin lymphoma in conjunction with anthracycline-containing combination chemotherapy. Intralesional treatment of external genital or perianal warts: AIDS-related Kaposi sarcoma: Chronic hepatitis C: In patients with compensated liver disease who have a history of blood or blood product exposure and/or patients who are hepatitis C virus (HCV)-antibody-positive. (Interferon alfa-2b also is indicated for hepatitis C in combination with ribavirin capsules. Chronic hepatitis B: In patients 1 year of age or older with compensated liver disease and hepatitis B virus (HBV) replication. Patients must be serum HBsAg-positive for at least 6 months and have HBV replication (serum HBeAg-positive) with elevated serum ALT.

Age Restrictions:



Other Criteria: If this medication is administered by a physician incident to a physician’s visit this would be covered by Medicare Part B



INTUNIV

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. For the treatment of attention-deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.

Age Restrictions: Ages 6 to 17 years


Coverage Duration: 1 Year

Other Criteria: To receive coverage of Intuniv, the patient would be required to first fail or have a documented contraindication to both methylphenidate and generic Adderall immediate release.



INVEGA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Invega is not approved for the treatment of patients with dementia-related psychosis.

Required Medical Documentation of past therapies and outcomes. Diagnosis for use: Schizophrenia

Age Restrictions: 12 years and older.



Other Criteria: Requests for new starts in patients with schizophrenia are covered following a trial and documented failure of Seroquel XR and risperidone (unless both are otherwise contraindicated).



ITRACONAZOLE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Not covered for cosmetic use. Required Medical Diagnosis for use. Covered for aspergillosis, blastomycosis, febrile neutropenia, empiric therapy of febrile neutropenic (ETFN) patients with suspected fungal infections, histoplasmosis (treatment of histoplasmosis, including chronic cavitary pulmonary disease and disseminated, nonmeningeal histoplasmosis in non-immunocompromised or immunocompromised patients). Treatment of onychomycosis of the toenail with or without fingernail involvement and onychomycosis of the fingernail because of dermatophytes (Tinea unguium) in non-immunocompromised patients. Covered for onychomycosis in immunocompromised, diabetics, or patients with peripheral vascular disease and a positive onychomycosis susceptible pathogen culture. Documented pain or impairment and a positive onychomycosis susceptible pathogen culture. Oropharyngeal/esophageal candidiasis.

Age Restrictions:


Coverage Duration: Onychomycosis: Fingernail- 6 weeks, Toenail-12 weeks. Other indications: 3 months

Other Criteria:



IXEMPRA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Ixempra is indicated for use in combination with capecitabine in the treatment of metastatic or locally advanced breast cancer in patients that have not responded to an anthracycline and taxane chemotherapy agent. Ixempra® is also indicated as monotherapy in patients with metastatic or locally advanced breast cancer in which the tumor is resistant or refractory to anthracyclines, taxanes and capecitabine.

Age Restrictions:






JAKAFI

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use-Treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis.

Age Restrictions:

Prescriber Restrictions: Oncologist or hematologist

Coverage Duration: Initial approval: 6 months. Extended approval 3 years

Other Criteria: Not covered for members who did not demonstrate reduction in spleen volume or symptom improvement after 6 months of therapy.



KADCYLA


Required Medical Left ventricular function test. HER2-protein expression test (require positive or equivocal HER2 over-expression test). Documentation of past therapies and outcomes. Diagnosis for use: For the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab (Herceptin) and a taxane, either separately or in combination. Patients must have received prior therapy for metastatic disease OR developed disease recurrence during or within six months of completing adjuvant therapy.

Age Restrictions:


Oncologist


Other Criteria:

If this medication is administered by a physician incident to a physician’s visit it would be covered by Medicare Part B. Left ventricular function should be evaluated in all patients prior to and during treatment. Discontinuation of Kadcyla treatment should be strongly considered in patients who develop a clinically significant decrease in left ventricular function.



KUVAN

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Kuvan is indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4-) responsive Phenylketonuria (PKU). Kuvan is to be used in conjunction with a Phe- restricted diet. There are currently no pharmacogenomic tests to identify patients most likely to respond to Kuvan.No consensus exists regarding the optimal levels of blood Phe. However, based on data regarding the relationship between Phe level and brain function, the National Institutes of Health (NIH) consensus panel recommends that Phe levels be maintained between:2-6 mg/dL (120-360 micromol/L) if less then 12 years of age, 2-10 mg/dL (120-600 micromol/L) if greater than 12 and less then 18 years of age, and 2-15 mg/dL (120-900 micromol/L) if greater than 18 years of age Initial extension will ONLY be granted for members who meet ALL of the following criteria: Documented response” to therapy as defined by greater that or equal to 30% reduction in baseline Phe level, AND Documented compliance with Kuvan, AND Documented compliance with a Phe-restricted diet, AND Still under the appropriate care and re-evaluations of a specialist knowledgeable in the management of PKU Extended Approval: 6 month intervals, based on documentation of ALL of the following: Maintenance of greater than or equal to 30% reduction in baseline Phe level, AND Documented compliance with Kuvan, AND Documented compliance with a Phe-restricted diet, AND Still under the appropriate care and re-evaluations of a specialist knowledgeable in the management of PKU.

Age Restrictions: 4 years and older

Prescriber Restrictions: specialist knowledgeable in the management of PKU

Coverage Duration: Initial Approval: 2 months. Extended Approval: 6 month intervals

Other Criteria:



LEUKINE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Neutropenia due to Hepatitis C therapy is not an approvable diagnosis. Required Medical Primary prophylaxis in conjunction with chemotherapy: in previously untreated adult and pediatric members with non-myeloid malignancies receiving established myelosuppressive chemotherapy that is expected to result in a greater than 20% incidence of febrile neutropenia OR members receiving chemotherapy who are at increased risk for chemotherapy-induced infectious complications because of bone marrow compromise or comorbidity. Febrile neutropenia: Adjunctive use with antibiotics in high-risk, febrile, neutropenic members who have one or more prognostic factors that are predictive of clinical deterioration: Documented neutropenia with absolute neutrophil count (ANC) under 1000/m, or uncontrolled primary disease, or Pneumonia, or Hypotension, or Multi-organ dysfunction (sepsis syndrome): or Invasive fungal infection. Dose-intensive chemotherapy: Use in settings where clinical research demonstrates that dose-intensive therapy produces improvement in disease control, when these therapies are expected to produce significant rates of febrile neutropenia. This include: Dose dense treatment given at every 2 weeks for early-stage breast cancer, or CHOP regimen for non-Hodgkin’s lymphoma. Acute myeloid leukemia: For administration shortly after the completion of induction AML therapy in members 55 years of age or older, to achieve modest decreases in the duration of neutropenia, OR for administration to members of any age, after the completion of consolidation chemotherapy for AML, to shorten the duration of neutropenia profoundly. Acute lymphoblastic leukemia (ALL): For administration after completion of the first few days of chemotherapy of the initial induction or first post-remission course. Myelodysplastic Syndromes: Intermittent use only in member with myelodysplastic syndromes who has less than 15% blasts in their bone marrow, AND has severe neutropenia (ANC less then 500/mL) and recurrent infections.

Age Restrictions:


Coverage Duration: Initial approval: 3 months. Extended approval: if therapy continues to be medically necessary


Other Criteria:



LEUPROLIDE




Other Criteria: If this medication is administered by a physician incident to a physician’s visit this would be covered by Medicare Part B. B vs. D. Requests for new starts in patients with prostate cancer will be covered following a trial of Trelstar (unless Trelstar is other contraindicated).



LINZESS


Required Medical :

Diagnosis for use: For the treatment of irritable bowel syndrome with constipation (IBS-C) OR for the treatment of chronic idiopathic constipation.

Age Restrictions:


Coverage Duration: 1 Year

Other Criteria: Requests for chronic idiopathic constipation will be covered following a trial and failure or contraindication to both polyethylene glycol AND lactulose.



LOTRONEX

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Lotronex is not covered unless the member is a female with severe diarrhea- predominant irritable bowel syndrome (IBS) who has chronic IBS symptoms (generally lasting 6 months or longer) and had anatomic or biochemical abnormalities of the gastrointestinal tract excluded. Clinical studies have not been performed to adequately confirm the benefits of Lotronex® in men.

Required Medical Irritable Bowel Syndrome: diarrhea predominant in women Age Restrictions:

Prescriber Restrictions: Physicians who have enrolled in GlaxoSmithKline's Prescribing Program for Lotronex®

Coverage Duration: Initial approval: 4 weeks. Extended approval: 6 months if improvement is seen

Other Criteria:



LYRICA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D, central pain syndrome, cancer pain, generalized anxiety disorder.

Exclusion Criteria: Required Medical Diagnosis for use. Past therapies and outcomes. Documentation of current Lyrica therapy. For diabetic peripheral neuropathy: HbA1c. For fibromyalgia: require documentation of diagnosis based on ACR classification criteria.

Age Restrictions:



Other Criteria: Requests for new starts in patients with seizure disorder are covered following trial of gabapentin. Requests for new starts in patients with generalized anxiety disorder are covered following trial and failure of both a SSRI and venlafaxine. Requests for fibromyalgia are covered following a trial and failure of Savella. Requests for diabetic peripheral neuropathy are covered following trial and failure of gabapentin. Lyrica is not covered for patients with diabetic peripheral neuropathy that are currently not on anti- diabetic therapy. Requests for post-herpetic neuralgia are covered following trial and failure of gabapentin. Characteristics of central pain include, but are not limited to, constant, moderate to severe burning pain (pins and needles or sharp pain may be present as well, this is often exacerbated by touch and temperature pain). Central pain does include diagnoses of central origin such as those caused by stroke, multiple sclerosis, CNS tumors, epilepsy, brain and/or spinal cord trauma, or Parkinson’s disease. Central pain does not include diagnoses not of central origin that are secondary to a vertebral disorder or dysfunction and therefore not considered central pain (examples of conditions not considered to be central pain include: idiopathic neuropathy, lumbago, spinal stenosis, radiculopathy from a herniated disk, failed back syndrome, and degenerative disk disorder). Note that non- pharmacologic therapies such as cognitive behavioral therapies, exercise etc. have documented benefit when used prior to drug therapy for fibromyalgia and should be explored in the appropriate patient.



MEKINIST

Covered Uses: All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria:

Patients with wild-type BRAF melanoma or THxID BRAF test with a negative result for V600E or V600K mutation of BRAF gene.

Required Medical Diagnosis for use. Documentation of current and past therapies and outcomes.

Age Restrictions:

Adults: 18 years and older


Oncologist or dermatologist


Other Criteria: Oncologist reviewed unresectable or metastatic melanoma and BRAF V600E or V600K mutation as detected by an FDA-approved test, like THxID BRAF test.



MEPRON

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documentation of past therapies and outcomes. Diagnosis for use. Age Restrictions:



Other Criteria: Requests for patients with Pneumocystis pneumonia will be covered following a trial and failure of co-trimoxazole (SMP/TMX) (unless SMP/TMX is otherwise contraindicated).



MESNEX

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documentation of ifosfamiide therapy. Age Restrictions:



Other Criteria: If this medication is administered by a physician incident to a physician’s visit this would be covered by Medicare Part B. IV Schedule: Mesnex is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage (w/w) at the time of ifosfamide administration and 4 and 8 hours after each dose of ifosfamide. The total daily dose of mesna is 60% of the ifosfamide dose. IV and Oral Dosing: Mesnex injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage (w/w) at the time of ifosfamide administration. Mesnex tablets are given orally in a dosage equal to 40% of the ifosfamide dose 2 and 6 hours after each dose of ifosfamide. The total daily dose of mesna is 100% of the ifosfamide dose. Patients who vomit within two hours of taking oral mesna should repeat the dose or receive intravenous mesna. The efficacy and safety of this ratio of IV and PO mesna has not been established as being effective for daily doses of Ifex higher than 2.0 g/m2. The dosing schedule should be repeated on each day that ifosfamide is administered. When the dosage of ifosfamide is adjusted (either increased or decreased), the ratio of Mesnex to Ifex should be maintained.



NAGLAZYME

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use: The intravenous administration of Naglazyme is indicated for patients with Maroteaux-Lamy syndrome (Mucopolysaccharidosis IV).

Age Restrictions: Not indicated in patients under 5 years old


Coverage Duration: Initial approval: 6 months Extended approval: Annual review will be based on response to therapy.




NEUMEGA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Thrombocytopenia, Severe, reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with non-myeloid malignancies who are at high risk for severe thrombocytopenia, Prophylaxis.

Age Restrictions:

Prescriber Restrictions: Certified hematologist and/or oncologist


Other Criteria:



NEUPOGEN

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Myelosuppressive chemotherapy: To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever. Acute myeloid leukemia (AML): To reduce the time to neutrophil recovery and the duration of fever following induction or consolidation chemotherapy treatment of adults with AML. Bone marrow transplant (BMT): To reduce the duration of neutropenia and neutropenia-related clinical sequelae (e.g., febrile neutropenia) in patients with non-myeloid malignancies undergoing myeloablative chemotherapy followed by BMT. Peripheral Blood Progenitor Cell (PBPC) Collection: For the mobilization of hematopoietic progenitor cells into the peripheral blood for leukapheresis collection. Mobilization allows for collection of increased progenitor cell numbers capable of engraftment compared with collection by leukapheresis without mobilization or bone marrow harvest. After myeloablative chemotherapy, the transplantation of an increased number of progenitor cells can lead to more rapid engraftment, decreasing the need for supportive care. Severe chronic neutropenia (SCN): Chronic administration to reduce the incidence and duration of sequelae of neutropenia in symptomatic patients with congenital, cyclic or idiopathic neutropenia.

Age Restrictions:


Coverage Duration: Initial approval: 3 months. Extended approval: If therapy continues to be medically necessary

Other Criteria: Adjuncts to progenitor-cell transplantation: Mobilization of autologous or donor hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis in order to increase the number of circulating peripheral- blood progenitor-cells (PBPC) collected for engraftment for allogenic peripheral stem cell transplantation: OR reduction in the duration of neutropenia and neutropenia-related infectious complications in members with non-myeloid malignancies undergoing myeloablative chemotherapy


followed by autologous or allogenic bone marrow transplantation (BMT): OR assisting in the recovery of members who experience delayed or inadequate neutrophil engraftment following progenitor-cell transplantation by speeding hematopoietic reconstitution following BMT or PBPC transplantation. Severe chronic neutropenia (with ANC less then 500/ml): Chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g. fever, infections, oropharyngeal ulcers) in symptomatic members with congenital neutropenia, cyclic neutropenia or idiopathic neutropenia. Advanced HIV: Members with advanced HIV and neutropenia (ANC under 1000/mL) to allow scheduled dosing of myelosuppressive anti-retroviral medication (e.g. zidovudine and ganciclovir).



NEXAVAR

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Nexavar is covered for patients with a diagnosis of advanced (unresectable or metastatic) renal cell carcinoma, and patients with ECOG performance status 0 or 1, and patients with low or intermediate prognostic risk category (MSKCC prognostic risk category). OR patients with advanced hepatocellular carcinoma (HCC), previously untreated and inoperable. Cardiac evaluation to determine if patient has any advanced cardiac condition.

Age Restrictions:



Other Criteria:



NITROFURANTOIN

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Culture and sensitivity report. The Physician must provide an explanation of the specific benefit established with the medication, and how that benefit outweighs the potential risk.

Age Restrictions: PA Criteria applies to patients 65 years and older. PA is not required for patients under the age of 65.



Other Criteria: Patients will be permitted to fill up to a 14 day supply as initial therapy for acute situations. Chronic suppressive therapy (greater than 14 days) will only be covered for patients aged 65 years and older if the culture and sensitivity report shows that nitrofurantoin is the only effective agent for the infection (unless other effective agents are contraindicated). Patients under the age of 65 will not be impacted by this prior authorization as the age edit applies only to patients aged 65 years and older.



NOXAFIL

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documentation of past therapies and outcomes. Diagnosis for use: For prevention of invasive Aspergillus and Candida infections in immunosuppressed patients or for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole.

Age Restrictions: Not approved for under 13 years old



Other Criteria: Requests for new starts with invasive Aspergillus infection in immunosuppressed patients are covered when the infection is refractory to itraconazole or the patient is intolerant to itraconazole. Requests for new starts with invasive Candida infection in immunosuppressed patients or oropharygeal candidiasis are covered when the infection is refractory to fluconazole or the patient is intolerant to fluconazole. Refractoriness is defined as progression of infection or failure of improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.



NULOJIX

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Not covered in patients who are EBV seronegative or with unknown EBV serostatus.

Required Medical Diagnosis for use. Documentation of concomitant therapies. EBV serostatus. Age Restrictions: Adults: 18 years and older.



Other Criteria: If this medication is administered by a physician incident to a physician’s visit this would be covered by Medicare Part B. Requests for new starts will be covered only in combination with basiliximab (Simulect) induction, mycophenolate mofetil, and corticosteroids.



NUVIGIL

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Require diagnosis for excessive daytime sleepiness associated with narcolepsy. For treatment of excessive daytime sleepiness associated with obstructive sleep apnea (OSA) when the patient meets the following criteria: A Standard Diagnostic Nocturnal Polysomnography (NPSG) has confirmed the diagnosis of OSA and meets ICSD or DSM diagnostic criteria. The patient has received nasal continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BIPAP) for at least 1 month. CPAP or BIPAP therapy must be continued on a routine basis in combination with Nuvigil therapy. The daytime fatigue is significantly impacting, impairing, or compromising the patient's ability to function normally. The prescribing physician has established a patient care plan to treat the cause of OSA in conjunction with treating the daily fatigue. Patients must be compliant with recommendations for OSA treatment. For shift work sleep disorder (SWSD): Require confirmed diagnosis and the patient must have a job that requires them to frequently rotate shifts or work at night, and be unable to adjust to their schedule.

Age Restrictions:

Prescriber Restrictions: Board certified as a sleep specialist, ear, nose and throat, neurologist or pulmonologist or has obtained a consult from a board certified sleep specialist.


Other Criteria:



OCTREOTIDE ACETATE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Acromegaly: To reduce blood levels of growth hormone and IGF-I in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation and bromocriptine at maximally tolerated doses. The goal is to achieve normalization of growth hormone and IGF-I levels. Carcinoid tumors: Symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits associated severe diarrhea and flushing episodes. Vasoactive intestinal peptide tumors (VIPomas): Treatment of the profuse watery diarrhea associated with VIP-secreting tumors.

Age Restrictions:



Other Criteria:



OMNITROPE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Growth Hormone Deficiency in Children and Adolescents: Patient has failed to respond to at least 2 standard GH stimulation tests. One abnormal GH test is sufficient for children with brain tumors and irradiation with documented multiple pituitary hormone deficiency (MPHD) AND Appropriate imaging (MRI or CT) of the brain to exclude tumor on hypothalamic-pituitary region One of the following criteria are met: Child has severe growth retardation with height standard deviation score (SDS) more than 3 SDS below the mean for chronological age and sex, OR Child has moderate growth retardation with height SDS –2 and –3 SDS below the mean chronological age and sex and decreased growth rate (growth velocity measured over one year below 25th percentile for age and sex), OR Child exhibits severe deceleration in growth rate (growth velocity measured over 1 year –2 SDS below the mean for age and sex), OR Child has decreasing growth rate combined with a predisposing condition like previous cranial irradiation or tumor, OR Child exhibits evidence of other pituitary hormone deficiencies or signs of congenital GHD (hypoglycemia, microphallus).GH Deficiency in Adults: Covered for adult GH deficiency who meet ALL the following criteria: Adult onset: Patients who have GH deficiency either alone or with multiple hormone deficiencies (hypopituitarism), as a result of EITHER, disease of the pituitary or hypothalamus, OR injury to either the pituitary or hypothalmus from surgery, radiation therapy, or trauma, OR Childhood onset: Patients who were GH deficient during childhood who have GH deficiency confirmed as adult before therapy is started., AND Biochemical diagnosis of GH deficiency, by means of a negative response to two standard GH stim tests (maximum peak less then 5 ng/ml when measured by RIA or less then 2.5 ng/ml when measured by IRMA) AND Patients already receiving supplementation of other hormones as required AND Objective measurement of clinical features of GH deficiency. Age Restrictions:

Prescriber Restrictions: Certified endocrinologist

Coverage Duration: Initial approval: 6 months. Extended approval: If therapy continues to be medically necessary.


Other Criteria:



ONDANSETRON IV




Other Criteria: Ondansetron IV will be covered following a trial of oral ondansetron tablets or documentation that the member cannot tolerate or receive oral ondansetron therapy.



ONFI

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Not covered for diagnoses related to anxiety disorders. Not covered for diagnosis of alcohol withdrawal syndrome.

Required Medical Documentation of previous/current therapy and outcomes. Diagnosis for use: For adjunct therapy to other anticonvulsants in the treatment of Lennox- Gastaut syndrome.

Age Restrictions: 2 years and older



Other Criteria:



ORENCIA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documentation of past therapies and outcomes. Diagnosis for use. Age Restrictions: 6 yrs and older

Prescriber Restrictions: Rheumatologist

Coverage Duration: Initial approval: 6 months Extended approval: 1 year

Other Criteria: Not covered when used in combination with another TNF antagonist or anakinra. If this medication is administered by a physician incident to a physician’s visit this would be covered by Medicare Part B. For RA and JIA: Require a trial and failure of either Humira or Enbrel (unless both Humira and Enbrel are otherwise contraindicated)



ORFADIN

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use: Orfadin capsules (nitisinone) are indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1.

Age Restrictions:


Coverage Duration: Initial approval: 6 months. Extended approval: Based on response to therapy

Other Criteria:



OXANDROLONE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Not Covered for the indication of weight gain. Required Medical Documentation to support diagnosis for use as follows: Bone pain: For the relief of the bone pain frequently accompanying osteoporosis. Protein catabolism: To offset the protein catabolism associated with prolonged administration of corticosteroids. For male and female, all ages

Age Restrictions:


Coverage Duration: 1 month, renewals for return of symptoms

Other Criteria:



PACLITAXEL




Other Criteria: If this medication is administered by a physician incident to a physician’s visit it would be covered by Medicare Part B.



PEGASYS

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use and documentation of labs to support diagnosis as follows: Chronic hepatitis C: For the treatment of chronic hepatitis C (alone or in combination with ribavirin) in patients with compensated liver disease without hepatic coma who have not completed the first 24 weeks of therapy and who are not non-responders to any previous interferon therapy. Patients with hepatitis C virus (HCV) and elevated ALT should undergo HCV genotyping. Those with genotype 1 or 4 should receive 48 weeks of peginterferon + ribavirin and those with genotype 2 or 3 should undergo 24 weeks of treatment. In Genotypes 1 and 4: Viral titer should be obtained at week 12 of therapy. Chronic hepatitis C (Triple therapy with peginterferon + ribavirin + Incivek): For the treatment of chronic hepatitis C infection (genotype 1) in adults with compensated liver disease-Viral titer should be obtained at weeks 4, 12, and 24 of therapy. Chronic hepatitis C (Triple therapy with peginterferon + ribavirin + Victrelis): For the treatment of chronic hepatitis C infection (genotype 1) in adults with compensated liver disease- Viral titer should be obtained at weeks 4, 8, 12, and 24 of therapy.

Age Restrictions:


Coverage Duration: Hep B:48wk. Hep C:Type1/4:16wk.Type 2/3:24wk.With Incivek:5wk &Victrelis:13 wk. Ext:See Other crit.

Other Criteria: For continuation of peginterferon,alone or in combination with ribavirin:Genotypes 1&4, if less than 2-log decline in HCV-RNA titer after 12 weeks of treatment further treatment (Tx) is not indicated. Approvable for up to 48 weeks in HCV genotype 1 or 4 patients having a virologic response (either undetectable HCV RNA [less than 50 IU/mL] or at least a 2-log drop in titer from baseline) at 12 weeks. Treatment longer than 24 weeks has not been shown to improve response in genotypes 2 or 3. For continuation of triple therapy (peginterferon/ribavirin/Incivek): All continuation requests after initial require RNA titers at Treatment Week (TW) 4, 12, and 24 of Tx. For all patients (Treatment Naïve, partial&null responders or relapser): If the RNA


titer at TW4 is less than 1000IU/ml additional 8 weeks of peginterferon/ribavirin can be approved, if at or greater than 1000IU/ml all Tx should be discontinued (not approved). If the RNA titer at TW12 is at or greater than 1000IU/ml all Tx should be discontinued. Treatment Naïve patients only: If titers are undetectable at Weeks 4 & 12, peginterferon/ribavirin approvable for 11 weeks to complete Tx at 24 weeks. If detectable at Weeks 4 or 12, peginterferon/ribavirin will be approved for 12 weeks. At week 24 if titer is undetectable, peginterferon/ribavirin will be approved for 23 weeks to complete Tx at 48 weeks. For retreatment of partial, null responder or relapsers only: If titer at TW 12 is less than 1000IU/ml, peginterferon/ribavirin approvable for 12 weeks. At week 24 if titer is undetectable, peginterferon/ribavirin approvable for 23 weeks to complete Tx at 48 weeks. If detectable, all treatment should be discontinued (not approved). For continuation of triple therapy (peginterferon/ribavirin/Victrelis): All continuation requests after initial require titers at TW 4, 8, 12, and 24 of Tx. For all patients (Treatment Naïve, partial & null responders or relapser): If the titer at TW12 is less than 100IU/ml an additional 12 weeks of peginterferon /ribavirin can be approved, if at or greater than 100IU/ml all Tx should be discontinued (not approved). If the RNA titer at TW 12 is at or greater than 100IU/ml all Tx should be discontinued. Treatment Naïve patients only: If RNA titers at TW 8 & 24 are undetectable, peginterferon/ribavirin approvable additional 3 weeks. If RNA titer is detectable at TW 8, but undetectable at TW 24, peginterferon/ribavirin approvable additional 23 weeks. If RNA titer is detectable at TW 24, all Tx should be discontinued (not approved). For retreatment of partial, null responder or relapsers only: If titers at TW 8 & 24 are undetectable, peginterferon/ribavirin approvable additional 11 weeks. If RNA titer is detectable at TW 8, but undetectable at TW 24, peginterferon/ribavirin approvable additional 23 weeks. If RNA titer is detectable at TW 24, all treatment should be discontinued (not approved).



PERJETA


Perjeta is NOT covered for members who are HER2-negative or When used as monotherapy for the treatment of breast cancer

Required Medical

Left ventricular function test, HER2-protein expression test (require positive or equivocal HER2 over-expression). Diagnosis for use: Used in combination with trastuzumab and docetaxel for the first-line treatment of patients with metastatic breast cancer whose tumors over-express the human epidermal growth-factor receptor-2 (HER2) protein, and who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Age Restrictions:


Oncologist


Other Criteria: If this medication is administered by a physician incident to a visit this would be covered By Medicare Part B.



PHENOBARBITAL

Covered Uses: All FDA-approved indications not otherwise excluded from Part D, epilepsy, cancer, and chronic mental health conditions.

Exclusion Criteria: Not covered for requests for sedation associated with conditions other than epilepsy, cancer, or chronic mental health conditions.

Required Medical Documentation of previous/current therapy and outcomes. Diagnosis for use. Age Restrictions:



Other Criteria:



POMALYST


Pregnant patients.

Required Medical Documentation of past therapies and outcomes. Diagnosis for use: For the treatment of patients with multiple myeloma who have received at least two prior therapies including an antineoplastic immunomodulator and bortezomib (Velcade) and whose disease has progressed after completion of the last therapy.

Age Restrictions:


Oncologist or hematologist


Other Criteria:

Requests for new starts will be covered with documentation of trial and failure of bortezomib (Velcade) AND either lenalidomide (Revlimid) or thalidomide (Thalomid).



POTIGA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Potiga is not covered as initial monotherapy for partial-onset seizure Required Medical Documentation of past therapies and outcomes. Diagnosis for use. Potiga is indicated as adjunct therapy for partial seizure disorder.

Age Restrictions: Adults: 18 years and older



Other Criteria: Requests for adjunct therapy for partial seizure disorder are covered with documentation that the patient is currently on an anticonvulsant (including lamotrigine, phenytoin, divalproex, levetiracetam, gabapentin, carbamazepine, topiramate, zonisamide).



PRENATAL VITAMINS

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Excluded for males. Excluded in non-pregnant or non-breast feeding women. Required Medical

Age Restrictions: Covered for patients less than 50 year old



Other Criteria:



PROCRIT

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Endogenous ESA level. Hemoglobin and hematocrit. Initiation of therapy is warranted when the hematocrit is below 30% or hemoglobin is below 10 g/dL. Use of ESA is indicated in states of anemia where there is presumed to be inadequate EPO production, requires laboratory evidence: hemoglobin (g/dL) and/or hematocrit (%), GFR, transferrin saturation (TSAT), serum ferritin, Vitamin B12 levels, folate levels, EPO level, recent transfusion history, to exclude other causes of anemia and patient has symptomatic anemia, with symptoms including, but not limited to, weakness, syncope, lethargy, malaise, dyspnea, chest pain, postural hypotension, tachycardia or a marked reduction in activities of daily living. Documentation that the physician and patient are enrolled in the APRISE program.

Age Restrictions:


Coverage Duration: Initial approval: Chemo-related anemia: 4 weeks, MDS:6 months: All other indications: 8 weeks

Other Criteria: Excluded from patients with ESRD and dialysis. Excluded from patients with Hgb at or above 11g/dL. Excluded from patients with cancer not on myelosuppressive anticancer chemotherapy for solid tumors, multiple myeloma, lymphoma and lymphocytic leukemia. Excluded from HIV-infected patients with anemia caused by other factors such as iron or folate deficiencies, hemolysis or GI bleeding. Excluded from patients who require immediate correction of severe anemia. Requests for Procrit for patients who are anemic due to Hepatitis C therapy will be covered with documentation that the patient has remained anemic despite dose tapering to 600mg of ribavirin daily and that discontinuation would risk therapy failure.



PROLIA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Documentation of past therapies and response. Age Restrictions: Adults: 18 years and older.



Other Criteria: If this medication is administered by a physician incident to a physician’s visit this would be covered by Medicare Part B. Not covered to prevent skeletal-related events in patients with bone metastases from solid tumors. Requests for the treatment of osteoporosis in postmenopausal women at high risk for fracture (NOT due to aromatase inhibitor therapy) are covered following a trial and failure or contraindication to formulary bisphophonates. Covered for osteoporosis prophylaxis in men at high risk for bone fractures after receiving androgen deprivation therapy for nonmetastatic prostate cancer and in women at high risk for bone fractures after receiving adjuvant aromatase inhibitor therapy for breast cancer.



PROMACTA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documented diagnosis of chronic, relapsed or refractory idiopathic thrombocytopenic purpura.




Other Criteria:

Requests for coverage for thrombocytopenia in chronic hepatitis C patients will be approved if the platelet count is less than (<) 50 billion cells/L AND the patient is not being treated with a direct acting antiviral such as Victrelis or Incivek. Promacta should be withheld when platelet counts exceed 400,000/mcL or if there’s no response within 4 weeks of treatment at the maximum dose (75mg/day). Not covered in the presence of clinical symptoms of liver injury or evidence of hepatic decompensation.



QUALAQUIN

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Not approved for treatment or prevention of leg cramps, prevention of malaria, or in patients with complicated P. falciparum.

Required Medical Indicated only for the treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented.

Age Restrictions: 16 years of age and older


Coverage Duration: 7 days (2 capsules every 8 hours)

Other Criteria:



REBIF

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis of definite or probable relapsing-remitting MS, secondary progressive MS with relapses, or progressive relapsing MS. Direct statement from a neurologist that diagnosis is a relapsing form of MS, or a first MS attack with documented MRI scan abnormalities characteristic of MS. OR Evaluation documenting EITHER: history of at least two focal neurological deficits (e.g. loss of vision, double vision , localized numbness or weakness), in which the first resolved and the second followed after a period of at least 6 months, OR History of one focal neurological deficit which has resolved, and an MRI suggestive of MS: At least 3 total lesions, each at least 5mm: At least one lesion with contrast enhancement: At least 2 out of 3 lesions in either, Periventricular white matter OR Brain stem (e.g., cerebellar penducle, pons) OR (3) Spinal cord. Lack of statement that lesions are consistent with ischemic disease.

Age Restrictions:



Other Criteria: For patients treated greater than 1 yr, annual certification that therapy has been effective, i.e. treatment has decreased relapses or diminished number of lesions on MRI, AND for patients previously treated with mitoxantrone, documentation that prior treatment with requested drug was successful in decreasing relapses or diminishing the number of lesions on MRI, AND dosage does not exceed the FDA approved dose.



REGRANEX

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Patients with non-diabetic related neuropathic ulcers. Required Medical Diagnosis for use. Treatment of lower-extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. To be used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control. Confirmed underlying diagnosis/status of diabetes either by history of current diabetic medical treatment or labs provided by the prescriber. Documentation of a wound care plan. Ulcer description of the following: located on the lower extremity, extends into the subcutaneous tissue or beyond, and has adequate blood supply. Reapproval requires 30% decrease in the ulcer size by the 10th week of therapy.

Age Restrictions:


Coverage Duration: Initial: 10 weeks. Reapproval: 10 weeks with documentation of response.

Other Criteria:



RELISTOR

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documentation of past therapies. Diagnosis for use: Treatment of opioid- induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.

Age Restrictions:



Other Criteria: Requests will be covered following a trial/failure or intolerance to lactulose AND polyethylene glycol



REMICADE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documentation of past therapies and outcomes. Diagnosis for use. For plaque psoriasis: Require documentation of body surface area (BSA) involvement greater than 10% . For fistulizing Crohn’s disease: Require diagnosis of fistulizing disease.

Age Restrictions: Pediatric Crohn’s Disease or ulcerative colitis: children 6 years of age and older. Chronic moderate to severe plaque psoriasis in adult patients over 18 years of age


Coverage Duration: Initially- 6 months: Extended authorization -Annually based on documented therapeutic response.

Other Criteria: If this medication is administered by a physician incident to a physician’s visit this would be covered by Medicare Part B. Not covered in combination therapy with Kineret (anakinra). For the indications of rheumatoid arthritis, psoriatic arthritis: Require trial and failure of either Humira or Enbrel (unless both are contraindicated). For ankylosing spondylitis: Require trial and failure of either Humira or Enbrel (unless both are contraindicated). For plaque psoriasis: Require trial and failure of either Humira or Enbrel (unless both are contraindicated). For moderate-severe Crohn’s disease: Require failure of Humira (unless contraindicated). Covered for ulcerative colitis. Remicade should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.



REVLIMID

Covered Uses: All FDA-approved indications not otherwise excluded from Part D, MDS with no 5q deletion, and first line treatment of multiple myeloma

Exclusion Criteria: Revlimid is only available under a restricted distribution program called RevAssist. Not covered for patients who are pregnant.

Required Medical Covered for patients with transfusion-dependent anemia in low- or intermediate-1 risk MDS with a 5 q (q31-33) cytogenetic abnormality, OR for members with no 5q deletion that have failed or have a contraindication to erythropoietin therapy. Transfusion dependence is defined as having greater than 2 units of red blood cells within 8 weeks of treatment. Low- or intermediate-1 risk MDS is defined as having an International Prognostic Scoring System (IPSS) Score for MDS of 0 to 1. Covered for members with multiple myeloma. For the diagnosis of mantle cell lymphoma (MCL) documentation that disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

Age Restrictions:



Other Criteria: Transfusion dependence is defined as having greater than 2 units of red blood cells within 8 weeks of treatment. Low- or intermediate-1 risk MDS is defined as having an International Prognostic Scoring System (IPSS) Score for MDS of 0 to 1.



RIBAVIRIN

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Must be administered with alpha interferon for treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon or who have relapsed following alpha interferon therapy. Diagnosis for use and documentation of labs to support diagnosis as follows: For the treatment of chronic hepatitis C in patients with compensated liver disease without hepatic coma who have not completed the first 24 weeks of therapy and who are not non-responders to previous interferon therapy. Patients with hepatitis C virus (HCV) and elevated ALT should undergo HCV genotyping. Those with genotype 1 or 4 should receive 48 weeks of peginterferon + ribavirin and those with genotype 2 or 3 should receive 24 weeks. In Genotypes 1 and 4:Viral titer should be obtained at week 12 of therapy. Chronic Hep C (Triple therapy with peginterferon + ribavirin + Incivek):Treatment of chronic Hep C infection (genotype 1) in adults with compensated liver disease-Viral titer should be obtained at weeks 4, 12, and 24 of therapy. Chronic Hep C (Triple therapy with peginterferon + ribavirin + Victrelis): Treatment of chronic Hep C infection (genotype 1) in adults with compensated liver disease-Viral titer should be obtained at weeks 4, 8, 12, and 24 of therapy.Those with genotype 1 or 4 should receive 48 weeks of peginterferon + ribavirin and those with genotype 2 or 3 should undergo 24 weeks of treatment. In Genotypes 1 and 4: Viral titer should be obtained at week 12 of therapy. In Genotypes 1,and 4, if there is less than a 2-log decline in HCV-RNA titer after 12 weeks of treatment further treatment is not indicated. Therapy is approvable for up to 48 weeks in HCV genotype 1 or 4 patients who have achieved a virologic response (either undetectable HCV RNA [less than 50 IU/mL] or at least a 2-log drop in HCV RNA titer from baseline) at 12 weeks of treatment. Treatment duration longer than 24 weeks has not been shown to improve response in genotypes 2 or 3.

Age Restrictions:


Coverage Duration: Hepatitis C:Types 1/4:16wk.Types 2/3:24wk.With Incivek:5wk &Victrelis:13 wk. Ext:See Other criteria


Other Criteria: Ribavirin 200mg caps/tabs are the preferred strength and dosage forms AND must be used unless documented contraindication. Continuation HCV:Genotypes 1&4, if less than 2-log decline in HCV-RNA titer after 12 weeks of treatment further treatment (Tx) is not indicated. Approvable for up to 48 weeks in HCV genotype 1 or 4 patients having a virologic response (either undetectable HCV RNA [less than 50 IU/mL] or at least a 2-log drop in titer from baseline) at 12 weeks. Treatment longer than 24 weeks has not been shown to improve response in genotypes 2 or 3. For continuation of triple therapy (peginterferon/ribavirin/Incivek): All continuation requests after initial require RNA titers at Treatment Week (TW) 4, 12, and 24 of Tx. For all patients (Treatment Naïve, partial&null responders or relapser): If the RNA titer at TW4 is less than 1000IU/ml additional 8 weeks of peginterferon/ribavirin can be approved, if at or greater than 1000IU/ml all Tx should be discontinued (not approved). If the RNA titer at TW12 is at or greater than 1000IU/ml all Tx should be discontinued. Treatment Naïve patients only: If titers are undetectable at Weeks 4 & 12, peginterferon/ribavirin approvable for 11 weeks to complete Tx at 24 weeks. If detectable at Weeks 4 or 12, peginterferon/ribavirin will be approved for 12 weeks. At week 24 if titer is undetectable, peginterferon/ribavirin will be approved for 23 weeks to complete Tx at 48 weeks. For retreatment of partial, null responder or relapsers only: If titer at TW 12 is less than 1000IU/ml, peginterferon/ribavirin approvable for 12 weeks. At week 24 if titer is undetectable, peginterferon/ribavirin approvable for 23 weeks to complete Tx at 48 weeks. If detectable, all treatment should be discontinued (not approved). For continuation of triple therapy (peginterferon/ribavirin/Victrelis): All continuation requests after initial require titers at TW 4, 8, 12, and 24 of Tx. For all patients (Treatment Naïve, partial & null responders or relapser): If the titer at TW12 is less than 100IU/ml an additional 12 weeks of peginterferon /ribavirin can be approved, if at or greater than 100IU/ml all Tx should be discontinued (not approved). If the RNA titer at TW 12 is at or greater than 100IU/ml all Tx should be discontinued. Treatment Naïve patients only: If RNA titers at TW 8 & 24 are undetectable, peginterferon/ribavirin approvable additional 3 weeks. If RNA titer is detectable at TW 8, but undetectable at TW 24, peginterferon/ribavirin approvable additional 23 weeks. If RNA titer is detectable at TW 24, all Tx should be discontinued (not approved). For retreatment of partial, null responder or relapsers only: If titers at TW 8 & 24 are undetectable, peginterferon/ribavirin approvable additional 11 weeks. If RNA titer is detectable at TW 8, but undetectable at TW 24, peginterferon/ribavirin approvable additional 23 weeks. If RNA titer is detectable at TW 24, all treatment should be discontinued (not approved).



RILUTEK

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use of Amyotrophic lateral sclerosis (ALS). Age Restrictions: Safety and efficacy have not been established in pediatric patients



Other Criteria:



RITUXAN




Other Criteria: If this medication is administered by a physician incident to a physician’s visit this would be covered by Medicare Part B. Reasons for Non-Coverage: Combination treatment of Orencia or an anti-TNF or a biologic response modifier. For moderately- to severely- active rheumatoid arthritis: failure of methotrexate (Rituxan must be in combination with methotrexate) and either Humira or Enbrel.



SABRIL

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis of use for infantile spasms. For complex partial seizure disorder in adults: Require documentation that the patient is currently stable on Sabril therapy OR that the patient is currently receiving another antiepileptic drug AND the patient has experienced treatment failure from two previous agents (antiepileptics include lamotrigine, phenytoin, divalproex, levetiracetam, gabapentin, carbamazepine, topiramate, zonisamide)

Age Restrictions: Tablets: 16 years or older. Oral Solution: 1 month to 2 years old



Other Criteria: Patients must be registered with the SHARE program (SHARE Call Center at 1-888-45-SHARE). Powder packets are only approved for treating Infantile Spasms. Dosing for Infantile Spasms: Sabril should be given as twice daily oral administration with or without food. The initial dosing is 50 mg/kg/day given in two divided doses and can be titrated by 25-50 mg/kg/day increments every 3 days up to a maximum of 150 mg/kg/day. Dosing for Refractory Complex Partial Seizures: Sabril 500 mg tablets should be given as twice daily oral administration with or without food. Therapy should be initiated at 1 g/day (500 mg twice daily). Total daily dose may be increased in 500 mg increments at weekly intervals depending on response. The recommended dose of Sabril in adults is 3 g/day (1.5 g twice daily). A 6 g/day dose has not been shown to confer additional benefit compared to the 3 g/day dose and is associated with an increased incidence of adverse events.



SAMSCA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. For hypervolemic or euvolemic hyponatremia: Patient with heart failure, cirrhosis, or SIADH, serum sodium is less then 125mEq/L, there is no urgent need to raise serum sodium, the patient is not anuric, the patient is able to sense and appropriately respond to thirst, the patient is treatment refractory to maximum diuretic therapy, the patient is experiencing the clinically significant symptoms of hyponatremia. For the diagnosis is SIADH the following must also be met: Causative pharmacologic agents are discontinued when possible, the drug was appropriately initiated/re-initiated in a hospital setting per the PI, the patient is not taking strong CYP3A inhibitors.


Prescriber Restrictions: The prescribing physician is board certified nephrologist, endocrinologist, gastroenterologist/hepatologist or has obtained a consult from such a specialist.


Other Criteria: The recommended starting dose is 15 mg once daily. Dosage may be increased at intervals greater than or equal to 24 hours to 30 mg once daily, and to a maximum of 60 mg once daily as needed to raise serum sodium. Monitor serum sodium and volume status.



SENSIPAR




Other Criteria: Requests for Sensipar are covered for treatment of Hypercalcemia in patients with parathyroid carcinoma OR treatment of severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy OR for treatment of Secondary Hyperparathyroidism in patients with Chronic Kidney Disease on dialysis following trial and failure of a vitamin D sterol and a phosphate binder.



SEROSTIM

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Serostim may be approved when prescribed for the diagnosis of AIDS wasting by a physician who has training and experience in treating those with AIDS and AIDS wasting The following information may be used as a guide to confirm the medical necessity for Serostim: Patient must have the diagnosis of AIDS wasting and/or cachexia The patient must be on anti-viral therapy and compliant with their regimen The patient must be evaluated for inadequate nutritional intake, malabsorption, opportunistic infections, and/or hyopgonadism as a potential cause for weight loss. Has the patient had progressive weight loss of greater than 10% of body weight from pre-illness? Does the patient have a BMI less then 20? Has the patient failed a trial of appetite stimulation (megestrol)? How many weeks has the patient received Serostim therapy (48 weeks maximum per manufacturer)? Is the request for more than one injection per day? If this is request for a re-approval: Has the patient lost weight since the last approval? Has the patient been compliant with Serostim therapy? Has the patient been compliant with their antiviral therapy?

Age Restrictions:


Coverage Duration: Initial approval: 12 weeks. Subsequent approval: 3 month periods: Max: 48 weeks

Other Criteria:



SIMVASTATIN 80MG

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Simvastatin 80mg and/or Vytorin 10/80mg are not covered for patients not already established on these medications (New starts for the 80mg dose)

Required Medical Documentation of current therapy containing 80mg of simvastatin Age Restrictions:



Other Criteria: Requests for continuation of therapy on simvastatin 80mg or Vytorin 10/80mg will only be covered for patients currently established on this dosage. Requests for new starts will not be covered in accordance with the latest FDA-approved labeling



SOLTAMOX

Covered Uses: All FDA-approved indications not otherwise excluded from Part D.

Exclusion Criteria:

Required Medical Diagnosis for use. Documentation of inability to swallow tablet formulation.

Age Restrictions: Prescriber Restrictions: Oncologist


Other Criteria:



SOMATULINE DEPOT

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use: Acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option., OR have failed an adequate trial of octreortide. DOSING :(initial) 90 mg deep SUBQ injection every 4 weeks for 3 months (maintenance) after 3 months, for GH levels greater than 1 ng/mL but less than or equal to 2.5ng/mL, normal insulin-like growth factor-1 (IGF-1), and controlled symptoms, continue 90 mg every 4 weeks:for GH greater than 2.5 ng/mL, elevated IGF-1, and/or uncontrolled symptoms, increase to 120 mg every 4 weeks: for GH of 1 ng/mL or less, normal IGF-1, and controlled symptoms, reduce dose to 60 mg every 4 weeks: thereafter, adjust dose according to response.



Coverage Duration: Initial approval: 3 months. Extended approval: 3 months with dose adjusted according to response.




SOMAVERT

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Acromegaly: For the treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapies, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-I (IGF-I) levels. Annual reauthororization is based upon patient's response to therapy as evidenced by normalization of IGF-I levels and liver function tests that are less than 5 times upper limit of normal, without signs/symptoms of hepatitis or other liver injury, or increase in serum TBIL.

Age Restrictions: Safety and effectiveness in pediatric patients have not been established



Other Criteria:



SPRYCEL

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documentation of past therapies and outcomes. Diagnosis for use. For the treatment of adults with chronic phase chronic myeloid leukemia (CML) newly diagnosed or those with resistance or intolerance to prior therapy including imatinib. Also for the treatment of accelerated, or myeloid, or lymphoid blast phase chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy including imatinib AND for the treatment of adults with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Use of Sprycel should continue for maintenance of major cytogenic response (0-35% Ph+ metaphases) and until disease progression or death.




Other Criteria:



STIVARGA


Documentation of previous therapies and outcomes. Diagnosis for use: Treatment of locally advanced, unresectable or metastatic gastrointestinal stromal tumors (GIST) in patients who have previously received imatinib or sunitinib OR for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF (vascular endothelial growth factor) therapy (e.g. Avastin). If KRAS wild type colorectal cancer, an anti-EGFR (endothelial growth factor receptor) therapy (e.g. Erbitux, Vectibix) must have been part of the treatment protocol.

Age Restrictions:


Oncologist

Coverage Duration: Remainder of the contract year. Other Criteria:



SUBOXONE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Reasons for Non-Coverage: Suboxone® and Subutex® requests for the indication of acute or chronic pain. In patients who continue to take opioids while using Suboxone. If patient is no longer in a counseling/treatment program.

Required Medical Suboxone is indicated for the treatment of opioid dependence. The patient must have a diagnosis of opioid dependence AND a formal substance abuse counseling/treatment program must be in place for the beneficiary AND a treatment plan must be documented which will include a dose maintenance plan. Extended Approval: 6 months, based on Suboxone compliance and the absence of concurrent opioid use. All renewal requests will be reviewed by a Pharmacist. The Pharmacist will verify the patient is still in a psychosocial support program and perform a profile review. The profile review will look for compliance with Suboxone therapy and ensure that the patient has not been concurrently receiving narcotics or doctor shopping. If the renewal criteria are met, authorizations will be allowed for 6 month time periods.

Age Restrictions:

Prescriber Restrictions: Must be certified to prescribe Suboxone with unique DEA registration

Coverage Duration: Initial approval: 3 months. Extended approval: 6 months

Other Criteria:



SUCRAID

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Not covered for patients known to be hypersensitive to yeast, yeast products, glycerin (glycerol) or papain.

Required Medical Diagnosis for use. Sucraid (sacrosidase) oral solution is indicated as oral replacement therapy of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency. (CSID)

Age Restrictions:


Coverage Duration: Initial approval: 6 months. Extended approval: 1Year

Other Criteria:



SUTENT


Age Restrictions:



Other Criteria: Requests for new starts for GIST will be covered following trial and failure of imatinib (unless imatinib is otherwise contraindicated).



SYLATRON

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use: Adjuvant treatment of malignant melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.







SYMBYAX

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Symbyax is not approved for the treatment of patients with dementia-related psychosis.

Required Medical Documentation of past therapies and outcomes. Diagnosis for use. Covered for treating depression associated with bipolar disorder and for treatment resistant major depressive disorder.

Age Restrictions:



Other Criteria: Requests for new starts with depression associated with bipolar disorder will be covered for patients who have failed to respond to or experience intolerable side effects from a traditional mood stabilizer (lithium, divalproex, or carbamazepine), or have a contraindication or have experienced intolerable side effects from traditional mood stabilizers AND are already taking an SSRI for depression. Requests for new starts with resistant major depressive disorder will be covered for patients who have failed to respond to at least 2 separate previous trials of antidepressants at adequate dose and duration during the same depressive episode.



SYMLIN

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Symlin is not covered for patients meeting any of the following criteria: An A1C less then 7% or greater than 9%. Recurrent severe hypoglycemia requiring assistance during the previous 6 months. Presence of hypoglycemia unawareness. Confirmed diagnosis of gastroparesis. Need for medications that stimulate GI motility.

Required Medical Type 2 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and have failed to achieve desired glucose control despite optimal insulin therapy, with or without a concurrent sulfonylurea agent and/or metformin. Type 1 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. Continued approval: 1 year based on response to therapy (improved glycemic control as evidenced by A1C lowering from baseline).

Age Restrictions:


Coverage Duration: Initial approval period of 6 months. Annual review will be based on response to therapy

Other Criteria: Type 1 diabetics: Using both basal insulin and short-acting insulin, and requires three or more insulin injections daily, or using an insulin pump. Type 2 diabetics: Using both basal insulin and short-acting insulin, AND requires three or more insulin injections daily, OR using an insulin pump, AND receiving maximum tolerated doses of metformin, unless the patient is not a candidate for metformin therapy. failure of achieve adequate glycemic control despite individualized insulin management defined as: A1C level is greater than 7% and less than 9%, and marked day-to-day variability in glucose levels (based on review of self-monitoring blood glucose levels). Require monitoring total daily carbohydrate intake. Currently receiving ongoing care under the guidance of a healthcare professional skilled in the use of insulin and supported by the services of diabetes educators



SYNAREL

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: SYNAREL should not be administered to patients who are hypersensitive to GnRH, GnRH agonist analogues or any of the excipients of SYNAREL, have undiagnosed vaginal bleeding, are pregnant or may become pregnant as major fetal abnormalities were observed in rats (not applicable when used in in vitro fertilization programs), are breast feeding.

Required Medical Diagnosis for use. Age Restrictions:



Other Criteria:



SYNRIBO


Required Medical

Documentation of past therapies and outcomes. Diagnosis for use. SYNRIBO for Injection is indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI).

Age Restrictions:


Oncologist


Other Criteria:



TAFINLAR

Covered Uses: All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria:

Patients with wild-type BRAF melanoma or THxID BRAF test with a negative result for V600E mutation of BRAF gene.

Required Medical Diagnosis for use. Documentation of current and past therapies and outcomes.

Age Restrictions: Adults: 18 years and older


Oncologist or dermatologist


Other Criteria: Oncologist reviewed unresectable or metastatic melanoma and BRAF V600E mutation as detected by an FDA-approved test, like THxID BRAF test.



TARCEVA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D and first line treatment of advanced or metastatic NSCLC

Exclusion Criteria: Required Medical Diagnosis for use. Covered for the treatment of locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. Covered for first line treatment for locally advanced or metastatic NSCLC, with or without platinium-based therapy, in patients with a known active EGFR mutation or overexpression in patients that have never smoked. Covered for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. Covered in combination with gemcitabine (Gemzar) for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Age Restrictions:



Other Criteria:



TARGRETIN

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: This medication should not be administered to patients who are pregnant. Required Medical Diagnosis for use. Documentation of past therapies and response. Age Restrictions:



Other Criteria:



TASIGNA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documentation of past therapies and outcomes. Diagnosis for use. For the treatment of adults with newly diagnosed chronic phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) or those resistant to or intolerant to prior therapy including imatinib. Also for the treatment of accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included imatinib. Use of Tasigna should continue for maintenance of major cytogenic response (0-35% Ph+ metaphases) and until disease progression or death.




Other Criteria:



TAXOTERE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Breast cancer, Adjuvant treatment in combination with doxorubicin and cyclophosphamide for patients. Breast cancer, Locally advanced/metastatic disease, after failure of prior chemotherapy Gastric cancer. Head and neck cancer, Locally advanced squamous cell disease, induction treatment in combination with cisplatin and fluorouracil. Metastatic prostate cancer, Androgen independent (hormone refractory), in combination with prednisone.Non-small cell lung cancer, Locally advanced/metastatic disease, as monotherapy after failure of prior platinum-based chemotherapy. Non-small cell lung cancer, Unresectable, locally advanced/metastatic disease, first-line therapy in combination with cisplatin.

Age Restrictions:



Other Criteria:



TESTRED

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use: Indicated for delay in sexual development AND/OR puberty, and hypogonadotropic hypogonadism and metastasis from malignant tumor of breast inoperable metastatic disease (skeletal) in women 1 to 5 years postmenopausal and primary hypogonadism. Testosterone levels (total and free), LH, and FSH levels (normal ranges as provided by office or clinic performing labs).

Age Restrictions:


Coverage Duration: 3 months then 1year if response noted.

Other Criteria:



THALOMID

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Not covered for patients who are pregnant. Required Medical Diagnosis for use. Indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). Indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. Covered for previously treated and untreated patients with multiple myeloma in combination with dexamethasone.

Age Restrictions:

Prescriber Restrictions: Prescribers registered with S.T.E.P.S.


Other Criteria: The drug is available only under a special restricted distribution program called the S.T.E.P.S(TM) Program (System for Thalidomide Education and Prescribing Safety)



TOPOTECAN

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. Carcinoma of cervix, Stage IVB, recurrent, or persistent and in combination with cisplatin OR Metastatic ovarian tumor, after failure of initial or subsequent chemotherapy OR small cell carcinoma of lung, after failure of first-line therapy. Documentation of previous therapies and outcomes if applicable.

Age Restrictions:






TRACLEER

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Not covered for the following: concomitant administration with cyclosporine or glyburide, AND pregnancy (monthly pregnancy tests should be obtained while on therapy).

Required Medical Pulmonary Arterial Hypertension (PAH): Approval may be granted for the treatment of pulmonary hypertension in adult patients when: the patient has been diagnosed with primary pulmonary hypertension, OR the patient has been diagnosed with secondary pulmonary hypertension due to scleroderma, sclerosis or autoimmune disease, AND the patient is WHO functional class II, III, or IV. Authorization is limited to 60 tablets a month for 4 months, due to a lack of demonstrated increased benefit, and an increased risk of liver toxicity from higher doses. Therapy beyond 4 months will require patient documentation of clinical response as defined by stabilization or improvement in functional status (NYHA functional class), OR improvement in PAP or other measures of pulmonary hypertension.

Age Restrictions:

Prescriber Restrictions: Pulmonologist or Cardiologist

Coverage Duration: Initial approval: 4 months. Extended approval: 1 year

Other Criteria: Requests for new starts will be covered following a trial and failure of calcium channel blockers (CCB) or documentation of a contraindication to CCB therapy. If negative vasodilatory response, then CCBs are not recommended and Tracleer will be approved if other criteria met.



TRETINOIN

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Acute Promyelocytic Leukemia (APL): for the induction of remission in patients with APL, French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the t(15,17) translocation and/or the presence of the PML/RARα gene, who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated. Tretinoin is for the induction of remission only. Patients should receive an accepted form of remission consolidation and/or maintenance therapy for APL after completion of induction therapy with tretinoin.

Age Restrictions:



Other Criteria:



TRISENOX

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Indicated for induction and consolidation of acute promyelocytic leukemia (APL) characterized by t(15,17) translocation or PML/RAR-alpha gene expression, in patients who are refractory to or have relapsed from retinoid and anthracycline chemotherapy

Age Restrictions:



Other Criteria: If this medication is administered by a physician incident to a physician’s visit this would be covered by Medicare Part B. Second-line therapy in acute promyelocytic leukemia (APL) characterized by t(15,17) translocation or PML/RAR-alpha gene expression.



TYGACIL



Coverage Duration: 14 days

Other Criteria:



TYKERB

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Tykerb is NOT covered for members with the following criteria: Patients who are HER2-negative.

Required Medical Tykerb is indicated for use in combination with Xeloda (capecitabine) for the treatment of patients with advanced or metastatic breast cancer whose tumors over-express HER2 and who have received prior therapy including an anthracycline (doxorubicin, daunorubicin, epirubicin, idarubicin), a taxane (paclitaxel, docetaxel), and Herceptin® (trastuzumab). Tykerb is indicated for first-line therapy in combination with letrozole for patients with hormone positive and HER-2 positive metastatic breast cancer.

Age Restrictions:



Other Criteria:



VANCOCIN HCL

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documentation of past therapies and outcomes. Diagnosis for use. Staphylococcal enterocolitis and antibiotic-associated pseudomembranous colitis produced by C. difficile. Require white blood count and serum creatinine levels (current and premorbid).

Age Restrictions:


Coverage Duration: 14 days

Other Criteria: Vancomycin oral is not covered for initial episodes of C. difficile infections (CDI) unless the episode is severe. CDI is severe when there is leukocytosis with a white blood cell count of 15,000 cells/microliter or higher or a serum creatinine level greater than or equal to 1.5 times the premorbid level. Vancomycin oral is not covered for the first recurrent episode if the initial therapy was metronidazole and the recurrent episode is not severe. Requests for Vancomycin oral will be covered in recurrent episodes of CDI following a trial of metronidazole and documentation that the recurrent episode is severe. Requests for Vancomycin oral in patients with a second recurrence will be covered following 2 recent trials of metronidazole. Vancomycin oral 500mg 4 times daily will be reserved for patients with severe, complicated CDI (including patients experiencing hypotension or shock, ileus or megacolon). Vancomycin is also available in an injectable form (vial) which requires no PA. This may be given orally and is more cost effective than the Vancomycin oral capsules.



VELCADE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use. For mantle cell lymphoma: Velcade is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy. For multiple myeloma: Velcade is indicated for first line treatment of patients with multiple myeloma in combination with melphalan and prednisone. Velcade is indicated as monotherapy for previously treated patients with refractory multiple myeloma.

Age Restrictions:



Other Criteria: If this medication is administered by a physician incident to a physician’s visit this would be covered by Medicare Part B. Dosing for mantle cell lymphoma: Starting dose is 1.3mg/m2/dose administered as a 3 to 5 second bolus intravenous injection twice weekly for 2 weeks followed by a 10 day rest period. Dosing for multiple myeloma in previously untreated patients: 1.3 milligrams/square meter (mg/m(2)) intravenous (IV) bolus twice weekly for 6 weeks (on days 1, 4, 8, 11, 22, 25, 29, and 32, then a rest period on days 33 through 42) for cycles 1 to 4, followed by once weekly IV for 6 weeks (on days 1, 8, 22, and 29, then a rest period for days 30 through 42) for cycles 5 through 9. Dosing for multiple myeloma in previously treated patients: 1.3 milligrams/square meter (mg/m(2)) per dose, administered as bolus intravenous injection twice weekly for 2 weeks (days 1, 4, 8, and 11) followed by a 10-day rest period (days 12 to 21). If an extended therapy of more than 8 cycles is required, bortezomib 1.3 mg/m(2) may administered on the standard schedule or on a maintenance schedule of once weekly for 4 weeks (days 1, 8, 15, and 22) followed by a 13-day rest period (days 23 to 35).



VENTAVIS

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documentation of past therapies and outcomes. Diagnosis for use: Pulmonary arterial hypertension in WHO Group I and patient has NYHA functional class III or IV symptoms. Therapy beyond 4 months will require patient documentation of clinical response as defined by stabilization or improvement in functional status (NYHA functional class), OR improvement in PAP or other measures of pulmonary hypertension.


Prescriber Restrictions: Pulmonologist or cardiologist

Coverage Duration: Initial approval: 4 months. Extended approval: 1 year, requires documentation of clinical response

Other Criteria: Ventavis is administered via a DME inhalation device and as such would be covered as a Part B benefit for non-institutionalized patients. Requests will be covered following a trial calcium channel blockers unless calcium channel blockers are contraindicated. If negative vasodilatory response, then CCBs are not recommended and Ventavis will be approved if other criteria met.



VIDAZA




Other Criteria:



VORAXAZE


Required Medical

Diagnosis for use. For the treatment of toxic plasma methotrexate concentrations (greater than 1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function.

Age Restrictions:


Coverage Duration: 1 week

Other Criteria: If administered incident to a Physicians office visit, this medication would be covered under Medicare Part B. Not indicated for use and not covered in patients who exhibit the expected clearance of methotrexate (plasma methotrexate concentrations within 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) or those with normal or mildly impaired renal function because of the potential risk of subtherapeutic exposure to methotrexate.



VOTRIENT




Other Criteria:



XALKORI

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use: Treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. Positive result confirming ALK using Vysis ALK Break Apart FISH Probe Kit or equivalent.




Other Criteria:



XENAZINE

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Xenazine is NOT covered for members with the following: Patients who are actively suicidal, or patients with untreated or inadequately treated depression. Patients with impaired hepatic function. Patients currently taking monoamine oxidase inhibitors. Patients currently taking reserpine.

Required Medical Documentation of the following: diagnosis of Huntington’s Disease with chorea, physician is properly monitoring the disease progression and making necessary dosing adjustments, and is compliant with REMS (Risk Evaluation and Mitigation Strategy)



Coverage Duration: Initial approval: 3 months. Extended approval: Annually based on continued therapeutic response

Other Criteria: In order to receive prior authorization, the patient must meet the clinical criteria mentioned above and have an FDA approved indication or indication recognized in the following compendia: American Hospital Formulary service drug information, United States Pharmacopeia-Drug Information, DrugDex information system. Quantity limits will apply



XOLAIR

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documentation of the following: Mod-severe persistent asthma (NHLBI definition) meeting all the following criteria: Evidence of reversible disease (12% or greater improvement in FEV1 with at least a 200ml increase or 20% or greater improvement in PEF as a result of a short-acting bronchodilator challenge). Evidence of specific allergic sensitivity to a perennial aeroallergen (+ skin test or in vitro test). Failure of an adequate trial of standard therapy as defined by a trial of at least a 3 month course of high-dose inhaled corticosteroids and long-acting beta2-agonists. Extended approval for 6 mo's if demonstrated benefit, meeting at least 2 of the following criteria: PEF improvement (12% or greater from baseline (prior to start of Xolair)), OR FEV1 improvement (12% or greater from baseline (prior to start of Xolair)), OR reduction in symptoms (wheezing, sob, cough, chest tightness), OR reduction in systemic corticosteroids and rescue drug use, OR reduction of asthma-related hospitalizations and other medical contacts.

Age Restrictions: 12 years of age or older

Prescriber Restrictions: Allergist, immunologist or pulmonologist

Coverage Duration: Initial: 6 months trial. Extended approval: 6 months if demonstrated benefit




XTANDI Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical

Documentation of past therapies and outcomes. Diagnosis for use: Treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.

Age Restrictions:


Oncologist

Coverage Duration: Remainder of the contract year. Other Criteria:

Requests for new starts are covered following unsatisfactory effects or contraindication to Zytiga (abiraterone).



YERVOY







ZALTRAP


Required Medical

Diagnosis for use and documentation of past and current therapies. Zaltrap is indicated for metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen, in combination with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI).

Age Restrictions:


Oncologist


Other Criteria: Zaltrap must be used in combination with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI). If this medication is administered by a physician incident to a physician’s visit, this would be covered by Medicare Part B. Not covered for exudative age-related macular degeneration.



ZAVESCA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: The drug is contraindicated in women who are or may become pregnant. Required Medical Diagnosis for use. Age Restrictions:



Other Criteria:



ZELBORAF

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Diagnosis for use: Treatment of unresectable or metastatic malignant melanoma in patients with V600E mutation of the BRAF gene as detected by an FDA-approved test. Positive result confirming mutation using Cobas 4800 BRAF V600 Mutation Test or equivalent.




Other Criteria:



ZOLINZA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Covered for cutaneous manifestations of cutaneous T-cell Lymphoma when the following criteria have been met: failed minimum of two systemic treatments: The recommended dose is 400 mg orally once daily with food. Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity. If a patient is intolerant to therapy, the dose may be reduced to 300 mg orally once daily with food. The dose may be further reduced to 300 mg once daily with food for 5 consecutive days each week, as necessary.

Age Restrictions:



Other Criteria:



ZOMETA




Other Criteria:



ZYTIGA

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Required Medical Documentation of past therapies. Diagnosis for use-Treatment of patients with metastatic castration-resistant prostate cancer (CRPC). Documentation that prednisone will be used in combination.

Age Restrictions:



Other Criteria:



ZYVOX

Covered Uses: All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria: Not covered with concomitant use of MAOI therapy. Required Medical Diagnosis for use. Age Restrictions:


Coverage Duration: MRSA: 2 weeks. VRE: Up to 4 weeks

Other Criteria:

2013 First Health Premier Prior Authorization Criteria - Coventry

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