Medicare Part D Drugs Requiring Prior Authorization

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1 Formulary ID 14068, Version 17 Last Updated 11/2014 Y0051_1622_508 Accepted 09/14/2012 Medicare Part D Drugs Requiring Prior Authorization MVP Health Care requires you or your doctor to get prior authorization for certain drugs. This means that you will need to get approval from MVP before you fill your prescriptions. If you don t get approval first, MVP may not cover the drug. You can ask MVP to make an exception to our coverage rules. For more information, refer to the MVP Health Care Medicare Part D Formulary ( How do I request an exception to MVP s Medicare Part D Formulary ). Drugs that require prior authorization have the abbreviation PA in the Formulary under the Notes column next to the drug name or are listed in the chart below. are subject to change if required and approved by Medicare. (Note: A formulary exception request may be required for a brand name drug if the drug is not listed on the Formulary and there is a generic equivalent available.) ACTEMRA All FDA-approved indications not otherwise excluded from Part D. Patients with clinically important active infections or a history of chronic or recurrent infections Active tuberculosis Doses greater than those in FDA approved package labeling Liver enzymes 5X ULN ANC <500 cells per mm 3 Platelet count <50,000 cells per mm 3 Documented moderate to severe active adult Rheumatoid Arthritis, or Juvenile Idiopathic Arthritis and chart notes identifying the following: Synovitis Number of swollen and/or tender joints Morning stiffness of significant duration PE findings Diagnosed with arthritis for at least 3 months

2 For continued therapy: Documentation of response to Actemra must be provided with each request for extension of therapy that identifies improvement in the clinical signs and symptoms Other Restricted to 18 years and older, except for juvenile arthritis which is restricted to 2 years and older Rheumatologist, immunologists Up to 12 months Subcutaneous Actemra will only be approved for the treatment of rheumatoid arthritis Documentation must include failure or inadequate response to a 12-week trial each of Humira and Enbrel, OR If chart notes identify intolerance, and/or clinical side effects, and/or contraindication to Enbrel and Humira, the following must be documented: Failed to respond to an adequate trial of maximally tolerated dose of methotrexate. If the member has a contraindication or significant intolerance to methotrexate, the member must have failed to respond for an adequate trial to at least one other nonbiologic DMARDs at a maximally tolerated dose ACTHAR All FDA-approved indications not otherwise excluded from Part D. Patients with medical contraindications for use identified in package label, including: scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, presence or history of peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin Treatment of conditions for which Acthar is indicated when they are accompanied by primary adrenocortical insufficiency or adrenocortical hyperfunction For use in children under 2 years of age with congenital infections Administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar Acute exacerbation of relapsing-remitting multiple sclerosis (RRMS): Neurology notes including all radiologic reports, supporting the diagnosis RRMS must be provided Documentation of intolerable side or failure of high-dose oral (prednisone 500mg) and/or

3 IV corticosteroid therapy Patient is currently being treated with an immunomodulatory drug (i.e. Betaseron, Avonex, or Copaxone Infantile spasms: Documentation supporting diagnosis of infantile spasms, including onset of age, symptom description, EEG results identifying hypsarryhthmia Treatment plan and goals submitted by prescriber, including dose, frequency, and number of vials per month being requested. Induction of diuresis or proteinuria remission in nephrotic syndrome: Documentation of proteinuria 3.5 grams/24 hours Member has been complaint with ACE/ARB therapy Documentation of intolerable side effect or contraindication to corticosteroid therapy; OR Documented failure to achieve complete (<300 mg/24 hours) or partial remission ( mg/24 hours) of proteinuria with high dose corticosteroids (prednisone up to 80mg/day) Rheumatic Disorders: Documentation of an acute episode or exacerbation of Psoriatic arthritis, Rheumatoid arthritis or Ankylosing spondylitis Patient is currently being treated with disease modifying antirheumatic drug (DMARD) Documentation of intolerable side or failure of high-dose oral and/or IV corticosteroid therapy Documentation of one of the following diagnosis: systemic lupus erythematosus, systemic dermatomyositis, severe erythema multiforme, Steven-Johnson syndrome, inflammatory ophthalmic disease, symptomatic sarcoidosis Documentation of all prior treatments Documentation of intolerable side and/or failure of high-dose oral and/or IV corticosteroid therapy Up to 3 months

4 Other For continuation of therapy-documentation must be provided indentifying anticipated length of therapy, treatment plan and improvement in clinical signs and symptoms ACTIMMUNE All FDA-approved indications not otherwise excluded from Part D Not covered for idiopathic pulmonary fibrosis (IPF). Target doses greater than or less than the recommended dose of 50mcg/m² are not covered except if severe reaction(s) occur. The dosage should be reduced by 50 percent or therapy interrupted if severe reaction(s) occur Supporting documentation including prescription history with intravenous antibiotics, complete blood count (CBC) with differential identifying anemia or thrombocytopenia. Documented diagnosis of Chronic Granulomatous Disease (CGD) and continued frequent serious infectious episodes while receiving prophylactic antibiotics, OR Diagnosis of severe, malignant osteopetrosis supported by radiological reports, documentation of previous therapy with intravenous antibiotics, and other relevant clinical findings that were used to diagnosis osteopetrosis and which will be monitored for outcomes such as: anemia, thrombocytopenia, splenomegaly, optic atrophy chronic osteomyelitis. Other Continued therapy will be considered based on demonstrated response identified by reduction in serious infections requiring intravenous antibiotics (CGD), reduction in hospitalizations due to serious infections (CGD), increase in hemoglobin and platelet counts (osteopetrosis), no more than 50dB decrease in hearing and no evidence of progressive optic atrophy (osteopetrosis), no evidence of a serious bacterial infection requiring antibiotics (osteopetrosis). Restricted to a hematologist, oncologist, infectious disease specialist, or endocrinologist. 3 months initial approval. Remainder of calendar year for extension of therapy.

5 Other ADAGEN All FDA-approved indications not otherwise excluded from Part D Baseline plasma enzyme adenosine deaminase (ADA) activity confirming diagnosis of ADA deficiency, AND Baseline level of deoxyadenosine triphosphate (datp) in erythrocytes confirming diagnosis of ADA deficiency, AND Documentation of severe combined immunodeficiency disease, AND Not a suitable candidate for BMT OR failure of BMT. Extension of therapy will be considered if the plasma ADA activity is maintained between 15-35micromol/hr/Ml. Immunologist or endocrinologist. Remainder of contract year. ADCIRCA All FDA-approved indications not otherwise excluded from Part D will not be provided if any of the following are true: Treatment of digital ulcers or erectile dysfunction. Combination therapy with other phosphodiesterase 5 (PDE5) inhibitors and/or nitrates. Combination therapy with other PAH agents will not be covered for initial therapy. Combination therapy requests will be reviewed when monotherapy in each appropriate drug class (e.g. PDE inhibitor, ERA, prostacyclin) has failed and when supporting clinical literature is provided and is consistent with the American College of Cardiology consensus statement. Use in WHO group II, III, IV, or V.

6 Other Doses greater than 40mg daily. Verification of WHO Group I pulmonary hypertension due to idiopathic (IPAH), familial (FPAH), or associated pulmonary hypertension (APAH) by right sided catheterization identifying: resting mean pulmonary artery pressure (mpap) greater than 25 mmhg, and pulmonary capillary wedge pressure (PCWP) less than 15 mmhg. NYHA Class II or III at baseline, Baseline and current 6-minute walk test result, Vasoreactive testing is recommended for all PAH patients.(documentation with rationale must be provided for patients that have not been tested.) A limited number of patients with idiopathic, familial, or anorexigen-induced PAH who are vasoreactive positive may respond favorably to calcium channel blockers. Previous and current therapies. Extension of therapy is dependent upon documentation of clinical response including but not limited to: Improvement in exercise capacity (6-minute walk test) versus baseline, Improvement in NYHA class versus baseline, Lack of deterioration (e.g. no hospitalizations due to worsening PAH, no addition of new PAH therapy, no worsening of the functional class). Restricted to members who are greater than 18 years old Ordered by or consult with pulmonologist or cardiologist Initial authorization up to 3 months. Extended authorizations up to 6 months ADEMPAS All FDA-approved indications not otherwise exclude from Part D. will not be provided if any of the following are true: Use in pregnancy Co-administration of Adempas with a phosphodiesterase inhibitor, including specific PDE-5 inhibitors (i.e. sildenafil, tadalafil, vardenafil), nonspecific PDE inhibitors (i.e. theophylline or dipyridamole), nitrates or nitric oxide donors

7 Treatment of WHO Group 2 or 3 Total daily dose exceeds package labeling Combination therapy with other pulmonary arterial hypertension (PAH) medications for the treatment of CTEPH (Chronic Thromboembolic Pulmonary Hypertension) Presence of pulmonary veno-occlusive disease Severe hepatic impairment Combination therapy with other PAH agents for treatment of WHO Group 1 will not be covered for initial therapy If WHO Group 1, verification of pulmonary arterial hypertension [due to iodiopathic (IPAH), familial (FPAH), or associated with other conditions/disorders (APAH)] via right heart catheterization identifying: i. Resting mean pulmonary arterial pressure (mpap) > 25 mmhg AND ii. Pulmonary capillary wedge pressure (PCWP) less than or equal to 15 mmhg If WHO Group 4, verification of CTEPH diagnosis via ventilation-perfusion scanning and confirmatory pulmonary angiograpy AND Documentation of persistence/recurrence of CTEPH following surgical treatment OR Documentation that indicates patient is not considered a surgical candidate for the treatment of CTEPH WHO Functional Class II or III at baseline Baseline and current 6-minute walk test results If WHO Group 1, vasoreactive testing is recommended for all PAH patients (documentation with rationale must be provided for patients for whom this testing is not performed). A limited number of patients with idiopathic, familial, or anorexigen-induced PAH who are vasoreactive positive may respond favorably to calcium channel blockers. Documentation of previous and current therapies identifying outcome Documentation of ClCr greater than or equal to15 ml/min Extension of therapy will be dependent upon documentation of clinical response, including but not limited to: i. Improvement in exercise capacity (6-minute walk test) compared to baseline ii. Improvement in WHO Functional Class compared to baseline iii. Lack of deterioration (e.g. no hospitalizations due to worsening PAH or CTEPH, no addition of new PAH therapy, no worsening in Functional Class status) Adults age 18 and over. Ordered by or in consult with a cardiologist or pulmonologist

8 Other Other Initial authorization will be limited to 3 months. Extension up to 12 months Female patients of childbearing potential must be enrolled in the Adempas REMS program For WHO Group 1 (new starts only), documentation is required demonstrating failure or inadequate response to a trial of one of the following: o Orally administered PDE-5 inhibitor approved for the treatment of PAH (i.e. Adcirca or sildenafil) o Endothelin receptor antagonist-letairis, Tracleer, or Opsumit ALDURAZYME All FDA-approved indications not otherwise excluded from Part D The use of Aldurazyme will not be considered medically necessary for the following situations: Dose and frequency outside of package labeling Diagnosis of Hurler or Hurler-Scheie forms of MPS 1 OR diagnosis of Scheie form with moderate to severe symptoms. Baseline forced vital capacity (FVC) less that 80% and ongoing FVC showing improvement with treatment. Distance walked in 6 minutes (6 minute walk test, 6MWT) at baseline and showing improvement with treatment. Documented deficiency in iduronate-2-sulfatase enzyme activity confirming diagnosis Mucopolysaccharidosis I. Extension of therapy: documentation supports continued benefit based upon improvement in FVC and 6MWT. Remainder of contract year ALPHA1-ANTITRPYSIN REPLACEMENT THERAPY Drugs: Aralast, Galssia, Prolastin-C, Zemaira All FDA-approved indications not otherwise excluded from Part D

9 Other Not covered if any of the following situations are true: 1. PiMZ or PiMS phenotypes 2. Members identified with selective IgA deficiencies (IgA level less than 15mg/dl) that have known antibodies against IgA, since they may experience severe reactions 3. Dosing exceeding package labeling 4. Frequency exceeding once weekly infusions 5. Member not compliant with therapy. is not provided for doses exceeding package labeling Progressive clinically evident emphysema with a documented rate of decline in forced expiratory volume in 1 second (FEV1) post bronchodilation between 30 and 65% predicted except when: 1. Nearly normal pulmonary function if they experience a rapid decline in lung function (FEV1 greater than 120 ml/yr) OR 2. Poor lung function and currently receiving standard treatment. AAT serum level less than 11 µm or less than 80mg/dL. Rate of decline in forced expiratory volume in 1 second (FEV1) post bronchodilation between 30 and 65% predicted. Non-smoker OR evaluated for smoking cessation counseling. Phenotype is identified as PiZZ, PiZ(null) or Pi(null)(null) Continued therapy will be considered based on demonstrated response in slowing progression of lung function decline AND member compliance with all pharmacologic therapies Must be ordered or followed by a pulmonologist 3 months initial approval. Remainder of contract year for extension of therapy. AMPYRA All FDA-approved indications not otherwise excluded from Part D Prior history of seizure. Moderate or severe renal impairment defined as a creatinine clearance (CrCl) of 50 ml/min.

10 Not covered for prevention of symptoms. History of hypersensitivity to Ampyra or 4-aminopyridine Use with 4-aminopyridine or fampridine Neurology chart notes must be provided over the past 2 years including all radiologic reports supporting the diagnosis of multiple sclerosis. EDSS score between (disability severe enough to impair full daily activities) OR documentation supporting the disability within that range. Prior to dalfampridine treatment, three timed 25-foot walk (T25FW) results (at least one week apart) and within the past 60 days and between 8 and 45 seconds. (Assistive devices must be consistently used across pre-treatment walk tests and identified in the chart notes.) For continuation of therapy for second request: Two T25FW results at least 1 week between tests must be documented with at least a 30% improvement over the baseline average or a minimum of 10 seconds decrease with demonstrated improvement in disability Continuation thereafter: Three T25FW results from 3 separate visits (at least one week apart) identifying a continued 30% improvement over the fastest baseline maximum speed. EDSS score remains 6.5 or below, and/or has not progressed to constant bilateral assistance (canes, crutches, braces) required to walk about 20 meters without resting which precludes full daily activities. Individuals must maintain initial 30% improvement in T25FW at each 6 month interval. Approval of Ampyra will be discontinued if the T25FW declines. Must be18 years or older Restricted to neurologists Initial: 4 weeks. Continuation up to 6 month intervals

11 Other Currently receiving a stable dose of disease-modifying therapy for RRMS (or on a stable dose of disease-modifying therapy for all other forms of MS if appropriate) for at least 60 days (e.g. no changes in therapy for 60 days prior to start of dalfampridine treatment). ANTIDEPRESSANTS Drugs: Fetzima, Brintellix All FDA-approved indications not otherwise excluded from Part D. Use in combination with MAOIs or linezolid Uncontrolled narrow-angle glaucoma for Fetzima only Documentation identifying diagnosis of major depressive disorder Previous therapies tried Other Restricted to 18 years and older Up to 12 months Documentation must include failure or inadequate response to a minimum of a 6 week trial of two of the following: o Citalopram o Escitalopram o Fluoxetine o Paroxetine o Sertraline o Trazodone o Venlafaxine o Duloxetine APTIOM All FDA-approved indications not otherwise excluded from Part D. Hypersensitivity or severe reaction (ie. Stevens-Johnson Syndrome or drug reaction with eosinophilia and systemic symptoms) to Aptiom OR oxcarbazepine Severe hepatic impairment or significant liver injury

12 Other Diagnosis of partial-onset seizures Prior and current therapies Documentation that Aptiom will be used as an adjunctive treatment Restricted to 18 years of age and older. Restricted to neurologists. 12 months ARANESP All FDA-approved indications not otherwise excluded from Part D and MDS. Uncontrolled hypertension. Hgb less than 10g/dL at start of therapy, transferrin saturation greater than 20 percent, ferritin greater than 100ng/ml, anemia not requiring immediate correction, anemia related to other conditions must be treated prior to therapy, and rule out the following causes of anemia: -folate deficiency, -B-12 deficiency, -iron deficiency, -hemolysis, -bleeding, or bone marrow fibrosis, acute or chronic blood loss A. Anemia due to chronic renal failure (CRF): 1. serum creatinine greater than 3mg/dl, 2. crcl less than 60ml/min, or GFR less than 60 ml/min/1.73m2. B. Current (not for prophylaxis) anemia due to current myelosuppressive noncurative chemotherapy: 1. Diagnosis of solid tumor, multiple myeloma, lymphoma or lymphocytic leukemia. 2. For continuation of therapy: Transfusion records identifying a reduction during ESA treatment. HGB must be maintained at 10g/dL average over 2 months and currently receiving or

13 within 8 weeks of final chemo dose. C. MDS requirement: 1. Myelodysplasia with less than 10% blasts, 2. Pretreatment epoetin level 500 or less, 3. Not transfusion dependent, 4. Anemia causing symptoms such as shortness of breath or tachycardia. 5. Continuation: significant increase in HGB/HCT or decrease in transfusions. To continue therapy for anemia related to CRF and MDS: Hgb between 10 and 12 g/dl (average over 3 months) OR hgb is 1g/dL or greater then pre-treatment level but less than 12g/dL. Continuation of therapy for all diagnoses, HGB must remain less than 12 grams/dl, no epo-type resistance due to neutralizing antibodies, doses follow package label, AND when iron stores are adequate, HGB must show an increase by 1-2gm/dl after 6 weeks at max doses to achieve HGB of gm/dl OR for MDS or non-myeloid dx on the member has must demonstrate a 50% reduction in transfusion requirements OR if HGB has normalized at 10 gm/dl or greater. Restricted to 5 years and older for anemia due to chemo Restricted to oncologists, hematologists, and nephrologists. Initial 3 month approval, followed by approvals up to 6 months. Other Hct/Hgb have been stabilized on erythropoietin for at least 8 weeks. Must have bone marrow potentially responsive to erythropoietin therapy. Diagnosis of non-hodgkins lymphoma, or chronic lymphocytic leukemia requires documentation of failure of prior adequate trial of high dose corticosteroids and or chemotherapy. Aranesp may be covered under Medicare Part B or D depending upon the circumstances. When covered under Part B, Aranesp is not covered under Part D. Information may need to be submitted describing the use and setting of the drug to make the determination. ARCALYST All FDA-approved indications not otherwise excluded from Part D Dosing other than FDA approved dosing regimen; In combination with other interleukin-1 inhibitor; In combination with TNF inhibitor;

14 Genetic test identifying CIAS1 (Cold-Induced Autoinflammatory Syndrome 1) gene mutation (also known as NLRP3, NALP3 or PYPAF). Skin biopsy if performed. Serum amyloid. C-reactive protein. Documentation of symptoms affecting activities of daily living (ADLs) due to CAPS symptoms. Extension of therapy will be medically necessary if documentation identifies symptom improvement or disease stability. Other Must be 12 years of age or older. Rheumatologist or immunologist Initial 6 month approval followed by an additional 6 months if medically necessary AUBAGIO All FDA-approved indications not otherwise excluded from Part D. Liver Function Tests (LFTs) elevated greater than 3 times the upper limit of normal (ULN) Pregnancy Concurrent treatment with leflunomide Neurology notes must be provided over the past 2 years including all radiologic reports supporting the diagnosis of relapsing-remitting form of multiple sclerosis. EDSS score less than or equal to 6 (disability severe enough to impair full daily activities) OR documentation supporting the disability within that range. Documentation of two relapses within the previous 12 months. Normal CBC within 6 months prior to the start of therapy No clinically important infection or a history of chronic or recurrent infections. Transaminase and bilirubin levels within 6 months prior to initiation of Abagio Use of reliable contraception. No evidence of active, latent, or inadequately treated tuberculosis infection.

15 Other Documentation needed for evaluation of TB infection with skin test. For continuation of therapy: Chart notes identifying continued benefit with a decrease in number of relapses from baseline. EDSS score remains less than or equal to 6. Restricted to patients aged 18 years of age and older. Restricted to neurologists. Up to 6 months. Treatment plan does not include Aubagio in combination with other disease-modifying multiple sclerosis medications. Documented failure or significant side effects to a trial of one interferon beta product and a trial of Copaxone. Documented failure is defined as having two of the following: 1. Two relapses within the previous 12 months, 2. MRI identifying lesion progression while on therapy, 3. Documented worsening disability while on therapy. B VS D Drugs Abelcet Inj Ipratropium/Albuterol Neb Abilify Maintena Inj Irinotecan Inj Abraxane Inj Isolyte Inj Acetylcysteine Vial Istodax Inj Acyclovir Inj Ixempra Inj Adriamycin Inj Jevtana Inj Albuterol Neb Leucovorin Inj Alimta Inj Levalbuterol Neb Amifostine Inj Levocarnitine Inj* Amino acid Inj Levocarnitine Oral Soln* Aminosyn Inj Levocarnitine Tabs* Amphotericin B Inj Liposyn III Inj Anzemet Tabs Lupron Depot Inj Apokyn Inj Melphalan Inj Arranon Inj Mesna Inj Arzerra Inj Methotrexate Inj

16 Avastin Inj Miacalcin Inj* Azasan Tabs Mitomycin Inj Azathioprine Tabs Mitoxantrone Inj Azathioprine Inj Mustargen Inj Bicnu Inj Mycophenolate Mofetil Caps Bleomycin Inj Mycophenolate Mofetil Tabs Brovana Neb Myfortic Tabs Budesonide Neb Nebupent Neb Busulfex Inj Neoral Caps Calcitriol Caps* Neoral Oral Soln Calcitriol Inj* Nephramine Inj Calcitriol Soln* Neulasta Inj Nipent Inj Carboplatin Inj Normosol-R Inj Cellcept Susp Nulojix Inj Cellcept Inj Ondansetron Oral Soln Cisplatin Inj Ondansetron Tabs Cladribine Inj Ondansetron Odt Clinimix Inj Ontak Inj Cromolyn Neb Oxaliplatin Inj Cubicin Inj* Paclitaxel Inj Cyclophosphamide Tabs Pentam 300 Inj Cyclosporine Caps Pentostatin Inj Cyclosporine Inj Perforomist Neb Cyclosporine Modified Caps Plasma-Lyte Inj Cyclosporine Modified Oral Soln Premasol Inj Cytarabine Inj Procalamine Inj Dacarbazine Inj Prograf Inj Dacogen Inj Prosol Inj Daunorubicin (& cerubidine) Inj Pulmicort Amp Dexrazoxane Inj Pulmozyme Amp Docefrez Inj Rabavert Inj Docetaxel Inj Rapamune Oral Soln

17 Doxil Inj Rapamune Tabs Rituxan Inj Doxorubicin Inj Sandimmune Caps Eligard Inj Sandimmune Inj Elitek Inj Sandimmune Oral Soln Ellence Inj Sandostatin Lar Depot Inj Elspar Inj Simulect Inj Emend Caps Tacrolimus Caps Epirubicin Inj Thiotepa Inj Erbitux Inj Thymoglobulin Inj Etopophos Inj Tobi Neb Etoposide Inj Tobramycin Inj Faslodex IM Topotecan Inj Firmagon Inj Torisel Inj Fludarabine Inj Tranexamic Acid Inj Fluorouracil Inj Travasol Inj Freamine III Inj Treanda Inj Ganciclovir Inj Trelstar Depot Inj Gemcitabine Inj Trisenox Inj Gengraf Caps Trophamine Inj Gengraf Oral Soln Vancomycin Inj* Geodon IM Vectibix Inj Granisetron Tabs Velcade Inj Granisol Oral Soln Vidaza Inj Halaven Inj Vinblastine Inj Hectorol Caps* Hectorol Inj* Vincasar Pfs Inj Heparin Inj* Vincristine Inj Hepatamine Inj Vinorelbine Inj Hepatasol Inj Vivitrol Inj Herceptin Inj Xopenex Neb Idarubicin Inj Zanosar Inj Ifex Inj Zemplar Caps*

18 Ifosfamide Inj Zemplar Inj* Imovax Rabies Inj Zinecard Inj Intralipid Inj Zortress Tabs Invega Sustenna Inj Ionosol Inj Ipratropium Neb These drugs may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug(s) to make the determination. Other *Subject to review for ESRD patients receiving dialysis to determine if drug should be obtained by the dialysis center. BOSULIF All FDA-approved indications not otherwise excluded from Part D. Documentation provided supporting the diagnosis of chronic, accelerated or blast phase Ph+ chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy. The following documentation must be provided: Diagnosis of Philadelphia chromosome-positive CML by a bone marrow biopsy. ANC (Absolute Neutrophil Count) greater than or equal to 1000x10 6 /L. Platelets greater than or equal to 50,000x10 6 /L. No history of the T315I mutation. Liver transaminases less than or equal to 2.5 x ULN (upper limit of normal), Resistance or tolerance to previous treatment with Tasigna or Sprycel defined by one of

19 Other Other the following: 1. failure to achieve or maintain any hematologic improvement within four weeks. 2. failure to achieve a complete hematologic response (CHR) by 3 months, cytogenetic response by 6 months or major cytogenetic response (MCyR) by 12 months. 3. progression of disease after a previous cytogenetic or hematologic response. 4. presence of a genetic mutation in the BCR-ABL gene associated with imatinib resistance. Must be 18 years of age or older. Oncologist Remainder of the contract year A dose escalation to 600 mg once daily with food may be considered in patients who do not reach complete hematological response (CHR) by week 8 or a complete cytogenetic response (CCyR) by week 12, who did not have Grade 3 or higher adverse reactions, and who are currently taking 500 mg daily. CAPRELSA All FDA-approved indications not otherwise excluded from Part D vandetanib will not be covered in the following situations: Uncorrected hypocalcemia, hypokalemia, or hypomagnesemia. History of congenital long QT Syndrome. Imaging reports and biopsy confirming diagnosis of symptomatic or progressive medullary thyroid cancer that is non-operable locally advanced or metastatic disease Must be 18 years of age or older Oncologists or endocrinologists required to be certified with the restricted distribution program called Caprelsa REMS Program Remainder of the contract year Frequency and dose must follow the FDA approved package labeling.

20 Drugs known to prolong the QT interval should be avoided. Chronic Hepatitis C Treatment Drugs: Infergen, Pegasys, Peg-Intron, Rebetol, Ribapak, Ribasphere, ribavirin All FDA-approved indications not otherwise excluded from Part D a. contraindications for the use of ribavirin, including pregnancy, renal failure, hemoglobinopathies b. contraindications for the use of pegylated interferon, including autoimmune hepatitis, decompensated liver disease (i.e. hepatic encephalopathy, acsites, portal hypertension, jaundice, etc. c. Investigation/experimental or indications not supported by the compendia are excluded from coverage. Pegylated interferon (or interferon alfa-2b) in combo with ribavirin in treatment naïve patients may be medically necessary if the following criteria are met: Chronic, compensated hepatitis C as documented by a positive HCV antibody and quantitative HCV PCR level, AND elevated ALT levels (greater than 6 months), OR normal ALT levels in the presence of a liver biopsy consistent with chronic hepatitis C (at least moderate inflammation and/or fibrosis) i.e. Ishak stage greater than 3 or METAVIR stage greater than F2. No contraindications for the use of ribavirin or pegylated interferon. Enrolled and compliant with substance abuse or alcohol support programs if relevant. Pegylated interferon monotherapy may be medically necessary if: member meets the appropriate above, AND member has a contraindication for use of ribavirin. Liver biopsy results identifying genotype of Hepatitis C. For continuation of therapy at 12 weeks for genotypes 1 and 4 not co-infected with HIV: HCV RNA is undetectable or reduced by at least 2 log10. In addition peginterferon alfa-2a (Pegasys) may be considered medically necessary in patients with chronic hepatitis B who have compensated liver disease if:

21 HBsAg positive status for at least 6 months. AND Evidence of viral replication as documented by HBV DNA greater than 20,000 IU/ml. AND Evidence of liver inflammation as documented by 2 times the upper limit of normal of ALT. OR biopsy show moderate/severe necroinflammation or significant fibrosis. Hepatitis B continuation of therapy will be considered medically necessary based on demonstrated response supported by all of the following: Member is compliant with therapy as determined by review of prescription drug history. Normalization of serum ALT. Decrease in serum HBV DNA level by 2 log. Loss of HBeAG with or without detection of anti-hbe. Stable or improvement in liver histology defined as > 2 point decrease in Knodell necroinflammatory score with no worsening of the Knodell fibrosis score. (Using the Ishak Fibrosis Score improvement is defined as > 1 point decrease). Other Restricted to 18 years of age or older except when medication is FDA approved for use in pediatrics Initial approval weeks depending on genotype. 48 weeks if approved for monotherapy. Complete therapy weeks. 1. Members with genotypes 2 and 3 who are not co-infected with HIV will be authorized for a total of 24 weeks of therapy. 2. Members with genotypes 1 and 4 who are not co-infected with HIV: obtain coverage review at 12 weeks for an additional 12 to 36-week extension if HCV RNA is undetectable or reduced by at least 2 log 10 members who have not achieved a greater than or equal to 2 log10 reduction in HCV RNA level at week 12 are unlikely to achieve SVR and further therapy is not considered medically necessary those members who achieve an EVR but are still HCV RNA positive at 12 weeks should be re-tested for HCV RNA at 24 weeks a. if HCV RNA is undetectable at 24 weeks, an additional 24 weeks will be authorized b. members who have a detectable HCV RNA level at 24 weeks are unlikely

22 to achieve SVR and further therapy is not considered medically necessary 3. Members with genotypes 2 and 3 who are co-infected with HIV: members with detectable HCV RNA levels and CD4 count greater or equal to 200 cells/µl will be authorized for 48 weeks of therapy members with detectable HCV RNA levels and CD4 count 100 to 199 cells/µl and HIV RNA titer less than 5000 copies/ml will be authorized for 48 weeks of therapy 4. Members with genotypes 1 and 4 who are co-infected with HIV: A. members with detectable HCV RNA levels and CD4 count greater or equal to 200 cells/µl will be authorized for an initial 12 weeks of therapy B. members with detectable HCV RNA levels and CD4 count 100 to 199 cells/µl and HIV RNA titer less than 5000 copies/ml will be authorized for an initial 12 weeks of therapy. Obtain coverage review at 12 weeks for an additional 12 to 36-week extension if HCV RNA is undetectable or reduced by at least 2 log members who have not achieved a greater or equal to 2 log10 reduction in HCV RNA level at week 12 are unlikely to achieve SVR and further therapy is not considered medically necessary 2. those members who achieve an EVR but are still HCV RNA positive at 12 weeks should be re-tested for HCV RNA at 24 weeks a. if HCV RNA is undetectable at 24 weeks, an additional 24 weeks will be authorized b. members who have a detectable HCV RNA level at 24 weeks are unlikely to achieve SVR and further therapy is not considered medically necessary 5. Members with all genotypes who are not co-infected with HIV and have contraindication for use of ribavirin: obtain coverage review at 12 weeks for an additional 12 to 36-week extension if HCV RNA is undetectable or reduced by at least 2 log10 those members who achieve an EVR but are still HCV RNA positive at 12 weeks should be re-tested for HCV RNA at 24 weeks if HCV RNA is undetectable at 24 weeks, an additional 24 weeks will be authorized members who have a detectable HCV RNA level at 24 weeks are unlikely to achieve SVR

23 and further therapy is not considered medically necessary CIALIS FOR BPH All FDA-approved indications not otherwise excluded from Part D. Concomitant use of nitrate-based drugs (nitroglycerin) for heart conditions, Hypersensitivity reaction to Cialis or Adcirca, Creatinine clearance less than 30 ml/minute, Planned cataract surgery, Not covered solely for erectile dysfunction (ED) symptoms for standard plans, Status post radical prostatectomy, Cialis use solely to reduce PSA levels, Cialis strengths not FDA approved for use in BPH are not covered for standard plans, When Cialis is approved for BPH, no additional quantities are covered for ED, Use in combination therapy with other PDE-5 inhibitors, Quantities exceeding one tablet per day Cialis (tadalafil) 2.5mg or 5mg may be considered medically necessary when the following criteria are met: Enlarged prostate AND bothered by symptoms for at least 50 percent of the time over one month. Moderate to severe uncontrolled symptoms due to benign prostatic hyperplasia (BPH) with an American Urological Association Symptom Index (AUA-SI) > 8. (Symptoms include incomplete emptying, frequency, intermittency, urgency, weak stream, straining, nocturia.) Failure (defined less than 50% improvement of symptoms after 3 month trial), to two different combination therapies consisting of an alpha-blocker with 1. Anticholinergic, OR 2. 5-alpha-reductase-inhibitors, OR

24 3. has a contraindication or are intolerant to all appropriate drug classes used to treat BPH. For continued therapy: At least a 50% reduction in symptoms, AND Prescription history identifies compliance for BPH use Other 18 years old or older To urologists (or urology consult identified). Remainder of contract year CICLOPIROX NAIL All FDA-approved indications not otherwise excluded from Part D. Positive KOH test from a nail scraping or a positive pathogenic fungal culture documenting the presence of hyphae consistent with a susceptible dermatophyte (Trichophyton rubrum) No lunula involvement. Member is immunocompromised (e.g. HIV/AIDS, undergoing chemotherapy, transplant recipient) or has a history of peripheral vascular disease (e.g. diabetes), and/or ADLs are significantly compromised due to the infection. Documented contraindication to terbinafine OR prescription history/chart notes identify a significant drug interaction with terbinafine. Restricted to 12 years and older

25 Other Remainder of the contract year. CIMZIA FDA-approved indications not otherwise excluded from Part D. Documentation of evaluation for latent TB infection with a TB skin test. If TB infection is present, TB treatment started prior to therapy if indicated. Not at risk for an infection. Dosing does not exceed the FDA approved dosing schedule of 400mg every four weeks (for Crohn s Disease/RA) or 200mg every other week for RA except for the initial one time induction period. For Crohn s Disease: Significant clinical signs, symptoms, and radiologic reports documenting moderate to severely active disease such as frequent liquid stools greater than 4 times/day, presence of abdominal pain, presence of abdominal mass, extra-intestinal symptoms, need for opiates or diphenoxylate/atropine for diarrhea, anemia, and weight loss greater than 10%. For Rheumatoid Arthritis: Significant clinical signs, symptoms, and radiologic reports documenting moderate to severe active disease which includes documented synovitis and morning stiffness of significant duration to inhibit activities of daily living (ADLs), PE findings, number of swollen and/or tender joints. Other For RA and Crohn s disease: Documentation of response to Cimzia must be provided with each request for extension of therapy that identifies improvement in the clinical signs and symptoms described. No signs of a serious infection. Restricted to 18 years of age and older. Restricted to gastroenterologists, rheumatologists, immunologists, and colorectal surgeons Initial approval for 3 months with extensions of up to 6 months intervals. For Crohn s Disease: Documentation must include failure or inadequate response to a 12-week trial of Humira. OR if chart notes identify intolerance and/or clinical side effects and/or contraindication to Humira, a trial of one corticosteroid and one anti-inflammatory aminosalicylate is required.

26 Other For Rheumatoid Arthritis: Documentation must include failure or inadequate response to a 12-week trial of Humira or Enbrel, OR If chart notes identify intolerance, and/or clinical side effects, and/or contraindication to etanercept and adalimumab, the following must be documented; Failed to respond to an adequate trial of maximally tolerated dose of methotrexate. (Failure is defined as ACR response less than 20.) If the member has a contraindication or significant intolerance to methotrexate, the member must have failed to respond for an adequate trial to at least one other nonbiologic DMARDs at a maximally tolerated dose. COMETRIQ All FDA-approved indications not otherwise excluded from Part D. Diagnosis of progressive, metastatic medullary thyroid cancer. Radiologic report with evidence of actively progressive disease. Evidence that surgery is inappropriate. Baseline Liver Function Test (LFTs) levels are less than 3 times the upper limit of normal (ULN). Normal blood pressure. No invasive dental treatments 28 days prior to initiation. Not pregnant and using effective contraception during and up to 4 months after completion of therapy. Restricted to patients aged 18 years and older. Oncologist or endocrinologist Remainder of the contract year CYPROHEPTADINE FDA-approved indications not otherwise excluded from part-d. Cyproheptadine is not covered in the following situations:

27 narrow-angle glaucoma bladder neck obstruction pyloroduodenal obstruction symptomatic prostatic hyperplasia stenosing peptic ulcer concurrent use of MAO inhibitors use in debilitated elderly patients use in premature and term newborns breast-feeding use for appetite stimulation Diagnosis of migraine and documented: interference with daily routine despite acute treatment contraindication/failure/overuse or adverse effects of acute therapies Frequency of migraine attacks over past 6 months Other Extension of therapy requires documentation of: reduced attack frequency, severity, improvement Reduction in functional impairment Restricted to 2 years of age and older. Remainder of contract year Failure of a 2 month trial of one of the following: 1. Divalproex sodium 2. Topiramate Elderly patients with a history of falls or confusion may not be appropriate candidates for cyproheptadine. CYSTARAN All FDA-approved indications not otherwise excluded from Part D. Diagnosis of cystinosis with corneal crystal accumulation

28 Other Other Corneal cystine crystal score prior to start of therapy Ophthalmologist Up to 12 months For continuation of therapy documentation must be provided identifying either a lack of increase or reduction in the corneal cystine crystal score. DIFICID FDA-approved indications not otherwise excluded from Part D. Stool sample positive for clostridium difficile toxin Restricted to18 years of age and older Infectious Disease Specialists and gastroenterologists 10 days Failure of a day course of treatment of metronidazole and oral vancomycin. (Recurrence of c. difficile AFTER treatment with vancomycin or metronidazole does not meet the criteria for failure of vancomycin or metronidazole.) ENBREL All FDA-approved indications not otherwise excluded from Part D. No TB skin test result provided or TB infection has not been treated appropriately. Concomitant therapy with Rituxan and other DMARDs or biologic therapies other than methotrexate. Doses greater than 50mg/wk except for the initial 12 weeks for a diagnosis of psoriasis (one induction per lifetime). Members who have not had plaque psoriasis for more than one year (when prescribed for

29 psoriasis). Members who have a clinically important infection or a history of chronic or recurrent infections. Members who have another form of psoriasis other than chronic plaque psoriasis (e.g. guttate, erythrodermic or pustular psoriasis as the sole or predominant form). Dose escalation beyond the initial 12-week period, including during psoriasis flares, is not a covered benefit. For continuation of coverage: clinical failure or less than desired effect with Enbrel and no clinical rationale provided for continuation of therapy. For the diagnosis of RA: No prior trial with mtx unless documentation of acute, aggressive, very rapidly progressive intense inflammatory symmetrical arthritis dz. Members with contraindication to TNF use. Increase in dose without prior authorization Other For a diagnosis of psoriatic arthritis: chart notes indicating at least 3 tender joints AND at least 3 swollen joints on 2 separate occasions at least one month apart. For a diagnosis of rheumatoid arthritis: chart notes identifying persistent or recurrent symptoms with documented synovitis and morning stiffness of significant duration to inhibit activities of daily living. For a diagnosis of ankylosing spondylitis (AS): Documented significant clinical symptoms such as those identified in the Bath ankylosing spondylitis disease activity index (BASDAI) greater than 4 (0-10). For a diagnosis of psoriasis: For initial treatment, documentation of moderate to severe plaque psoriasis Polyarticular juvenile idiopathic arthritis covered for patients ages 2 and older. Over 18 years old for all other indications Restricted to rheumatologists or immunologists for members with arthropathies, dermatologists. Initial approval for 3 months with extensions of up to 6 months intervals. Must be screened for immunologic and infectious diseases. A. For the treatment of moderate to severe active adult rheumatoid arthritis with documented synovitis and morning stiffness of significant duration to inhibit activities of daily living (ADLs),

30 the following criteria must be met: Failed to respond to one or more nonbiologic DMARDs, one of which includes an adequate trial of a maximally tolerated dose of methotrexate (MTX) before Enbrel is covered. If the member has a contraindication or intolerance to methotrexate, the member must have failed to respond to an adequate trial of one other DMARD at a maximally tolerated dose. B. For the treatment of moderate to severe polyarticular-course juvenile chronic rheumatoid arthritis as indicated by 4 affected joints with limitation of motion, pain, tenderness or both, or persistent symptoms in oligoarticular disease, the following criteria must be met: Failed to respond to an adequate trial of at least one DMARD. C. For the treatment of moderate to severe psoriatic arthritis as indicated by three or more tender joints AND three or more swollen joints on two separate occasions at least one month apart, the following criteria must be met: Must have had an inadequate response to at least one NSAID, and Failed to respond to an adequate trial of at least 1 DMARD. D. For the treatment of plaque psoriasis the following criteria must be met: Members with severe psoriasis or those with functional disability and/or intractable recalcitrant psoriasis which interferes with ADLs due to the affected areas (e.g. hands and/or feet). Severe chronic plaque psoriasis or involvement of the palms, soles of feet and scalp for at least 1 yr. An appropriate treatment trial of at least one of the following agents was not effective: MTX, oral retinoids, cyclosporine. Continuation of therapy will require documentation of improved patient status in the monitoring parameters of all of the following: A significant improvement of clinical signs/symptoms of psoriasis (eg. itching, redness, scaling, psoriatic body surface area coverage) at three months. Quality of life assessments - improved per patient and/or physician. E. For the treatment of active moderate to severe ankylosing spondylitis the following criteria must be met: Failure during a 3 month period of at least one NSAID at maximum tolerated dose; AND;

31 Bath ankylosing spondylitis disease activity index (BASDAI) > 4 (0-10); AND Failure of a 4 month trial of sulfasalazine at maximum tolerated dose in patients with persistent peripheral arthritis; AND Patients with pure axial manifestations do not have to have a trial of DMARDs; AND Continued coverage will be based on significant symptom improvement and/or 2 units (on a 0-10 scale) of the BASDAI. EPOETIN All FDA-approved indications not otherwise excluded from Part D and MDS. Uncontrolled hypertension All diagnoses except surgical patients: Hgb less than 10g/dL at start of therapy, transferrin saturation more than 20%, ferritin more than 100ng/ml, anemia not requiring immediate correction, anemia related to other conditions must be treated prior to therapy, and rule out the following causes of anemia: -folate deficiency, -B-12 deficiency, -iron deficiency, -hemolysis, -bleeding, or bone marrow fibrosis, acute or chronic blood loss. A. Anemia due to chronic renal failure (CRF) criteria: 3. serum creatinine greater than 3mg/dl, 4. crcl less than 60ml/min, or GFR less than 60 ml/min/1.73m2. B. Current (not for prophylaxis) anemia due to current myelosuppressive noncurative chemotherapy: 3. Diagnosis of solid tumor, multiple myeloma, lymphoma or lymphocytic leukemia. 4. For continuation of therapy: Transfusion records identifying a reduction during ESA treatment. HGB must be maintained at 10g/dL average over 2 months and currently receiving or within 8 weeks of final chemo dose. C. Anemia related to AZT or other Nucleoside Reverse Transcriptase Inhibitors (NRTI) therapy for HIV patients: 1. Epoetin level 500 or less, 2. Anemia causing symptoms such as shortness of breath or tachycardia.

32 D. MDS requirement: 1. Myelodysplasia with less than 10% blasts, 2. Pretreatment epoetin level 500 or less, 3. Not transfusion dependent, 4. Anemia causing symptoms such as shortness of breath or tachycardia. 5. Continuation: significant increase in HGB/HCT or decrease in transfusions. E. Pre-surgical, HGB less than 13 grams/dl 1. Surgical procedure and date of surgery, 2. Elective, noncardiac, nonvascular surgery, 3. Not able to donate autologous blood, 4. Must be at high risk for perioperative transfusions with anticipated blood loss greater than 2 units, 5. Hgb between 10 and 13 g/dl and evaluation identifying anemia due to chronic disease, To continue therapy for anemia related to CRF, AZT, and MDS: Hgb between 10 and 12 g/dl (average over 3 months) OR hgb is 1g/dL or greater then pre-treatment level but less than 12g/dL. HGB must remain less than 12 grams/dl, no epo-type resistance due to neutralizing antibodies, doses follow package label, AND when iron stores are adequate, HGB must show an increase by 1-2gm/dl after 6 weeks at max doses to achieve HGB of gm/dl OR for MDS or non-myeloid dx on chemo the member must demonstrate a 50% reduction in transfusion requirements OR the HGB has normalized at 10 gm/dl or greater. Other ESAs restricted to 5 years and older for anemia due to chemo. Restricted to oncologists, hematologists, and nephrologists. Chemo/CRF/AZT/MDS - Initial 3 month approval, followed by approvals up to 6 months. Presurgical limited to1 month. Must have bone marrow potentially responsive to erythropoietin therapy. Diagnosis of non-hodgkins lymphoma, or chronic lymphocytic leukemia requires documentation of failure of prior adequate trial of high dose corticosteroids and or chemotherapy. Epogen may be covered under Medicare Part B or D depending upon the circumstances. When covered under Part B, Epogen is not covered under Part D. Information may need to be submitted describing the use and setting of the drug to make the determination. ERIVEDGE

33 Other Other FDA-approved indications not otherwise excluded from Part D. Documentation supporting diagnosis of: 1. Metastatic basal cell carcinoma (mbcc), OR 2. Locally advanced BCC (labcc) that has recurred following surgery and patient is not a candidate for radiation. For continuation of therapy the following criteria must be met: Absence of disease progression and for labcc at least one of the following: 1. Greater than or equal to 30 percent reduction in lesion size from baseline by radiographic assessment, 2. Greater than or equal to 30 percent reduction in sum of the longest diameter from baseline in externally visible dimension of target lesions, 3. Complete resolution of ulceration in all target lesions, 4. Complete response with no residual basal cell carcinoma on sampling tumor biopsy. Absence of disease progression (for labcc) as defined by the package label as any of the following: 1. Greater than or equal to 20 percent increase in the sum of the longest diameter from nadir in target lesions (either by radiography or by externally visible dimension). 2. New ulceration of target lesions persisting without evidence of healing for at least 2 weeks, 3. New lesions by radiographic assessment or physical examination, Progression of non-target lesions by Response Evaluation in Solid Tumors (RECIST). Restricted to 18 years old and older. Dermatologists, oncologists Remainder of contract year. Exjade may be considered medically necessary if all of the following criteria are met: Chronic iron overload due to blood transfusions or non-transfusion dependent thalassemia syndromes. Documentation of failure, contraindication, or significant intolerance to deferoxamine