Medicare Part D Drugs Requiring Prior Authorization

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

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

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 (300-3500 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

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.

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.

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

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

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

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.

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 5.0-6.0 (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

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

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

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 10-12 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;

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.

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

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

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*

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

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.

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:

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 12-48 weeks depending on genotype. 48 weeks if approved for monotherapy. Complete therapy 24-48 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

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 10 1. 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

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

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

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.

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:

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

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 10-14 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

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),

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;

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.

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 10-12 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

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

treatment. FYCOMPA All FDA-approved indications not otherwise excluded from Part D. Diagnosis of partial-onset seizures. Documentation that Fycompa will be used as adjunctive therapy. Not adequately controlled on a combination of 2 antiepileptic drugs (AEDs). Creatinine clearance > 30 ml/min. Not on dialysis. Baseline Liver Function Test (LFTs) levels must be less than 3 times the upper limit of normal (ULN). Restricted to 12 years of age or older. Restricted to neurologists. Remainder of the contract year. FABRY DISEASE Drug: Fabrazyme All FDA-approved indications not otherwise excluded from Part D. The use of Fabrazyme will not be considered medically necessary in the following situations: members who are carriers of the disease, doses or frequency exceeding FDA approved dosing regimen Mainz Severity Score Index (MSSI) or FOS Mainz Severity Score Index and/or globotriaosylceramide level confirming diagnosis. Treatment with Fabrazyme will be considered medically necessary when the following criteria are

met: The diagnosis of α-galactosidase deficiency has been confirmed which is supported by at least one of the following: 1. pain in the extremities 2. hypohidrosis 3. corneal opacities 4. kidney dysfunction 5. cardiac dysfunction 6. cerebrovascular disorders. Other Continued coverage criteria: appropriate doses and absence of disease progression. Restricted to members who are greater than 8 years old. Remainder of the contract year FENTANYL All FDA-approved indications not otherwise excluded from Part D. Increased strength and/or frequency other than approved dosing are excluded. Treatment of acute or postoperative pain. Combination use of short-acting fentanyl products. Monotherapy Diagnosis of cancer. Documentation identifies that use is for breakthrough cancer pain. For extension of therapy: documentation provided must identify: 1. continued benefit from therapy, AND 2. dosing of long-acting product has been evaluated and is at the maximum tolerated dose Transmucosal solid dosage form restricted to 16 and older. All other forms restricted to18 years and older.

Other Restricted to oncologists and pain management. Initial 3 months approval followed by 6-month intervals. Fentanyl oral transmucosal or buccal solid dosage forms require prior authorization (for all quantities) and may be considered medically necessary when all of the following criteria are met: 1. Immediate-release (short-acting) opioid drugs are ineffective supported by documentation of excessive rescue doses used. 2. Already receiving and compliant but tolerant to a chronic pain around-the-clock extended release formulation. (Opioid tolerant patients are those who are taking around-the-clock medicine consisting of at least 60mg oral morphine, 30mg oral oxycodone, 8mg of oral hydromorphone, or an equianalgesic dose of another opioid daily for one week or longer.) FIRAZYR All FDA-approved indications not otherwise excluded from Part D. Documentation of the following must be provided: 1. Laboratory data confirming diagnosis of hereditary angioedema (HAE): C1-INH activity and serum complement factor 4 level below the reference range, AND Serum C1q level within normal reference range, AND Family history of HAE, if any. 2. Medications that may trigger or worsen angioedema have been evaluated and discontinued if appropriate. (Examples of these are estrogen contraceptives, hormone replacement therapy, and ACE-Inhibitors.) 3. Prescribed for acute attacks (not for prophylaxis) and not for stock for future attacks (i.e. not stockpiling). 4. Member is not currently receiving medications that may trigger or worsen angioedema. For continued use, the following documentation must be identified following Firazyr use: diminished symptoms, decreased severity of attack, reduced duration of attacks, and decreased hospitalizations when compared to previous therapies. Please provide date of last attack. Must be greater than 18 years of age. Allergist, immunologist, or hematologist

Other Three month intervals Not to be used in combination with Kalbitor or Berinert. Triggers (e.g. surgery, major dental work, etc.) of attacks have been prophylactically treated appropriately and severe HAE attacks persist OR contraindication (such as pregnancy or lactatin) or severe intolerance to attenuated androgens (e.g. danazol). Member has been compliant with preventative therapy, therapy has been optimized, and severe HAE attacks persist. Note: Severe attacks are defined as attacks that compromise the airway, compromise activities of daily living for at least 5 days per month, or last more than 72 hours. GAUCHERS DISEASE Drugs: Cerezyme, Vpriv, Zavesca All FDA-approved indications not otherwise excluded from Part D. The use of these agents will not be considered medically necessary in the following situations: members with Type 2 or Type 3 Gaucher's Disease. asymptomatic Type 1 disease. carriers of Gaucher's Disease. combination use of any of these agents. Miglustat is not covered for severe disease (severe disease defined as a hemoglobin concentration below 9 g/dl or a platelet count below 50 x 10 9 /L or active bone disease). Miglustat is not covered for diagnosis other than Type 1 Gaucher Disease. Miglustat is not covered if there is no documented allergy, hypersensitivity, or poor venous access to enzyme replacement therapy. These agents are not covered for any diagnosis other than Gaucher's disease. medical information for imiglucerase, velaglucerase alfa, and alglucerase is as follows: diagnosis of Gaucher's Disease Type 1 confirmed by biochemical assay AND member is experiencing symptomatic manifestations of the disease as evidenced by one of the following: 1. documented skeletal disease (osteopenia, avascular osteosclerosis, marrow infiltration, lytic lesions); 2. anemia (Hgb less than or equal to 11.5gm/dL females, Hgb less than or equal to

12.5gm/dL males or 1.0gm/dL below lower limit of normal for age and sex); 3. thrombocytopenia (platelet count less than or equal to 120,000/mm3) 4. hepatomegaly or splenomegaly. medical information for miglustat is as follows: diagnosis of Gaucher's Disease Type 1 confirmed by biochemical assay AND member is experiencing symptomatic manifestations of the disease AND member has a contraindication for use of enzyme replacement therapy such as allergy, hypersensitivity reaction or poor venous access. Other Imiglucerase and alglucerase are restricted to greater than 2 years old. Miglustat is restricted to ages greater than 18 years and less than 65 years old. Velaglucerase alfa is restricted to 4 years of age and greater GILENYA FDA-approved indications not otherwise excluded from Part D Mycocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure occurring within the last 6 months History or presence of Mobitz Type II 2 nd degree or 3 rd degree AV block or sick sinus syndrome, unless patient has a pacemaker Baseline QTc interval greater than or equal to 500ms Treatment with Class Ia or Class III anti-arrhythmic drugs Diagnosis of relapsing-remitting form of multiple sclerosis and: Neurology chart notes must be provided over the past 2 years including all radiologic reports. EDSS (Expanded Disability Status Scale) 5.5 or less OR documentation supporting the disability is 5.5.or less.

Inability to inject medication due to physical or mental conditions will be considered on a case-by-case basis. Chart notes describing the physical condition or circumstances and severity of symptoms observed to establish the diagnosis of needle phobia must be submitted if used as justification for the oral product. Drug regimen not to include combination use of Gilenya with glatiramer, interferon beta, or natalizumab (Tysabri). Gilenya dosing within the FDA approved package label. For continuation of therapy for up to 6 months: 1. Continued benefit with a decrease in number of relapses. 2. EDSS score remains 5.5 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. Other Greater than 18 years old Neurologists Up to 6 months Documented failure or significant side effects to a trial of one interferon beta product and a trial of glatiramer (Copaxone). Documented failure defined as: At least 2 relapses within the past 12 months, AND MRI identifying lesion progression. GILOTRIF All FDA-approved indication not otherwise excluded from Part D. Dosing which exceeds package labeling Patients who experience any of the following while receiving therapy: Life-threatening bullous, blistering, exfoliative skin lesions Confirmed interstitial lung disease Severe drug-induced hepatic impairment Persistent ulcerative keratitis Symptomatic left ventricular dysfunction

Other Severe or intolerable adverse reaction occurring at a dose of 20 mg per day Interstitial lung disease Diagnosis and documentation of metastatic non-small cell lung cancer AND Documentation of tumor epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21(L858R) substitution mutation as detected by an FDA-approved test Extensions available for patients without documented: Disease progression Tolerability issues 18 years of age and older. Oncologist 12 months GRASTEK All FDA-approved indications not otherwise excluded from Part D. Severe, unstable or uncontrolled asthma History of esinophilic esophagitis History of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy Documented allergic rhinitis with or without conjunctivitis Positive skin test or in vitro testing for pollen-specific IgE antibodies for the specific allergen extract OR a strongly cross-reactive allergen to the following: Pollen-specific IgE antibodies-timothy Grass Strongly Cross-Reactive Allergen-members of the pooideae sub family (includes but not limited to orchard, fescue, ryegrass, June, and sweet vernal) Allergen must be identified as the cause of the major clinical sympotms 5 through 65 years of age

Other Initial 4 months, extensions up to 6 months Treatment must be initiated at least 12 before expected pollen season based on geographic location (start of season usually late April in Northeast) Therapy should be initiated in January/February in Northeast Documentation must identify failure of at least two of the following treatments: Intranasal corticosteroids Oral antihistamine Oral leukotriene receptor antagonist For continuation of treatment, the benefits of treatment (decrease of symptoms, increase tolerance to grass pollen) must be documented in the member s chart along with medication compliance based on prescription claims review Extension requests for ongoing therapy after end of allergen season-prescription claims review must show compliance with each renewal. Patients that were on active therapy daily for 3 consecutive years must wait at least 1 year until coverage may be reinitiated, unless patients experience a documented severe increase in symptoms compared to the past 3 years Will not be covered if receiving subcutaneous allergen immunotherapy GROWTH HORMONE THERAPY Drugs: Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Tev-Tropin All FDA-approved indications not otherwise excluded from Part D. GH will not be covered for the following: An active malignant condition. If GHD results from an intracranial tumor, absence of tumor growth or tumor recurrence must be documented for at least 6 months prior to therapy initiation; GH is not indicated for treatment of wounds or burns; PWS with 1 or more risk factors including severe obesity, history of respiratory impairment or sleep apnea, or unidentified respiratory infection; Catabolic illnesses or to improve muscle strength or exercise tolerability; Members w/ proliferative or pre-proliferative diabetic retinopathy;

Current or predicted height without GH therapy greater than or equal to mid-parental height; Non-euthyroid state. Extension of therapy for children for GHD will not be covered if no further growth or midparental ht is achieved OR epiphyseal fusion is complete OR bone age indicates growth is complete OR renal transplant has occurred (for CRI) OR growth rate of 2cm/yr has not occurred Growth Hormone Deficiency (GHD): height must be beneath the 3rd percentile of normal or 2 standard deviations (SD) below the 50th percentile AND growth velocity must be less than the 10th percentile of normal or greater than 2 SD below the mean AND lack of response to two separate GH provocative tests B. Children with Turners Syndrome or Growth Retardation due to Chronic Renal Insufficiency (CRI): present height must be below the 5th percentile of normal OR height greater than 2 SD below the mid-parental height prediction or growth velocity less than 25% for bone age and bone age less than 14 years. C. Children w/ Prader-Willi Syndrome (PWS): Severe hypotonia in neonates, followed by hyperphagia and obesity. D. Idiopathic Short Stature: in the presence of growth hormone deficiency AND with open growth plates AND height less than the 3rd percentile AND growth velocity less than the 10th percentile. Continued therapy for children for all growth hormone deficiency diagnoses require: height velocity more than 2 cm over one year of therapy year AND open growth plates AND bone age is less than 14 years in girls or 16 years in boys AND Mid-parental adult height has not been achieved Per package label

Other Restricted to endocrinologists and nephrologists Remainder of contract year. HUMIRA FDA-approved indications not otherwise excluded from Part D. Negative for TB or treated if positive. Chronic plaque psoriasis as the sole or predominant form (if treating for psoriasis) and not used concomitantly with Rituxan or biologic therapies other than MTX. Frequency/dose not greater than 40mg every other week except for the initial 2-week induction period for Crohn's Disease or Ulcerative colitis and plaque psoriasis OR for rheumatoid arthritis after a failure of every other week dosing. For arthritis: Prior trial with mtx unless documentation of acute, aggressive, very rapidly progressive intense inflammatory symmetrical arthritis disease. Chart notes including physical exam findings, number of swollen or tender joints, duration of morning stiffness, other symptoms, requested dose and frequency and expected duration of therapy. For Crohn's disease and Ulcerative colitis: Documentation must include response to or an intolerance to conventional therapy. Assessment of growth, nutrition, therapy-induced complications and functional ability must also be documented as well as clinical signs and symptoms such as frequency of stools, severity grade and frequency of abdominal pain, presence of an abdominal mass, extra-intestinal symptoms, prescription history and current and past weights. Radiologic results. For psoriasis: %BSA involvement current and with extension of therapy, previous and current therapies and responses, quality of life assessments at baseline and current. For a diagnosis of AS, chart notes including status of back pain and spinal mobility. Restricted to 18 years of age and older, except for Juvenile Rheumatoid Arthritis (JRA) which is restricted to 4 years and older. Restricted to rheumatologists or immunologists for members with arthropathies, dermatologists, gastroenterologists, and colorectal surgeons

Other Initial approval for 3 months with extensions of up to 6 months intervals. Must be screened for immunologic and infectious diseases including hepatitis and TB. For the treatment of Crohn's disease and Ulcerative colitis, Humira may be considered medically necessary when all of the following are met: intolerance to two different drug classes (e.g. corticosteroids and immunomodulators such as AZA or 6-MP). clinical signs and symptoms such as frequent liquid stools greater than 4 times/day, presence of abdominal pain, need for opiates or diphenoxylate/atropine for diarrhea, anemia, and weight loss greater than 10%. For the treatment of moderate to severe active adult Rheumatoid Arthritis (RA) as defined by persistent or recurrent symptoms with documented synovitis and morning stiffness of significant duration to inhibit activities of daily living (ADLs), the following criteria must be met: Failed to respond to one or more nonbiologic disease-modifying anti-rheumatic drugs (DMARDs), one of which includes an adequate trial of maximally tolerated dose of MTX. If the member has a contraindication or intolerance to MTX, the member must have failed to respond to an adequate trial of 1 other DMARD at a maximally tolerated dose for at least 3 months. 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; 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 documentation of significant symptom improvement and/or 2 units (on a 0-10 scale) improvement in the BASDAI score. For the treatment of moderate to severe Polyarticular-course juvenile chronic Rheumatoid Arthritis as indicated by 5 swollen joints and three or more 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. For the treatment of moderate to severe Psoriatic Arthritis as indicated by 3 or more tender joints AND 3 or more swollen joints on 2 separate occasions at least 1 month apart, the following criteria must be met: Must have had an inadequate response to one Non Steroidal Anti-inflammatory Drug (NSAID), and failed to respond to an adequate trial of at least one DMARD. For the treatment of Plaque Psoriasis the following criteria must be met: Moderate to severe chronic plaque psoriasis or involvement of the palms, soles of feet and scalp for at least 1 year. An appropriate trial was not effective or contraindicated with 2 of the following: MTX, oral retinoids, cyclosporine. And who have functional impairment related to symptomatology of psoriasis. For psoriasis: Continuation of therapy will be allowed for up to 6 months and 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. ICLUSIG All FDA-approved indications not otherwise excluded from Part D. Documentation provided supporting: Diagnosis of chronic phase, accelerated phase or blast phase chronic myelogenous leukemia (CML) OR Philadelphia chromosome positive acute lymphoblastic leukemia (Ph + ALL). Resistant or intolerant to prior tyrosine kinase inhibitor therapy after failing to achieve a complete hematologic response (by 3 months), a minor cytogenetic response (by 6 months), or a major cytogenetic response (by 12 months). Patients who experienced a loss of response or development of a kinase domain mutation in the absence of a complete cytogenetic response or progression to accelerated phase chronic myelogenous leukemia or blast-phase chronic myelogenous leukemia at any time on prior TKI therapy.

Other Other ANC >1000 mm 3 and platelet count >50,000 mm 3. Baseline Liver Function Test (LFTs) levels must be less than 3 times the upper limit of normal (ULN) AND a bilirubin elevation less than 2 times the upper limit of normal. Less than grade 4 pancreatitis. Stable blood pressure. Patients with a history or pancreatitis or alcohol abuse need to have a baseline serum lipase < 1.5 X ULN and no abdominal symptoms. No concurrent therapy with strong CYP3A inducers such as carbamazepine, phenytoin, rifampin, and St. John s Wort or drugs which elevate gastric ph such as proton pump inhibitors, H2 blockers, or antacids Restricted to patients 18 years of age or older. Restricted to oncologists. Remainder of contract year. Pregnancy should be avoided while on medication due to risk of fetal harm. IMBRUVICA All FDA-approved indications not otherwise excluded from Part D. Co-administration with strong and moderate CYP3A inhibitors Documentation including workup and biopsy results identifying diagnosis of Mantle Cell Lymphoma Previous therapies CBC with differential including platelet count Restricted to 18 years of age and older. Oncologists Up to 12 months Documentation must identify previous failure with at least one therapy used for the treatment of Mantle Cell Lymphoma supported by the NCCN Guidelines IMMUNOGLOBIN THERAPY (IVIG) Drugs: Carimune, Gamastan S/D, Gammagard, Gammaplex, Gamunex-C, Privgen

All FDA-approved indications not otherwise excluded from Part D AND the following for intravenous form only: Chronic inflammatory demyelinating polyneuropathy, Idiopathic Thrombocytopenia Purpura (ITP), Bone marrow transplant patients at risk for septicemia, Interstitial pneumonia, Idiopathic infections, Graft vs. host disease (GVHD) or cytomeglovirus (CMV), HIV infected children B-cell chronic lymphatic leukemia (CLL), Guillian-Barre syndrome, Relapsing-remitting MS, Myasthenia gravis with acute severe decompensation Kawasaki disease, Autoimmune mucocutaneous blistering diseases, Recurrent severe infection with documented severe deficiency or absence of IgG subclass, Clinically significant functional deficiency of humoral immunity, Solid organ transplantation. Acute and chronic inflammatory demyelinating polyradiculoneuropathy. ITP in pregnancy. Humoral or vascular allograft rejection. Hemolytic uremic syndrome. Polymyositis and dermatomyositis. Sensitized renal cell transplant patients for IVIG (intravenous only) will be considered when the following is documented: Myasthenia gravis with acute severe decompensation when 2 other standard treatments such as pyridostigmine and corticosteroids have failed. HIV infected children with CD-4 counts greater than 200u/L, Recurrent severe infection with severe deficiency or absence of IgG subclass, Clinically significant functional deficiency of humoral immunity as evidenced by documented failure to produce antibodies to specific antigens and a history of recurrent

infections, Solid organ transplantation if the transplant was for a MVP covered indication and the patient was sero-negative for CMV before transplantation and the donor is sero-positive. ITP in pregnancy if: pregnant who have previously delivered infants with autoimmune thrombocytopenia, have platelet counts less than 75,000/mm3 during the current pregnancy, or past history of splenectomy. Polymyositis and dermatomyositis. The patient must be unresponsive or intolerant to steroids and immunosuppressants. The IVIG will be used to decrease the doses of other drugs that are needed for treatment. Must show that there was a measurable response within 6 months of use of IVIG, or its use will no longer be covered., Sensitized renal cell transplant patients: IVIG and/or plasmapheresis are used in several sequential treatments pre or post-transplant to help with patients sensitized to living or cadaveric donors. This attempts to modify panel reactive antibody level (PRA), a cross match result, with prevention and/or treatment of organ rejection). Kawasaki use of IVIG within 7 days of fever. Patients with hypogammaglobulinemia and B-cell chronic lymphocytic leukemia undergoing allogeneic bone marrow transplantation and at risk for septicemia. Autoimmune mucocutaneous blistering diseases, interstitial pneumonia in post-bmt patients - failure of corticosteroids. Idiopathic infections: 3 hospitalizations within the past 12 months due to infections AND low IgG Graft vs. host disease (GVHD) or cytomeglovirus (CMV): for use in BMT patients Guillian-Barre syndrome, Hemolytic uremic syndrome failure of plasma exchange Relapsing-remitting MS after failure of methylprednisolone and Copaxone or interferon. Polyradiculoneuropathy failure of two therapies such as corticosteroids and azathioprine or methotrexate. ITP in pregnancy: IVIG can be used first line with corticosteroids. Humoral or vascular allograft rejection: IVIG can be used first line. Other Per the package label Initial approval 3 months with extension of 6-month intervals. IVIG may be covered under Medicare Part B or D depending upon the circumstances. When

covered under Part B, IVIG is not covered under Part D. Information may need to be submitted describing the use and setting of the drug to make the determination. INCIVEK FDA-approved indications not otherwise excluded from Part D. 1. Contraindications for the use of ribavirin, and/or pegylated interferon, 2. Pregnant women, and men whose female partners are pregnant, 3. Co-administration with drugs that: 1. are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (e.g. alfuzosin, ergot derivatives, cisapride, lovastatin, simvastatin, sildenafil or tadalafil when used for pulmonary arterial hypertension, other PDE-5 inhibitors if use daily). 2. strongly induce CYP3A which may lead to lower exposure and loss of efficacy of Incivek (e.g. rifampin, St. John s wort). 3. Doses exceeding or less than 750mg three times daily 4. Development of severe skin reaction while receiving Incivek Negative status for HIV and Hepatitis B, No previous history of failure of a protease inhibitor (e.g. Incivek, Victrelis) or more than one course of treatment per lifetime without supporting clinical documentation. Documentation of: Chronic HCV genotype 1 infection AND one of the following: 1. Treatment naïve patients with at least one other risk factor for poor prognosis including: moderate inflammation and/or fibrosis (i.e. Ishak stage greater than 3 or METAVIR stage greater than F2, Diabetes or African heritage, OR 2. Prior relapse (an undetectable HCV RNA level at the end of treatment, with a detectable HCV RNA level within 12 weeks of treatment follow-up) to prior peginterferon-ribavirin therapy, OR 3. Partial response (a decrease in the HCV RNA level of at least 2 log10 IU/mL by week 12 but with a detectable HCV RNA level during the therapy period) to prior peginterferonribavirin therapy, OR 4. Null responders (less than 2 log10 IU/mL reduction in HCV RNA at week 12) to prior peginterferon-ribavirin therapy.

Other Other For continuation of therapy: viral load less than 1000 IU/mL at 4 weeks Restricted to 18 years of age and older. Infectious disease physician, gastroenterologist or hepatologist 4 weeks initial, up to 8 additional weeks second approval. Concurrent administration of Pegylated Interferon AND ribavirin is required (must meet criteria in Hepatitis C Treatment, Chronic policy.) INLYTA FDA-approved indications not otherwise excluded from Part D. Untreated brain metastasis, Recent active gastrointestinal bleeding. Documentation of: Relapse or stage IV clear cell renal cancer carcinoma, and Medically or surgically unresectable Must be 18 years of age and older. Oncologists AND nephrologists. Remainder of contract year Failure/relapse or contraindication to Votrient (pazopanib). INTRAVENOUS (IV) VS. ORAL Drugs: Aloxi inj, Anzemet inj, Avelox inj, ciprofloxacin inj, granisetron inj, levofloxacin inj, Nexium inj, ondansetron inj, ranitidine inj All FDA-approved indications not otherwise excluded from Part D. Medical information identifying that the patient was unable to tolerate the oral preparation prior to

Other initiation of the intravenous form of the medication. Medical information must include ONE of the following: For any medication under this prior authorization group including anti-emetics: 1. patient suffers from esophageal cancer and cannot swallow, 2. patient has had recent head and neck irradiation and has severe mucositis and cannot swallow, 3. patient is already suffering from clinically significant severe nausea and vomiting when the medication is needed, 4. Radiologic reports indicating non-functional gastrointestinal tract (e.g. short gut syndrome). 5. Chart notes identifying the rationale for using an intravenous medication, when there is an equivalent oral medication available for all other instances will be reviewed on a case-bycase when scientific studies are provided identifying that only the intravenous version is appropriate. For anti-emetics: one of the above criteria (1-5) OR one criteria below (6 or 7) needs to be met: 6. An appropriate oral anti-emetic drug failed to prevent chemotherapy induced nausea and vomiting at the maximum dosage and frequency. The intravenous formulation must be the same as the failed oral drug. If the IV formulation requested is of a different drug, then the oral formulation of that different drug must be shown to be ineffective or contraindicated before the IV form is covered. 7. Scientific studies of chemotherapy regimens identifying only the IV form of the anti-emetic drug where proven to be effective. However if the studies show that both oral and IV forms are effective, then the oral drug would need to be tried. Restricted to FDA approved package labeling age restrictions. Initial 3-month trial to evaluate outcomes. Approval in 6-month intervals thereafter. 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. The oral formulation of Emend must be tried before using the IV formulation even if the patient develops CINV after administration of an oral anti-emetic (other than Emend). Only covered for FDA approved indications not otherwise excluded from Part D For continuation of the injectable version, chart notes must identify a better response than the

oral product. Other ITRACONAZOLE All FDA-approved indications not otherwise excluded from Part D. Combination therapy with more than one antifungal agent (terbinafine, itraconazole, ciclopirox) will not be covered. For onychomycosis: Positive KOH test from a nail scraping or a positive pathogenic fungal culture documenting the presence of hyphae consistent with susceptible dermatophytes (tinea unguium). Member is non-immunocompromised (e.g. negative HIV status, not undergoing chemotherapy, not a transplant recipient). Identify location of onychomycosis (e.g. fingernails and/or toenails). For lung fungal infections, start date of itraconazole and: Fungal cultures identifying one of the following 1. Blastomycosis 2. Histoplasmosis 3. Aspergillosis Restricted to18 years old and older. Onychomycosis daily x 12 weeks or 2 treatment pulses x 6weeks.Lung infections 12 months. For onychomycosis infection: failure or contraindication to terbinafine. For aspergillosis fungal infection: failure or contraindication to amphotericin B therapy. JAKAFI All FDA-approved indications not otherwise excluded from Part D. Platelet count less than 100 X 10 to the 9th/L at start of therapy.platelet count less than 50 X 10 to the 9th/L.Polycythemia vera, chronic myelogenous leukemia, myelodysplastic syndrome, or other myeloid neoplasm.

Documentation provided supporting the diagnosis of intermediate-2 (2 prognostic factors) or highrisk (3 or more prognostic factors) myelofibrosis including primary myelofibrosis, postpolycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis. The following documentation must be provided: Prominent teardrops on peripheral smear. Normocellular or hypocellular marrow with moderate to marked fibrosis. Absence of the Philadelphia chromosome or the BCR/ABL translocation. Palpable spenomegaly at least 5 cm below the costal margin. Demonstration of JAK2V617F or other clonal marker; OR in the absence of a clonal marker, no evidence of bone marrow fibrosis caused by an underlying inflammatory disease or another neoplastic disease. (WHO criteria). Baseline Modified Myelofibrosis Symptom Assessment Form (mmfsaf) total symptom score. The mmfsaf total symptom score is comprised of the following symptoms: night sweats, itchiness, abdominal pain, pain under the ribs on the left side, feeling of fullness, and bone/muscle pain. Prognostic factors based on the International Working Group Consensus : greater than 65 years old, White blood cell count greater than 25 x 10 9 /L, Hemoglobin less than 10 g/dl, Peripheral blood blast greater than or equal to 1 percent, Positive for constitutional symptoms (e.g. fatigue, weight loss, night sweats, and bone pain). Other For continuation of therapy documentation provided must identify a 35% reduction in spleen size and decrease in symptoms vs baseline MFSAF total symptom score. Restricted to 18 years old and older Restricted to Oncologists Remainder of the contract year. JUXTAPID

All FDA-approved indications not otherwise excluded from Part D. Pregnancy Concomitant use with strong or moderate CYP3A4 inhibitors Moderate or severe hepatic impairment or active liver disease including unexplained persistent abnormal liver function tests Dose and frequency outside of package labeling. Diagnosis of homozygous familial hypercholesterolemia Baseline ALT, AST, alkaline phosphatase, and total bilirubin Baseline cholesterol panel That a low-fat diet supplying less than 20% of energy from fat has been initiated Continuation of therapy will be considered if there is a 30% decrease in LDL cholesterol from baseline Other Restricted to patients aged 18 years and older. Restricted to cardiologists Initial approval- 6 months Extensions-remainder of contract year Failure to achieve goal LDL-C based on the National Cholesterol Education Program (NCEP) ATP III guidelines despite a 6 month trial with LDL apheresis (if available in the member s geographic location) and a combination of two of the following: 1. High-dose statin 2. Bile acid sequestrant 3. Zetia (ezetimibe) KADCYLA All FDA-approved indications not otherwise excluded from Part D. Documentation of either of the following: Received prior therapy for HER2-positive metastatic disease (trastuzumab and a taxane, separately or in combination), or Developed disease recurrence during or within 6 months of completing adjuvant therapy

Other Diagnosis of HER2-positive breast cancer using either an FDA approved IHC assay or an FISH assay. Baseline LFT s less than or equal to 2.5 times upper limit of normal and bilirubin level less than times1.5 upper limit of normal prior to initiation of Kadcyla. Left ventricular ejection fraction greater than 50% prior to initiation of Kadcyla Platelet count greater than 100,000/mm 3 prior to initiation of Kadcyla Restricted to patients aged 18 years and older. Saftey and efficacy not established in pediatric patients Oncologists Remainder of the contract year Pregnancy and breastfeeding should be avoided. Pregnant women should enroll in the MotHER Pregnancy Registry. KALYDECO FDA-approved indications not otherwise excluded from Part D. Documentation of: Diagnosis of cystic fibrosis (CF). G551D co-mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene identified by an FDA cleared CF mutation test. FEV1 40% predicted. Maximized on appropriate first line treatments (e.g. inhaled tobramycin, oral azithromycin, dornase alfa, hypertonic saline) with continued symptoms and exacerbations. Liver function tests less than 3 times upper limit of normal (ULN). For continuation of therapy, documentation provided must identify continued benefit supported by the following: Improvement in lung function as determined by the mean absolute change from baseline in percent predicted pre-dose FEV1, Decrease in pulmonary exacerbations. [A pulmonary exacerbation is defined as a change in antibiotic therapy (IV, inhaled, or oral) as a result of 4 or more of 12 pre-specified sino-

pulmonary signs/symptoms], Improvement in cystic fibrosis symptoms including relevant respiratory symptoms such as cough, sputum production, and difficulty breathing, Liver function tests less than 5 times upper limit of normal (ULN). Must be 6 years of age and older. Pulmonologist Remainder of contract year. Other More than 60 tablets per 30 days are not covered, Kalydeco is not effective in patients with CF who are homozygous for the F508del mutation in the CFTR gene. KUVAN All FDA-approved indications not otherwise excluded from Part D. The use of Kuvan will not be considered medically necessary for the following situations: Diagnosis other than PKU with Hpa due to BH4- Doses above 20mg/kg/day. Less than a 30 percent decrease of Phe after initiation of Kuvan therapy. Noncompliance with Phe-restricted diet. Non-responders (i.e. do not have a decrease in blood Phe with Kuvan treatment after one month of treatment at the maximum dose). Not maintaining Phe levels below baseline. Previous failure of Kuvan Documentation must be provided for all of the following: Patients is motivated to control PKU and maintain dietary restrictions. Patient has a history of adherence to routine follow-up for the diagnosis of PKU with at least annual visits. Diagnosis of phenylketonuria and current mean blood phenylalanine concentration above the upper limit of the recommended ranges which are: Neonates through 12 years of age and during pregnancy: 2-6mg/dL (120 to 365 micromol per L). Greater than 12 years of age: 2-10mg/dL (120 to 605 micromol per L). Phe-restricted diet has been continuously utilized for a period of at least 6 months prior to

initiation of the request and a mean blood Phe concentration less than or equal to the upper limits above was not attainable during the period. If the patient has been using the medication prior to the initial MVP request, the above criteria must have been met prior to initiation and evidence demonstrating a clinically relevant decrease from the baseline mean blood Phe Concentration after one month of Kuvan 20mg/kg/day must be documented in the medical record. Other Extension of therapy will be considered if documentation supports: Phe-restricted diet has been continuously utilized since initiation of Kuvan treatment and a mean blood Phe concentration with a clinically signficant decrease of blood phenylalanine (Phe) from mean pretreatment levels continues. Patients continue to be motivated to control PKU and maintain dietary restrictions. Maintenance of diet which is at least as stringent as the pretreatment diet unless the dietary needs of the patient have changed Must be 4 years of age or older. Specialist or prescriber with experience in PKU. 2 months initial approval. Up to 6 months for each extension of therapy. KYNAMRO All FDA-approved indications not otherwise excluded from Part D. Moderate or severe hepatic impairment, or active liver disease, including unexplained persistent elevations of serum transaminases. Known sensitivity to product components. Patients concurrently on LDL apheresis Doses above 200mg per week Diagnosis of homozygous familial hypercholesterolemia Baseline ALT, AST, alkaline phosphatase, and total bilirubin Baseline cholesterol panel That a low-fat diet supplying less than 20% of energy from fat has been initiated Continuation of therapy will be considered if there is a 25% decrease in LDL cholesterol from baseline

Other Restricted to patients aged 18 years and older. Restricted to cardiologists Initial approval- 6 months Extensions-Up to 12 months Failure to achieve goal LDL-C based on the National Cholesterol Education Program (NCEP) ATP III guidelines despite a 6 month trial of a combination of two of the following: 1. High-dose statin 2. Bile acid sequestrant 3. Zetia (ezetimibe LAZANDA All FDA-approved indication not otherwise excluded from Part D. Management of acute or postoperative pain, including dental pain, or headache/migraine. Management of pain in patients who are non-opioid tolerant Intolerance or hypersensitivity to fentanyl Diagnosis of cancer Documentation of intended use for breakthrough cancer pain Documentation of current opioid use for one week or longer which equals or surpasses: 60 mg oral morphine/day 25 mcg transdermal fentanyl/hour 30 mg oral oxycodone/day 8 mg oral hydromorphone/day 25 mg oral oxymorphone/day or any equanalgesic dose of another opioid Documentation of failure of greater than 1 immediate release opioid or contraindication to the use of oral immediate release products Extension of therapy requires documentation of: continued benefit from therapy optimized long-acting opioid therapy at maximum tolerated dose

Other Restricted to patients 18 years of age and older. Oncologist, Anesthesiologist, Hopsice & Palliative Care specialist Initial 3 months approval followed by 6 month intervals. Patients must: Remain and be compliant on chronic long acting opioid therapy and continue to meet the definition of opioid tolerance while taking Lazanda Show ineffective relief from immediate-release opioids by excessive rescue doses despite optimal long-acting opioid therapy s must enroll in the TIRF REMS Access program LETAIRIS FDA-approved indications not otherwise excluded from Part D. will not be provided if any of the following are true: Use in pregnancy. More than 1 tablet per day, Treatment of digital ulcers or erectile dysfunction, 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 Treatment of WHO Group II, III, IV, or V is not provided for doses exceeding package labeling For use in idiopathic pulmonary fibrosis Verification of WHO Group I pulmonary hypertension [due to idiopathic (IPAH), familial (FPAH) or associated with connective tissue disease] 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. WHO Functional Class II or III symptoms at baseline, Baseline and current 6-minute walk test result,

Other 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 identifying outcome. 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 WHO functional 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 18 years and older. Ordered by or consult with pulmonologist or cardiologist. Initial authorization will be limited to 3 months. Extended authorizations will be limited to 6 months. LYRICA ORAL SOLUTION All FDA-approved indications not otherwise excluded from Part D. Hypersensitivity to pregabalin or any of its components Documented diagnosis of one of the following is required: Neuropathic pain associated with diabetic peripheral neuropathy (DPN), Postherpetic neuralgia (PHN), Adjunctive therapy for adult patients with partial onset seizures, Fibromyalgia, Neuropathic pain associated with spinal cord injury. Documentation of a physical reason for a patient being unable to swallow capsules/tablets. Must be 18 years of age or older.

Remainder of contract year Other For Postherpetic neuralgia: failure of gabapentin immediate release at a therapeutic dose for at least 30 days. For adjunctive therapy in patients with partial onset seizures: failure of lamotrigine and levetiracetam. Inability to swallow Lyrica capsules. MEGESTROL All FDA-approved indications not otherwise excluded from Part D and cystic fibrosis with cachexia. Megestrol is excluded for the following: To promote weight gain. Treatment of anorexia. Treatment of weight loss. The use of megestrol may be considered medically necessary when the medical information provided documents one of the following: 1. Diagnosis of advanced caricinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease), AND megestrol to be used as palliative treatment. 2. Diagnosis of acquired immunodeficiency syndrome (AIDS), AND AIDS wasting syndrome or cachexia. 3. Diagnosis of cystic fibrosis and cachexia. medical information for continued therapy: stable weight or increase in weight from baseline. Other Restricted to 18 years and older. Remainder of contract year.

Other MEKINIST All FDA-approved indications not otherwise excluded from Part D Prior BRAF inhibitor therapy Retinal Vein Occlusion Interstitial Lung Disease Intolerable Grade 2 or Grade 3 or 4 rash that does not improve within 3 weeks despite interruption of therapy Doses less than 1mg per day Diagnosis of unresectable or metastatic melanoma FDA-approved test that shows the presence of BRAF V600E or V600K mutation Echocardiogram or MUGA scan prior to initiation of therapy, at one month and then 2-3 month intervals while on therapy 18 years of age and older Oncologists 12 months Patients with pre-existing left ventricular dysfunction or with symptomatic congestive heart failure will be evaluated on a case-by-case basis MEPRON All FDA-approved indications not otherwise excluded from Part D Documentation identifies that patient is intolerant to trimethoprim-sulfamethoxazole (TMP-SMX), AND one of the following: 1. Immunocompromised which requires prevention of Pneumocystis carinii pneumonia (PCP). 2. Documented acute mild-to-moderate PCP. Restricted to13 years and older. Infectious disease prescriber and oncologists.

Other Prevention 12 months. Treatment 21 days. Patients that have failed therapy with TMP-SMX are excluded. MOZOBIL All FDA-approved indications not otherwise excluded from Part D Presence of leukemia. CBC with differential including platelet count, bone marrow biopsy and/or radiologic reports confirming diagnosis of non-hodgkin s lymphoma or multiple myeloma. 18 years of age and older Oncologist or hematologist is for four days of therapy for each stem cell transplant. Other Failure of GCSF at 10 micrograms/kg for at least 4 days. GCSF will be administered for 4 days prior to the first dose of Mozobil. Undergoing stem cell transplant MYOZYME All FDA-approved indications not otherwise excluded from Part D. The use of Myozyme will not be considered medically necessary for the following situations: Dose and frequency outside of package labeling. LFTs IgG antibiodies every 3 months Enzyme assay test of cultured skin fibroblasts, muscle biopsy, or lymphocyte testing demonstrating reduced or absent activity for lysosomal enzyme acid alpha-glucosidase (GAA) confirming diagnosis of Pompe disease.

Other Up to 12 months Myozyme may be considered medically necessary if all of the following criteria are met: Documented infantile-onset Pompe disease GAA deficiency No invasive ventilatory support at the time of the first infusion. Extension of therapy will be considered if documentation supports continued benefit based on continued absence of invasive ventilatory support requirement NAGLAZYME All FDA-approved indications not otherwise excluded from Part D. The use of Naglazyme will not be considered medically necessary for the following situations: Dose and/or frequency outside of package labeling. Naglazyme may be considered medically necessary if all of the following criteria are met: Documentation identifying diagnosis of MPS VI based on urine test identifying excess mucopolysaccharides AND enzyme assays testing a variety of cells or body fluids in culture for enzyme deficiency. 12-minute walk test between 5 and 400 meters. Extension of therapy will be considered if documentation identifies continued benefit based on improvement vs baseline and continued stability of the 12-minute walk test Up to 12 months. Other NUEDEXTA All FDA-approved indications not otherwise excluded from Part D. Concomitant use with quinidine, quinine or mefloquine

Patients with a history of quinidine, quinine or mefloquine-induced thrombocytopenia, hepatitis, or other hypersensitivity reaction Hypersensitivity to dextromethorphan Use with MAOI or within 14 days of stopping an MAOI Prolonged QT interval. Congenital long QT syndrome, history suggestive of torsades de pointes, or heart failure Complete AV block without implanted pacemaker, or patients at high risk of complete AV block Concomitant use of drugs that both prolong QT interval and are metabolized by CYP2D6 Other Diagnosis of pseudobulbar affect (PBA) with underlying amyotrophic lateral sclerosis (ALS) or multiple sclerosis(ms) Chart notes for the previous 3 months identifying the member s frequency of laughing and crying episodes Center of Neurologic Studies Liability Scale (CNS-LS) score of greater than 13 Restricted to patients aged 18 years and older. Initial approval 3 months with extensions for remainder of contract year Extensions of therapy will be based on improvement in frequency of laughing and crying episodes and CNS-LS score from baseline OLYSIO All FDA-approved indications not otherwise excluded from Part D. HCV RNA level For subtype 1a negative results for the NS3 Q80K polymorphism Compensated liver disease No previous history of failure of a protease inhibitor (e.g. Incivek, Victrelis) Documentation of: Chronic HCV genotype 1 infection AND one of the following: Treatment naïve, OR Prior relapse (an undetectable HCV RNA level at the end of treatment with peginterferonribavirin, with a detectable HCV RNA level 24 weeks after completion of therapy), OR

Other Partial response (a decrease in the HCV RNA level of at least 2 log10 IU/mL by week 12 but with a detectable HCV RNA level during the therapy period) to prior peginterferonribavirin therapy, OR Null responders (less than 2 log10 IU/mL reduction in HCV RNA at week 12) to prior peginterferon-ribavirin therapy Restricted to 18 years of age and older. Infectious disease physician, gastroenterologist or hepatologist 12 weeks Must be used in combination with peginterferon and ribavirin if not used in combination with Sovaldi Must meet the following to be used in combination with Sovaldi: Genotype 1 Interferon ineligible Not previously treated with Solvaldi or Olysio Member is considered interferon ineligible if one of the following: Platelet count <75,000/m 3 Decompensated liver cirrhosis (CTP Class B or C, CTP score 7) Severe mental health conditions that may be exacerbated by interferon and/or may respond poorly to medical therapy Autoimmune diseases that may be exacerbated by interferon Inability to complete a prior treatment course due to documented interferon-related adverse effects Hemoglobin below 10g/dL-anemia must be related to the primary issue of hepatitis C Neutrophil count below 1500/uL OPSUMIT All FDA-approved indications not otherwise exclude from Part D. will not be provided if any of the following are true: Use in pregnancy

Treatment of digital ulcers 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-5 inhibitor, prostacyclin, sgc stimulator) has failed and when supporting clinical literature is provided that is consistent with the American College of Cardiology/American Heart Association consensus statement Treatment of WHO Group 2, 3, 4, or 5 is not provided when dosing exceeds product labeling Use in idiopathic pulmonary fibrosis Presence of pulmonary veno-occlusive disease Verification of WHO Group 1 pulmonary 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 to15 mmhg WHO Functional Class II or III at baseline Baseline and current 6-minute walk test results Vasoreactive testing is recommended for all PAH patients (documentation with rationale must be provided for patients for whom this testing was 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 absence of clinically relevant anemia at start of therapy Extension of therapy will be dependent upon documentation of clinical response, including but not limited to: iv. Improvement in exercise capacity (6-minute walk test) compared to baseline v. Improvement in WHO Functional Class compared to baseline vi. Lack of deterioration (e.g. no hospitalizations due to worsening PAH, 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 Initial authorization will be limited to 3 months. Extension up to 12 months

Other Other Documentation must include failure or inadequate response to an adequate trial of Letairis (for new starts only). Female patients of childbearing potential must be enrolled in the Opsumit REMS program ORALAIR All FDA-approved indications not otherwise excluded from Part D. Severe, unstable or uncontrolled asthma History of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy Documented allergic rhinitis with or without conjunctivitis Positive skin test or in vitro testing for pollen-specific IgE antibodies for the specific allergen extract OR a strongly cross-reactive allergen to the following: Pollen-specific IgE antibodies-sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract Strongly Cross-Reactive Allergen- members of the pooideae sub family (includes but not limited to orchard, fescue, ryegrass, June, and sweet vernal) Allergen must be identified as the cause of the major clinical symptoms 10 through 65 years of age Initial 5 months, extensions through remainder of allergen season Treatment must be initiated at least 4 months before expected pollen season based on geographic location(usually late April in Northeast) Therapy should be initiated in January in Northeast Documentation must identify failure of at least two of the following treatments: Intranasal corticosteroids Oral antihistamine Oral leukotriene receptor antagonist For continuation of treatment, the benefits of treatment (decrease of symptoms, increase tolerance to grass pollen) must be documented in the member s chart along with medication compliance based on prescription claims review.

Extension will be through remainder of allergen season-typically October in Northeast Will not be covered if receiving subcutaneous allergen immunotherapy Other ORENCIA SQ All FDA-approved indications not otherwise excluded from Part D. TB test result (if positive, treatment started prior to Orencia) AND For the treatment of moderate to severe rheumatoid arthritis: medical information supporting diagnosis including all of the following: Synovitis, Morning stiffness in and around joints for at least one hour, At least 4 swollen and 4 tender joints, Diagnosed with rheumatoid arthritis for at least 3 months, For continued therapy: Achieving ACR 20 response AND documentation supporting continued benefit. 18 years old or greater Restricted to rheumatologists, immunologists. Initial approval for 3 months with extensions of up to 6 months intervals. Must be screened for immunologic and infectious diseases. 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. (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 OSTEOPOROSIS MEDICATIONS Drugs: Boniva inj, Forteo, pamidronate, Zometa All FDA-approved indications not otherwise excluded from Part D. Doses exceeding package labeling are not covered. Teriparatide is not a covered benefit in the following situations: Prevention of osteoporosis in men and women; Members with Paget s disease or unexplained elevations of alkaline phosphatase; Members with a history of bone metastases, skeletal malignancies and/or metabolic bone disease other than osteoporosis; Members with hypercalcemia; In combination with a bisphosphonate. Teriparatide is not covered after two years of treatment. Injectable bisphosphonates are not a covered benefit in the following situations: Prevention of osteoporosis, Uncorrected hypocalcemia, Dose and/or frequency exceeding package label. Forteo required information: Diagnosis of osteoporosis in postmenopausal female or primary hypogonadal male Glucocorticoid induced osteoporosis on a daily dose equivalent to 5mg or greater of prednisone for at least 3 months And at high risk for fracture AND one of the following: 1. BMD T score of less than or equal to -2.5 SD AND radiologic evidence of failure of an adequate trial with oral alendronate or ibandronate, except if the member has a documented contraindication and/or intolerance to oral alendroante and ibandronate. BMD T score declines despite oral bisphosphonate therapy. 2. New ostoporotic/fragility fractures despite an adequate trial of oral alendronate or

ibandronate. Injectable bisphosphonates required information: For Boniva inj-bmd score of less than or equal to -2.5 or lower at the femoral neck or spine AND one of the following; 1. Unable to sit upright for 30 minutes. 2. Radiologic reports supporting active or recurrent peptic ulcer disease, or esophageal stricture. 3. Significant intolerance to at least two oral ibandronate and alendronate. Pamidronate requires a diagnosis of Paget s disease, hypercalcemia of malignancy, osteolytic bone metastases of breast cancer or osteolytic lesions of multiple myeloma. For continued therapy must demonstrate maintenance in BMD of the lumbar spine, femoral neck, or whole body, and member is compliant with therapy and office visits. Other Restricted to 18 years of age or older Injectable bisphosphonate-remainder of contract year. Forteo-up to 24 months OTEZLA All FDA-approved indications not otherwise excluded from Part D. Diagnosis of active psoriatic arthritis for at least 6 months Progress notes including number of tender and swollen joint, and psoriatic lesion involvement. If no active psoriatic lesions family history (diagnosis in a first or second degree relative) of psoriasis Previous therapies

Other Continuation of therapy will require documentation of improvement in the clinical signs and symptoms described 18 years of age and older Dermatologist and rheumatologist Initial 4 months, extensions up to 12 months Documentation must identify the follow: Failure, intolerance or contraindication to a 12 week trial each of Humira and Enbrel If contraindication or intolerance to Humira or Enbrel the following criteria must be met: An appropriate trial was not effective or contraindicated to a Non-Steroidal Antiinflammatory Drug and one of the following DMARDs: o Leflunomide o Sulfasalazine o Methotrexate Other PERJETA FDA-approved indications not otherwise excluded from Part D. Nursing mothers Documentation of metastatic breast cancer HER2 positive (using an FDA-approved test) AND to be used in combination with trastuzumab and docetaxel. Must be 18 years of age and older. oncologist Remainder of contract year. POMALYST All FDA-approved indications not otherwise excluded from Part D.

Pregnancy Documentation of the following: Documentation of failure of at least two therapies including lenalidomide and bortezomib. Demonstration of disease progression on or within 60 days of completion of the last therapy. Baseline serum creatinine < 3.0 mg/dl Females of reproductive potential must have two negative pregnancy tests. The first test is to be performed 10 to 14 days prior to prescribing, and the second test within 24 hours prior to prescribing. Documentation that all of the following are met for Multiple Myeloma: CBC with differential inducing platelet count, bone marrow biopsy and/or radiologic reports confirming diagnosis of multiple myeloma. A diagnosis of stage II or III, active, symptomatic* multiple myeloma with at least one of the following: o Hemoglobin < 8.5g/dL; o Serum calcium > 12 mg/dl; o Advanced lytic bone lesions (scale 3); o High M-component production rate IgG > 7 g/dl; AND IgA value > 5 g/dl; AND Bence Jones protein > 12g/24 hour; o Serum beta2-microglobulin > 5.5 mg/dl *active, symptomatic multiple myeloma requires at least one of the following: o calcium >11.5 (>2.65 mmol/l) o creatinine >2 g/l (>177 µmol/l) o hemoglobin < 10g/dL or 2 g/dl less than normal o lytic or osteopenic bone disease Absolute neutrophil counts (ANC) 3 > 500 cells/mm 3 ; Platelet counts > 50,000/mm 3 at baseline; Serum SGOT/AST or SGPT/ALT < 3 x upper limit of normal; > 18 years of age; Serum bilirubin < 2.0 mg/dl;

Documentation of transplant status must be provided. Other Restricted to patients aged 18 years and older. Oncologist or hematologist Remainder of the contract year PROMACTA All FDA-approved indications not otherwise excluded from Part D. PROMACTA will not be covered under Part D if used in an attempt to normalize platelet counts. ALT levels less than 3X upper limit of normal (ULN) Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin prior to initiation of PROMACTA, every 2 weeks during the dose adjustment phase and monthly following establishment of a stable dose. Documentation whether member has had a splenectomy. Diagnosis of chronic immune idiopathic thrombocytopenia purpura: CBC with differential with Platelet count less than 30 x 10 9 /L. Outcome and length of previous therapies such as IVIG, corticosteroids, cytotoxic therapies, danazol, and azathioprine Diagnosis of thrombocytopenia in patients with chronic hepatitis C to allow initiation and maintenance of interferon-based therapy: Documentations that the patient is eligible to receive interferon-based therapy CBC with differential with Platelet count less than 75 x 10 9 /L Outcomes of any previous therapies such as splenic artery embolization, splenectomy or TIPS Continuation of therapy: Platelet count must not exceed 400 x10 9 /L after 2 weeks of therapy at the lowest FDA approved dose. ALT levels must remain less than 3x upper limit of normal (ULN) and are not: I. Progressive, or II. Persistent for greater than or equal to 4 weeks, or

III. Accompanied by increased direct bilirubin, or clinical symptoms of liver injury or evidence for hepatic decompensation. Chronic immune idiopathic thrombocytopenia purpura: i. Requires adequate response with a platelet count of > 50 x 10 9 /L. ii. Platelet count must increase after 4 weeks at the maximum dose. Other Chronic hepatitis C to allow initiation and maintenance of interferon-based therapy: a) Requires adequate response with a platelet count of greater than 90 x 10 9 /L. b) Platelet count must increase after 2 weeks at the maximum FDA approved dose 18 years of age and older Hematologist and hepatologist Initial approval will be for 3 months. Extension of therapy up to one year. Diagnosis of chronic immune idiopathic thrombocytopenia purpura: Degree of thrombocytopenia and clinical condition puts member at increase risk of bleeding, AND Failure or contraindication to two of the following: 1. IVIG, 2. corticosteroids, 3. splenectomy Diagnosis of thrombocytopenia in patients with chronic hepatitis C: 1. Degree of thrombocytopenia does not allow member to start interferon-based therapy 2. Other therapies such as splenic artery embolization, splenectomy or TIPS would not be clinically appropriate. RAGWITEK All FDA-approved indications not otherwise excluded from Part D. Severe, unstable or uncontrolled asthma History of esinophilic esophagitis History of any severe systemic allergic reaction or any severe local reaction to sublingual

Other allergen immunotherapy Documented allergic rhinitis with or without conjunctivitis Positive skin test or in vitro testing for pollen-specific IgE antibodies for the specific allergen extract OR a strongly cross-reactive allergen to the following: Pollen-specific IgE antibodies- Short Ragweed Pollen Allergen Extract Strongly Cross-Reactive Allergen- Short, giant, western, and false ragweed Allergen must be identified as the cause of the major clinical symptoms 18 through 65 years of age Initial 4 months, extensions through remainder of allergen season Treatment must be initiated at least 12 weeks before expected pollen season based on geographic location(usually mid-august in Northeast) Therapy should be initiated by April in Northeast Documentation must identify failure of at least two of the following treatments: Intranasal corticosteroids Oral antihistamine Oral leukotriene receptor antagonist For continuation of treatment, the benefits of treatment (decrease of symptoms, increase tolerance to grass pollen) must be documented in the member s chart along with medication compliance based on prescription claims review Extension will be through remainder of allergen season-typically October in Northeast Will not be covered if receiving subcutaneous allergen immunotherapy REMICADE All FDA-approved indications not otherwise excluded from Part D Not evaluated for latent TB infection with a TB skin test and treatment of the infection prior to therapy if indicated. Treatment of JRA (Juvenile Rheumatoid Arthritis). Concomitant therapy with Rituxan and other DMARDs or biologic therapies other than

methotrexate. Members who do not have chronic plaque psoriasis (when prescribed for psoriasis) or have another form of psoriasis other than chronic plaque psoriasis (e.g. guttate, erythrodermic or pustular psoriasis as the sole or predominant form). Active infection or a history of chronic or recurrent infections. Members with CHF with NYHA class III/IV at doses of greater than 5mg/kg. Dosing greater than 5mg/kg and/or more frequently than every 8 weeks for UC, psoriasis, pediatric Crohn's, or PSA after induction regimen at 0, 2, and 6 wks. For AS: Dosing greater than 5mg/kg and/or more frequently than every 6 weeks. For RA: More frequently then every 8 weeks unless failure/contraindication to 10mg/kg every 8 weeks. Members with Wegener s granulomatosis prior to failure of at least two of the following agents: azathioprine, cyclophosphamide, glucocorticoids, MTX. Clinical failure or less than desired effect with Remicade and no clinical rationale provided for continuation of therapy. Increase in dose without prior authorization. Rheumatoid arthritis: documentation of persistent or recurrent symptoms with documented synovitis and morning stiffness of significant duration to inhibit (Active Daily Living) ADLs. For continued therapy: Achieving ACR 20 response AND demonstrated beneficial response. B. Psoriatic arthritis: documentation of at least 3 tender joints AND at least 3 swollen joints on 2 separate occasions at least 1 month apart. For RA and PsA: Continuation of therapy requires a decrease in swollen or tender joints and duration of morning stiffness. C. Psoriasis: documentation of severe chronic plaque psoriasis with 10% BSA involvement OR involvement of the palms, soles of feet and scalp causing functional disability. Continuation of therapy will require documentation of improved patient status in the monitoring parameters of the following: A significant improvement of clinical signs/symptoms of psoriasis (e.g. itching, redness, scaling, psoriatic body surface area coverage) at 3 months. QOL assessments improved per patient and/or physician.

D. Ankylosing spondylitis (AS), chart notes including status of back pain and spinal mobility and BASDAI greater than or equal to 4. Continued coverage: documentation must support significant symptom improvement and/or 2 units of the BASDI. E. Crohn's disease/uc: 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%. Fistulizing Crohn's disease: present for at least 3 months. For continuation: documentation of improvement in symptoms. Other Restricted to 18 years of age and older, except for Crohn's/UC which is restricted to 6 years and older Restricted to rheumatologists, immunologists, dermatologists, gastroenterologists, colorectal surgeons. Initial approval for 3 months with extensions of up to 6 months intervals. Must be screened for immunologic and infectious diseases including hepatitis and TB. A. Rheumatoid Arthritis:Documentation must include failure or inadequate response to a 12- week trial each of Humira and Enbrel and given in combination with at least 12.5mg/week of methotrexate or maximum dose tolerable for the patient, 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. (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. B. Crohn's Disease and Ulcerative Colitis: Documentation must include failure or inadequate response to a 12-week trial of Humira and one of the following: 1. Corticosteroids, OR

2. Anti-inflammatory aminosalicylates (e.g. sulfasalazine) OR if chart notes identify intolerance and/or clinical side effects and/or contraindication to Humira, a trial of both corticosteroids and anti-inflammatory aminosalicylates is required. C. For Psoriatic Arthritis, Plaque Psoriasis, and Ankylosing Spondylitis: 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: Psoriatic Arthritis: Failed to respond to an adequate trial of one DMARD. Plaque Psoriasis: An appropriate treatment trial of two of the following agents was not effective: methotrexate, oral retinoids, cyclosporine. Ankylosing Spondylitis: Failure during a 3 month period of 1 NSAID at maximum tolerated dose and insufficient response to 1 local corticosteroid inj (peripheral arthritis), Failure of a 4 month trial of sulfasalazine at maximum tolerated dose in patients with persistent peripheral arthritis. No trial of DMARDS required for pure axial manifestations REVATIO Drugs: Revatio, sildenafil 20mg 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 will not be covered for initial therapy. Combination therapy requests will be reviewed when monotherapy in each appropriate drug class (e.g. PDE, 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. Verification of WHO Group I pulmonary hypertension [due to idiopathic (IPAH), familial (FPAH) or associated with connective tissue disease] 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 Functional Class II or III symptoms 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.) Previous and current therapies identifying outcome. 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 functional 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). Other Restricted to members who are greater than 18 years old Ordered by or consult with pulmonologist or cardiologist Initial authorization will be limited to 3 months. Extended authorizations limited to 6 months. Documentation must include failure or inadequate response to an adequate trial of Adcirca (for new starts only). SAMSCA All FDA-approved indications not otherwise excluded from Part D. Need to raise serum sodium acutely Patients who are unable to respond appropriately to thirst Hypovolemic hyponatremia Concomitant use of strong CYP 3A inhibitors Anuric patients Patients with liver disease Documentation of the following: Evaluated for factors contributing to hyponatremia Euvolemic (no edema) hyponatremia with Syndrome of Inappropriate Antidiuretic Hormone

(SIADH) OR hypervolemic (edema) hyponatremia with heart failure or cirrhosis Serum sodium less than 125 meq/l OR hyponatremic with a serum sodium greater than or equal to 125 meq/l AND symptomatic AND unable to restrict fluid due to documented disorder or condition that would limit compliance with fluid restriction Tolvaptan must be initiated, titrated, and re-initiated in a hospital setting until stable Unless contraindicated: failure of fluid restriction, saline infusion, drug therapy and/or sodium restriction (if indicated) or removal of offending medication. For continuation of therapy: Continued necessity of tolvaptan vs. standard of care therapies Continued benefit from tolvaptan with stabilization of serum sodium to normal limits Restricted to patients aged 18 years and older. Endocrinologists, Nephrologists Maximum of 30 days Other Patients with symptoms that may indicate liver injury should discontinue treatment with Samsca Samsca should not be used longer than 30 days SIMPONI All FDA-approved indications not otherwise excluded from Part D. TB test result (if positive, treatment started prior to Simponi) AND For the treatment of moderate to severe rheumatoid arthritis: medical information supporting diagnosis including all of the following: Synovitis, Morning stiffness in and around joints for at least one hour, At least 4 swollen and 4 tender joints, Diagnosed with rheumatoid arthritis for at least 3 months, To be used in combination with methotrexate as per package label (not for monotherapy use). For continued therapy: Achieving ACR 20 response AND documentation supporting

continued benefit. For the treatment of active psoriatic arthritis (PsA): Chart notes supporting diagnosis including: Morning stiffness in and around joints for at least one hour, At least 3 swollen and 3 tender joints on two separate occasions at least one month apart, Diagnosed with psoriatic arthritis for at least 6 months Psoriatic lesion of at least 2 cm in diameter Documented inadequate response to at least one Non Steroidal Anti-inflammatory Drug, and For continued therapy: Achieving ACR 20 response OR equivalent response AND documentation supporting continued benefit. For the treatment of active ankylosing spondylitis (AS): chart notes supporting sustained active spinal disease diagnosis including all of the following: Bath AS Disease Activity Index (BASDAI) greater than or equal to 4, At least 4 cm on the 0 to 10 cm spinal pain visual analogue scale (VAS) Diagnosed with AS for at least 3 months, For continued therapy: response of at least 50% improvement or 2 units (on a 0-10 scale) of the BASDAI OR achieving an ASAS 20 response Other 18 years old or greater Restricted to rheumatologists, immunologists or gastroenterologists Initial approval for 3 months with extensions of up to 6 months intervals. Must be screened for immunologic and infectious diseases 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. (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. For Psoriatic Arthritis and Ankylosing Spondylitis: 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: Psoriatic Arthritis: Failed to respond to an adequate trial of one DMARD (e.g. sulfasalazine). Ankylosing Spondylitis: Failure during a 3 month period of 1 NSAIDS at maximum tolerated dose, Failure of a 4 month trial of sulfasalazine at maximum tolerated dose in patients with persistent peripheral arthritis. No trial of DMARDS required for pure axial manifestations SIRTURO All FDA-approved indications not otherwise excluded from Part D. Clinical significant ventricular arrhythmia QTcF interval greater than 500 ms AST and total bilirubin greater than 2 times upper limit of normal AST greater than 8 times upper limit of normal Treatment of latent tuberculosis (TB) Treatment of extra-pulmonary tuberculosis Doses outside of FDA approved package labeling Documentation of multi-drug resistant tuberculosis with isolate susceptibility results ECG reading prior to starting treatment Baseline ALT, AST, alkaline phosphatase, serum aminotransferase and bilirubin levels Baseline potassium, calcium, and magnesium levels Documentation that the members is participating in directly observed therapy (DOT) 18 years of age or older Infectious Disease Specialists and Pulmonologists 24 weeks

Other 1. Patients with the following risk factors for QT prolongation will be evaluated on a case-by-case basis: a. History of Torsade de Pointes b. History of congenital long QT syndrome c. History of hypothyroidism and bradyarrhythmias d. History of uncompensated heart failure e. Serum calcium, magnesium, or potassium levels below the lower limits of normal f. Receiving other QT prolonging drugs 2. Drug regimen must contain at least 3 other drugs to which the patient s TB isolate has been shown to be susceptible in vitro. SOVALDI All FDA-approved indications not otherwise excluded from Part D. Negative status for Hepatitis B HCV RNA level and genotype Patents with hepatocellular carcinoma awaiting liver transplantation: Member meets Milan criteria and will be receiving transplant within 48 week Other Restricted to 18 years of age and older. Infectious disease physician, gastroenterologist or hepatologist Up to 48 weeks based on indication Combination therapy with Victrelis or Incivek will not be covered Genotype 1 or 4 : Treatment naïve-when used as single agent must be used in combination with ribavirin and pegylated interferon unless contraindication to pegylated interferon. Approval will be for 12 weeks Nonresponders-when used with pegylated interferon and ribavirin approval will be for 12 weeks. When used with ribavirin only due to pegylated interferon contraindication

approval will be for 24 weeks. Genotype 2: Must be used in combination with ribavirin Approval will be for 12 weeks Genotype 3: Must be used in combination with ribavirin Approval will be for 24 weeks Patents with hepatocellular carcinoma awaiting liver transplantation Must be used in combination with ribavirin Maximum approval for 48 weeks Member is considered interferon ineligible if one of the following: Platelet count <75,000/m 3 Decompensated liver cirrhosis (CTP Class B or C, CTP score 7) Severe mental health conditions that may be exacerbated by interferon and/or may respond poorly to medical therapy Autoimmune diseases that may be exacerbated by interferon Inability to complete a prior treatment course due to documented interferon-related adverse effects Hemoglobin below 10g/dL-anemia must be related to the primary issue of hepatitis C Neutrophil count below 1500/uL Must meet the following to be used in combination with Olysio: Genotype 1 Interferon ineligible Not previously treated with Solvaldi or Olysio Cirrhosis Approval will be for 12 weeks STELARA 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 Patients with guttate, erythrodermic, or pustular psoriasis Doses greater than those in FDA approved package labeling Concurrent treatment with immunosuppressive therapies For psoriasis: Diagnosis of moderate to severe plaque psoriasis Body surface area (BSA) involvement Progress notes including previous and current therapies and responses Continuation of therapy will require documentation of improved patient status in the monitoring parameters of all of the following: Significant improvement of clinical signs and symptoms of psoriasis (itching, redness, scaling, BSA involvement) at three months Quality of life assessments-improved For psoriatic arthritis: Diagnosis of psoriatic arthritis Diagnosis of psoriasis or family history (diagnosis in a first or second degree relative) of psoriasis Progress notes including number of tender and swollen joint, previous and current therapies and responses Other Continuation of therapy will require documentation of improvement in the clinical signs and symptoms described Restricted to 18 years and older Dermatologist and rheumatologist Up to 12 months For psoriasis: The following criteria must be meet: Moderate to severe plaque psoriasis or involvement of the face, genitals, hands or feet, or scalp for at least 1 year Failure, intolerance or contraindication to a 12 week trial each of Humira and Enbrel

If contraindication or intolerance to Humira and Enbrel the following criteria must be met: An appropriate trial was not effective or contraindicated with one of the following: o Methotrexate o Oral retinoids o Cyclopsorine For psoriatic arthritis: Failure, intolerance or contraindication to a 12 week trial each of Humira and Enbrel If contraindication or intolerance to Humira or Enbrel the following criteria must be met: An appropriate trial was not effective or contraindicated to a Non Steroidal Antiinflammatory Drug and one of the following DMARDs: o Leflunomide o Sulfasalazine o Methotrexate STIVARGA FDA-approved indications not otherwise excluded from Part D Documentation of the following must be provided for metastatic colorectal cancer: Radiologic report identifying metastatic Colorectal Cancer KRAS gene status Previous treatment with with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vegf therapy (e.g. bevacizumab), and, if KRAS wild type, an anti- EGFR (e.g. cetuximab, panitumumab) therapy Documentation required for gastrointestinal stromal tumor (GIST): Radiologic reports and biopsy results identifying GIST Previous failure with imatinib and sunitinib Liver functions tests (ALT, AST, bilirubin) must be provided before initiation of Stivarga therapy and continue to be monitored at least every 2 weeks for first two months. Must be 18 years of age or older. Oncologist

Other Remainder of contract year Stivarga therapy should be interrupted if the following occur: Grade 2 hand-foot skin reaction (HFSR) [palmar-plantar erythrodysesthesia (PPE)] that is recurrent or does not improve within 7 days despite dose reduction; interrupt therapy for a minimum of 7 days for Grade 3 HFSR. Symptomatic Grade 2 hypertension. Stivarga therapy should be discontinued if the following occur: Stivarga should be permanently discontinued if any occurrence of a severe or lifethreatening hemorrhage. Any occurrence of AST or ALT more than 20 times the upper limit of normal (ULN). Any occurrence of AST or ALT more than 3 times ULN with concurrent bilirubin more than 2 times ULN. Re-occurrence of AST or ALT more than 5 times ULN despite dose reduction to 120 mg. Failure to tolerate 80mg dose. SYLATRON FDA-approved indications not otherwise excluded from Part D 1. Autoimmune hepatitis 2. Hepatic impairment (Child-Pugh score >6) 3. Persistent or worsening severe neuropsychiatric disorders 4. Grade 4 non-hematologic toxicities after starting therapy with Sylatron 5. Inability to tolerate a dose of 1mcg/kg/week 6. New or worsening retinopathy 7. New onset of ventricular arrhythmia or cardiovascular decompensation 8. New development of hypothyroidism, hyperthyroidism or diabetes mellitus that cannot be effectively managed 9. Dosing exceeding package label 1. Documented diagnosis of melanoma with microscopic or gross nodal involvement. (Stage III clinically positive nodes or sentinel node positive). 2. Treatment plans identifies Sylatron to be used as adjuvant monotherapy treatment after surgery. 3. Definitive surgical resection including complete lymphadenectomy. 4. Date of surgical resection within 84 days of initiation of Sylatron therapy.

5. Sylatron therapy start date less than 5 years ago. Other Must be 18 years of age and older Oncologist or dermatologist Remainder of contract year. For continuation of therapy the following criteria must be met: 1. Dose modification guidelines followed per package label 2. Able to tolerate minimum dose of 1mcg/kg/week 3. Relapse free. SYNRIBO Approved indications not otherwise excluded from Part D. The following documentation must be provided: Diagnosis of chronic or accelerated phase chronic myeloid leukemia (CML) by histologic or cytologic evidence, Documentation of resistance and/or intolerance to two of the following tyrosine kinase inhibitors (TKI). 1. imatinib (Gleevec), 2. nilotinib (Tasigna), 3. dasatinib (Sprycel). Resistance or tolerance to previous treatment is defined by one of the following: 5. failure to achieve or maintain any hematologic improvement within four weeks. 6. failure to achieve a complete hematologic response (CHR) by 3 months, cytogenetic response by 6 months or major cytogenetic response (MCyR) by 12 months. 7. progression of disease after a previous cytogenetic or hematologic response. ANC (Absolute Neutrophil Count) greater than or equal to 1.0 x 10 9 /L. Platelets greater than or equal to 50 x 10 9 /L Must be 18 years of age and older.

Other Other Oncologist Remainder of contract year TAFINLAR All FDA-approved indications not otherwise excluded from Part D Tafinlar is not covered under the following situations: Patients with wild-type BRAF melanoma Prior therapy with a BRAF inhibitor Doses less than 50mg twice daily Diagnosis of unresectable or metastatic melanoma FDA-approved test that shows the presence of BRAF V600E mutation Dermatologic evaluation prior to therapy and then every 2 month while on therapy 18 years of age and older Oncologists 12 months TAZORAC All FDA-approved indications not otherwise excluded from Part D. Cosmetic use including wrinkles. Treatment of acne previously treated with other retinoids or resistant to oral antibiotics. The use of topical TAZORAC may be considered medically necessary if all of the following criteria are met: Diagnosis of mild to moderate acne vulgaris, OR

Diagnosis of stable plaque psoriasis less than 20% body surface area involvement. Subsequent requests will be considered if there is documentation of: Improvement in lesions. Other At least 12 years old Remainder of contract year For a diagnosis of acne: Failure of a one month trial (compliance supported by documentation) of each of the following: combination formulary agent containing topical erythromycin and benzoyl peroxide. combination formulary agent containing topical clindamycin and benzoyl peroxide. For a diagnosis of plaque psoriasis: Failure of a three month trial (compliance supported by documentation) of one topical corticosteroid. TOBI PODHALER All FDA-approved indications not otherwise excluded from Part D. Hypersensitivity to any aminoglycoside Forced expiratory volume in 1 second less than 25% or greater than 80% of predicted normal range Colonization with Burkholderia cepacia Diagnosis of cystic fibrosis Positive sputum culture for Pseudomonas aeruginosa Base line FEV 1 % For continuation of therapy the following criteria must be met: Improvement in FEV 1 % from baseline Restricted to patients aged 6 years and older. Pulmonologist

Other Other 12 months Doses greater than twice daily for 28 days followed by a 28 day drug free period will not be covered TRACLEER All FDA-approved indications not otherwise excluded from Part D. Use in pregnancy Verification of WHO Group I pulmonary hypertension [due to idiopathic (IPAH), familial (FPAH), associated with connective tissue disease OR associated with congenital systemicto-pulmonary shunts] 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 Functional Class II, III, or IV symptoms 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 identifying outcome. 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 functional 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 will be limited to 3 months. Extended authorizations limited to 6 months. Documentation must include failure or inadequate response to an adequate trial of Letairis (for new starts only). For NYHA Functional Class IV: trial of Letairis is not required.

If liver aminotransferase elevations are accompanied by clinical symptoms of liver injury (such as nausea, vomiting, fever, abdominal pain, jaundice, or unusual lethargy or fatigue) or increases in bilirubin greater than or equal to 2 x ULN, treatment with Tracleer must be stopped. If liver aminotransferase elevations exceed 8 times ULN during Tracleer use, treatment should be stopped and Tracleer not re-introduced. Treatment of digital ulcers or erectile dysfunction is not supported in the package label or Medicare compendia and is therefore not covered under the Part D benefit. FDA approved dosing regimen must be followed for coverage under the Part D benefit. 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 inhibitors, ERA, prostacyclin) has failed and when supporting clinical literature is provided and is consistent with the American College of Cardiology consensus statement. Other TRETINOINS All FDA-approved indications not otherwise excluded from Part D. Cosmetic use including wrinkles. The use of topical tretinoins may be considered medically necessary if all of the following criteria are met: Diagnosis of acne vulgaris, Subsequent requests will be considered if there is documentation of: Improvement in acne lesions at least 12 years old Remainder of contract year Failure of a one month trial (compliance supported by documentation) of each of the following: combination formulary agent containing topical erythromycin and benzoyl peroxide.

combination formulary agent containing topical clindamycin and benzoyl peroxide Other TYSABRI All FDA-approved indications not otherwise excluded from Part D. Patients who have or have had PML Patients who have had a hypersensitivity reaction to Tysabri Patients with significantly compromised immune function Multiple Sclerosis: Diagnosis of relapsing-remitting form of multiple sclerosis, neurology notes from the past 2 years and baseline MRI scan prior to initiation of Tysabri. For continuation of therapy-chart notes identifying continued benefit with a decrease in number of relapses from baseline. Crohn s Disease: Moderate to severe active Crohn s disease confirmed by endoscopy or capsule endoscopy when appropriate. Documentation of active disease such as frequent liquid stools greater than 4 times/day, presence of abdominal pain, presence of abdominal mass, extraintestinal symptoms, need for opiates or diphenoxylate/atropine for diarrhea, anemia, and weight loss greater than 10%. For continuation of therapy-chart notes identifying response to Tysabri must be provided with each request for extension of therapy that identifies improvement in the clinical signs and symptoms described. Restricted to patients aged 18 years and older. Neurologist or Gastroenterologist Initial approval 3 months with extensions for 6 months Multiple Sclerosis: 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. 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. Tysabri may be covered under Medicare Part B or D depending upon the circumstances. When covered under Part B, Tysabri is not covered under Part D. Information may need to be submitted describing the use and setting of the drug to make the determination. TYVASO All FDA-approved indications not otherwise excluded from Part D. Verification of WHO Group I primary 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 Functional Class III Baseline and current 6-minute walk test result Patient does not have significant lung disease (such as asthma or chronic obstructive pulmonary disease) or bleeding disorder 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. Total daily Tyvaso dose less than 216 mcg/day 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 patients aged 18 years and older. Ordered by or Consult with pulmonologist or cardiologist

Other Up to 12 months 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 inhibitors, ERA, prostacyclin) has failed and when supporting clinical literature is provided and is consistent with the American College of Cardiology consensus statement. Tyvaso may be covered under Medicare Part B or D depending upon the circumstances. When covered under Part B, Tyvaso is not covered under Part D. Information may need to be submitted describing the use and setting of the drug to make the determination. will be considered if all of the following criteria are met: NYHA Class III primary pulmonary hypertension or pulmonary hypertension secondary to any of the following conditions: Connective tissue disease, Congenital heart disease, Schistomsomiasis, Chronic hemolytic anemia, Portal hypertension, HIV infection, drugs/toxins. ULORIC All FDA-approved indications not otherwise excluded from Part D Uloric in combination with azathioprine or mercaptopurine. Documentation of the following must be provided: Recurrent acute gout flares (i.e. symptomatic gout with at least 3 gout flares in the previous 18 months or at least 1 gout tophus or gouty arthritis). Presence of monosodium urate (MSU) crystals in joint fluid. If aspiration of synovial fluid is contraindicated or not feasible, documentation must identify radiographic changes due to gout, and/or gouty arthritis. CrCl greater than 30 ml/min. Serum uric acid level greater than or equal to 6 mg/dl. Provide a liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin) as a baseline before initiating Uloric and monitor for signs and symptoms indicative of liver injury; During treatment, if the ALT is greater than three times the upper limit of the reference range, Uloric treatment should be interrupted and investigation done to establish the probable cause. Uloric should not be restarted without another explanation for the liver test abnormalities. Serum ALT greater than three times the reference range with serum total bilirubin greater than two times the reference range without alternative etiologies are at risk for severe druginduced liver injury and should not be restarted on Uloric. For patients with lesser elevations of serum ALT or bilirubin and with an alternate probable cause, treatment with Uloric can be used with caution.

Must be greater than 18 years of age. Remainder of contract year. Other Failure of 90 day continuous trial of allopurinol therapy (greater than or equal to 600mg/day), If allopurinol is contraindicated, failure of 90 day trial of probenecid (greater than or equal to 500mg twice a day) unless contraindicated. VENTAVIS All FDA-approved indications not otherwise excluded from Part D Verification of WHO Group I primary 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 III or IV, Baseline and current 6-minute walk test result, Cardiac index at rest more than 1.5 (or less than 4 liters/minute/m2 of BSA), Bilirubin less than 3mg/dL, Creatinine clearance more than 30ml/min, FVC more than 50%, Total daily Ventavis dose less than 45 mcg/day, FEV1 more than the mean normal value minus twice the standard deviation. 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. 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). Other Restricted to members who are greater than 18 years old Ordered by or Consult with pulmonologist or cardiologist Remainder of contract year. 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 inhibitors, ERA, prostacyclin) has failed and when supporting clinical literature is provided and is consistent with the American College of Cardiology consensus statement. Ventavis may be covered under Medicare Part B or D depending upon the circumstances. When covered under Part B, Ventavis is not covered under Part D. Information may need to be submitted describing the use and setting of the drug to make the determination. will be considered if all of the following criteria are met: NYHA Class III or IV primary pulmonary hypertension or pulmonary hypertension secondary to any of the following conditions: Congenital systemic to vascular shunts, Collagen vascular disease, Portal hypertension, HIV infection, drugs/toxins. VERSACLOZ All FDA-approved indications not otherwise excluded from Part D. History of clozapine-induced agranulocytosis or severe granulocytopenia Documented diagnosis of one of the following: Treatment-resistant schizophrenia Suicidal behavior with schizophrenia or schizoaffective disorder Documentation of a physical reason for patient being unable to swallow tablets Restricted to 18 years of age and older. 12 months

Other Member must be unable to swallow clozapine tablets or use clozapine ODT (oral dispersible tablets) VICTRELIS All FDA-approved indications not otherwise excluded from Part D. 1. Contraindications for the use of ribavirin, and/or pegylated interferon, 2. Pregnant women, and men whose female partners are pregnant, 3. Co-administration with drugs that: a. are highly dependent on CYP3A4/5 for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (e.g. alfuzosin, ergot derivatives, cisapride, lovastatin, simvastatin, sildenafil or tadalafil when used for pulmonary arterial hypertension, other PDE-5 inhibitors if use daily). b. strongly induce CYP3A4/5 which may lead to lower exposure and loss of efficacy of Incivek (e.g. rifampin, St. John s wort). c. Caution is warranted with other medications (refer to package label). 1. Negative status for HIV and Hepatitis B, 2. No previous history of failure of a protease inhibitor (e.g. Incivek, Victrelis) or more than one course of treatment per lifetime without supporting clinical documentation. Documentation of: Chronic HCV genotype 1 infection AND one of the following: 1. Treatment naïve patients with at least one other risk factor for poor prognosis including: moderate inflammation and/or fibrosis (i.e. Ishak stage greater than 3 or METAVIR stage greater than F2, Diabetes or African heritage, OR 2. Prior relapse (an undetectable HCV RNA level at the end of treatment, with a detectable HCV RNA level within 12 weeks of treatment follow-up) to prior peginterferon-ribavirin therapy, OR 3. Partial response (a decrease in the HCV RNA level of at least 2 log10 IU/mL by week 12 but with a detectable HCV RNA level during the therapy period) to prior peginterferonribavirin therapy. For continuation of therapy: All patients must have a HCV-RNA level of less than or equal to 100 IU/mL at Victrelis week 8 (treatment week 12) for continued coverage. Previously untreated patients: Victrelis week 4 = HCV-RNA detectable, week 20 (treatment

Other week 24) undetectable are eligible for an additional 8 weeks of Victrelis therapy. Previous partial responders or relapsers: HCV-RNA undetectable at week 20 (treatment week 24) are eligible for an additional 8 weeks of Victrelis therapy. Documentation identifies continuing on FDA approved dosing and in combination with pegylated interferon AND ribavirin. Must be 18 years of age or older. Infectious disease physician, gastroenterologist or hepatologist 8 weeks initial, up to 12 additional weeks second approval if criteria are met. Treatment regimen includes a preceding 4 week regimen of pegylated interferon AND ribavirin prior to administration of Victrelis (must meet criteria in Hepatitis C Treatment, Chronic policy.) Pegylated interferon AND ribavirin must be used in combination with Victrelis. Patients with compensated cirrhosis are eligible for a total of 44 weeks of Victrelis when all other criteria are met. Previously untreated patients who are HCV-RNA undetectable at Victrelis week 4 and week 20 (treatment week 24) are not covered for more than 24 weeks of Victrelis. HCV-RNA levels of greater than or equal to 100 IU/mL at Victrelis week 8 (treatment week 12). XALKORI FDA-approved indications not otherwise excluded from Part D. Xalkori will not be covered or coverage continued if previous use of Xalkori resulted in any of the following: Grade 2, 3 or 4 ALT or AST elevation with concurrent Grade 2, 3 or 4 total bilirubin elevation (in the absence of cholestasis or hemolysis). Any Grade pneumonitis. Grade 4 QTc prolongation. Documentation of: Locally advanced or metastatic non-small cell lung cancer (NSCLC), AND Anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. Must be 18 years of age and older. Oncologist

Other Other Remainder of contract year XELJANZ All FDA-approved indications not otherwise excluded from Part D. Documented moderate to severe active adult rheumatoid arthritis and chart notes identifying the following: Documented synovitis Number of swollen and/or tender joints. Morning stiffness of significant duration PE findings Diagnosed with rheumatoid arthritis for at least 3 months, Liver function tests (LFTs) less than 3 times the upper limit of normal, Lymphocyte count greater than or equal to 500 cells/mm3, absolute neutrophil count (ANC) greater than or equal to 1000 cells/mm3, and hemoglobin level greater or equal to 9 g/dl. In addition, there must be no indication of the following: No evidence of active or inadequately treated tuberculosis infection. No clinically important infection or a history of chronic or recurrent infections. No history of live vaccine administration 6 weeks prior to receiving Xeljanz. Not on any concurrent biologic DMARD therapy For continued therapy: Documentation of response to Xeljanz must be provided with each request for extension of therapy that identifies improvement in the clinical signs and symptoms described Restricted to patients aged 18 years and older. Restricted to rheumatologists, immunologists. Initial approval for 3 months with extensions of up to 6 months intervals 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. Other XENAZINE All FDA-approved indications not otherwise excluded from Part D. Concomitant use with reserpine or use of reserpine within the past 20 days. Doses above 50mg per day in members who are poor metabolizers of CYP2D6. Doses above 100mg per day in any member. Members with liver disease. Uncontrolled or untreated depression Chart notes including: baseline and any subsequent total Chorea Score or the Unified Huntington s Disease Rating Scale (UHDRS), neurological exam, genetic testing confirming Huntington s disease. documentation of functional disability due to chorea symptoms from Huntington s disease. For continuation of therapy, total Chorea Score improved at least 3.5 units since initiating Xenazine therapy or the chorea has significantly improved. 18 years of age and older Restricted to Neurologists Initial approval for 3 months. Continuation of therapy up to six months XGEVA

All FDA-approved indications not otherwise excluded from Part D. Hyocalcemia Prevention of skeletal-related events in patients with multiple myeloma Patients with creatinine clearance of less than 30 ml/min Bone Metastasis from Solid Tumors: Radiologic report identifying bone metastases from solid tumors Giant Cell Tumor of Bone: Histologically confirmed measurable giant cell tumor of bone Tumor is unresectable or surgical resection is likely to result in severe morbidity For extension of therapy-documentation identifying continued clinical benefit and no evidence of osteonecrosis or uncontrolled hypocalcemia. Other Oncologists Initial approval 3 months with extensions for remainder of contract year Documentation of intolerance, failure or contraindication to injectable bisphosphonates indicated for bone metastases. Xgeva may be covered under Medicare Part B or D depending upon the circumstances. When covered under Part B, Xgeva is not covered under Part D. Information may need to be submitted describing the use and setting of the drug to make the determination. XIFAXAN All FDA-approved indications not otherwise excluded from Part D Hepatic encephalopathy. Diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli. Prophylactic use. Travel purposes. Diverticular disease.

Diagnosis of active non-invasive travelers diarrhea. Moderate to severe distressing symptoms of travelers diarrhea are present and proven or strongly suspected to be caused by Escherichia coli based upon symptoms and travel destination. (When culture and susceptibility information are available, culture must identify E. coli and susceptible to rifaximin.) Ordering no more than 9 tablets. Other Must be at least 12 years of age Three days. XTANDI All FDA-approved indications not otherwise excluded from Part D. Pregnancy Documentation provided supporting the diagnosis of metastatic castration-resistant prostate cancer in patients who have progressed or are resistant to docetaxel treatment. The following documentation must be provided: Diagnosis of prostate cancer by histologic or cytologic evidence. Diagnosis of metastatic prostate cancer by radiographic evidence. Castrate levels of testosterone less than 50 ng/dl (0.5 ng/ml). Previous treatment with docetaxel containing regimens. Concomitant use of ADT (androgen deprivation therapy) only. No other concomitant chemotherapy agents noted. Requested dose does not exceed package label of 160mg (4 capsules) per day. No history of seizure. No predisposing factor for seizure. Must be 18 years of age or older. Oncologist or Urologist Remainder of the contract year.

Other Other XYREM All FDA-approved indications not otherwise excluded from Part D. The use of Xyrem may be considered medically necessary when the medical information provided documents the following: Definitive diagnosis of narcolepsy based upon objective sleep studies, AND Quantitatively documented symptoms of excessive daytime sleepiness and/or cataplexy, AND No history of GHB abuse, AND No concomitant use with sedative hypnotics (including anxioloytics) or CNS depressants and daily dose of Xyrem does not exceed 9 grams. Continued therapy will be considered based on demonstrated response of decreasing cataplexy events and improvement in score for appropriate test (e.g. Epworth Sleepiness Scale, Clinical Global Impression of Change, etc.) for EDS. at least 16 years old Registered with the Xyrem Success Program. Initial approval: up to 3 months. Continued therapy: remainder of contract year. Documented intolerance, contraindication, or failure of a 1 month trial of the following: For excessive daytime sleepiness (EDS) modafinil 200mg daily or armodafinil 150mg daily, AND formulary amphetamine product YERVOY FDA-approved indications not otherwise excluded from Part D.

Other 1. Persistent moderate adverse reactions or inability to reduce corticosteroid dose to 7.5mg of prednisone or prednisone equivalent per day while on Yervoy, 2. Failure to complete full treatment course within 16 weeks from administration of first dose 3. Severe or life-threatening adverse reactions, including any of the following: a. Colitis with abdominal pain, fever, ileus, or peritoneal signs. increase in stool frequency (7 or more over baseline), stool incontinence, need for intravenous hydration for more than 24 hours, gastrointestinal hemorrhage, and gastrointestinal perforation, b. AST or ALT greater than 5 times the upper limit of normal or total bilirubin greater than 3 times the upper limit of normal, c. Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations, d. Severe motor or sensory neuropathy, Guillain-Barré syndrome, or myasthenia gravis e. Severe immune-mediated reactions involving any organ system, f. Immune-mediated ocular disease that is unresponsive to topical immunosuppressive therapy, 4. Serious underlying autoimmune disorder or receiving systemic immunosuppression therapy for organ transplantation, 5. More than one course of treatment (4 doses) (retreatment) without supporting documentation that meets the Experimental or Investigational Procedures Policy. Yervoy may be considered medically necessary when the following criteria are met: 1. Documented diagnosis of unresectable or metastatic melanoma of a. Stage III (clinically positive nodes and/or in-transit disease), b. Stage IV (distant metastatic disease), 2. ECOG performance status 0-1. Must be 18 years of age or older. Oncologist or dermatologist Up to 4 months ZALTRAP

FDA-approved indications not otherwise excluded from Part D. Other Documentation provided supporting the diagnosis of metastatic colorectal cancer (mcrc) resistant to or progression following an oxaliplatin-containing regimen. The following documentation must be provided: Diagnosis of colorectal cancer by histologic or cytologic evidence, Diagnosis of metastatic colorectal cancer by radiographic evidence, Documented resistance to or progression during treatment with or 6 months after receiving oxaliplatin-based combination chemotherapy, with or without prior bevacizumab, Concomitant use with 5-fluorouracil, leucovorin and irinotecan (FOLFIRI), Neutrophil count is at or above 1.5 x 10 9 /L. Must be 18 years of age or older. Oncologist or Gastroenterologist Remainder of contract year. ZELBORAF FDA-approved indications not otherwise excluded from Part D. Wild-type BRAF melanoma, Patient previously experienced severe dermatologic reactions on Zelboraf, Patient has a second appearance of Grade 4 adverse effect. Documentation of: Confirmation of BRAF V600E mutation-positive melanoma, AND Unresectable or metastatic melanoma Must be 18 years of age and older. Oncologists AND dermatologists. Remainder of contract year.

Other ZOHYDRO All FDA-approved indications not otherwise excluded from Part D. Increased strength and/or dosing frequency other than FDA-approved dosing Treatment of acute or post-operative pain Use as a prn (as needed) analgesic Presence of acute or severe bronchial asthma or hypercarbia Presence of significant respiratory depression Confirmed or suspected presence of paralytic ileus Other Documented persistent, moderate to severe pain that requires continuous, around-the-clock analgesia with an opioid for an extended period of time Documentation demonstrating patient is opioid-tolerant (opioid-tolerant defined as taking around-the-clock pain regimen consisting of at least 60mg oral morphine, 30mg oral oxycodone, 8mg oral hydromorphone, or another equianalgesic opioid regimen for at least one week) Previous opioid regimens used for the treatment of pain Restricted to 18 years of age and older. Oncologists and pain management specialists Initial 3 month approval, followed by extensions up to 12 months Documented intolerance or treatment failure with trials of two of the following long-acting opioid analgesics: 1. Oxycodone ER 2. Morphine ER 3. Oxymorphone ER If approved a quantity limit of 60 capsules per month will apply

Other ZYDELIG All FDA-approved indications not otherwise excluded from Part D. History of serious allergic reactions including anaphylaxis and toxic epidermal necrolysis Current chart notes documenting of one of the following: Relapsed Chronic Lymphocytic Leukemia Relapsed Follicular B-cell non-hodgkin Lymphoma Relapsed Small Lymphocytic Lymphoma Current liver function tests (LFTs) and bilirubin Previous treatments 18 years and older Oncologists 12 months Relapsed Chronic Lymphocytic Leukemia Must be used in combination with rituximab Must be used in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities Relapsed Follicular B-cell non-hodgkin Lymphoma Must have received at least two prior systemic therapies supported in the National Comprehensive Cancer Network guidelines Relapsed Small Lymphocytic Lymphoma Must have received at least two prior systemic therapies supported in the National Comprehensive Cancer Network guidelines ZYKADIA All FDA-approved indications not otherwise excluded from Part D.

Other Other Documentation of: Locally advanced or metastatic non-small cell lung cancer (NSCLC), AND Anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. 18 years and older Oncologists 12 months Documentation must be provided identifying failure or intolerance to Xalkori (crizotinib) ZYTIGA All FDA-approved indications not otherwise excluded from Part D Symptoms and biopsy confirming diagnosis of metastatic castration-resistant prostate cancer. Frequency/dose must be within the FDA approved labeling. Blood pressure must be under control at initiation and for continuation. Potassium must be within normal limits. For continuation of therapy: No severe hepatotoxicity has been noted. ALT has not exceeded 5 X ULN during treatment of Zytiga. AST has not exceeded 5 X ULN during treatment of Zytiga. Total bilirubin has not exceeded 3 X ULN. Must be 18 years of age or older. Oncologist Remainder of the contract year. Use in combination with prednisone. For patients with symptomatic disease-failure or significant adverse effects from docetaxel

treatment. ZYVOX (LINEZOLID) All FDA-approved indications not otherwise excluded from Part D. The use of linezolid will not be considered medically necessary for the following situations: 1. Infectious organism is not VRSA, or MRSA where first-line therapy has not failed or is contraindicated 2. Culture is result of colonization AND member is not experiencing symptoms of active infection 3. Infection other than pneumonia or skin/skin structure 4. Treatment of decubitis ulcers 5. Concomitant therapy with one of the following pharmacologic therapies: a. SSRI or SNRI, MAOI b. Myelosuppressive therapy Chart notes including: 1. Site of active infection of a. Vancomycin-resistant enterococci (VRE) infections, including cases of concurrent bacteremia, OR b. one of the following infections that is vancomycin-resistant or methicillin-resistent when vancomycin (or other sensitive antimicrobial) is contraindicated, has failed or is not tolerated: i. noscomial pneumonia ii. skin and skin structure infection, including diabetic foot infections, without concomitant osteomyelitis. iii. community-acquired pneumonia 2. Current or previous therapies and outcomes for current active infection, 3. Recent culture and sensitivity data identifying organism is only susceptible to linezolid 4. Infectious disease consultation recommending the use of linezolid, 5. Requested dose and duration of therapy, 6. Data to support the contraindication/intolerance to first-line therapies. 7. For parenteral linezolid, chart notes must indicate one of the following:

a. patient suffers from esophageal cancer and cannot swallow, b. patient has had recent head and neck irradiation and has severe mucositis and cannot swallow, c. radiologic reports indicating non-functional gastrointestinal tract (e.g. short gut syndrome). Other Restricted to infectious disease specialist. 28 days