Medicare Advantage Employer Group Plans

Medicare Advantage Employer Group Plans 2016 Prior Authorization and Step Therapy Updated: May 1, 2016 Health First Health Plans is an HMO plan with a Medicare Contract. Enrollment in Health First Health Plans depends on contract renewal. Y0089_MPINFO4918 (09/15) 1

ACTIMMUNE ACTIMMUNE PA Details Age Other Hypersensitivity to interferon gamma, E. coli derived proteins, or any component of the formulation. Diagnosis of chronic granulomatous disease or severe malignant osteoporosis. 6 months Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. 2

ACTIQ FentaNYL Citrate BUCCAL PA Details Age Other Management of acute or post-operative pain, including headache/migraine, dental pain, or use in the emergency room. Opioid non-tolerant patients. Diagnosis of cancer AND 1. Use is for breakthrough cancer pain, AND 2. Patient is opioid tolerant and taking at least 60 mg morphine/day, at least 25 mcg transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer, AND 3. Other formulary short-acting strong narcotic analgesic alternatives (other than fentanyl) have been ineffective, not tolerated, or contraindicated, AND 4. is registered in the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy Access program. 16 years or older Prescribed by an oncologist or pain specialist. 3 months 3

ADCIRCA ADCIRCA PA Details Age Other Receiving nitrate therapy (includes intermittent use). Diagnosis of pulmonary arterial hypertension WHO Group I with New York Heart Association (NYHA) Functional Class II or III symptoms. 18 years or older Cardiologist or Pulmonologist Through end of benefit year 4

ADEMPAS ADEMPAS PA Details Age Other Pregnancy. Concomitant administration with nitrates or nitric oxide donors (such as amyl nitrate) in any form. Concomitant administration with phosphodiesterase inhibitors, including specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or non-specific PDE inhibitors (such as dipyridamole or theophylline). Diagnosis of pulmonary arterial hypertension WHO group I with New York Heart Association Functional Class II or III AND diagnosis was confirmed by right heart catheterization OR Patient has a diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH, WHO group 4) AND patient has persistent or recurrent disease after surgical treatment (e.g., pulmonary endarterectomy) or has CTEPH that is inoperable AND female patients are enrolled in the ADEMPAS REMS program 18 years of age or older Through end of benefit year For renewal, medication was effective (i.e. improved 6 minute walk distance, oxygen saturation, etc.) 5

AFINITOR AFINITOR AFINITOR DISPERZ PA Details Age Other Diagnosis of one of the following: A)Advanced metastatic renal cell carcinoma and patient has failed therapy (disease progressed) with Sutent or Nexavar, or B)Pancreatic neuroendocrine tumors (pnet) that are unresectable, locally advanced or metastatic, or C)Renal angiomyolipoma with tuberous sclerosis complex (TSC) and patient does not require immediate surgery, or D)Advanced hormone receptor-positive, HER2- negative breast cancer and patient is a postmenopausal woman and patient has failed treatment with Femara or Arimidex and the medication will be used in combination with Aromasin, or E)Subependymal giant cell astrocytoma (SEGA) associated with TSC that requires therapeutic intervention but is not a candidate for curative surgical resection. 18 years of age or older for RCC, pnet, and renal angiomyolipoma with TSC. 1 year of age or older for SEGA. Through end of benefit year 6

ALDURAZYME ALDURAZYME PA Details Age Other Diagnosis of Hurler or Hurler-Scheie form of Mucopolysaccharidosis I (MPS I) or Diagnosis of Scheie form of MPS I with moderate to severe symptoms. Through end of benefit year 7

ALECENSA (ALECTINIB) ALECENSA PA Details Age Other Through end of benefit year 8

AMPYRA AMPYRA PA Details Age Other History of seizure. Moderate or severe renal impairment (creatinine clearance less than or equal to 50 ml/minute). Patient currently using any other forms of 4-aminopyridine. Diagnosis of multiple sclerosis AND patient is ambulatory (able to walk at least 25 feet) AND patient has walking impairment. Neurologist Initial: 1 month. Renewal: through end of benefit year. For renewal, documentation that walking speed has improved from baseline must be provided. 9

ANADROL-50 (OXYMETHOLONE) ANADROL-50 PA Details Age Other 1. Carcinoma of the prostate or breast in male patients. 2. Carcinoma of the breast in females with hypercalcemia, androgenic anabolic steroids may stimulate osteolytic resorption of bones. 3. Pregnancy 4. Nephrosis or the nephrotic phase of nephritis. 5. Severe hepatic dysfunction. Acquired Aplastic Anemia: 1. History of failure to erythropoietic stimulating agent, OR 2. Used in combination with antilymphocyte globulin or both antilymphocyte globulin and corticosteroid treatment. Hypoplastic Anemia: 1. Diagnosis of hypoplastic anemia due to myelotoxic drugs, AND 2. Failure to erythropoietic stimulating agent. Pure Red Cell Aplasia: Failure of immunosuppressive therapy. Anemia of Chronic Renal Failure: Failure to an erythropoietic stimulating agent. Preferred Erythropoietin Stimulating Agent: Procrit. Tablet should not replace correcting iron, folic acid, and vitamin B12. Through end of benefit year 10

APOKYN APOKYN PA Details Age Other Use with 5HT3-antagonist (e.g., ondansetron, granisetron, dolasetron, palonosetron, alosetron). Neurologist for initial prescription Through end of benefit year 11

APTIOM APTIOM PA Details Age Other Through end of benefit year 12

ARCALYST ARCALYST PA Details Age Other Diagnosis of cryopyrin-associated period syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and/or Muckle- Wells Syndrome (MWS). 12 years of age and older Prescribed by or in consultation with or recommendation of, an immunologist, allergist, dermatologist, rheumatologist, neurologist, or other medical specialist. Through end of benefit year Approve doses based on FDA labeling. 13

AVONEX AVONEX AVONEX PEN INTRAMUSCULAR* AVONEX PREFILLED INTRAMUSCULAR* PA Details Age Other Treatment of primary progressive MS is not covered. Combination therapy with a beta interferon product, Gilenya, Aubagio, Tecfidera, Tysabri or Copaxone is not covered. Diagnosis of relapsing form of multiple sclerosis OR diagnosis of first clinical episode and MRI features consistent with multiple sclerosis Through end of benefit year 14

BANZEL BANZEL ORAL SUSPENSION BANZEL ORAL TABLET 200 MG, 400 MG PA Details Age Other Banzel is not covered for members with the diagnosis of Familial Short QT syndrome Diagnosis of Lennox- Gastaut syndrome. Documentation of previous therapies and that the current medication regimen is inadequate to control disease. Must be 1 years of age or older Through end of benefit year Patient must be refractory to at least 2 of the following: Felbamate (Felbatol), Lamotrigine (Lamictal),Topiramate (Topamax), Valproic acid (Depakene),Divalproex sodium (Depakote) 15

BENLYSTA BENLYSTA INTRAVENOUS* SOLUTION RECONSTITUTED 120 MG PA Details Age Other Benlysta (belimumab) therapy is not considered medically necessary for members with the following concomitant conditions: severe active lupus nephritis, severe active central nervous system lupus, or in combination with other biologic products (examples include Humira, Enbrel, Remicade,Rituxan, Stelara, Cimzia, Kineret, Amevive, Orencia, Simponi, Actemra), including B-cell targeted therapies or intravenous (IV) cyclophosphamide. Benlysta (belimumab) will require prior authorization. This agent may beconsidered medically necessary when the following criteria are met:systemic Lupus Erythematosus (SLE). The member must have adiagnosis of active systemic lupus erythematosus (SLE).The membermust be auto-antibody positive in the absence of any drugs for SLEdefined as: ANA titer greater than or equal 1:80 or anti-dsdna levelgreater than or equal 30 I/mL.The member must be utilizing Benlysta(belimumab)in combination with standard treatment regimens for SLEwhich may include: corticosteroids (ex:prednisone), hydroxychloroquine,azathioprine. 18 years of age and older Through end of benefit year 16

BETASERON BETASERON SUBCUTANEOUS* KIT PA Details Age Other Treatment of primary progressive MS is not covered. Combination therapy with a beta interferon product, Gilenya, Aubagio, Tecfidera, Tysabri or Copaxone is not covered. Diagnosis of relapsing form of multiple sclerosis OR diagnosis of first clinical episode and MRI features consistent with multiple sclerosis. Through end of benefit year 17

BOSULIF BOSULIF PA Details Age Other is not provided in those that have the BCR-ABL1 T315I mutation and use of Bosulif in combination with other kinase inhibitors (for example sorafenib, sunitinib, etc.) Diagnosis of Philadelphia chromosome-positive chronic myelogenous leukemia AND disease is resistant or intolerant to prior therapy (such as Gleevec, Sprycel, or Tasigna). 18 years of age and older Hematologist/Oncologist 3 Months 18

BRINTELLIX BRINTELLIX PA Details Age Other Through end of benefit year 19

BUTALBITAL CONTAINING PRODUCTS Butalbital-Acetaminophen Butalbital-APAP-Caff-Cod ORAL CAPSULE 50-325-40-30 MG Butalbital-APAP-Caffeine ORAL CAPSULE Butalbital-APAP-Caffeine ORAL TABLET 50-325-40 MG Butalbital-Aspirin-Caffeine ORAL CAPSULE PA Details Age Other documentation of FDA-approved indication including physician indication for the continued use of the HRM (high risk medication) with an explanation of the specific benefit established with the medication, and how that benefit outweighs the potential risk. AND The physician must document the ongoing monitoring plan for the agent. AND The physician must document that patient counseling has and will continue to take place outlining the risks and potential side effects of the medication. AND trial and failure or contraindication to one preferred alternatives. Preferred alternatives include: NSAIDs such as ibuprofen. PA applies to patients 65 years or older Through benefit year 20

CANCIDAS CANCIDAS PA Details Age Other Diagnosis of one of the following: A)Empirical therapy for presumed fungal infections in febrile, neutropenic patients, or B)Treatment of candidemia and other Candida infections (intraabdominal abscesses, peritonitis and pleural space infections), or C)Treatment of esophageal candidiasis, or D)Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies (amphotericin B, itraconazole). 3 months of age or older 3 months 21

CAPRELSA CAPRELSA ORAL TABLET 100 MG, 300 MG PA Details Age Other Congenital long QT syndrome Diagnosis of symptomatic or progressive medullary thyroid cancer with unresectable locally advanced or metastatic disease. 18 years or older Oncologist or endocrinologist 3 Months 22

CARBAGLU CARBAGLU PA Details Age Other Through end of benefit year 23

CAYSTON CAYSTON PA Details Age Other Diagnosis of cystic fibrosis AND patient has evidence of P. aeruginosa in the lungs 7 years of age and older Through end of benefit year For renewal, Patient is benefiting from treatment (i.e. improvement in lung function [FEV1], decreased number of pulmonary exacerbations) 24

CINRYZE CINRYZE PA Details Age Other 13 years of age or older Must be prescribed by Dermatologist, Hematologist, or Allergist/Immunologist 3 months 25

COMETRIQ COMETRIQ (100 MG DAILY DOSE) COMETRIQ (140 MG DAILY DOSE) COMETRIQ (60 MG DAILY DOSE) PA Details Age Other Gastrointestinal perforation. Fistula. Severe hemorrhage. Diagnosis of progressive metastatic, medullary thyroid cancer. 18 years or older Oncologist/Hematologist 3 Months 26

COPAXONE COPAXONE SUBCUTANEOUS* PA Details Age Other Treatment of primary progressive MS is not covered. Combination therapy with a beta interferon product, Gilenya, Aubagio, Tecfidera, Tysabri or Copaxone is not covered. Diagnosis of relapsing-remitting multiple sclerosis OR diagnosis of first clinical episode with MRI features consistent with multiple sclerosis. Through end of benefit year 27

COTELLIC (COBIMETINIB) COTELLIC PA Details Age Other Through end of benefit year. 28

CYCLOSET CYCLOSET PA Details Age Other Diagnosis of type 2 diabetes mellitus Through end of benefit year Must use as an adjunct to diet and exercise. 29

CYRAMZA (RAMUCIRUMAB) CYRAMZA PA Details Age Other Oncologist 3 months Subject to Part D vs. Part B review. 30

CYSTAGON CYSTAGON PA Details Age Other Diagnosis of nephropathic cystinosis. 3 Months 31

DAKLINZA_PENDING CMS APPROVAL DAKLINZA PA Details Age Other Provider must submit medical records documenting the diagnosis of chronic hepatitis C with genotype and subtype, if applicable (i.e., genotype 3) AND submit medical records documenting viral load taken within 6 months of beginning therapy. 18 years of age and older Prescribed by, or in consultation with, a gastroenterologist, hepatologist, or infectious disease physician PENDING CMS APPROVAL: 12 to 24 weeks based on the AASLD treatment guidelines. 32

DARZALEX (DARATUMUMAB) DARZALEX INTRAVENOUS* SOLUTION 100 MG/5ML PA Details Age Other Through end of benefit year. 33

DELESTROGEN (ESTRADIOL INJECTION) DELESTROGEN INTRAMUSCULAR* OIL 10 MG/ML Estradiol Valerate INTRAMUSCULAR* OIL 20 MG/ML, 40 MG/ML PA Details Age Other Through benefit year. 34

DEMSER DEMSER PA Details Age Other Statement of diagnosis. Must have surgical resection planned, have a contraindication to surgery, or have malignant pheochromocytoma. For reauthorization: must have chart documentation from prescriber indicating improvement in condition. By or in consultation with endocrinologist or endocrine surgeon Initial: 90 days. Reauthorization: through end of benefit year. 35

DIFICID DIFICID PA Details Age Other Diagnosis of Clostridium difficile associated diarrhea (CDAD) with one of the following: A) Patient has mild to moderate CDAD and failure, contraindication or intolerance to oral Flagyl (metronidazole) and oral Vancocin (vancomycin), or B) Patient has severe CDAD. 18 years or older 10 Days 36

DRONABINOL Dronabinol PA Details Age Other Diagnosis of one of the following: A) Treatment of chemotherapyinduced nausea and vomiting refractory to conventional antiemetic agents (i.e. ondansetron, granisetron, dexamethasone, aprepitant), or B) Treatment of anorexia associated with weight loss in patients with HIV with documented trial and failure, contraindication, or intolerance to megestrol. 3 Months Dronabinol is subject to Part B vs. Part D review. Part B if related to cancer treatment and is a full replacement for IV antiemetic within 48 hours of cancer treatment. Part D if related to cancer treatment after the 48-hour period, or for any other medically accepted diagnosis. 37

ELITEK ELITEK INTRAVENOUS* SOLUTION RECONSTITUTED 1.5 MG PA Details Age Other Diagnosis of hyperuricemia in children and adults with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. 5 days Clinically documented failure of allopurinol. Rasburicase is indicated for only a single course of treatment. 38

EMCYT EMCYT PA Details Age Other Diagnosis of metastatic and/or progressive prostate cancer. 18 years or older 6 months 39

EMPLICITI (ELOTUZUMAB) EMPLICITI PA Details Age Other Through end of benefit year. 40

EMSAM EMSAM PA Details Age Other Pheochromocytoma. Patient is taking or will take any of the following: SSRIs, SNRIs, tricyclic antidepressants (TCAs), bupropion, buspirone, meperidine, tramadol, methadone, pentazocine, dextromethorphan, St. John's wort, mirtazapine, cyclobenzaprine, oral selegiline, other MAOIs, oxcarbazepine, carbamazepine, and/or sympathomimetic amines. Diagnosis of major depressive disorder, AND 1) Failure of at least two generic oral antidepressants from different classes(at least one should be from the following list: selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, mirtazapine, or bupropion unless contraindicated), AND 2) Patient had an adequate washout period (for patients previously on agents requiring a washout period), AND 3) Patients exceeding doses over 6mg/24 hours will be on a tyramine restricted diet (i.e. avoid aged/spoiled/fermented meat and cheese, tap beer, fava beans, or any foods with high amounts of tyramine). 12 years old and greater Prescription written by licensed psychiatrist Through end of benefit year 41

ENBREL ENBREL SUBCUTANEOUS* ENBREL SUBCUTANEOUS* KIT ENBREL SURECLICK SUBCUTANEOUS* PA Details Age Active serious infection (including tuberculosis). Diagnosis of one of the following: A) Moderate to severe rheumatoid arthritis and patient had an inadequate response to, intolerance to, or contraindication to at least one non-biologic disease modifying antirheumatic drugs (DMARD) and one NSAID for at least 3 consecutive months, or B) Moderate to severe polyarticular juvenile idiopathic arthritis and patient had an inadequate response, intolerance or contraindication to at least one DMARD and one NSAID for at least 3 consecutive months, OR C) Psoriatic arthritis and patient had an inadequate response, intolerance, or contraindication to methotrexate, or D) Ankylosing spondylitis and patient had an inadequate response, intolerance or contraindication to at least two NSAIDs, or E) Moderate to severe chronic plaque psoriasis (affecting more than 5% of body surface area or affecting crucial body areas such as the hands, feet, face, or genitals) and patient had an inadequate response, intolerance or contraindication to conventional therapy with to at least two of the following: phototherapy (including but not limited to Ultraviolet A with a psoralen [PUVA] and/or retinoids [RePUVA] for at least one continuous month or one or more oral systemic treatments (i.e. methotrexate, cyclosporine, acitretin, sulfasalazine) for at least 3 consecutive months. 2 years of age or older for JIA. 18 years of age or older for all other indications. Through end of benefit year 42

Other Preferred NSAIDs include: ibuprofen, naproxen, ketoprofen, meloxicam. Preferred DMARDs include: methotrexate, sulfasalazine, hydroxychloroquine, cuprimine, azathioprine, leflunomide. Patient has been tested for TB and latent TB has been ruled out or is being treated. Dosing as per FDA approved labeling. 43

ENTRESTO (SACUBITRIL/VALSARTAN) ENTRESTO PA Details Age Other Cardiologist Through end of benefit year 44

EPOETIN ALPHA PROCRIT INJECTION SOLUTION 10000 UNIT/ML, 2000 UNIT/ML, 20000 UNIT/ML, 3000 UNIT/ML, 4000 UNIT/ML, 40000 UNIT/ML PA Details Age Uncontrolled hypertension. Pure red cell aplasia that begins after ESA treatment. Pre-treatment hemoglobin level less than 10 g/dl AND Patient has adequate iron stores prior to initiation of therapy defined as ferritin more than 100 mcg/l or serum transferrin saturation greater than 20% AND other causes of anemia such as iron deficiency, folate deficiency or B12 deficiency, hemolysis, gastrointestinal bleeding, other active or occult bleeding, or underlying hematologic disease (such as sickle cell anemia, thalassemia, and porphyria) have been ruled out AND Diagnosis of one of the following: A) Anemia due to chronic kidney disease (CKD) with or without hemodialysis, OR B) Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy and two additional months of chemotherapy is anticipated, C) Treatment of anemic in a patient at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusion, D) Anemia in zidovudine-treated HIV infection with serum erythropoietin levels 500 munits/ml or less and zidovudine doses 4,200 mg/week or less. CKD - prescribed by a nephrologist or hematologist. Non-myeloid malignancies - prescribed by an oncologist/hematologist. Surgery - Prescribed by a surgeon. HIV - Prescribed by an infectious disease specialist. Initial: 3 months. Renewal: CKD-12 months, Non-myeloid cancers, HIV- 4 months. Surgery-3 months 45

Other For renewal of CKD (dialysis patients): Hb less than 11 g/dl or physician will decrease or interrupt dose. For renewal of CKD (non-dialysis patients): Hb less than 10 g/dl or physician will decrease or interrupt dose. For renewal of non-myeloid malignancies: Concurrent myelosuppressive chemotherapy and Hb is 12g/dL or less and there is measurable response after eight weeks (defined as an increase in Hb 1 g/dl or more or a reduction in red blood cell transfusion requirements). For renewal of zidovudine-treated HIV, Hb is 12g/dL or less AND Zidovudine dose remains 4,200 mg/week or less and there is a measurable response after eight weeks (defined as an increase in Hb or a reduction in RBC transfusion requirements or documented dose escalation [up to max of 300 units/kg/dose]). Subject to Part D versus Part B coverage determination. 46

ERIVEDGE ERIVEDGE PA Details Age Other Diagnosis of metastatic basal cell carcinoma OR Diagnosis of locally advanced basal cell carcinoma that has recurred following surgery or when the patient is not a candidate for surgery and radiation. 18 years or older 3 months 47

ERWINAZE ERWINAZE INJECTION PA Details Age Other Member has experienced any of the following with prior asparaginase therapy: serious hypersensitivity reactions, including anaphylaxis, serious pancreatitis, serious thrombosis, serious hemorrhagic events. Diagnosis of acute lymphoblastic leukemia AND Patient has a hypersensitivity to E. coli-derived asparaginase. 3 months 48

ESBRIET ESBRIET PA Details Age Other The patient has a diagnosis of idiopathic pulmonary fibrosis confirmed by a high resolution CT scan or biopsy AND the patient does not have evidence or suspicion of an alternative interstitial lung disease diagnosis AND liver function tests have been performed prior to start of therapy Prescribed by or in consultation with a pulmonologist Through benefit year For renewal, patient experienced stabilization from baseline or a less than 10 percent decline in force vital capacity AND the patient has not experienced AST or ALT elevations greater than 5 times the upper limit of normal or greater than 3 times the upper limit of normal with signs or symptoms of severe liver damage. 49

EXJADE EXJADE PA Details Creatinine clearance less than 40 ml/minute. Platelet count less than 50 x 109/L. Poor performance status. Severe (Child-Pugh class C) hepatic impairment. High-risk myelodysplastic syndromes. Advanced malignancies. Gastrointestinal ulceration or hemorrhage. Age 2 years of age or older for chronic iron overload due to transfusions. 10 years of age or older for chronic iron overload due to NTDT. Other 3 months 50

FARYDAK FARYDAK PA Details Age Other Through 2016 benefit year 51

FAZACLO CloZAPine ORAL TABLET DISPERSIBLE FAZACLO ORAL TABLET DISPERSIBLE 100 MG, 12.5 MG, 25 MG PA Details Age Other If the patient has any of the following contraindications: agranulocytosis, bone marrow suppression, coma, ileus, leukopenia, myocarditis or neutropenia, OR if the patient has CNS depression, dementia-related psychosis or uncontrolled epilepsy. A statement showing the patient is unwilling or unable to take tablets or capsules orally or at high risk for non-compliance AND is not receiving other tablets or capsules indicating that the patient can take nondissolvable tablets. Part of a clozapine registry. Through end of benefit year 52

FERRIPROX FERRIPROX ORAL TABLET PA Details Age Other Diagnosis of transfusional iron overload due to thalassemia syndromes AND patient has failed prior chelation therapy with Desferal or Exjade (failure is defined as a serum ferritin level greater than 2,500 mcg/l) or patient has a contraindication or intolerance to Desferal or Exjade AND Patient has an absolute neutrophil count greater than 1.5 x 109/L. Prescribed by a hematologist/oncologist or hepatologist Through benefit year For renewal, patient has experienced at least a 20% reduction in serum ferritin levels and has an absolute neutrophil count greater than 0.5 x 109/L 53

FIRAZYR FIRAZYR PA Covered Uses Age Other Details All FDA-approved indications not otherwise exluded for part D Initial: 1 month. Renewal: 90 days. 54

FORTEO FORTEO SUBCUTANEOUS* SOLUTION 600 MCG/2.4ML PA Details Age Other Because of an increased incidence of osteosarcoma, Forteo should not be prescribed for patients who are at increased baseline risk for osteosarcoma (including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, or prior radiation therapy involving the skeleton). Diagnosis of one of the following: A) Osteoporosis in a postmenopausal female, or B) Primary or hypogonadal osteoporosis in a male, or C) Osteoporosis associated with sustained systemic glucocorticoid therapy AND patient is considered to be at high-risk for fracture by meeting one or more of the following: 1) History of osteoporotic fracture, or 2) Multiple risk factors for facture (including older age, female gender, prior osteoporotic fracture, low body mass index, rheumatoid arthritis, smoker, alcohol intake more than 3 drinks/day, parental history of hip fracture, oral glucocorticoid therapy or patient ever took prednisone at a dose of 5 mg or higher ), or 3) Documented trial and failure of bisphosphonate and Prolia, or 4) Documented contraindication or intolerance to bisphosphonate therapy and Prolia. Patient has not received more than 2 years of therapy with Forteo. Initial: 1 year. Renewal: 1 year not to exceed 2 years of total therapy. Treatment failure is defined as documented continued bone loss after at least three months despite treatment with a bisphosphonate or Prolia. Note: Since the effects of long-term treatment with Forteo are not known at this time, therapy for more than 2 years duration is considered experimental and investigational. 55

FYCOMPA FYCOMPA ORAL TABLET 10 MG, 12 MG, 2 MG, 4 MG, 6 MG, 8 MG PA Details Age Other Through end of benefit year 56

GARDASIL GARDASIL GARDASIL 9 PA Details Covered Uses All FDA-approved indications not otherwise excluded from part D. Age Other Patient age Must be between 9 and 26 years of age Through end of benefit year Dosing 0.5 ml/dose IM. Give the first dose at an elected date, the second dose 2 months after the first, and the third dose 6 months after the first dose. The vaccine is not intended to be used for treatment of active external genital lesions. cervical, vulvar, vaginal, and anal cancers. CIN. VIN. VaIN. or AIN. 57

GATTEX GATTEX PA Details Age Active gastrointestinal malignancy (gastrointestinal tract, hepatobiliary, pancreatic), colorectal cancer, or small bowel cancer Diagnosis of short bowel syndrome AND patient is receiving specialized nutritional support (i.e. parenteral nutrition) 18 years of age or older Through end of benefit year Other For renewal, patient has a reduced need for parenteral support (20% reduction) after at least 6 months of therapy. 58

GILENYA GILENYA PA Details Age Other Recent (within the last 6 months) occurrence of: myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure. History or presence of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome, unless patient has a pacemaker. Baseline QTc interval greater than or equal to 500 ms. Receiving concurrent treatment with Class Ia or Class III anti-arrhythmic drugs (quinidine, procainamide, amiodarone, sotalol). Treatment of primary progressive MS is not covered. Combination therapy with a beta interferon product, Gilenya, Aubagio, Tecfidera, Tysabri or Copaxone is not covered. Diagnosis of a relapsing form of multiple sclerosis or diagnosis of first clinical episode with MRI features consistent with MS AND Patient will be observed for signs and symptoms of bradycardia in a controlled setting for at least 6 hours after the first dose. Through end of benefit year 59

GILOTRIF GILOTRIF PA Details Age Other Diagnosis of metastatic non-small cell lung cancer AND patient has known active epidermal growth factor receptor (EGFR) exon 19 deletions of exon 21 (L858R) substitution mutation as detected by an FDAapproved test or Clinical Laboratory Improvement Amendmentsapproved facility AND the medication will be used first-line. Through end of benefit year 60

GLEEVEC GLEEVEC ORAL TABLET 100 MG, 400 MG PA Details Age Other Diagnosis of one of the following: A) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), or B) Ph+ acute lymphoblastic leukemia (ALL), or C) Gastrointestinal tumor (GIST) where patient has documented c-kit (CD117) positive unresectable or metastatic malignant GIST or patient had resection of c-kit positive GIST and imatinib will be used as an adjuvant therapy, or D) Dermatofibrosarcoma protuberans that is unresectable, recurrent, or metastatic, or E) Hypereosinophilic syndrome or chronic eosinophilic leukemia, or F) Myelodysplastic syndrome or myeloproliferative disease associated with platelet-derived growth factor receptor gene rearrangements, or G) Aggressive systemic mastocytosis without the D816V c-kit mutation or with c-kit mutation or with c-kit mutational status unknown. 1 year of age or older - newly diagnosed CML in the chronic phase or newly diagnosed Ph+ ALL. 18 years of age or older for other indications. Through end of benefit year 61

HARVONI HARVONI PA Details Age Provider must submit medical records documenting the following: 1) medical diagnosis of Chronic Hepatitis C with labs documenting genotype and subtype, AND 2) medical records documenting viral load taken within 6 months of beginning therapy, AND 3) fibrosis score to confirm appropriate duration of treatment, AND 4) documentation of previous HCV therapies to confirm appropriate duration of treatment. Patient must be 18 years of age or older Prescribed by, a gastroenterologist, hepatologist, or infectious disease physician. 12 or 24 week duration depending on treatment history & cirrhosis status (see Other below) 62

Other Genotype 1a, 1b: A) Treatment-naïve with or without cirrhosis: 12 weeks, or B) Treatment-experienced (failed after PEG/ RBV or PEG/ RBV + HCV PI) without cirrhosis: 12 weeks, or C) Treatment-experienced (failed after PEG/RBV or PEG/RBV + HCV PI) with cirrhosis AND concurrent therapy with RBV: 12 weeks, or D) Treatment-experienced (regardless of previous response to PEG/ RBV or PEG/ RBV + HCV PI) with cirrhosis and is RBV ineligible or intolerant: 24 weeks, or E) Treatment experienced (experienced relapse after treatment with a Sovaldi containing regimen) without cirrhosis: 12 weeks with RBV, or F) Treatment experienced (experienced relapse after treatment with a Sovaldi containing regimen) with cirrhosis AND concurrent therapy with RBV: 24 weeks and RBV, or G) Decompensated cirrhosis and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma: 12 weeks with RBV, or H) Decompensated cirrhosis and may or may not be a candidate for liver transplantation including those with Hepatocellular Carcinoma and is RBV ineligible or intolerant: 24 weeks, or I) Decompensated cirrhosis who may or may not be eligible for a liver transplant and may or may not have Hepatocellular Carcinoma who failed a previous Sovaldi containing regimen: 24 weeks + RBV, or J) Post liver transplantation: 12 weeks with RBV, or K) Treatment naïve post liver transplantation and is RBV ineligible or intolerant: 24 weeks, or L) Post liver transplantation AND decompensated: 12 weeks with low dose RBV. Genotype 4: A) Treatment-naïve with or without cirrhosis: 12 weeks, or B) Treatmentexperienced (failure after PEG/RBV) with or without cirrhosis: 12 weeks, or C) Post liver transplantation: 12 weeks with RBV, or D) Treatmentnaïve post liver transplantation and is RBV ineligible or intolerant: 24 weeks, or E) Post liver transplantation AND has decompensated cirrhosis: 12 weeks with low dose RBV, or F) Decompensated cirrhosis who may or may not be eligible for a liver transplant and may or may not have Hepatocellular Carcinoma: 12 weeks with RBV, or G) Decompensated cirrhosis who may or may not be eligible for a liver transplant and may or may not have Hepatocellular Carcinoma and is RBV ineligible or intolerant: 24 weeks, or H) Decompensated cirrhosis who may or may not be eligible for a liver transplant and may or may not have Hepatocellular Carcinoma who failed a previous Sovaldi containing regimen: 24 weeks with RBV. Genotype 5: A) treatment-naïve with or without cirrhosis: 12 weeks, or B) treatment experienced (failure after PEG/RBV) with or without cirrhosis: 12 weeks. Genotype 6: A) treatment-naïve with or without cirrhosis: 12 weeks, or B)treatment experienced (failure after PEG/RBV) with or without cirrhosis: 12 weeks 63

HETLIOZ HETLIOZ PA Details Age Other Documented diagnosis of non-24-hour sleep-wake disorder (non-24) AND member is totally blind. 18 years of age and older Through end of benefit year 64

HRM - AMPHETAMINES Dexmethylphenidate HCl Methylphenidate HCl ER ORAL TABLET EXTENDEDRELEASE* 20 MG Methylphenidate HCl ORAL TABLET PA Details Age Other The drug is being prescribed for an FDA-approved indication AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older Through end of benefit year 65

HRM - ANTI-ARRHYTHMICS Disopyramide Phosphate ORAL PA Details Age Other The drug is being prescribed for an FDA-approved indication AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older. Through end of benefit year 66

HRM - ANTIHISTAMINES Clemastine Fumarate ORAL TABLET 2.68 MG Cyproheptadine HCl ORAL PHENADOZ SUPPOSITORY 12.5 MG PHENERGAN Promethazine HCl INJECTION Promethazine HCl ORAL SYRUP Promethazine HCl ORAL TABLET Promethazine HCl SUPPOSITORY PROMETHAZINE VC PLAIN PROMETHEGAN SUPPOSITORY 25 MG, 50 MG PA Details Age Other The drug is being prescribed for an FDA-approved indication AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older Through end of benefit year 67

HRM - ANTIPARKINSON AGENTS Benztropine Mesylate ORAL Trihexyphenidyl HCl PA Details Age Other The drug is being prescribed for an FDA-approved indicationand the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older Through end of benefit year 68

HRM - ANTIPSYCHOTICS Thioridazine HCl ORAL PA Details Age Other The drug is being prescribed for an FDA-approved indication AND the patient has tried and failed at least one non-hrm alternative (listed in OTHER CRITERIA) AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older Through end of benefit year Applies to New Starts only. Non-HRM alternatives include: quetiapine, risperidone, aripiprazole, asenapine, olanzapine, ziprasidone 69

HRM - BARBITURATES PHENobarbital ORAL ELIXIR PHENobarbital ORAL TABLET PA Details Age Other Verify the medication is being used for an FDA-approved diagnosisand the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years and older. Through end of benefit year 70

HRM - CALCIUM CHANNEL BLOCKERS, DIHYDROPYRIDINE NIFEdipine ORAL PA Details Age Other The drug is being prescribed for an FDA-approved indication AND the patient has tried and failed at least one non-hrm alternative (listed in OTHER CRITERIA) AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older Through end of benefit year Non-HRM alternatives include: extended-release nifedipine, nicardipine, amlodipine 71

HRM - CENTRAL NERVOUS SYSTEM, OTHER Meprobamate PA Details Age Other The drug is being prescribed for an FDA-approved indication AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older Through end of benefit year 72

HRM - ONCOLOGY Megestrol Acetate ORAL SUSPENSION 40 MG/ML Megestrol Acetate ORAL TABLET PA Details Age Other The drug is being prescribed for an FDA-approved indication AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older Through end of benefit year Applies to New Starts only. 73

HRM - ORAL AND TRANSDERMAL ESTROGENS AND PROGESTINS DUAVEE Estradiol ORAL Estradiol TRANSDERMAL Estradiol-Norethindrone Acet ORAL TABLET 1-0.5 MG MENEST PREMARIN ORAL PREMPHASE PREMPRO PA Details Age Other documentation of FDA-approved indication including physician indication for the continued use of the HRM (high risk medication) with an explanation of the specific benefit established with the medication, and how that benefit outweighs the potential risk. AND The physician must document the ongoing monitoring plan for the agent. AND The physician must document that patient counseling has and will continue to take place outlining the risks and potential side effects of the medication. AND trial and failure or contraindication to two preferred alternatives for established indication. Preferred alternatives include: Vasomotor symptoms of menopause: requires provider acknowledgement of HRM status, Vulvar or vaginal atrophy: Premarin cream, Osteoporosis: alendronate, ibandronate, raloxifene. PA applies to patients 65 years or older Through end of benefit year 74

HRM - PLATELET INHIBITORS Dipyridamole ORAL PA Details Age Other The drug is being prescribed for an FDA-approved indication AND the patient has tried and failed at least one non-hrm alternative (listed in OTHER CRITERIA) AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older Through end of benefit year A trial and failure of clopidogrel is required prior to approval of dipyridamole and ticlopidine. 75

HRM - SKELETAL MUSCLE RELAXANTS Cyclobenzaprine HCl ORAL TABLET 10 MG, 5 MG Methocarbamol ORAL PA Details Age Other The drug is being prescribed for an FDA-approved indication AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older Through end of benefit year Provider must attest to the risks and benefits of therapy and desire to prescribe muscle relaxant. The attestation can be verbal or written. 76

HRM - SULFONYLUREAS GlyBURIDE Micronized ORAL TABLET 1.5 MG, 3 MG, 6 MG GlyBURIDE ORAL TABLET 1.25 MG, 2.5 MG, 5 MG GlyBURIDE-MetFORMIN ORAL TABLET 1.25-250 MG, 2.5-500 MG, 5-500 MG PA Details Age Other The drug is being prescribed for an FDA-approved indication AND the patient has tried and failed at least one non-hrm alternative (listed in OTHER CRITERIA) AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older Through end of benefit year Non-HRM alternatives include: glimepiride, glipizide 77

HRM - TERTIARY TCAS Amitriptyline HCl ORAL ClomiPRAMINE HCl ORAL Doxepin HCl ORAL Imipramine HCl ORAL Perphenazine-Amitriptyline PA Details Age Other The drug is being prescribed for an FDA-approved indication AND the patient has tried and failed at least one non-hrm alternative (listed in OTHER CRITERIA) AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older Through end of benefit year Applies to New Starts only. Non-HRM alternatives include: nortriptyline, desipramine, trazodone, SSRIs (fluoxetine, paroxetine, citalopram, escitalopram), SNRIs (venlafaxine, duloxetine), mirtazapine, bupropion. 78

HUMIRA HUMIRA PEDIATRIC CROHNS START SUBCUTANEOUS* 40 MG/0.8ML, 40 MG/0.8ML (6 PACK) HUMIRA PEN SUBCUTANEOUS* HUMIRA PEN-CROHNS STARTER SUBCUTANEOUS* HUMIRA SUBCUTANEOUS* 10 MG/0.2ML, 20 MG/0.4ML, 40 MG/0.8ML PA Details Diagnosis of one of the following: A) Moderate to severe rheumatoid arthritis and inadequate response, intolerance, or contraindication to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs) (e.g., hydroxychloroquine [HCQ], sulfasalazine, methotrexate [MTX], leflunomide, azathioprine, cyclosporine) for at least 3 consecutive months, or B)Moderate to severe polyarticular juvenile idiopathic arthritis and inadequate response, intolerance or contraindication to one or more non-biologic DMARDs (e.g., HCQ, sulfasalazine, MTX, leflunomide, azathioprine, cyclosporine) for at least 3 consecutive months, or C) Psoriatic arthritis and inadequate response, intolerance, or contraindication to MTX, or D) Ankylosing spondylitis and inadequate response, intolerance or contraindication to one or more NSAIDs, or E)Moderate to severe chronic plaque psoriasis (affecting more than 5% of body surface area or crucial body areas such as the hands, feet, face, or genitals) and inadequate response, intolerance or contraindication to at least one of the following: phototherapy (including but not limited to Ultraviolet A with a psoralen [PUVA] and/or retinoids [RePUVA] for at least one continuous month or one or more oral systemic treatments (e.g., MTX, cyclosporine, acitretin, sulfasalazine) for at least 3 consecutive months, or F) Moderate to severe Crohn's disease and inadequate response, intolerance, or contraindication to two or more of the following: corticosteroids (e.g., prednisone, methylprednisolone) or non-biologic DMARDs (e.g., azathioprine, MTX, mercaptopurine), or G) Moderate to severe ulcerative colitis and inadequate response, intolerance or contraindication to two or more of the following: corticosteroids (e.g., prednisone, methylprednisolone), 5-ASA (i.e. mesalamine, sulfasalazine, balsalazide, olsalazine) or non-biologic DMARDs (azathioprine, MTX, mercaptopurine). 79

Age Other 2 years of age or older for JIA. 6 years of age and older for pediatric Crohn's disease. 18 years of age or older for all other indications. Through end of benefit year 80

IBRANCE IBRANCE PA Details Age Other Through benefit year 81

ICLUSIG ICLUSIG PA Details Age Other Diagnosis of one of the following: A) Chronic myelogenous leukemia (CML) and patient has tried and failed or has an intolerance to two firstline tyrosine kinase inhibitors OR patient has a known T315I mutation, or B) Philadelphia chromosome-positive acute lymphoblastic leukemia and the patient has tried and failed or had an intolerance to two previous tyrosine kinase inhibitors OR patient has a known T315I mutation. 18 years or older Prescribed by a hematologist/oncologist 3 Months 82

ILARIS ILARIS PA Details Age Other Authorized for patients 4 years of age and older with Cryopyrinassociated periodic syndromes or 2 years of age and older with Systemic juvenile idiopathic arthritis. Through end of benefit year 83

IMBRUVICA IMBRUVICA PA Details Age Other 3 Months 84

INCRELEX INCRELEX PA Details Age Other Closed epiphyses. Active or suspected malignancy. Diagnosis of one of the following: A) Severe primary IGF-1 deficiency, defined as height standard deviation score (SDS) less than or equal to -3.0 AND basal IGF-1 SDS less than or equal to -3.0 AND normal or elevated growth hormone, or B) Growth hormone deletion with development of neutralizing antibodies to growth hormone AND othercauses of IGF-1 deficiency (e.g., hypothyroidism, nutritional deficiencies, pituitary disorders, etc.) have been ruled out or corrected prior to initiating therapy. Pediatric endocrinologist 6 months to 1 year Not a substitute for GH treatment. For renewal, Patient had a minimum growth rate of at least 2 cm/year. 85

INLYTA INLYTA PA Details Age Other Diagnosis of advanced renal cell carcinoma AND patient failed one or more systemic therapies for renal cell carcinoma (e.g., sunitinib-, bevacizumab-, temsirolimus-, or cytokine-containing regimens) 18 years of age or older 3 months 86

INTRON A INTRON A INJECTION SOLUTION RECONSTITUTED 18000000 UNIT, 50000000 UNIT PA Details Age Type B viral Hepatitis (HBeAg positive): Serum HBsAg positive for at least six months, AND elevated serum ALT 2 times ULN or moderate to severe hepatitis or fibrosis on biopsy. Type B Viral Hepatitis (HBeAg negative) HBsAG positive for at least 6 months AND BHV DNA level of 2000 IU/ml or more than 11,200 copies/ml AND One of the following, persistent ALT 2 times UNL or moderate to severe hepatitis or fibrosis on biopsy. Documentation must be provided showing trial and failure to our preferred agent Peg-Intron. Chronic Hepatitis C: Positive HCV antibody and HCV RNA. Documentation must be provided showing trial and failure to our preferred agent Peg-Intron. Condyloma Acuminatum or Perianal Warts: Must have documentation of trial and failure to preferred alternative or intolerance/contraindication to preferred alternatives. For external perianal warts, condylox gel, for external genital warts, podofilox, or imiquimod. Hairy Cell Leukemia: documentation indicating diagnosis. Malignant Melanoma: Indicated as adjuvant to surgical treatment with malignant melanoma who are free of disease but at high risk for systemic recurrence, within 56 days of surgery. Follicular Lymphoma: Indicated for the initial treatment of clinically aggressive follicular Non-Hodgkins Lymphoma in conjunction with anthracyclinecontaining combination chemotherapy. Efficacy in patients with lowgrade, low-tumor burden follicular Non-Hodgkins Lymphoma has not been demonstrated. AIDS-Related Kaposis Sarcoma: Indicated for the treatment of selected patients. The likelihood of response to therapy is greater in patients who are without systemic symptoms, who have limited lymphadenopathy and who have a relatively intact immune system as indicated by total CD4 count. For Hepatitis B- age 1 or older, For Hepatitis C - age 3 or older, All other diagnoses- 18 years or older. 87

Other 1 year 88

INVEGA INVEGA ORAL TABLET EXTENDED RELEASE 24 HR* 1.5 MG, 3 MG, 6 MG, 9 MG INVEGA SUSTENNA Paliperidone ER ORAL TABLET EXTENDED RELEASE 24 HR* 1.5 MG, 3 MG, 6 MG, 9 MG PA Details Age Other Diagnosis of Schizophrenia AND documented treatment failure or intolerable side effects from treatment with two formulary antipsychotic medications such as risperidone, ziprasidone, quetiapine. 12 years and older Through end of benefit year 89

IRESSA (GEFITINIB) IRESSA PA Details Age Other Through end of benefit year. 90

ITRACONAZOLE Itraconazole ORAL PA Details Age Other 3 months 91

IXEMPRA KIT IXEMPRA KIT INTRAVENOUS* SOLUTION RECONSTITUTED 45 MG PA Details Age Other History of severe (CTC grade 3/4) hypersensitivity reaction to agents containing Cremophor EL or its derivatives. Neutrophils count less than 1500 cells/mm3 or a platelet count less than 100,000 cells/mm3. AST or ALT more than 2.5 times the upper limit of normal (ULN) or bilirubin more than 1 time the ULN when used in combination with capecitabine. Diagnosis of metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane or whose cancer is taxaneresistant and for whom further anthracycline therapy is contraindicated AND the medication will be used in combination with capecitabine. Diagnosis of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine AND the medication will be used as monotherapy. Oncologist 3 months. Continued approval based on lack of disease progression. Patient must have documented prior anthracycline and taxane use. 92

JAKAFI JAKAFI PA Details Age Other Diagnosis for treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia veramyelofibrosis and post-essential thrombocythemiamyelofibrosis AND lab work indicating a complete blood count and platelet count before initiating therapy AND recent lab work indicating complete blood count AND platelet count for a dosage adjustment. Lab work must indicate platelets are more than 50 x 109/L and dose must be less than 50 mg per day. No dose increases will be approved within 4 weeks of therapy and not more frequently than every 2 weeks. If no spleen reduction or symptom improvement after 6 months then discontinue the drug. 18 years or older 3 months 93

JUXTAPID JUXTAPID PA Details Age Pregnancy. Concomitant administration of moderate or strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinalvir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil, etc.). Moderate to severe liver impairment or active liver disease including unexplained persistent abnormal liver function tests. Dosage regimen above 60 mg per day. Diagnosis of homozygous familial hypercholesterolemia as evidenced by one of the following: A) genetic confirmation of 2 mutant alleles at the LDL receptor, ApoB, PCSK9, or autosomal recessive hypercholesterolemia (ARH) adaptor protein gene locus OR B) untreated/pre-treatment LDL greater than 500 mg/dl with at least one of the following: cutaneous or tendonous xanthoma before age 10 years, history of early vascular disease (men younger than 55 years, women younger than 60 years) on both sides fo the family if parenteral LDL levels are unknown, elevated LDL cholesterol levels before lipid-lowering therapy consistent with heterozygous FH in both parents where LDL levels are known: LDL cholesterol more than 250 mg/dl in a patient 30 years of age or older, LDL cholesterol greater than 220 mg/dl for patients 20 to 29 years of age, LDL cholesterol greater than 190 mg/dl in patients younger than 20 years AND Medication will be used as adjunct to a lowfat diet and other lipid-lowering treatments AND Patient has tried and had an inadequate response to the maximum tolerated dose of a high potency statin (e.g., atorvastatin, rosuvastatin), unless all statin are contraindicated 18 years of age and older Provider and patient must be registered in the Juxtapid REMS program Intial: 6 months, Reauthorization: through benefit year 94

Other For renewal, patient has responded to therapy with at least a 20% decrease in LDL levels from baseline 95

KALYDECO KALYDECO PA Details Age Other documentation of cystic fibrosis AND member has a G551D mutation in the CFTR gene AND member does not have a Homozygous F508del mutation in CFTR gene. Ivacaftor oral granules are approved in patients 2 years of age and older. Ivacaftor oral tablets are approved in patients 6 years of age and older. Endocrinologist or Pulmonologist Through end of benefit year 96

KINERET KINERET SUBCUTANEOUS* PA Details Age Other Evidence of infection. Use of TNF-blocking or other biologic agent in combination with anakinra. Statement of diagnosis. Must have negative tuberculosis skin test. Must have recent ANC. For Rheumatoid Arthritis (RA): must have moderately to severely active RA, must have adequate trial and failure of etanercept and adalimumab with inadequate response or significant side effects/toxicity unless contraindicated. For cryopyrin-associated periodic syndromes: must have neonatal-onset multisystem inflammatory disease, must have chart doc of diagnosis confirmed by genetic test (must have documentation of lab result confirming mutation in NLRP3 gene) or a clinical diagnosis (must have 2 of the following: urticarial rash, fever, epiphyseal or patellar overgrowth on radiography, ocular involvement, CNS involvement). For reauthorization: must have chart documentation from prescriber indicating improvement in condition and that ANC is being monitored consistently. RA: age 18 years or older. Neonatal-onset Multisystem inflammatory disease: no age restrictions. Rheumatologist Initial: 90 days. Reauth: through end of benefit year. 97

KORLYM KORLYM PA Details Age Other Pregnancy Category X and for patients who require concomitant treatment with systemic corticosteroids for serious medical conditions or illnesses (e.g., immunosuppression after organ transplantation). Stated diagnosis to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushings syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. Korlym should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushings syndrome. Do not exceed 20 mg/kg per day. 18 years and older Endocrinologist Through benefit year 98

KUVAN KUVAN ORAL TABLET SOLUBLE PA Details Age Other Diagnosis of phenylketonuria (PKU) and patient is and will be maintained on a phenylalanine-restricted diet. 1 month and older Initial: 2 months. Renewal: through end of benefit year For initial approval, Patient will have phenylalanine levels measured one week after starting therapy and periodically for up to two months of therapy to determine response. For renewal, patient has been determined to be a responder to therapy (i.e. phenylalanine levels have decreased by at least 30% from baseline) and phenylalanine levels will be measured periodically during therapy. 99

KYNAMRO KYNAMRO SUBCUTANEOUS* PA Details Age Other Moderate or severe hepatic impairment (Child-Pugh class B or C) or active liver disease, including unexplained persistent elevations of serum transaminases, known hypersensitivity to any component of this product. Diagnosis of homozygous familial hypercholesterolemia as evidenced by one of the following: A) genetic confirmation of 2 mutant alleles at the LDL receptor, ApoB, PCSK9, or autosomal recessive hypercholesterolemia (ARH) adaptor protein gene locus OR B) untreated/pre-treatment LDL greater than 500 mg/dl with at least one of the following: cutaneous or tendonous xanthoma before age 10 years, history of early vascular disease (men younger than 55 years, women younger than 60 years) on both sides of the family if parenteral LDL levels are unknown, elevated LDL cholesterol levels before lipid-lowering therapy consistent with heterozygous FH in both parents AND Medication will be used as adjunct to a low-fat diet and other lipid-lowering treatments AND Patient has tried and had an inadequate response to the maximum tolerated dose of a high potency statin (e.g., atorvastatin, rosuvastatin), unless all statin are contraindicated. 18 years and older Through benefit year 100

LENVIMA LENVIMA 10 MG DAILY DOSE LENVIMA 14 MG DAILY DOSE LENVIMA 20 MG DAILY DOSE LENVIMA 24 MG DAILY DOSE PA Details Age Other Through benefit year 101

LETAIRIS LETAIRIS PA Details Age Other Known or suspected pregnancy. Treat women of child-bearing potential only after a negative pregnancy test and treat only women who are using two reliable methods of contraception OR have had a tubal sterilization OR a Copper T 380A IUD or LNg 20 IUD inserted. Diagnosis of Pulmonary Arterial Hypertension (PAH) AND has WHO Group I PAH AND Patient has New York Heart Association (NYHA) Functional Class II or III AND pregnancy must be excluded prior to the start of therapy and will be prevented thereafter with two forms of reliable contraception in female patients of reproductive potential. Trial and failure of Revatio or Adcirca. 18 years and older 3 months Available only to those enrolled in the Letairis Education Access Program (LEAP). 102

LEUKINE LEUKINE INTRAVENOUS* PA Details Age Other Chemotherapy or radiotherapy within 24 hours or concomitantly, excess leukemic myeloid blasts in the bone marrow or blood (10% or greater), hypersensitivity to granulocyte-macrophage colony-stimulating factor (GM-CSF) or yeast-derived products, allergic or anaphylactoid reactions to the medication in the past. Diagnosis of one of the following: A) Patient has undergone allogeneic or autologous bone marrow transplant (BMT) and engraftment is delayed or failed and patient does not have excessive leukemic myeloid blasts in bone marrow/peripheral blood (more than 10%), or B) Patient is undergoing autologous peripheral-blood progenitor cell transplant to mobilize progenitor cells for collection by leukapheresis, or C) Medication will be used for myeloid reconstitution after an autologous or allogeneic BMT, or D) Patient has acute myeloid leukemia and administration will be after completion of induction chemotherapy. Oncologist or Hematologist Through end of benefit year This drug may be covered under Medicare Part B or D depending upon the circumstances. may need to be submitted describing the use and setting of the drug to make the determination. Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. 103

LIDODERM Lidocaine EXTERNAL PATCH 5 % PA Details Age Other Through end of benefit year 104

LONSURF (TIPIRACIL/TRIFLURIDINE) LONSURF PA Details Age Other Through end of benefit year. 105

LOTRONEX Alosetron HCl PA Details Age Initial therapy for Irritable Bowel Syndrome (IBS) in the male gender. Initial Therapy for Irritable Bowel Syndrome (IBS): 1. Confirmed diagnosis of IBS with diarrhea predominant symptoms for at least 6 months Reauthorization for Irritable Bowel Syndrome (IBS): 1. Recurrence of diarrhea predominant IBS, AND 2. documentation of positive clinical response while on Lotronex. 18 years of age or older must be specially trained gastrointestinal physician IBS Initial Therapy: 12 weeks Reauthorization: 6 months Other Initial Therapy for Irritable Bowel Syndrome (IBS): 1. Failure to both: a. An antispasmodic AND b. An anti-diarrhea agent. 106

LUMIZYME LUMIZYME PA Details Age Other 3 months 107

LUPRON LUPRON DEPOT INTRAMUSCULAR* KIT 11.25 MG, 22.5 MG, 3.75 MG, 30 MG, 45 MG, 7.5 MG LUPRON DEPOT-PED INTRAMUSCULAR* KIT 11.25 MG, 15 MG PA Details Age Pregnancy in patients with child-bearing potential. Breastfeeding. Undiagnosed abnormal vaginal bleeding. Diagnosis of one of the following: A) Advanced or metastatic prostate cancer (7.5 mg 1-month, 22.5 mg 3-month, 30 mg 4-month, & 45 mg 6- month depots only), or B) Endometriosis (3.75 mg 1-month & 11.25 mg 3-month depots only) AND 1. For initial authorization, patient has had an inadequate pain control response or has an intolerance or contraindication to one of the following: Danazol or combination [estrogen/progesterone] oral contraceptives or progestins, or 2. For retreatment course, patient is experiencing recurrence of symptoms after an initial course of therapy with leuprolide acetate and norethindrone acetate 5 mg daily will be coadministered, or C) Anemia due to uterine Leiomyomata (Fibroids) (3.75 mg 1-month &11.25 mg 3-month depots only) AND patient is preoperative AND has tried and had an inadequate response to monotherapy with iron AND patient will be receiving concomitant iron therapy while on leuprolide, or D) Central precocious puberty (Lupron Depot-Ped) AND submission of pubertal gonadal sex steroid levels (testosterone greater than 30 ng/dl, estradiol greater than 20 pg/ml AND a pubertal LH increase upon native GnRH stimulation AND pelvic ultrasound assessment (girls) is required for approval along with notes indicating premature development of secondary sexual characteristics at or before the age of 8 yrs in girls and 9 yrs in boys and significant advancement of bone age and/or a poor adult height prediction AND other causes of sexual precocity must be excluded. For precocious puberty: 11 years or less in males and 10 years or less in females, For Endometriosis 18 years or older Oncologist, Endocrinologist, or Gynecologist to prescribe Prostate cancer: through benefit year, Uterine Leiomyoma: 3 months, All other indications: 6 months 108

Other For endometriosis and uterine fibroids, patient will be using nonhormonal contraception during and for 12 weeks after therapy. 109

LYNPARZA LYNPARZA PA Details Age Other Through end of benefit year 110

MEKINIST MEKINIST PA Details Age Other Patients who have received prior BRAF-inhibitor therapy. Diagnosis of unresectable or metastatic melanoma, positive BRAF V600E or V600K mutation as detected by an FDA-approved test (THxID-BRAF Kit) or Clinical Laboratory Improvement Amendments (CLIA)-approved facility, and the patient has not received prior BRAF-inhibitor therapy. 18 years or older Oncologist 3 months 111

MODAFINIL Modafinil PA Details Age Other Clinical documentation of narcolepsy, obstructive sleep apnea, or shift work sleep disorder. Idiopathic hypersomnia-- approve if the diagnosis is confirmed by a sleep specialist physician or at an institution that specializes in sleep disorders (i.e., sleep center) Through end of benefit year 112

MOLINDONE MOLINDONE HCL PA Details Age Other Through end of benefit year. 113

NAGLAZYME NAGLAZYME PA Details Age Other Through end of benefit year 114

NATPARA NATPARA PA Details Age Other Because of the potential risk of osteosarcoma, recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone, has not been studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations or in patients with acute postsurgical hypoparathyroidism. Documented diagnosis of hypocalcemia secondary to hypoparathyroidism, AND hypocalcemia is not corrected by calcium supplements and active forms of vitamin D alone, AND member is concurrently taking a calcium supplement and an active form of vitamin D 18 years and older Through benefit year 115

NEULASTA NEULASTA SUBCUTANEOUS* PA Details Age Other For use as primary prophylaxis of febrile neutropenia (FN) in one of the following patients: A) Patient has a 20% or higher risk of FN based on chemotherapy regimen OR B) Patient has a less than 20% risk of developing FN based on chemotherapy regimen AND at least one of the following risk factors are present: 65 years or older, Poor performance status, Poor nutritional status, Previous episodes of febrile neutropenia, Extensive prior treatment including large radiation ports, Cytopenias due to bone marrow involvement by tumor, Administration of combined chemoradiotherapy, Presence of open wounds or active infections, Other serious comorbidities (including renal or liver dysfunction notably elevated bilirubin), or C) Patient is receiving a dose-dense chemotherapy regimen in breast cancer, small cell lung cancer, or non-hodgkin's lymphoma. Must be prescribed and followed by Oncologist 3 months and is renewable in situations where it continues to provide clinical benefit Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. Forward to clinical pharmacist to review. 116

NEUPRO NEUPRO PA Details Age Other Statment of diagnosis. For Parkinson's disease: must have adequate trial and failure of pramipexole or ropinirole. For Restless Legs Syndrome: must have moderate to severe dx, must have adequate trial and failure of pramipexole or ropinerole (defined as insufficient efficacy of pramipexole 0.5mg per day or ropinirole 4mg per day or intolerance to these meds) AND must have adequate trial and failure of gabapentin (defined as insufficient efficacy of gabapentin 1800mg per day or intolerance to med despite slow dose titration or contraindication). Through end of benefit year 117

NEXAVAR NEXAVAR PA Details Age Other Combination use with other tyrosine kinase inhibitors such as sorafenib, sunitinib. Squamous cell lung cancer being treated with carboplatin and paclitaxel. Diagnosis of one of the following: A) Advanced renal cell carcinoma, or B) Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment, or C) Unresectable hepatocellular carcinoma. Patient must be at least 18 years old or older. Initial: 3 months, Renewal: through end of benefit year w/ stable disease 118

NINLARO (IXAZOMIB) NINLARO PA Details Age Other Through end of benefit year. 119

NORTHERA NORTHERA PA Details Age Other 18 years of age or older Through benefit year For renewal, Patient does not have persistent or sustained supine hypertension (SBP more than 180 mmhg or DBP more than 110 mmhg), Patient does not have persistent or sustained standing or sitting hypertension (SBP more than 180 mmhg or DBP more than 110 mmhg), and Patient had improvement in symptoms of NOH. Sustained mean elevated blood pressure that persists for longer than 5 minutes after change in position. Persistent means elevated BP that occurs on more than one occasion on separate physician office visits 120

NUEDEXTA NUEDEXTA PA Details Age Other Through end of benefit year 121

NULOJIX NULOJIX PA Details Age Other Transplant recipients who are Epstein-Barr virus (EBV) seronegative or with unknown EBV serostatus. For prophylaxis of organ rejection in adults receiving kidney transplant, in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids, AND documentation of patient's EBV serostatus. 18 years of age or older Through end of benefit year Subject to Part B vs. Part D review. 122

NUVIGIL NUVIGIL PA Details Age Other Clinical documentation of narcolepsy, obstructive sleep apnea, or shift work sleep disorder. Patient must be at least 17 years or older Idiopathic hypersomnia-- approve if the diagnosis is confirmed by a sleep specialist physician or at an institution that specializes in sleep disorders (i.e., sleep center) Through end of benefit year 123

ODOMZO (SONIDEGIB) ODOMZO PA Details Age Other Through end of benefit year. 124

OFEV OFEV PA Details Age Other The patient has a diagnosis of idiopathic pulmonary fibrosis confirmed by a high resolution CT scan or biopsy AND the patient does not have evidence or suspicion of an alternative interstitial lung disease diagnosis AND liver function tests have been performed prior to start of therapy 18 years and older Prescribed by or in consultation with a pulmonologist Through benefit year For renewal, patient experienced stabilization from baseline or a less than 10 percent decline in force vital capacity AND the patient has not experienced AST or ALT elevations greater than 5 times the upper limit of normal or greater than 3 times the upper limit of normal with signs or symptoms of severe liver damage. 125

OMNITROPE OMNITROPE SUBCUTANEOUS* SOLUTION PA Details Age Other Through end of benefit year 126

ONCASPAR ONCASPAR INJECTION PA Details Age Other 3 months 127

ONFI ONFI ORAL SUSPENSION ONFI ORAL TABLET 10 MG, 20 MG PA Details Age Other Diagnosis of Lennox-Gastaut syndrome AND is being used as adjunctive therapy. 2 years and older Prescribed by or in consultation with a neurologist. Initial: 3 months, Renewal: through end of benefit year w/ stable disease 128

OPDIVO OPDIVO INTRAVENOUS* SOLUTION 40 MG/4ML PA Details Age Other Through end of benefit year 129

OPSUMIT OPSUMIT PA Details Age Other Pregnancy Documented diagnosis of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] group I). 18 years of age and older Inital: 6 months, Reauthorization: Through benefit year For renewal, medication was effective (i.e. improved 6 minute walk distance, oxygen saturation, etc.) 130

ORENCIA ORENCIA INTRAVENOUS* ORENCIA SUBCUTANEOUS* PA Details Age Other Do not coadminister abatacept with tumor necrosis factor (TNF) antagonists (i.e. Humira, Enbrel, Cimzia, Remicade, Simponi). Abatacept is not recommended for use concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra. 6 years of age or older Rheumatologist Through end of benefit year 131

OXANDROLONE Oxandrolone ORAL TABLET 10 MG, 2.5 MG PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Pregnancy Category X Statement indicating use to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight, and to offset the protein catabolism associated with prolonged administration of corticosteroids. Statement indicating use for orphan drug indication, short stature associated with Turner syndrome, constitutional delay of growth and puberty, moderate or severe acute alcoholic hepatitis, Duchenne and Becker muscular dystrophy. Initial Therapy for AIDS Wasting: Diagnosis of AIDS wasting/cachexia. For treatment of anorexia associated with weight loss in patients with HIV: 1. Patient is receiving AIDS anti-retroviral therapy AND 2. experienced as least a. 7.5% unintentional weight loss over 6 months b. 10% unintentional weight loss over 12 months c. 5% body cell mass (BCM) loss within 6 months d. BMI less than 20 kg/m2 e. BCM less than 35% male (less than 23% female) and a BMI less than27 kg/m2 AND 3. documentation of trial and failure, contraindication, or intolerance to megestrol at doses up to 800mg daily. HIV Wasting: 3 months. All other indications: Through the Benefit Year 132

PANRETIN PANRETIN PA Details Age Other Oncologist or HIV specialist Through end of benefit year 133

PEGYLATED INTERFERONS PEG-INTRON REDIPEN PEG-INTRON SUBCUTANEOUS* KIT 50 MCG/0.5ML PA Details Age Other Uncontrolled depression. Autoimmune hepatitis. Known hypersensitivity reactions (urticaria, angioedema, bronchoconstriction, anaphylaxis, or Stevens-Johnson syndrome) to alpha interferons or any of its components. Hepatic decompensation in cirrhotic patients. Diagnosis supporting FDA approved indication. All patients with hepatitis C or hepatitis B, peginterferon must be prescribed by an infectious disease physician, gastroenterologist, hepatologist, or a transplant physician or in consultation with these physicians 12 Weeks to 12 Months 134

PERJETA PERJETA PA Details Age Other Diagnosis of one of the following: A) HER2-positive metastatic breast cancer AND medication is being used in combination with trastuzumab and docetaxel AND Patient has not received prior anti-her2 therapy (e.g., trastuzumab) or chemotherapy for metastatic disease, or B) Neoadjuvant treatment of locally advanced, inflammatory, or early stage HER2-positive breast cancer (either greater than 2 cm in diameter or node positive) in combination with trastuzumab and docetaxel (as part of a complete treatment regimen for early breast cancer). 3 Months Pregnancy status will be verified prior to initiation of therapy AND females of reproductive potential will be advised of the risks of embryofetal death and birth defects, and the need for effective contraception during and after pertuzumab treatment. 135

POMALYST POMALYST PA Details Age Other Patient has a diagnosis of multiple myleoma and the patient has received two prior therapies, including Revlimid and Velcade unless the patient has a contraindication or intolerance to Revlimid or Velcade and the patient has demonstrated disease progression on or within 60 days of completion of last therapy. 3 Months, pharmacist, and patient must be enrolled in the Pomalyst REMS program. 136

POTIGA POTIGA ORAL TABLET 200 MG, 300 MG, 400 MG, 50 MG PA Details Age Other Statement of FDA approved indication for treatment as adjunctive therapy for partial-onset seizures. Through end of benefit year 137

PRALUENT_PENDING CMS APPROVAL PRALUENT PA Details Age Concurrent use of Praluent with Repatha (evolocumab injection for SC use), Juxtapid (lomitapide capsules) or Kynamro (mipomersen injection). The efficacy and safety of Repatha, Juxtapid and Kynamro in combination with Praluent have not been established. Clinical documentation (e.g., chart notes, laboratory values) required for "initial" authorization includes: 1. Documentation of one of the following diagnoses: A.) Heterozygous familial hypercholesterolemia (HeFH), OR B.) Atherosclerotic cardiovascular disease (ASCVD), AND 2. Documentation of any one of the following: a) Patient has been receiving at least 12 consecutive weeks of high intensity statin therapy and will continue to receive high-intensity statin at maximally tolerated dose, b) Patient is unable to tolerate high-intensity statin, c) Patient has been receiving at least 12 consecutive weeks of moderate-intensity statin therapy and will continue to receive a moderate-intensity statin d) Patient has a documented labeled contraindication to all statins, e)patient has experienced rhabdomyolysis or muscle symptoms with statin treatment f)patient has undergone a trial of statin rechallenge with another lowintensity statin with documented reappearance of muscle symptoms (only 2 trials of a statin can be required prior to the approval of a PCSK9). Clinical documentation required for "reauthorization" includes: 1. Patient continues to receive statin at maximally tolerated dose (unless patient has documented inability to take statins), 2. Submission of medical records documenting LDL-C reduction while on Praluent therapy. Greater than 18 years old Cardiologist, Endocrinologist, Lipid specialist Initial Authorization will be for 6 months. Reauthorization will be for 1 year. 138

Other PENDING CMS APPROVAL: A.) HeFH: The patient has a low-density lipoprotein cholesterol (LDL-C level) greater than or equal to 160 mg/dl (after treatment with antihyperlipidemic agents but prior to PCSK9 inhibitor therapy. B.) ASCVD: The patient has a low-density lipoprotein cholesterol (LDL-C) greater than or equal to 70 mg/dl (after treatment with antihyperlipidemic agents but prior to PCSK9 inhibitor therapy. ASCVD diagnosis is confirmed by one of the following: acute coronary syndromes, history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, peripheral arterial disease presumed to be of atherosclerotic origin. Examples of high-intensity statin therapy include atorvastatin 40-80 mg, Crestor (rosuvastatin) 20-40 mg. Examples of moderate-intensity statin therapy include atorvastatin 10-20 mg, Crestor (rosuvastatin) 5-10 mg, simvastatin greater than or equal to 20 mg, pravastatin greater than or equal 40 mg, lovastatin 40 mg, Lescol XL (fluvastatin XL) 80 mg, or fluvastatin 40 mg twice daily. Provider attestation is sufficient for defining statin intolerance. 139

PROMACTA PROMACTA PA Details Age Other Diagnosis of one of the following: A) Relapsed/refractory chronic immune (idiopathic) thrombocytopenic purpura (ITP) for greater than 6 months AND Baseline platelet count is less than 50,000/mcL AND Degree of thrombocytopenia and clinical condition increase the risk of bleeding AND Patient had an insufficient response, intolerance, contraindication to corticosteroids or immune globulin or inadequate response or contraindication to splenectomy, or B) Chronic hepatitis C and patient has thrombocytopenia defined as platelets less than 90,000/mcL for initiation (pre-treatment) of interferon therapy, or C) Severe aplastic anemia and patient has insufficient response to immunosupressive therapy. 18 years of age or older. 3 Months 140

PULMOZYME PULMOZYME PA Details Age Other Diagnosis of cystic fibrosis. Through end of benefit year Pulmozyme should be used in conjunction with standard therapies for CF. For renewal, Patient is benefiting from treatment (i.e. improvement in lung function [FEV1], decreased number of pulmonary exacerbations). 141

PURIXAN PURIXAN PA Details Age Other Through benefit year 142

QUNINE QuiNINE Sulfate ORAL PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other For malaria the authorization is for 7 days. For babesiosis the authorization is 10 days. 143

RAVICTI RAVICTI PA Details Age Other Acute hyperammonemia. N-acetylglutamate synthase (NAGS) deficiency Diagnosis of urea cycle disorder involving deficiencies of carbamoyl phosphate syntehtase (CPS), ornithine transcarbamoylase (OTC), or argininosuccinic acid synthetase (AAS) confirmed via enzymatic, biochemical, or genetic testing AND protein-restricted diet alone or amino acid supplements alone has been ineffective AND patient has tried and had an inadequate response, is intolerant, or has a contraindication to Buphenyl for at least 3 months AND patient will maintain a proteinrestricted diet while on therapy. 2 years of age or older Through benefit year 144

RELISTOR RELISTOR SUBCUTANEOUS* SOLUTION 12 MG/0.6ML PA Details Age Other Known or suspected mechanical gastrointestinal obstruction. On renewal, patient does not have severe or persistent diarrhea. Diagnosis of opioid-induced constipation with advanced illness (receiving palliative care) or with chronic noncancer pain AND 1) patient has used opioid medication for a minimum of 2 weeks, AND 2) is experiencing fewer than 3 bowel movements in a week or no bowel movement for longer than 2 days, AND 3) has tried and had an insufficient response with two (2) preferred alternative laxatives (lactulose, polyethylene glycol 3350 (PEG), Amitiza) OR a documented contraindication, allergy or intolerance to the preferred alternatives. 18 years and older 4 months (16 weeks) 145

REMICADE REMICADE PA Details is not provided for use of Remicade in combination with other biologics e.g., Enbrel, Kineret or Humira, etc Diagnosis of one of the following: A) Moderate to severe rheumatoid arthritis and patient had an inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying antirheumatic drugs (DMARDs)for at least 3 consecutive months and patient will be on concomitant methotrexate, or B) Ankylosing spondylitis and patient had an inadequate response, intolerance or contraindication to one or more NSAIDs, or C)Severe chronic plaque psoriasis (affecting more than 10% of body surface area or affecting crucial body areas such as the hands, feet, face, or genitals) and patient had an inadequate response, intolerance or contraindication to conventional therapy with at least one of the following: phototherapy (including but not limited to Ultraviolet A with a psoralen [PUVA] and/or retinoids [RePUVA] for at least one continuous month or one or more oral systemic treatments for at least 3 consecutive months, or D) Moderate to severe Crohn's disease and patient had an inadequate response, intolerance, or contraindication to conventional therapy with two or more of the following: corticosteroids or non-biologic DMARDs, or E) Fistulizing Crohn's disease, or F) Moderate to severe ulcerative colitis and patient had an inadequate response, intolerance or contraindication to conventional therapy with two or more of the following: corticosteroids, 5-ASA (i.e. mesalamine, sulfasalazine, balsalazide, olsalazine) or non-biologic DMARDs, or G) Psoriatic arthritis and patient had an inadequate response, intolerance or contraindication to methotrexate. Age 6 years of age or older for UC or Crohn's disease (non-fistulizing). 18 years of age or older for all other indications, including fistulizing Crohn's disease Rheumatologist, GI specialist, or Dermatologist should make initial diagnosis and prescription. Through end of benefit year 146

Other Patient has been tested for TB and latent TB has been ruled out or is being treated. 147

REPATHA_PENDING CMS APPROVAL REPATHA REPATHA SURECLICK PA Details Age Concurrent use of Repatha with Praluent (alirocumab injection for SC use), Juxtapid (lomitapide capsules) or Kynamro (mipomersen injection). The efficacy and safety of Praluent, Juxtapid and Kynamro in combination with Repatha have not been established. Clinical documentation (e.g., chart notes, laboratory values) required for "initial" authorization includes: 1. Documentation of one of the following diagnoses: A) Homozygous familial hypercholesterolemia (HoFH), B) Heterozygous familial hypercholesterolemia (HeFH), OR C) Atherosclerotic cardiovascular disease (ASCVD), AND 2. Documentation of any one of the following: a) Patient has been receiving at least 12 consecutive weeks of high intensity statin therapy and will continue to receive high-intensity statin at maximally tolerated dose, b) Patient is unable to tolerate high-intensity statin, c) Patient has been receiving at least 12 consecutive weeks of moderate-intensity statin therapy and will continue to receive a moderate-intensity statin d) Patient has a documented labeled contraindication to all statins, e)patient has experienced rhabdomyolysis or muscle symptoms with statin treatment, f)patient has undergone a trial of statin rechallenge with another lowintensity statin with documented reappearance of muscle symptoms (only 2 trials of a statin can be required prior to the approval of a PCSK9). Clinical documentation required for "reauthorization" includes: 1. Patient continues to receive statin at maximally tolerated dose (unless patient has documented inability to take statins), 2. Submission of medical records documenting LDL-C reduction while on Repatha therapy. HeFH,ASCVD: 18 years and older. HoFH: 13 years and older Cardiologist, Endocrinologist, Lipid specialist Initial Authorization will be for 6 months. Reauthorization will be for 1 year. 148

Other PENDING CMS APPROVAL: A) HoFH: Patient meets one of the following: a) Patient has genetic confirmation of two mutant alleles at LDLR, APOB, PCSK9 or LDLRAP1 gene locus OR b) Patient has an untreated LDL-C level greater than 500 mg/dl (prior to treatment with antihyperlipidemic agents) OR c) Patient has a treated LDL-C level greater than or equal to 300 mg/dl (after treatment with antihyperlipidemic agents but prior to agents such as Repatha, Kynamro, or Juxtapid OR d) Patient has clinical manifestations of HoFH (e.g., cutaneous xanthomas, tendon xanthomas, arcus cornea, tuberous xanthomas or xanthelasma B) HeFH: The patient has a low-density lipoprotein cholesterol (LDL-C level) greater than or equal to 160 mg/dl (after treatment with antihyperlipidemic agents but prior to PCSK9 inhibitor therapy. C) ASCVD: The patient has a low-density lipoprotein cholesterol (LDL-C) greater than or equal to 70 mg/dl (after treatment with antihyperlipidemic agents but prior to PCSK9 inhibitor therapy. ASCVD diagnosis is confirmed by one of the following: acute coronary syndromes, history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, peripheral arterial disease presumed to be of atherosclerotic origin. Examples of high-intensity statin therapy include atorvastatin 40-80 mg, Crestor (rosuvastatin) 20-40 mg. Examples of moderate-intensity statin therapy include atorvastatin 10-20 mg, Crestor (rosuvastatin) 5-10 mg, simvastatin greater than or equal to 20 mg, pravastatin greater than or equal 40 mg, lovastatin 40 mg, Lescol XL (fluvastatin XL) 80 mg, or fluvastatin 40 mg twice daily. Provider attestation is sufficient for defining statin intolerance. 149

REVLIMID REVLIMID PA Details Age Other Pregnancy (category X) Diagnosis of one of the following: A) Multiple myeloma and patient has received at least one prior therapy and medication will be used in combination with dexamethasone, or B) Diagnosis of transfusiondependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, or C) Mantle cell lymphoma and patient's disease has relapsed or progressed after trying at least two prior therapies (Velcade and one of the following: bendamustine, cladribine, fludarabine, rituximab) AND patient is enrolled in the RevAssist Program. 18 years and older Hematologist/oncologist. Registered in RevAssist. 3 Months 150

REXULTI (BREXPIPRAZOLE) REXULTI PA Details Age Other Through end of benefit year 151

SABRIL SABRIL PA Details Age Other Diagnosis of one of the following: A) Refractory complex partial seizures (CPS) AND has previously tried and failed two medications for the diagnosis of refractory complex partial seizures (i.e. carbamazepine, ethotoin, felbamate, fosphenytoin, gabapentin, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, phenytoin, pregabalin, primidone, tiagabine, topiramate, valproic acid, divalproex sodium, zonisamide), or B) Infantile spasms (IS) 10 years and older for CPS diagnosis. Children aged 1 month to 2 years old for IS. Neurologist registered with the SHARE program Through end of benefit year 152

SAMSCA SAMSCA PA Details Age Other Samsca not approved as an intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms. Samsca should not be initiated or re-initiated outside of a hospital setting. Serum sodium levels. Initial therapy for hyponatremia (hypervolemic and euvolemic): 1. Diagnosis of significant hyponatremia (euvolemic or hypervolemic), AND 2. Treatment has been initiated or re-initiated in a hospital setting prior to discharge. Reauthorization for hypervolemic and euvolemic hyponatremia: 1. Documentation of clinical benefit, AND 2. Treatment hasbeen initiated or re-initiated in a hospital setting prior to discharge. 1 month Documentation of trial and failure of fluid restriction required. 153

SANDOSTATIN SANDOSTATIN LAR DEPOT PA Details Age Other Diagnosis of one of the following: A) Acromegaly and patient had an inadequate response or cannot be treated with surgical resection, pituitary irradiation, and/or bromocriptine mesylate at maximally tolerated doses, or B) Metastatic carcinoid tumor requiring symptomatic treatment of severe diarrhea and flushing episodes, or C) Vasoactive intestinal peptide tumor requiring treatment of profuse watery diarrhea.acromegaly: Documentation of inadequate response to surgery and/or radiotherapy, or documentation that patient is not a candidate for surgery and/or radiotherapy. Reauthorization will require statement indicating growth hormone (GH) levels are stabilized at less than 5.0ng/mL and IGF-1 levels are normalized (male less than 1.9U/mL or female less than 2.2 U/mL) as matched by age and gender, or the patient has a documented clinical response defined by a reduction of tumor mass, a reduction in the signs and symptoms of acromegaly, or an improvement in significant comorbidities. Through end of benefit year For renewal of acromegaly, IGF-1 level has normalized or improved. For renewal of metastatic carcinoid tumor, patient has improvement in diarrhea and flushing episodes. For renewal of vasoactive intestinal peptide tumor, improvement in diarrhea episodes. 154

SEROSTIM SEROSTIM SUBCUTANEOUS* SOLUTION RECONSTITUTED 4 MG, 5 MG, 6 MG PA Details Age Other Acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure. Active malignancy. Active proliferative or severe non-proliferative diabetic retinopathy. Diagnosis of AIDS-wasting syndrome or cachexia (defined as unintentional weight loss of at least 10% of baseline weight) AND Treatment failure with or intolerance to dronabinol or megestrol AND Patient is currently receiving treatment with antiretrovirals. 3 months initial, renewable every 6 months For renewal, patient has experienced an increase in body weight and/or improvement in lead body mass AND wasting is still evident. 155

SIGNIFOR SIGNIFOR PA Details Age Other Documentation of Cushing's Disease diagnosis AND pituitary surgery is not an option or has not been curative Through benefit year For renewal, patient had a clinically meaningful reduction in 24-hour urinary free cortisol levels and/or improvement in signs or symptoms of the disease 156

SIGNIFOR LAR SIGNIFOR LAR PA Details Age Other Documented diagnosis of acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option 18 years of age and older Through benefit year For renewal, patient's growth hormone level or insulin-like growth factor 1 (IGF-1) level for age and gender has normalized/improved. 157

SILDENAFIL 20 MG (REVATIO) Sildenafil Citrate ORAL PA Details Age Other Should not be used in combination with organic nitrates. Statement of FDA approved diagnosis of pulmonary arterial hypertension 18 years and older Cardiologist or Pulmonologist Through end of benefit year This product is only indicated for Pulmonary Hypertension and is not to be used for Erectile Dysfunction. 158

SIRTURO SIRTURO PA Details Age Other Concomitant use with a systemic strong CYP3A4 inhibitor for longer than 14 days. Concomitant use with a strong CYP3A4 inducer. Bedaquiline should not be used for latent, extrapulmonary (eg, CNS), or drug-sensitive TB, or non-tb mycobacteria. Diagnosis of pulmonary multidrug-resistant tuberculosis (MDR-TB). Bedaquiline should only be used in combination with at least 3 other drugs to which the patient's MDR-TB isolate has been shown to be susceptible in vitro. If in vitro testing results are unavailable, treatment may be initiated with bedaquiline in combination with at least 4 other drugs to which the patient's MDR-TB isolate is likely to be susceptible. Isolates from patients who fail to convert or relapse following treatment should be tested for bedaquiline minimum inhibitory concentrations. 18 years and older 24 weeks Use for more than 24 weeks should be evaluated on a case-by-case basis. Bedaquiline should be administered by directly observed therapy (DOT). Throughout treatment with, and following the last dose, patients should continue to take their companion drugs as directed. 159

SOMATULINE SOMATULINE DEPOT PA Details Age Other Diagnosis of A) acromegaly AND Inadequate response to surgery and/or radiation therapy or patient cannot be treated with surgery and/or radiotherapy, or B) unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 18 years of age and older 3 months initial. Continuation 6 months if no progression For renewal, patient's IGF-1 levels has normalized or improved. 160

SORIATANE Acitretin PA Details Age Other Severely impaired liver or kidney function. Chronic abnormally elevated blood lipid values. Concomitant use of methotrexate or tetracyclines. Pregnancy. Females of child-bearing potential who intend to become pregnant during therapy or at any time for at least 3 years after discontinuing therapy. Females of child-bearing potential who will not use reliable contraception while undergoing treatment and for at least 3 years following discontinuation. Females of child-bearing potential who drink alcohol during treatment or for two months after cessation of therapy. Diagnosis of severe psoriasis. 18 years of age or older Through end of benefit year 161

SOVALDI (SOFOSBUVIR)_PENDING CMS APPROVAL SOVALDI PA Details Age Other Provider must submit medical records documenting the diagnosis of chronic hepatitis C with genotype and subtype, if applicable (i.e., genotype 1a, genotype 1b) AND submit medical records documenting viral load taken within 6 months of beginning therapy. 18 years of age and older Prescribed by, or in consultation with, a gastroenterologist, hepatologist, or infectious disease physician PENDING CMS APPROVAL: 12 to 24 weeks based on the AASLD treatment guidelines PENDING CMS APPROVAL: and coverage durations will be applied consistent with current AASLD/IDSA guidance 162

SPRYCEL SPRYCEL PA Details Age Other Diagnosis of one of the following: A) Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, or B) Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML AND failure, resistance, or intolerance to imatinib, or C) Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) with resistance or intolerance to imatinib. 18 years or older must be an oncologist. Through end of benefit year 163

STIVARGA STIVARGA PA Details Age Other Diagnosis of one of the following: A) Metastatic colorectal cancer AND patient has previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based therapy, an anti-vascular endothelial growth factor (VEGF) therapy, and, if KRAS wild type, an anti-epidermal growth factor receptor (EGFR) therapy, or B) Gastrointestinal stromal tumors that is locally advanced, unresectable or metastatic and patient has tried and had an inadequate response, contraindication or intolerance to Gleevec or Sutent. 18 years and older Oncologist 3 Months Hepatic function will be monitored prior to and during treatment and, if patient has elevated liver function tests of hepatocellular necrosis, therapy will be interrupted and then reduced or discontinued. 164

SUCRAID SUCRAID PA Details Age Other 3 Months 165

SURMONTIL Surmontil Trimipramine Maleate ORAL PA Details Age Other 3 Months 166

SUTENT SUTENT PA Details Age Other Combination use with other kinase inhibitors (for example, sorafenib, etc). Diagnosis of one of the following: A) Advanced/metastatic renal cell carcinoma, or B) Gastrointestinal stromal tumors after disease progression on or intolerance to Gleevec, or C) Progressive, well-differentiated pancreatic neuroendocrine tumors in a patient with unresectable locally advanced or metastatic disease. Patient must be at least 18 years of age. Must be prescribed by oncologist 3 months initial, then renewable in 6 month increments 167

SYLATRON SYLATRON SUBCUTANEOUS* KIT 200 MCG, 300 MCG, 600 MCG PA Details Age Other Autoimmune hepatitis. Hepatic decompensation (Child-Pugh score greater than 6 [Class B or C]) Stated diagnosis from oncologist of treatment needed for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. 18 years or older Oncologist 3 months 168

SYNAGIS SYNAGIS INTRAMUSCULAR* SOLUTION 50 MG/0.5ML PA Details Age Other Through end of benefit year. 169

SYNRIBO SYNRIBO PA Details Age Other Diagnosis of chronic myelogenous leukemia (CML) AND patient has tried and failed or has a contraindication or intolerance to two prior tyrosine kinase inhibitor therapies [eg, Gleevec (imatinib),sprycel (dasatinib), Tasigna (nilotinib), Bosulif (bosutinib)]. 18 years of age or older Prescribed by a hematologist and/or oncologist 3 Months 170

TAFINLAR TAFINLAR PA Details Age Other Diagnosis of unresectable or metastatic melanoma along with BRAF V600E or BRAF V600K mutation status as detected by a US Food and Drug Administration-approved test. 18 years or older Oncologist 3 Months 171

TAGRISSO (OSIMERTINIB) TAGRISSO PA Details Age Other Through end of benefit year. 172

TARCEVA TARCEVA PA Details Age Other Diagnosis of one of the following: A) Locally advanced, unresectable, or metastatic pancreatic cancer and Tarceva will be used in combination with gemcitabine, or B) First-line treatment of metastatic non-small cell lung cancer in which tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an Food and Drug Administration (FDA)-approved test, or C) Maintenance treatment of locally advanced or metastatic non-small cell lung cancer when disease has not progressed after 4 cycles of platinumbased first-line chemotherapy, or D) Treatment of locally advanced or metastatic non-small cell lung cancer after failure of at least 1 prior chemotherapy regimen. 18 years or older must be an oncologist. Through end of benefit year 173

TASIGNA TASIGNA PA Details Age Other Long QT syndrome. Uncorrected hypokalemia. Uncorrected hypomagnesemia. Concomitant use with a drug known to prolong the QT interval or strong cytochrome P450 3A4 inhibitors. Diagnosis of one of the following: A) Newly diagnosed adult patients with Philadephia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase, or B) Ph+ chronic or accelerated phase chronic myeloid leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included imatinib. 18 years and older Must be prescribed by Oncologist Initial: 3 months, Renewal: 6 months with documentation of continued benefit 174

TECFIDERA TECFIDERA ORAL TECFIDERA ORAL CAPSULE DELAYED RELEASE PA Details Age Other Treatment of primary progressive MS is not covered. Combination therapy with a beta interferon product, Gilenya, Aubagio, Tecfidera, Tysabri or Copaxone is not covered. Diagnosis of relapsing forms of multiple sclerosis (relapsing-remitting MS or progressive-relapsing MS, or secondary-progresive MS) OR patient has experienced a first clinical episode and has MRI features consistent with multiple sclerosis. Through end of benefit year 175

TESTOSTERONE REPLACEMENT (INJECTIBLE) Testosterone Cypionate INTRAMUSCULAR* SOLUTION 100 MG/ML, 200 MG/ML Testosterone Enanthate INTRAMUSCULAR* SOLUTION PA Details Age Use in women. Men with carcinoma of the breast or known or suspected carcinoma of the prostate. Low testosterone due to aging (per FDA, this is not included in the indication of "idiopathic" hypogonadism). Clinical documentation (notes and lab results) of testosterone deficiency diagnosis based on FDA approved indication and monitoring for safety and efficacy of testosterone therapy: Clinical documentation required for "initial" authorization includes: 1) Documentation of FDA-approved indication as described under "Covered Use", AND 2) Written description of symptoms and signs relating to possible androgen deficiency, AND 3) At least two morning serum testosterone levels (free or total) below the normal range for the laboratory, AND 4) Baseline hematocrit must be less than 50%, AND 5) Prostate-specific antigen (PSA): a. Patients with palpable prostate nodule or induration or PSA more than 4 ng/ml or PSA more than 3 ng/ml in men at high risk of prostate cancer require urological evaluation prior to approval, and/or b. Men older than 40 years with baseline PSA more than 0.6 ng/ml will require prostate exam and PSA measurement prior to treatment approval, AND 6) Assessment of patient's past medical history (i.e. breast or prostate cancer, age, cardiovascular disease, liver disease, diabetes, age, obesity, obstructive sleep apnea, BPH) and documented discussion about the risks and benefits of testosterone therapy. Clinical documentation required for "reauthorization" includes: 1) Morning serum testosterone levels must be within normal range for the laboratory value at 3-6 months after initiating treatment (all levels outside of normal will require dose adjustment), AND 2)Hematocrit must be less than 54%, AND 3) Men older than 40 years with baseline PSA more than 0.6 ng/ml, will require prostate exam and PSA measurement at 3-6 months after treatment is initiated, AND 4) Re-assessment of patients past medical history and documented discussion about the risks and benefits of testosterone therapy 176

Other Initial: 6 months, Reauthorization: 1 year Replacement therapy in congenital or acquired conditions associated with a deficiency or absence of endogenous testosterone, such as: 1) Primary hypogonadism (congenital or acquired): Testicular failure caused by cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], LH) above the normal range. OR 2) Hypogonadotropic hypogonadism (congenital or acquired): Idiopathic gonadotropin or luteinizing hormone (LH)-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low serum testosterone concentrations but have gonadotropins in the normal or low range. The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man's symptoms seem related to low testosterone. We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. (FDA Drug Safety Communication (03-03-2015). Studies have suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. The Endocrine Society suggests it may be prudent to avoid testosterone therapy in men who have experienced a cardiovascular event (e.g., myocardial infarction [MI], stroke, acute coronary syndrome) in the past 6 months. These risks are currently under review by the FDA.The Endocrine Society recommends against starting testosterone therapy in patients with untreated severe obstructive sleep apnea, severe untreated BPH with International Prostate Symptom Score of more than 19, or uncontrolled or poorly controlled heart failure. 177

TESTOSTERONE REPLACEMENT TOPICAL ANDROGEL ANDROGEL PUMP TRANSDERMAL 12.5 MG/ACT (1%), 20.25 MG/ACT (1.62%) PA Details Age Use in women. Men with carcinoma of the breast or known or suspected carcinoma of the prostate. Low testosterone due to aging (per FDA, this is not included in the indication of "idiopathic" hypogonadism). Clinical documentation (notes and lab results) of testosterone deficiency diagnosis based on FDA approved indication and monitoring for safety and efficacy of testosterone therapy: Clinical documentation required for "initial" authorization includes: 1) Documentation of FDA-approved indication as described under "Covered Use", AND 2) Written description of symptoms and signs relating to possible androgen deficiency, AND 3) At least two morning serum testosterone levels (free or total) below the normal range for the laboratory, AND 4) Baseline hematocrit must be less than 50%, AND 5) Prostate-specific antigen (PSA): a. Patients with palpable prostate nodule or induration or PSA more than 4 ng/ml or PSA more than 3 ng/ml in men at high risk of prostate cancer require urological evaluation prior to approval, and/or b. Men older than 40 years with baseline PSA more than 0.6 ng/ml will require prostate exam and PSA measurement prior to treatment approval, AND 6) Assessment of patient's past medical history (i.e. breast or prostate cancer, age, cardiovascular disease, liver disease, diabetes, age, obesity, obstructive sleep apnea, BPH) and documented discussion about the risks and benefits of testosterone therapy. Clinical documentation required for "reauthorization" includes: 1) Morning serum testosterone levels must be within normal range for the laboratory value at 3-6 months after initiating treatment (all levels outside of normal will require dose adjustment), AND 2)Hematocrit must be less than 54%, AND 3) Men older than 40 years with baseline PSA more than 0.6 ng/ml, will require prostate exam and PSA measurement at 3-6 months after treatment is initiated, AND 4) Re-assessment of patients past medical history and documented discussion about the risks and benefits of testosterone therapy 18 years or older Endocrinologist, Urologist 178

Other Initial: 6 months, Reauthorization: 1 year Replacement therapy in congenital or acquired conditions associated with a deficiency or absence of endogenous testosterone, such as: 1) Primary hypogonadism (congenital or acquired): Testicular failure caused by cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], LH) above the normal range. OR 2) Hypogonadotropic hypogonadism (congenital or acquired): Idiopathic gonadotropin or luteinizing hormone (LH)-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low serum testosterone concentrations but have gonadotropins in the normal or low range. The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man's symptoms seem related to low testosterone. We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. (FDA Drug Safety Communication (03-03-2015. Studies have suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. The Endocrine Society suggests it may be prudent to avoid testosterone therapy in men who have experienced a cardiovascular event (e.g., myocardial infarction [MI], stroke, acute coronary syndrome) in the past 6 months. These risks are currently under review by the FDA. The Endocrine Society recommends against starting testosterone therapy in patients with untreated severe obstructive sleep apnea, severe untreated BPH with International Prostate Symptom Score of more than 19, or uncontrolled or poorly controlled heart failure. 179

THALOMID THALOMID PA Details Age Other Pregnancy (category X) Diagnosis of one of the following: A) Multiple myeloma that is newly diagnosed and is receiving concurrent dexamethasone, or B) Acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) AND the medication will not be used as monotherapy if the member has moderate to severe neuritis, or C) Maintenance therapy for prevention and suppression of cutaneous manifestations of ENL recurrence. Greater than 12 years Candidates must follow S.T.E.P. program requirements. Provider and pharmacy must be registered with this program. 3 months 180

TRACLEER TRACLEER PA Details Age Other Receiving concomitant cyclosporine A or glyburide therapy. Aminotransferase elevations are accompanied by signs or symptoms of liver dysfunction or injury or increases in bilirubin at least 2 times the upper limit of normal. Diagnosis of pulmonary arterial hypertension (PAH) WHO Group I AND New York Heart Association (NYHA) Functional Class II-IV AND 1. Patient does not have moderate-to-severe hepatic impairment or appropriate baseline liver function tests have or will be performed prior to the start of therapy for patients with mild hepatic impairment, AND 2. For female patients, pregnancy must be excluded prior to the start of therapy and will be prevented thereafter with reliable contraception. Greater than 12 years of age Available only to those enrolled in the Tracleer Access Program (T.A.P.). Prescription is written by or in consultation with a pulmonologist or cardiologist 3 Months Liver aminotransferases will be measured prior to initiation of treatment and then monthly. 181

TRISENOX TRISENOX PA Details Age Other Patient's APL must be characterized by the t(15:17) translocation or PML/RAR-alpha gene expression. Verification of translocation must be provided with request for coverage. Safety and efficacy have not been established in children less than 5 years of age. Prescription must be written for by Oncologist. 14 weeks, includes induction and consolidation treatment. 182

TYKERB TYKERB PA Details Age Other Diagnosis of breast cancer with tumors that overexpress human epidermal growth factor receptor 2 (HER2) AND 1. the medication will be used in combination with Xeloda in a patient with advanced or metastatic disease and the patient has received prior therapy including an anthracycline, a taxane, and trastuzumab, or 2) The medication will be used in combination with Femara for the treatment of a postmenopausal woman with hormone receptor-positive metastatic disease for whom hormonal therapy is indicated. 18 years or older Must be prescribed by Oncologist and Oncologist must monitor treatment Initial: 3 months, Renewal: 6 months with documentation of continued benefit 183

TYSABRI TYSABRI INTRAVENOUS* CONCENTRATE 300 MG/15ML PA Details Age Other Treatment of primary progressive MS is not covered. Combination therapy with a beta interferon product, Gilenya, Aubagio, Tecfidera, Tysabri or Copaxone is not covered. Diagnosis of one of the following: A) Relapsing form of multiple sclerosis and medication will be used as monotherapy and patient had an inadequate response, intolerance, or contraindication to conventional therapy with one of the following: An interferon beta product, Copaxone, Tecfidera, Gilenya, or B) Moderate to severe active Crohn's disease and medication will not be used in combination with immunosuppressants or inhibitors of tumor necrosis factor-alfa and patient had an inadequate response, intolerance, or contraindication to 5-aminosalicylic acid, glucocorticoid (budesonide ER), and at least one TNF-alpha (Humira, Remicade) therapy. Through end of benefit year 184

VALCHLOR VALCHLOR PA Details Age Other Documentated diagnosis of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skindirected therapy. Through benefit year 185

VANCOMYCIN Vancomycin HCl ORAL PA Details Age Other Diagnosis of A) Clostridium difficile-associated diarrhea, AND Stool culture report within the previous 30 days indicating positive C. difficile toxin, AND documented trial and failure or contraindication to preferred agent, metronidazole, or B) Staphylococcus aureus (including methicillinresistant strains)enterocolitis 14 days, Patients with multiple relapses: 6 weeks 186

VELCADE VELCADE INJECTION PA Details Age Other Hypersensitivity to bortezomib, boron, or mannitol. Medication will be given intrathecally. Diagnosis of A) multiple myeloma, or B) Relapsed or refractory mantle cell lymphoma Must be written for by an Oncologist Initial: 3 months, Renewal: 6 months with documentation of continued benefit 187

VERSACLOZ VERSACLOZ PA Details Age Other Refractory Schizophrenia/Schizoaffective Disorder: Versacloz will be approved upon receipt of physician statement that member requires the use of an atypical antipsychotic for the treatment of refractory schizophrenia that has failed to respond adequately to appropriate courses of standard formulary antipsychotic agents or to reduce the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder AND is intolerant to oral solutions or unable to swallow other oral formulations. Formulary antipsychotics include: clozapine (tablet), risperidone (orally disintegrating tablet, tablet, solution), quetiapine (tablet), and olanzapine (tablet). 18 years or older Part of a clozapine registry Through the benefit year 188

VIDAZA AzaCITIDine PA Details Age Other Advanced malignant hepatic tumor. Patient has a diagnosis of one of the following myelodysplastic syndrome subtypes: refractory anemia, refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, or chronic myelomonocytic leukemia. Vidaza must be prescribed by Hematologist or Oncologist. Initial approval 4 months. Continued approval based on response. 189

VIMPAT VIMPAT INTRAVENOUS* VIMPAT ORAL SOLUTION VIMPAT ORAL TABLET Vimpat ORAL TABLET PA Details Age Other Approved as adjunctive therapy in the treatment of partial seizures in patients with epilepsy. Documentation indicating current seizure drug regimen. 17 years of age or older Through end of benefit year Max dose 400mg/day 190

VORICONAZOLE Voriconazole ORAL PA Details Age Other Documentation of invasive aspergillosis, bronchopulmonary aspergillosis, candidemia and disseminated candidiasis in skin, abdomen, kidney, bladder wall and wounds, esophageal candidiasis, and serious Candida infections, infections caused by the emerging pathogens Scedosporium sp. and Fusarium sp., or rare and refractory fungal infections should be provided. Preferred alternative for Candida: oral fluconazole 12 years or older 6 months 191

VOTRIENT VOTRIENT PA Details Age Other Diagnosis of one of the following: A) Advanced/metastatic renal cell carcinoma, or B) Advanced soft tissue sarcoma and patient received at least one prior chemotherapy (e.g., doxorubicin, dacarbazine, ifosfamide, epirubicin, gemicitabine, docetaxel, or vinorelbine). 18 years of age and older Oncologist Initial: 3 months, Renewal: 6 months with documentation of continued benefit 192

XALKORI XALKORI PA Details Age Other Diagnosis of late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) with expression of the abnormal anaplastic lymphoma kinase (ALK) gene as detected by an FDA approved test. 18 years and older Oncologist 3 months 193

XENAZINE XENAZINE ORAL TABLET 12.5 MG, 25 MG PA Details Age Other Actively suicidal. Untreated or inadequately treated depression. Impaired hepatic function. Concomitant use of monoamine oxidase inhibitors. Concomitant use of reserpine or within 20 days of discontinuing reserpine. Diagnosis of chorea associated with Huntington's disease AND any medication possibly contributing to the underlying symptoms of chorea has been discontinued (e.g., antipsychotics, metoclopramide, amphetamines, methylphenidate, dopamine agonists, etc.) unless cessation would be detrimental to the underlying condition. Initial Therapy: 3 months. Reauthorization: through end of benefit year Should not be used in patients who have inadequately treated depression, or patients who are actively suicidal. 194

XGEVA XGEVA PA Details Age Other Hypocalcemia (calcium less than 8.0 mg/dl). Diagnosis of one of the following: A) Solid tumor (e.g., breast cancer, castrate-resistant prostate cancer, thyroid carcinoma, kidney, or non-small cell lung cancer) and patient has bone metastases and medication will be used for the prevention of skeletal-related events (e.g., spinal cord compression, hypercalcemia, bone pain or lesions requiring radiation or surgery), or B) Giant cell tumor of bone that is unresectable or surgical resection is likely to result in severe morbidity AND patient will receive supplementation with calcium and vitamin D, or C) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy (i.e. alendronate, ibandronate, risedronate). Through end of benefit year 195

XIFAXAN XIFAXAN ORAL TABLET 200 MG, 550 MG PA Details Allergy to rifamycin agents Diagnosis of traveler's diarrhea and patient does not have fever or blood in the stool OR Diagnosis of hepatic encephalopathy and tried and failed lactulose therapy Age Traveler's diarrhea: 12 years of age or older, Hepatic encephalopathy: 18 years of age or older Other Traveler's diarrhea: 3 days, Hepatic encephalopathy: 6 months 196

XOLAIR XOLAIR PA Details Age Other Diagnosis of A) moderate to severe persistent allergic asthma AND Evidence of specific allergic sensitivity confirmed by positive skin test (i.e. prick/puncture test) or blood test (i.e. radioallergosorbent test) for a specific IgE or in vitro reactivity to a perennial aeroallergen AND Pretreatment serum IgE levels greater than 30 and less than 700 IU/mL AND Symptoms are not adequately controlled with high-dose inhaled corticosteroid (ICS) plus long-acting beta2-agonist (LABA) for at least 3 months, or B) Treatment of chronic idiopathic urticaria in adults and adolescents 12 years and older who remain symptomatic despite H1 antihistamine treatment (i.e. loratidine, cetirizine, levocetirizine, fexofenadine, etc.). 12 years of age or older Initial drug order must be by an allergist/immunologist or a pulmonologist 6 months For renewal, patient has experienced an objective response to therapy, defined as one or more of the following: 1. Reduction in number of asthma exacerbations from baseline (i.e. asthma exacerbation requiring treatment with systemic corticosteroids or doubling of ICS dose from baseline), or 2. Improvement in forced expiratory volume in 1 second (FEV1) from baseline, or 3. Decreased use of rescue medications from baseline. 197

XTANDI XTANDI PA Details Age Other Diagnosis of metastatic castration-resistant prostate cancer AND the patient has tried and had an inadequate response, contraindication or intolerance to Zytiga. Oncologist or urologist 3 Months Must try and fail Zytiga first. 198

XYREM XYREM PA Details Age Other Contraindications: Patient is being treated with sedative hypnotic agents, other CNS depressants, or using alcohol. Patient has succinic semialdehyde dehydrogenase deficiency. Diagnosis of one of the following: A) Excessive daytime sleepiness in patients with narcolepsy AND 1. Submission of sleep study with narcolepsy diagnosis, AND 2. currently NOT taking any sedative hypnotics or other CNS depressants AND 3. has experienced inadequate response or intolerable side effects to two preferred products (modafinil, armodofinil, methylphenidate, or dextroamphetamine) AND 4. The requested dose does not exceed the FDA indicated maximum (9gm/night), or B) Cataplexy in patients with narcolepsy AND 1. Submission of sleep study showing narcolepsy diagnosis, AND 2. currently NOT taking any sedative hypnotics or other CNS depressants, AND 3. does not have sleep apnea, AND 4. The dose does not exceed the FDA indicated maximum (9gm/night). 18 years of age or older Initial: 3 months, Renewal: 6 months with documentation of continued benefit Patient and physician must adhere to all regulations of the Xyrem Success Program. For renewal, the patient had a positive response to the medication (increased sleep quality for patients with narcolepsy). 199

YERVOY YERVOY INTRAVENOUS* SOLUTION 50 MG/10ML PA Details Age Other Diagnosis of unresectable or metastatic melanoma AND If the request is for re-induction, the patient had no significant toxicity with the prior course of Yervoy AND the patient experienced progression after having stable disease for longer than three months or relapse after having a clinical response to therapy AND the prescriber is aware of the Yervoy REMS program. 16 weeks 200

ZALTRAP ZALTRAP INTRAVENOUS* SOLUTION 100 MG/4ML PA Details Age Other Severe hemorrhage, development of gastrointestinal perforation, compromised wound healing. Diagnosis of metastatic colorectal cancer AND will be used in combination with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) AND disease is resistant to or has progressed following an oxaliplatincontaining regimen. Oncologist 3 Months Patient will be monitored for signs and symptoms of gastrointestinal bleeding and other severe bleeding. Therapy will be suspended for at least 4 weeks prior to elective surgery and not resumed for at least 4 weeks following major surgery and until the wound is fully healed. 201

ZAVESCA ZAVESCA PA Details Age Other Pregnancy (category X) Diagnosis of mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option (e.g., due to constraints such as allergy, hypersensitivity, or poor venous access). 18 years or older Through end of benefit year Patients have been advised of the risk of fetal harm and the need for contraception. 202

ZELBORAF ZELBORAF PA Details Age Other Combination use with ipilimumab Diagnosis of unresectable or metastatic melanoma whose tumors express a gene mutation called BRAF V600E detected by an FDA approved test. Vemurafenib is not recommended for use in patients with wild-type BRAF melanoma. 18 years or older Oncologist 3 months 203

ZOMETA Zoledronic Acid INTRAVENOUS* CONCENTRATE PA Details Age Other Current treatment with Reclast. Diagnosis of one of the following: A) Hypercalcemia of malignancy and has a corrected calcium greater than or equal to 12 mg/dl, or B) Multiple myeloma and associated bone disease (e.g., osteolytic bone lesions, bone metastases, osteopenia, etc.), or C) Solid tumor (e.g., breast cancer, prostate cancer that has progressed after at least one hormonal therapy (i.e. antiandrogen [bicalutamide, flutamide, nilutamide], LHRH agonist [leuprolide, goserelin], LHRH antagonists [degarelix]), kidney cancer, non-small cell lung cancer, or thyroid cancer) and patient has bone metastases and medication will be used in conjunction with standard antineoplastic therapy and medication is used for the prevention of skeletal-related events (e.g. spinal cord compression, hypercalcemia, bone pain or lesions requiring radiation or surgery) AND Patient will be supplemented with calcium and vitamin D AND Patient has tried and had an inadequate response or has a contraindication/intolerance to pamidronate. 18 years and older Through end of benefit year This drug may be covered under Medicare Part B or D depending upon the circumstances. may need to be submitted describing the use and setting of the drug to make the determination. 204

ZYDELIG ZYDELIG PA Details Age Other Through end of benefit year. 205

ZYKADIA ZYKADIA PA Details Age Other 3 months 206

ZYTIGA ZYTIGA PA Details Age Other Diagnosis of metastatic prostate cancer AND Patient has castrationresistant disease (defined by tumor growth/disease progression, risk in PsA levels, new metastases) AND Zytiga will be used in combination with prednisone. 3 months 207

ZYVOX Linezolid ORAL ZYVOX ORAL SUSPENSION RECONSTITUTED PA Details Age Patients that are currently myelosuppressed due to any cause Culture and sensitivity reports verifying: 1. VRE infections within past 30 days. 2. Nosocomial pneumonia (MRSA) within past 30 days. 3. Nosocomial or CAP (MSSA or S. pneumoniae) within past 30 days and failure/resistance to 2 preferred antibiotics 4. Complicated SSI without osteomyelitis (MRSA) within past 30 days. 5. Uncomplicated SSI (MRSA) within past 30 days or empirical treatment of uncomplicated or community-acquired complicated SSI without osteomyelitis (MRSA likely) and failure/resistance to 2 preferred antibiotics. 6. Uncomplicated or complicated SSI without osteomyelitis (MSSA, S. pyogenes, or S. agalactiae (complicated SSI only)) within past 30 days and failure/resistance to 2 preferred antibiotics. Presribing physician must be an infectious disease specialist Non-MRSA nosocomial or community acquired pneumonia, SSI: 14 days Other uses: 28 days Other Nosocomial or community acquired pneumonia (MSSA or S. pneumoniae) preferred antibiotics: Amoxicilin/Clavulanate, Azithromycin, Cephalexin, Clarithromycin, Levaquin. Uncomplicated SSI (MRSA) or empirical treatment of patients with uncomplicated or community-acquired complicated SSI without osteomyelitis (MRSA likely) preferred antibiotics: Trimethoprim/sulfamethoxazole, Tetracycline, Doxycycline, Minocycline, Clindamycin. Uncomplicated or complicated SSI without osteomyelitis (MSSA, S. pyogenes, or S. agalactiae (complicated SSI only)) preferred antibiotics: Amoxicillin/clavulanate, Cephalexin, Ciprofloxacin, Clindamycin, Levaquin, Trimethoprim/Sulfamethoxazole, Dicloxacillin. 208

PART B VERSUS PART D ABELCET INTRAVENOUS* SUSPENSION 5 MG/ML ABRAXANE INTRAVENOUS* SUSPENSION RECONSTITUTED 100 MG Acetylcysteine INHALATION SOLUTION 10 %, 20 % Acyclovir Sodium INTRAVENOUS* SOLUTION 50 MG/ML ADAGEN INTRAMUSCULAR* SOLUTION 250 UNIT/ML ADRUCIL INTRAVENOUS* SOLUTION 500 MG/10ML A-HYDROCORT INJECTION SOLUTION RECONSTITUTED 100 MG Albuterol Sulfate INHALATION NEBULIZATION SOLUTION (2.5 MG/3ML) 0.083%, (5 MG/ML) 0.5%, 1.25 MG/3ML ALIMTA INTRAVENOUS* SOLUTION RECONSTITUTED 500 MG AMBISOME INTRAVENOUS* SUSPENSION RECONSTITUTED 50 MG Amifostine INTRAVENOUS* SOLUTION RECONSTITUTED 500 MG Aminophylline INTRAVENOUS* SOLUTION 25 MG/ML AMINOSYN II INTRAVENOUS* SOLUTION 10 %, 15 %, 7 %, 8.5 % Aminosyn II/Electrolytes INTRAVENOUS* SOLUTION 8.5 % AMINOSYN M INTRAVENOUS* SOLUTION 3.5 % Aminosyn/Electrolytes INTRAVENOUS* SOLUTION 8.5 % AMINOSYN-HBC INTRAVENOUS* SOLUTION 7 % AMINOSYN-PF INTRAVENOUS* SOLUTION 10 %, 7 % Amiodarone HCl INTRAVENOUS* SOLUTION 150 MG/3ML Amphotericin B INJECTION SOLUTION RECONSTITUTED 50 MG ARZERRA INTRAVENOUS* CONCENTRATE 100 MG/5ML AVASTIN INTRAVENOUS* SOLUTION 100 MG/4ML, 400 MG/16ML AZASAN ORAL TABLET 100 MG, 75 MG AzaTHIOprine ORAL TABLET 50 MG BELEODAQ INTRAVENOUS* SOLUTION RECONSTITUTED 500 MG Bleomycin Sulfate INJECTION SOLUTION RECONSTITUTED 30 UNIT Buprenorphine HCl INJECTION SOLUTION 0.3 MG/ML Calcitriol INTRAVENOUS* SOLUTION 1 MCG/ML CAPASTAT SULFATE INJECTION SOLUTION RECONSTITUTED 1 GM CARIMUNE NF INTRAVENOUS* SOLUTION RECONSTITUTED 6 GM CELLCEPT INTRAVENOUS INTRAVENOUS* SOLUTION RECONSTITUTED 500 MG CEREZYME INTRAVENOUS* SOLUTION RECONSTITUTED 400 UNIT ChlorproMAZINE HCl INJECTION SOLUTION 50 MG/2ML Chorionic Gonadotropin INTRAMUSCULAR* SOLUTION RECONSTITUTED 10000 UNIT CLINIMIX E/DEXTROSE (2.75/10) INTRAVENOUS* SOLUTION 2.75 % CLINIMIX E/DEXTROSE (2.75/5) INTRAVENOUS* SOLUTION 2.75 % CLINIMIX E/DEXTROSE (4.25/10) INTRAVENOUS* SOLUTION 4.25 % CLINIMIX E/DEXTROSE (4.25/25) INTRAVENOUS* SOLUTION 4.25 % CLINIMIX E/DEXTROSE (4.25/5) INTRAVENOUS* SOLUTION 4.25 % CLINIMIX E/DEXTROSE (5/15) INTRAVENOUS* SOLUTION 5 % CLINIMIX E/DEXTROSE (5/20) INTRAVENOUS* SOLUTION 5 % 209

CLINIMIX E/DEXTROSE (5/25) INTRAVENOUS* SOLUTION 5 % CLINIMIX/DEXTROSE (2.75/5) INTRAVENOUS* SOLUTION 2.75 % CLINIMIX/DEXTROSE (4.25/10) INTRAVENOUS* SOLUTION 4.25 % CLINIMIX/DEXTROSE (4.25/20) INTRAVENOUS* SOLUTION 4.25 % CLINIMIX/DEXTROSE (4.25/25) INTRAVENOUS* SOLUTION 4.25 % CLINIMIX/DEXTROSE (4.25/5) INTRAVENOUS* SOLUTION 4.25 % CLINIMIX/DEXTROSE (5/15) INTRAVENOUS* SOLUTION 5 % CLINIMIX/DEXTROSE (5/20) INTRAVENOUS* SOLUTION 5 % CLINIMIX/DEXTROSE (5/25) INTRAVENOUS* SOLUTION 5 % CLINISOL SF INTRAVENOUS* SOLUTION 15 % Cromolyn Sodium INHALATION NEBULIZATION SOLUTION 20 MG/2ML Cyclophosphamide ORAL CAPSULE 25 MG, 50 MG CycloSPORINE INTRAVENOUS* SOLUTION 50 MG/ML CycloSPORINE Modified ORAL CAPSULE 100 MG, 25 MG, 50 MG CycloSPORINE Modified ORAL SOLUTION 100 MG/ML CycloSPORINE ORAL CAPSULE 100 MG, 25 MG DAUNOXOME INTRAVENOUS* INJECTABLE 2 MG/ML Decitabine INTRAVENOUS* SOLUTION RECONSTITUTED 50 MG DEPO-PROVERA INTRAMUSCULAR* SUSPENSION 400 MG/ML Desmopressin Acetate INJECTION SOLUTION 4 MCG/ML Dexamethasone Sodium Phosphate INJECTION SOLUTION 10 MG/ML, 120 MG/30ML Dextrose INTRAVENOUS* SOLUTION 10 %, 5 % Digoxin INJECTION SOLUTION 0.25 MG/ML Diltiazem HCl INTRAVENOUS* SOLUTION 50 MG/10ML Diltiazem HCl INTRAVENOUS* SOLUTION RECONSTITUTED 100 MG DiphenhydrAMINE HCl INJECTION SOLUTION 50 MG/ML ELAPRASE INTRAVENOUS* SOLUTION 6 MG/3ML EMEND ORAL CAPSULE 125 MG, 40 MG, 80 & 125 MG, 80 MG ENGERIX-B INJECTION SUSPENSION 10 MCG/0.5ML, 10 MCG/0.5ML (0.5ML SYRINGE), 20 MCG/ML EPOGEN INJECTION SOLUTION 10000 UNIT/ML, 2000 UNIT/ML, 20000 UNIT/ML, 3000 UNIT/ML, 4000 UNIT/ML FABRAZYME INTRAVENOUS* SOLUTION RECONSTITUTED 35 MG Famotidine INTRAVENOUS* SOLUTION 20 MG/2ML FASLODEX INTRAMUSCULAR* SOLUTION 250 MG/5ML Fluorouracil INTRAVENOUS* SOLUTION 2.5 GM/50ML Furosemide INJECTION SOLUTION 10 MG/ML GAMMAGARD INJECTION SOLUTION 2.5 GM/25ML GAMUNEX-C INJECTION SOLUTION 1 GM/10ML Ganciclovir Sodium INTRAVENOUS* SOLUTION RECONSTITUTED 500 MG Gentamicin in Saline INTRAVENOUS* SOLUTION 0.8-0.9 MG/ML-%, 1-0.9 MG/ML- % Gentamicin Sulfate INJECTION SOLUTION 40 MG/ML Gentamicin Sulfate INTRAVENOUS* SOLUTION 10 MG/ML Granisetron HCl INTRAVENOUS* SOLUTION 0.1 MG/ML, 1 MG/ML Granisetron HCl ORAL TABLET 1 MG Heparin Sodium (Porcine) INJECTION SOLUTION 1000 UNIT/ML, 10000 UNIT/ML, 20000 UNIT/ML, 5000 UNIT/ML 210

HEPATAMINE INTRAVENOUS* SOLUTION 8 % HERCEPTIN INTRAVENOUS* SOLUTION RECONSTITUTED 440 MG HydrALAZINE HCl INJECTION SOLUTION 20 MG/ML Intralipid INTRAVENOUS* EMULSION 20 % INTRON A INJECTION SOLUTION 6000000 UNIT/ML INTRON A INJECTION SOLUTION RECONSTITUTED 10000000 UNIT Ipratropium Bromide INHALATION SOLUTION 0.02 % Ipratropium-Albuterol INHALATION SOLUTION 0.5-2.5 (3) MG/3ML Ketorolac Tromethamine INJECTION SOLUTION 15 MG/ML, 30 MG/ML KEYTRUDA INTRAVENOUS* SOLUTION 100 MG/4ML KEYTRUDA INTRAVENOUS* SOLUTION RECONSTITUTED 50 MG Labetalol HCl INTRAVENOUS* SOLUTION 5 MG/ML Leucovorin Calcium INJECTION SOLUTION RECONSTITUTED 100 MG, 350 MG Levoleucovorin Calcium INTRAVENOUS* SOLUTION 175 MG/17.5ML Lidocaine HCl (PF) INJECTION SOLUTION 0.5 % LINCOCIN INJECTION SOLUTION 300 MG/ML Lincomycin HCl INJECTION SOLUTION 300 MG/ML Linezolid INTRAVENOUS* SOLUTION 2 MG/ML Methadone HCl INJECTION SOLUTION 10 MG/ML Methotrexate Sodium (PF) INJECTION SOLUTION 1 GM/40ML Methotrexate Sodium INJECTION SOLUTION RECONSTITUTED 1 GM MethylPREDNISolone Acetate INJECTION SUSPENSION 40 MG/ML, 80 MG/ML MethylPREDNISolone Sodium Succ INJECTION SOLUTION RECONSTITUTED 125 MG, 40 MG Metoclopramide HCl INJECTION SOLUTION 5 MG/ML Metoprolol Tartrate INTRAVENOUS* SOLUTION 1 MG/ML MOZOBIL SUBCUTANEOUS* SOLUTION 24 MG/1.2ML MYCAMINE INTRAVENOUS* SOLUTION RECONSTITUTED 100 MG Mycophenolate Mofetil ORAL CAPSULE 250 MG Mycophenolate Mofetil ORAL SUSPENSION RECONSTITUTED 200 MG/ML Mycophenolate Mofetil ORAL TABLET 500 MG Mycophenolic Acid ORAL TABLET DELAYED RELEASE 180 MG, 360 MG MYFORTIC ORAL TABLET DELAYED RELEASE 180 MG, 360 MG NEBUPENT INHALATION SOLUTION RECONSTITUTED 300 MG NEPHRAMINE INTRAVENOUS* SOLUTION 5.4 % NEUPOGEN INJECTION 300 MCG/0.5ML, 480 MCG/0.8ML NEUPOGEN INJECTION SOLUTION 300 MCG/ML, 480 MCG/1.6ML Nitroglycerin INTRAVENOUS* SOLUTION 5 MG/ML Octreotide Acetate INJECTION SOLUTION 100 MCG/ML, 1000 MCG/ML, 200 MCG/ML, 50 MCG/ML, 500 MCG/ML Ondansetron HCl INJECTION SOLUTION 4 MG/2ML Ondansetron HCl ORAL SOLUTION 4 MG/5ML Ondansetron HCl ORAL TABLET 24 MG, 4 MG, 8 MG Ondansetron ORAL TABLET DISPERSIBLE 4 MG, 8 MG PACLitaxel INTRAVENOUS* CONCENTRATE 300 MG/50ML 211

Pamidronate Disodium INTRAVENOUS* SOLUTION 30 MG/10ML, 6 MG/ML, 90 MG/10ML PENTAM INJECTION SOLUTION RECONSTITUTED 300 MG PrednisoLONE Sodium Phosphate ORAL TABLET DISPERSIBLE 10 MG, 15 MG, 30 MG PREMARIN INJECTION SOLUTION RECONSTITUTED 25 MG PREMASOL INTRAVENOUS* SOLUTION 10 %, 6 % Procainamide HCl INJECTION SOLUTION 100 MG/ML PROCALAMINE INTRAVENOUS* SOLUTION 3 % PROGRAF INTRAVENOUS* SOLUTION 5 MG/ML PROLASTIN-C INTRAVENOUS* SOLUTION RECONSTITUTED 1000 MG PROLEUKIN INTRAVENOUS* SOLUTION RECONSTITUTED 22000000 UNIT Propranolol HCl INTRAVENOUS* SOLUTION 1 MG/ML PROSOL INTRAVENOUS* SOLUTION 20 % PROTONIX INTRAVENOUS* SOLUTION RECONSTITUTED 40 MG Ranitidine HCl INJECTION SOLUTION 150 MG/6ML RAPAMUNE ORAL SOLUTION 1 MG/ML RAPAMUNE ORAL TABLET 0.5 MG, 1 MG, 2 MG RECOMBIVAX HB INJECTION SUSPENSION 10 MCG/ML, 10 MCG/ML Details (1ML SYRINGE), 40 MCG/ML, 5 MCG/0.5ML REMODULIN INJECTION SOLUTION 1 MG/ML, 10 MG/ML, 2.5 MG/ML, 5 MG/ML Rifampin INTRAVENOUS* SOLUTION RECONSTITUTED 600 MG RITUXAN INTRAVENOUS* SOLUTION 500 MG/50ML Sirolimus ORAL TABLET 0.5 MG, 1 MG, 2 MG SOLU-CORTEF INJECTION SOLUTION RECONSTITUTED 100 MG, 250 MG Tacrolimus ORAL CAPSULE 0.5 MG, 1 MG, 5 MG THIOTEPA INJECTION SOLUTION RECONSTITUTED 15 MG THYMOGLOBULIN INTRAVENOUS* SOLUTION RECONSTITUTED 25 MG Tobramycin INHALATION NEBULIZATION SOLUTION 300 MG/5ML TPN Electrolytes INTRAVENOUS* SOLUTION TRAVASOL INTRAVENOUS* SOLUTION 10 % TREANDA INTRAVENOUS* SOLUTION 45 MG/0.5ML TREANDA INTRAVENOUS* SOLUTION RECONSTITUTED 100 MG TROPHAMINE INTRAVENOUS* SOLUTION 10 %, 6 % Verapamil HCl INTRAVENOUS* SOLUTION 2.5 MG/ML VIVITROL INTRAMUSCULAR* SUSPENSION RECONSTITUTED 380 MG VPRIV INTRAVENOUS* SOLUTION RECONSTITUTED 400 UNIT ZORTRESS ORAL TABLET 0.25 MG, 0.5 MG, 0.75 MG This drug may be covered under Medicare Part B or D depending upon the circumstances. may need to be submitted describing the use and setting of the drug to make the determination. 212

STEP THERAPY CRITERIA: ANTIDEPRESSANT THERAPY Step 2: FETZIMA CAPSULE EXTENDED RELEASE 24 HOUR 120 MG ORAL FETZIMA CAPSULE EXTENDED RELEASE 24 HOUR 20 MG ORAL FETZIMA CAPSULE EXTENDED RELEASE 24 HOUR 40 MG ORAL FETZIMA CAPSULE EXTENDED RELEASE 24 HOUR 80 MG ORAL FETZIMA TITRATION 20 & 40 MG ORAL MARPLAN TABLET 10 MG ORAL PRISTIQ TABLET EXTENDED RELEASE 24 HR* 100 MG ORAL PRISTIQ TABLET EXTENDED RELEASE 24 HR* 25 MG ORAL PRISTIQ TABLET EXTENDED RELEASE 24 HR* 50 MG ORAL VIIBRYD STARTER PACK KIT 10 & 20 MG ORAL VIIBRYD TABLET 10 MG ORAL VIIBRYD TABLET 20 MG ORAL VIIBRYD TABLET 40 MG ORAL Details Step 1 - Member needs to have documented trial of any of the two following drugs: fluoxetine, citalopram, or bupropion in the previous 120 days prior to moving to Step 2 drugs: Viibryd, Pristiq, Fetzima, or Marplan. 213

ANTI-MIGRAINE THERAPY Step 2: Naratriptan HCl TABLET 1 MG ORAL Naratriptan HCl TABLET 2.5 MG ORAL Rizatriptan Benzoate TABLET 10 MG ORAL Rizatriptan Benzoate TABLET 5 MG ORAL Rizatriptan Benzoate TABLET DISPERSIBLE 10 MG ORAL Rizatriptan Benzoate TABLET DISPERSIBLE 5 MG ORAL ZOLMitriptan TABLET 2.5 MG ORAL ZOLMitriptan TABLET 5 MG ORAL ZOLMitriptan TABLET DISPERSIBLE 2.5 MG ORAL ZOLMitriptan TABLET DISPERSIBLE 5 MG ORAL Details Step 1 - Member needs to have documented trial of sumatriptan in the previous 365 days prior to moving to Step 2 drug: naratriptan, rizaptriptan and Zomig. 214

ARB THERAPY Step 2: BENICAR HCT TABLET 20-12.5 MG ORAL BENICAR HCT TABLET 40-12.5 MG ORAL BENICAR HCT TABLET 40-25 MG ORAL BENICAR TABLET 20 MG ORAL BENICAR TABLET 40 MG ORAL BENICAR TABLET 5 MG ORAL Details Step 1 - Member needs to have documented trial of losartan in the previous 120 days prior to moving to Step 2 drug: Benicar. 215

ATYPICAL ANTIPSYCHOTICS THERAPY Step 2: FANAPT TABLET 1 MG ORAL FANAPT TABLET 10 MG ORAL FANAPT TABLET 12 MG ORAL FANAPT TABLET 2 MG ORAL FANAPT TABLET 4 MG ORAL FANAPT TABLET 6 MG ORAL FANAPT TABLET 8 MG ORAL FANAPT TITRATION PACK TABLET 1 & 2 & 4 & 6 MG ORAL LATUDA TABLET 120 MG ORAL LATUDA TABLET 20 MG ORAL LATUDA TABLET 40 MG ORAL LATUDA TABLET 60 MG ORAL LATUDA TABLET 80 MG ORAL RISPERDAL CONSTA SUSPENSION RECONSTITUTED 12.5 MG INTRAMUSCULAR* RISPERDAL CONSTA SUSPENSION RECONSTITUTED 25 MG INTRAMUSCULAR* RISPERDAL CONSTA SUSPENSION RECONSTITUTED 37.5 MG INTRAMUSCULAR* RISPERDAL CONSTA SUSPENSION RECONSTITUTED 50 MG INTRAMUSCULAR* SAPHRIS TABLET SUBLINGUAL 10 MG SUBLINGUAL SAPHRIS TABLET SUBLINGUAL 2.5 MG SUBLINGUAL SAPHRIS TABLET SUBLINGUAL 5 MG SUBLINGUAL Details Step 1 - Member needs to have documented trial of any of the two following drugs: clozapine, olanzapine, risperidone, quetiapine, ziprasidone in the previous 120 days prior to moving to step 2 drugs: Fanapt, Latuda, Risperdal Consta, Saphris. 216

GOUT THERAPY Step 2: ULORIC TABLET 40 MG ORAL ULORIC TABLET 80 MG ORAL Details Step 1 - Member needs to have documented trial of allopurinol in the previous 365 days prior to moving to Step 2 drug: Uloric. 217

PHOSPHATE BINDER THERAPY Step 2: RENAGEL TABLET 800 MG ORAL RENVELA TABLET 800 MG ORAL Details Step 1 - Member needs to have documented trial of Calcium Acetate in the previous 120 days prior to moving to Step 2 drugs: Renagel and Renvela. 218