HealthPartners, Inc Medicare Part D Formulary ID 13142, Version 22 Prior Authorization Criteria. Last Updated: 11/01/2013

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1 ACTEMRA Actemra (1) DIAGNOSIS OF MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS, OR (2) JUVENILE IDIOPATHIC ARTHRITIS, AND (3) DOCUMENTATION OF MEDICAL CONTRAINDICATIONS OR FAILURE WITH ENBREL OR HUMIRA. RESERVED FOR PRESCRIBING BY RHEUMATOLOGY Page 1 of 128

2 ACTIMMUNE Actimmune FOR NEW START PATIENTS: DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. Page 2 of 128

3 AMEVIVE Amevive (1) DIAGNOSIS OF MODERATE TO SEVERE PLAQUE PSORIASIS, AND (2) DOCUMENTATION OF MEDICAL CONTRAINDICATIONS OR FAILURE WITH ENBREL AND HUMIRA. RESERVED FOR PRESCRIBING BY DERMATOLOGY Page 3 of 128

4 AMPYRA Ampyra (1) DIAGNOSIS OF MULTIPLE SCLEROSIS, AND (2) DOCUMENTATION OF AN EXPANDED DISABILITY STATUS SCALE SCORE (EDSS) GREATER THAN OR EQUAL TO 5 AND LESS THAN OR EQUAL TO 7, AND (3) DOCUMENTATION OF A WALKING SPEED BETWEEN 8 AND 45 SECONDS FOR A 25-FOOT WALK. INITIAL CRITERIA - (1) DIAGNOSIS OF MULTIPLE SCLEROSIS, AND (2) DOCUMENTATION OF AN EXPANDED DISABILITY STATUS SCALE SCORE (EDSS) GREATER THAN OR EQUAL TO 5 AND LESS THAN OR EQUAL TO 7, AND (3) DOCUMENTATION OF A WALKING SPEED BETWEEN 8 AND 45 SECONDS FOR A 25-FOOT WALK. RENEWAL CRITERIA - DOCUMENTATION OF A POSITIVE RESPONSE TWO MONTHS, THEN BALANCE OF CONTRACT YEAR IF POSITIVE RESPONSE. A POSITIVE RESPONSE IS DEFINED AS A 25% IMPROVEMENT IN WALKING SPEED, OR AN IMPROVEMENT IN FUNCTIONAL IMPAIRMENT AND ACTIVITIES OF DAILY LIVING. Page 4 of 128

5 ANDROGEN THERAPY Androderm, AndroGel, Androxy, testosterone cypionate, testosterone enanthate (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTED TESTOSTERONE DEFICIENCY IN MALES OF LESS THAN 300 NG/DL. Page 5 of 128

6 ANTINEOPLASTIC INJECTABLES Abraxane, Adcetris, Alimta, amifostine crystalline, Arranon, Arzerra, AVASTIN, azacitidine, BiCNU, Busulfex, Campath, carboplatin, cisplatin, CLOLAR, Cosmegen, dacarbazine, Dacogen, dactinomycin, daunorubicin, decitabine, docetaxel, Elspar, epirubicin, Erbitux, Erwinaze, etoposide, Faslodex, Firmagon, fludarabine, Folotyn, gemcitabine, Halaven, Herceptin, idarubicin, ifosfamide, irinotecan, Istodax, Ixempra, Jevtana, Kadcyla, Lupron Depot, Lupron Depot (3 Month), Lupron Depot (4 Month), Lupron Depot (6 Month), Lupron Depot-Ped (3 Month), Marqibo, melphalan, mitomycin, mitoxantrone, Mustargen, Oncaspar, Ontak, oxaliplatin, paclitaxel, pentostatin, Photofrin, Proleukin, Taxotere, Temodar, teniposide, thiotepa, topotecan, Torisel, Treanda, Trisenox, Vectibix, Velcade, Vidaza, vincristine, vinorelbine, Voraxaze, Yervoy, Zanosar FOR NEW START PATIENTS: (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, OR (2) DOCUMENTATION THAT A PATIENT IS CURRENTLY RECEIVING OR HAS PREVIOUSLY RECEIVED AND BENEFITED FROM THE USE OF THIS MEDICATION FOR THE TREATMENT OF CANCER. Page 6 of 128

7 ANTINEOPLASTIC INJECTABLES WITH BVD Adriamycin PFS, bleomycin, cladribine, cytarabine, cytarabine (PF), doxorubicin HCl peg-liposomal, fluorouracil, vinblastine FOR NEW START PATIENTS: (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, OR (2) DOCUMENTATION THAT A PATIENT IS CURRENTLY RECEIVING OR HAS PREVIOUSLY RECEIVED AND BENEFITED FROM THE USE OF THIS MEDICATION FOR THE TREATMENT OF CANCER. THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR PART D DEPENDING ON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE OF THE DRUG AND SETTING WHERE THE DRUG IS DISPENSED TO MAKE THE PART B OR PART D COVERAGE DETERMINATION. Page 7 of 128

8 APOKYN APOKYN DIAGNOSIS OF ADVANCED PARKINSON'S DISEASE WITH ACUTE, INTERMITTENT EPISODES OF HYPOMOBILITY (LOSS OF CONTROL OF BODY MOVEMENTS). Page 8 of 128

9 ARCALYST Arcalyst DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. Page 9 of 128

10 ATYPICAL ANTIPSYCHOTIC AGENTS Fanapt, Invega, Latuda, Saphris FOR NEW START PATIENTS: (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION OF AN INADEQUATE RESPONSE OR MEDICAL CONTRAINDICATION TO TWO OF THE FOLLOWING ALTERNATIVES: RISPERIDONE, ZIPRASIDONE, OLANZAPINE, QUETIAPINE REGULAR RELEASE, SEROQUEL XR OR ABILIFY. Page 10 of 128

11 AUBAGIO Aubagio (1) DIAGNOSIS OF RELAPSING FORMS OF MULTIPLE SCLEROSIS, AND (2) DOCUMENTATION OF FAILURE OR MEDICAL CONTRAINDICATION TO COPAXONE AND REBIF. RESERVED FOR PRESCRIBING BY NEUROLOGY Page 11 of 128

12 BARBITURATES Butisol, phenobarbital, phenobarbital sodium FOR NEW START PATIENTS AND THE REQUESTED BARBITURATE MEDICATION IS BEING USED TO TREAT ONE OF THE FOLLOWING CONDITIONS: (1) EPILEPSY OR SEIZURE DISORDER (2) CANCER OR (3) A CHRONIC MENTAL HEALTH DISORDER. Page 12 of 128

13 BETASERON Betaseron (1) DIAGNOSIS OF MULTIPLE SCLEROSIS, AND (2) DOCUMENTED FAILURE WITH EXTAVIA. Page 13 of 128

14 BOSULIF Bosulif FOR NEW START PATIENTS: INITIAL CRITERIA - DIAGNOSIS OF CHRONIC, ACCELERATED, OR BLAST PHASE PH+ CHRONIC MYELOGENOUS LEUKEMIA (CML) WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY FOR ADULT PATIENTS. RENEWAL CRITERIA - DOCUMENTATION EVERY 3 MONTHS THAT DISEASE PROGRESSION HAS NOT OCCURRED. DURATION: THREE MONTHS, WITH APPROVAL EVERY THREE MONTHS IF RENEWAL CRITERIA ARE MET. THREE MONTHS, WITH APPROVAL EVERY THREE MONTHS IF RENEWAL CRITERIA ARE MET. Page 14 of 128

15 BUTORPHANOL NASAL butorphanol tartrate (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTED FAILURE WITH TWO OTHER FORMULARY OPIOID ANALGESICS, SUCH AS MORPHINE, HYDROMORPHONE, OXYCODONE WITH OR WITHOUT ACETAMINOPHEN, HYDROCODONE WITH ACETAMINOPHEN, ACETAMINOPHEN WITH CODEINE AND OTHERS. Page 15 of 128

16 CALCITRIOL TOPICAL calcitriol (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION OF FAILURE WITH OR CONTRAINDICATIONS TO POTENT TOPICAL STEROIDS OR A GENERIC TOPICAL CALCIPOTRIENE PRODUCT. Page 16 of 128

17 CARBAGLU Carbaglu DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, IF MEDICALLY NECESSARY. RESERVED FOR PRESCRIBING BY PROVIDERS SPECIALIZING IN GENETICS AND METABOLISM. Page 17 of 128

18 CIMZIA Cimzia, Cimzia Powder for Reconst FOR RHEUMATOLOGY: (1) DIAGNOSIS OF MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND DOCUMENTATION OF MEDICAL CONTRAINDICATIONS OR FAILURE WITH ENBREL AND HUMIRA, OR FOR GASTROENTEROLOGY: (2) DIAGNOSIS OF MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE, AND DOCUMENTATION OF MEDICAL CONTRAINDICATIONS OR FAILURE WITH HUMIRA. RESERVED FOR PRESCRIBING BY RHEUMATOLOGY AND GASTROENTEROLOGY WITHIN THE SCOPE OF THE APPLICABLE PRESCRIBER SPECIALTY. Page 18 of 128

19 COMETRIQ Cometriq FOR NEW START PATIENTS: INITIAL CRITERIA - DIAGNOSIS OF PROGRESSIVE, METASTATIC MEDULLARY THYROID CANCER. RENEWAL CRITERIA - DOCUMENTATION THAT (1) DISEASE PROGRESSION HAS NOT OCCURRED AND (2) THE PATIENT HAS NOT EXPERIENCED UNACCEPTABLE TOXICITY THREE MONTHS, WITH APPROVAL EVERY THREE MONTHS IF RENEWAL CRITERIA ARE MET. Page 19 of 128

20 CUVPOSA Cuvposa (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION THAT A PATIENT IS UNABLE TO USE ORAL GENERIC GLYCOPYRROLATE TABLETS, WHOLE OR CRUSHED Page 20 of 128

21 CYCLOSET Cycloset (1) DIAGNOSIS OF TYPE 2 DIABETES MELLITUS AND (2) INADEQUATE GLYCEMIC CONTROL AFTER USE OF TWO OTHER ORAL DIABETES MEDICATIONS. Page 21 of 128

22 DALIRESP Daliresp (1) DIAGNOSIS OF SEVERE COPD CONFIRMED WITH AN FEV-1 LESS THAN 50 PERCENT OF PREDICTED, AND (2) ASSOCIATED CHRONIC BRONCHITIS AS DEFINED BY THE PRESENCE OF COUGH AND SPUTUM PRODUCTION FOR AT LEAST 3 MONTHS IN EACH OF TWO CONSECUTIVE YEARS, AND (3) DOCUMENTATION OF INADEQUATE RESPONSE OR MEDICAL CONTRAINDICATIONS TO TWO OF THE FOLLOWING: LONG-ACTING BETA- AGONIST (SUCH AS FORMOTEROL OR SALMETEROL), ANTICHOLINERGIC (SUCH AS IPRATROPIUM) OR ORAL INHALED STEROID (SUCH AS BECLOMETHASONE, BUDESONIDE, FLUTICASONE OR MOMETASONE). Page 22 of 128

23 DIFICID Dificid (1) DIAGNOSIS OF CLOSTRIDIUM DIFFICILE INFECTION, AND (2) DOCUMENTATION OF AN INADEQUATE RESPONSE OR MEDICAL CONTRAINDICATION TO METRONIDAZOLE AND VANCOMYCIN. Page 23 of 128

24 EMSAM Emsam FOR NEW START PATIENTS: (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION OF AN INADEQUATE RESPONSE OR MEDICAL CONTRAINDICATION TO ONE PREFERRED DRUG FROM EACH OF THE FOLLOWING TWO ANTIDEPRESSANT SUB-CLASSES: (A) SSRI'S SUCH AS CITALOPRAM, ESCITALOPRAM, FLUOXETINE, PAROXETINE, SERTRALINE, AND (B) SNRI'S SUCH AS VENLAFAXINE OR CYMBALTA. Page 24 of 128

25 ENBREL Enbrel RHEUMATOLOGY: (1) DIAGNOSIS OF AN FDA-APPROVED RHEUMATOLOGY DISORDER, AND (2) DOCUMENTATION OF MEDICAL CONTRAINDICATIONS OR FAILURE WITH METHOTREXATE. DERMATOLOGY: (1) DIAGNOSIS OF SEVERE PSORIASIS, AND (2) DOCUMENTATION OF FAILURE WITH UVB PHOTOTHERAPY, OR MEDICAL CONTRAINDICATIONS OR FAILURE WITH SYSTEMIC THERAPY (METHOTREXATE OR SORIATANE). RESERVED FOR PRESCRIBING BY DERMATOLOGY AND RHEUMATOLOGY WITHIN THE SCOPE OF THE APPLICABLE PRESCRIBER SPECIALTY. DERMATOLOGY: 3 MONTHS, THEN CONTRACT YEAR BALANCE IF POSITIVE RESPONSE. RHEUMATOLOGY: CONTRACT YEAR. RHEUMATOLOGY: INITIAL DOSES ARE LIMITED TO FDA-APPROVED DOSAGES OF 50MG PER WEEK. DERMATOLOGY: INITIAL DOSES ARE LIMITED TO FDA-APPROVED DOSAGES OF 50MG TWO TIMES PER WEEK FOR THREE MONTHS, FOLLOWED BY 50MG PER WEEK IF POSITIVE RESPONSE. DOCUMENTATION OF POSITIVE RESPONSE AFTER 3 MONTHS TO CONTINUE THERAPY FOR SEVERE PSORIASIS. Page 25 of 128

26 ENZYME REPLACEMENT Adagen, Aldurazyme, Buphenyl, Ceredase, Cystagon, ELAPRASE, Elelyso, Elitek, Fabrazyme, Ilaris (PF), Lumizyme, Myozyme, Naglazyme, Orfadin, Ravicti, sodium phenylbutyrate, VPRIV DOCUMENTED ENZYME DEFICIENCY APPLICABLE TO THE USE OF THIS MEDICATION. Page 26 of 128

27 EPLERENONE eplerenone (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTED INTOLERANCE TO SPIRONOLACTONE. Page 27 of 128

28 ERIVEDGE Erivedge FOR NEW START PATIENTS: (1) DIAGNOSIS OF METASTATIC BASAL CELL CARCINOMA, OR (2) DIAGNOSIS OF LOCALLY ADVANCED BASAL CELL CARCINOMA THAT HAS EITHER RECURRED FOLLOWING SURGERY OR WHEN THE PATIENT IS NOT A CANDIDATE FOR SURGERY OR RADIATION. Page 28 of 128

29 ERYTHROPOIESIS STIMULATING AGENTS Aranesp (in polysorbate), Procrit (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) FOR CANCER DIAGNOSIS: DOCUMENTED CHEMOTHERAPY- ASSOCIATED ANEMIA (HEMOGLOBIN LESS THAN 10G/DL OR HEMATOCRIT LESS THAN 30%). THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR PART D DEPENDING ON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE OF THE DRUG AND SETTING WHERE THE DRUG IS DISPENSED TO MAKE THE PART B OR PART D COVERAGE DETERMINATION. Page 29 of 128

30 EXJADE Exjade DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. RESERVED FOR PRESCRIBING BY HEMATOLOGY AND ONCOLOGY. Page 30 of 128

31 FENTANYL LOZENGE fentanyl citrate (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION THAT THE PATIENT IS UNABLE TO USE ORAL NARCOTIC TABLETS OR CAPSULES AND (3) IS UNABLE TO USE ORAL NARCOTIC SOLUTION Page 31 of 128

32 FERRIPROX Ferriprox DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. Page 32 of 128

33 FIRAZYR Firazyr DIAGNOSIS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS. Page 33 of 128

34 FONDAPARINUX fondaparinux (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND DOCUMENTATION OF FAILURE OR MEDICAL CONTRAINDICATIONS WITH ENOXAPARIN, OR (2) DIAGNOSIS OF HEPARIN-INDUCED THROMBOCYTOPENIA, OR (3) DIAGNOSIS OF MALIGNANCY WITH HYPERCOAGULABLE STATE. THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR PART D DEPENDING ON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE OF THE DRUG AND SETTING WHERE THE DRUG IS DISPENSED TO MAKE THE PART B OR PART D COVERAGE DETERMINATION. Page 34 of 128

35 FORTEO Forteo DOCUMENTATION OF: (1) OSTEOPOROSIS (BONE MINERAL DENSITY T-SCORE IS MINUS 2.5 OR LOWER), AND (A) PREVIOUS FRACTURE (SPINE OR HIP), OR (B) INTOLERANCE OR CONTRAINDICATION TO ORAL AND INTRAVENOUS BISPHOSPHONATE THERAPY, OR (C) PROGRESSIVE BONE LOSS (BONE LOSS OF 3% OR GREATER OVER TWO YEARS) DESPITE THERAPY WITH BISPHOSPHONATES (COMPLIANCE 75% OR GREATER), ADEQUATE CALCIUM AND ADEQUATE VITAMIN D INTAKE (SERUM LEVELS 30NG/ML OR GREATER), OR (2) SEVERE OSTEOPOROSIS (BONE MINERAL DENSITY T-SCORE OF SPINE, HIP, OR FEMORAL NECK IS MINUS 3.5 OR LOWER). Page 35 of 128

36 FULYZAQ Fulyzaq INITIAL: (1) DIAGNOSIS OF NON-INFECTIOUS DIARRHEA IN ADULT PATIENTS WITH HIV OR AIDS ON ANTIRETROVIRAL THERAPY AND (2) CONTRAINDICATIONS OR INADEQUATE RESPONSE TO LOPERAMIDE AND DIPHENOXYLATE/ATROPINE. RENEWAL: DOCUMENTATION OF BENEFICIAL RESPONSE. THREE MONTHS, THEN BALANCE OF CONTRACT YEAR IF RENEWAL CRITERIA ARE MET. Page 36 of 128

37 GATTEX Gattex One-Vial INITIAL CRITERIA - (1) TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME, AND (2) WHO HAVE BEEN DEPENDENT ON PARENTERAL (OR A COMBINATION OF PARENTERAL AND ENTERAL) NUTRITION FOR ALL NUTRITIONAL REQUIREMENTS FOR AT LEAST ONE YEAR, AND (3) IN WHOM A TAPER FROM PARENTERAL REQUIREMENTS HAS NOT BEEN POSSIBLE OR PLANNED, AND (4) THE DOSE REQUESTED IS 5 MG DAILY OR LESS. RENEWAL CRITERIA - DOCUMENTED REDUCTION IN PARENTERAL NUTRITION REQUIREMENTS OF AT LEAST 20% FROM BASELINE. THREE MONTHS, THEN BALANCE OF CONTRACT YEAR IF RENEWAL CRITERIA ARE MET. Page 37 of 128

38 GILENYA Gilenya (1) DIAGNOSIS OF REPLAPSING FORMS OF MULTIPLE SCLEROSIS, AND (2) DOCUMENTATION OF FAILURE OR MEDICAL CONTRAINDICATION TO COPAXONE AND REBIF. RESERVED FOR PRESCRIBING BY NEUROLOGY Page 38 of 128

39 GILOTRIF Gilotrif FOR NEW START PATIENTS: INITIAL CRITERIA - (1) DIAGNOSIS OF METASTATIC NON- SMALL CELL LUNG CANCER (NSCLC) WITH TUMORS THAT HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST OR AT A CLIA-APPROVED FACILITY AND (2) NO OTHER EGFR MUTATIONS ARE PRESENT. RENEWAL CRITERIA - DOCUMENTATION EVERY 3 MONTHS THAT THERE HAS BEEN NO DISEASE PROGRESSION. THREE MONTHS, WITH APPROVAL EVERY THREE MONTHS IF RENEWAL CRITERIA ARE MET. Page 39 of 128

40 HEREDITARY ANGIOEDEMA Berinert, Cinryze, Kalbitor DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. Page 40 of 128

41 HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA AGENTS Juxtapid, Kynamro INITIAL: (1) DIAGNOSIS OF HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA. RENEWAL: DOCUMENTATION OF BENEFICIAL RESPONSE. THREE MONTHS, THEN BALANCE OF CONTRACT YEAR IF RENEWAL CRITERIA ARE MET. Page 41 of 128

42 HUMIRA Humira, Humira Crohn's Dis Start Pck FOR RHEUMATOLOGY: (1) DIAGNOSIS OF ANKYLOSING SPONDYLITIS OR (2) DIAGNOSIS OF RHEUMATOID ARTHRITIS, JUVENILE IDIOPATHIC ARTHRITIS OR PSORIATIC ARTHRITIS AND DOCUMENTATION OF MEDICAL CONTRAINDICATIONS OR FAILURE WITH METHOTREXATE, OR FOR DERMATOLOGY: (3) DIAGNOSIS OF SEVERE PSORIASIS AND DOCUMENTATION OF FAILURE WITH UVB PHOTOTHERAPY, OR MEDICAL CONTRAINDICATIONS OR FAILURE WITH SYSTEMIC THERAPY (METHOTREXATE OR SORIATANE), OR FOR GASTROENTEROLOGY: (4) DIAGNOSIS OF MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE, AND FAILURE ON CONVENTIONAL THERAPY (SUCH AS AZATHIOPRINE, METHOTREXATE OR MERCAPTOPURINE). RESERVED FOR PRESCRIBING BY DERMATOLOGY, GASTROENTEROLOGY AND RHEUMATOLOGY WITHIN THE SCOPE OF THE APPLICABLE PRESCRIBER SPECIALTY. RHEUMATOLOGY: INITIAL DOSES ARE LIMITED TO FDA-APPROVED DOSAGES OF 40MG EVERY OTHER WEEK. DERMATOLOGY: INITIAL DOSES ARE LIMITED TO FDA- APPROVED DOSAGES OF 80MG ONCE, THEN 40MG EVERY TWO WEEKS STARTING ONE WEEK AFTER THE INITIAL DOSE FOR A TOTAL OF THREE MONTHS, FOLLOWED BY 40MG EVERY OTHER WEEK IF POSITIVE RESPONSE. DOCUMENTATION OF POSITIVE RESPONSE AFTER 3 MONTHS TO CONTINUE THERAPY FOR SEVERE PSORIASIS. Page 42 of 128

43 ICLUSIG Iclusig FOR NEW START PATIENTS. INITIAL CRITERIA: (1) DIAGNOSIS OF CHRONIC PHASE, ACCELERATED PHASE, OR BLAST PHASE CHRONIC MYELOID LEUKEMIA (CML) THAT IS RESISTANT OR INTOLERANT TO PRIOR TYROSINE KINASE INHIBITOR THERAPY, OR (2) DIAGNOSIS OF PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ALL) THAT IS RESISTANT OR INTOLERANT TO PRIOR TYROSINE KINASE INHIBITOR THERAPY. THREE MONTHS, WITH APPROVAL EVERY THREE MONTHS IF RENEWAL CRITERIA ARE MET. Page 43 of 128

44 IMMUNE GLOBULIN Bivigam, Carimune NF Nanofiltered, Flebogamma, Flebogamma DIF, GamaSTAN S/D, Gammagard Liquid, Gammaked, Gammaplex, Gamunex-C, Hizentra, Octagam, Privigen, Vivaglobin DIAGNOSIS OF AN FDA-APPROVED INDICATION NOT OTHERWISE EXCLUDED FROM PART D. THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR PART D DEPENDING ON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE OF THE DRUG AND SETTING WHERE THE DRUG IS DISPENSED TO MAKE THE PART B OR PART D COVERAGE DETERMINATION. Page 44 of 128

45 INCIVEK Incivek (1) DIAGNOSIS OF HEPATITIS C WITH DOCUMENTATION OF HCV GENOTYPE 1 AND VIRAL LOAD, AND (2) PRESCRIBED IN COMBINATION WITH PEGYLATED INTERFERON AND RIBAVIRIN. RESERVED FOR PRESCRIBING BY GASTROENTEROLOGY, OR HEPATOLOGY, OR INFECTIOUS DISEASE SPECIALISTS. 12 WEEKS, BALANCE OF CONTRACT YEAR, OR FDA-APPROVED DURATION, Page 45 of 128

46 INFERGEN Infergen (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION FOR THIS MEDICATION, AND (2) DOCUMENTED FAILURE WITH PEG-INTRON OR PEGASYS OR INTRON-A. Page 46 of 128

47 INJECTABLES, NON-SELF ADMINISTERED Abilify Maintena, amikacin, ammonium chloride, Aralast NP, Atgam, Benlysta, Cancidas, Capastat, chloramphenicol sod succinate, chorionic gonadotropin, human, CUBICIN, Cyklokapron, Eraxis(Water Diluent), fomepizole, Fusilev, Glassia, Invega Sustenna, Kepivance, Krystexxa, Lupron Depot-Ped, Mozobil, Prolastin, rifampin, Soliris, Somavert, tobramycin in 0.9 % NaCl, tobramycin sulfate, tranexamic acid, Xgeva, Xolair, Zemaira, Zorbtive DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. Page 47 of 128

48 INJECTABLES, NON-SELF ADMINISTERED WITH BVD amphotericin B, foscarnet DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR PART D DEPENDING ON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE OF THE DRUG AND SETTING WHERE THE DRUG IS DISPENSED TO MAKE THE PART B OR PART D COVERAGE DETERMINATION. Page 48 of 128

49 INLYTA Inlyta FOR NEW START PATIENTS: (1) DIAGNOSIS OF ADVANCED RENAL CELL CARCINOMA AND (2) FAILURE OF ONE PRIOR SYSTEMIC THERAPY AGENT. Page 49 of 128

50 ITRACONAZOLE itraconazole, Sporanox (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) FOR COMPLEX FUNGAL NAIL INFECTIONS (ONYCHOMYCOSIS): DOCUMENTED FAILURE ON ORAL TERBINAFINE. Page 50 of 128

51 JAKAFI Jakafi FOR NEW START PATIENTS: INITIAL CRITERIA - DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. RENEWAL CRITERIA - DOCUMENTATION OF IMPROVEMENT IN SPLEEN REDUCTION OR SYMPTOM IMPROVEMENT. SIX MONTHS, THEN BALANCE OF CONTRACT YEAR IF RENEWAL CRITERIA ARE MET. Page 51 of 128

52 KALYDECO Kalydeco DIAGNOSIS OF CYSTIC FIBROSIS WITH A G551D MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGRULATOR (CFTR) POTENTIATOR. PATIENTS AGE 6 YEARS OF AGE OR OLDER Page 52 of 128

53 KAPVAY clonidine, Kapvay, Kapvay Dose Pack (1) DIAGNOSIS OF ADHD, AND (2) DOCUMENTED FAILURE WITH STANDARD GENERIC ADHD MEDICATIONS SUCH AS METHYLPHENIDATE OR DEXTROAMPHETAMINE- AMPHETAMINE COMBINATION. Page 53 of 128

54 KINERET Kineret (1) DIAGNOSIS OF RHEUMATOID ARTHRITIS, AND (2) DOCUMENTED FAILURE ON ENBREL AND HUMIRA. RESERVED FOR PRESCRIBING BY RHEUMATOLOGY. Page 54 of 128

55 KUVAN Kuvan DIAGNOSIS OF PKU AND ELEVATED PHENYLALANINE LEVELS DESPITE A PHENYLALANINE-RESTRICTED DIET. RESERVED FOR PRESCRIBING BY PROVIDER SPECIALISTS IN THE MANAGEMENT OF PHENYLKETONURIA (PKU). 3 MONTHS, THEN BALANCE OF CONTRACT YEAR IF POSITIVE RESPONSE. Page 55 of 128

56 KYPROLIS Kyprolis FOR NEW START PATIENTS: INITIAL CRITERIA - (1) DIAGNOSIS OF MULTIPLE MYELOMA AND (2) AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND (3) DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF LAST THERAP THREE MONTHS, WITH APPROVAL EVERY THREE MONTHS IF RENEWAL CRITERIA ARE MET. Page 56 of 128

57 LINZESS Linzess INITIAL: (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION OF MEDICAL CONTRAINDICATIONS OR INADEQUATE RESPONSE TO LACTULOSE AND POLYETHYLENE GLYCOL (PEG 3350). RENEWAL: DOCUMENTATION OF BENEFICIAL RESPONSE THREE MONTHS, THEN BALANCE OF CONTRACT YEAR IF RENEWAL CRITERIA ARE MET. Page 57 of 128

58 LOTRONEX Lotronex (1) DIAGNOSIS OF IRRITABLE BOWEL SYNDROME (IBS) WHOSE PREDOMINANT SYMPTOM IS SEVERE DIARRHEA IN WOMEN ONLY, AND (2) DOCUMENTATION OF CHRONIC IBS SYMPTOMS (GENERALLY LASTING 6 MONTHS OR LONGER), AND (3) ANATOMIC OR BIOCHEMICAL ABNORMALITIES OF THE GASTROINTESTINAL TRACT HAVE BEEN RULED OUT, AND (4) DOCUMENTATION OF INADEQUATE RESPONSE TO CONVENTIONAL THERAPY, AND (5) DOCUMENTATION OF SYMPTOMS CAUSING SIGNIFICANT DISABILITY (E.G. HOSPITALIZATIONS, OR MISSING WORK OR RESTRICTION OF DAILY ACTIVITIES). RESTRICTED ONLY TO PROVIDERS WHO ARE ENROLLED IN THE PRESCRIBING PROGRAM FOR LOTRONEX (PPL). 4 WEEKS, THEN BALANCE OF CONTRACT YEAR ONLY IF SIGNIFICANT IMPROVEMENT IN DISABILITY. Page 58 of 128

59 LYSTEDA Lysteda, tranexamic acid (1) DIAGNOSIS OF CYCLIC HEAVY MENSTRUAL BLEEDING IN ADULTS AGED 18 AND OLDER, AND (2) DOCUMENTATION OF INADEQUATE RESPONSE TO A HORMONAL THERAPY SUCH AS ANY ORAL CONTRACEPTIVE. Page 59 of 128

60 MECASERMIN Increlex DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. RESERVED FOR PRESCRIBING BY ENDOCRINOLOGY. Page 60 of 128

61 MEDROXYPROGESTERONE 400 MG/ML IM INJECTION Depo-Provera (1) DIAGNOSIS OF CANCER FOR A NEW START PATIENT, OR (2) DOCUMENTATION THAT A PATIENT IS CURRENTLY RECEIVING OR HAS PREVIOUSLY RECEIVED AND BENEFITED FROM DEPO-PROVERA 400MG/ML INTRAMUSCULAR INJECTION FOR THE TREATMENT OF CANCER. Page 61 of 128

62 MEKINIST Mekinist INITIAL CRITERIA: FOR NEW START PATIENTS: (1) DIAGNOSIS OF UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS AND (2) NO PRIOR BRAF INHIBITOR THERAPY. RENEWAL CRITERIA: DOCUMENTATION OF NO DISEASE PROGRESSION THREE MONTHS, THEN BALANCE OF CONTRACT YEAR IF RENEWAL CRITERIA ARE MET. Page 62 of 128

63 MENEST Menest FOR NEW START PATIENTS: (1) PRESCRIBED AS PALLIATIVE THERAPY FOR SELECTED PATIENTS WITH METASTATIC BREAST CANCER OR ADVANCED PROSTATE CANCER OR (2) PRESCRIBED FOR ANY OTHER FDA APPROVED INDICATION AND PREVIOUS USE OF TWO OF THE FOLLOWING: PREMARIN TABLETS, ESTRADIOL TABLETS OR ESTROPIPATE TABLETS. Page 63 of 128

64 MULTAQ Multaq (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTED FAILURE WITH OR MEDICAL CONTRAINDICATIONS TO FIRST-LINE MEDICATIONS SUCH AS AMIODARONE, FLECAINIDE, PROPAFENONE OR SOTALOL. RESERVED FOR PRESCRIBING BY CARDIOLOGY Page 64 of 128

65 MYRBETRIQ Myrbetriq (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION OF AN INADEQUATE RESPONSE OR CONTRAINDICATIONS TO TWO GENERIC FORMULARY ALTERNATIVES SUCH AS OXYBUTYNIN, TOLTERODINE OR TROSPIUM. Page 65 of 128

66 NAMENDA Namenda, Namenda Titration Pak DIAGNOSIS OF MODERATE TO SEVERE ALZHEIMER'S DISEASE. Page 66 of 128

67 NEUMEGA Neumega DOCUMENTATION TO SUPPORT USE FOR THE PREVENTION OF SEVERE THROMBOCYTOPENIA (REDUCED PLATELET COUNT) FOLLOWING MYELOSUPPRESSIVE CHEMOTHERAPY IN ADULT PATIENTS WITH NONMYELOID MALIGNANCIES WHO ARE AT HIGH RISK FOR THROMBOCYTOPENIA. Page 67 of 128

68 NEUPRO Neupro (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION OF SIGNIFICANT SIDE EFFECTS, LOSS OF EFFICACY, OR COMPLIANCE CONCERNS WITH REGULAR RELEASE PRAMIPEXOLE OR ROPINIROLE. Page 68 of 128

69 NUVIGIL Nuvigil (1) DIAGNOSIS OF NARCOLEPSY OR IDIOPATHIC HYPERSOMNOLENCE, OR (2) DIAGNOSIS OF RESIDUAL SLEEPINESS FROM SLEEP APNEA IF CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) HAS BEEN OPTIMIZED, OR (3) DIAGNOSIS OF SHIFT WORK DISORDER, OR (4) DIAGNOSIS OF MULTIPLE SCLEROSIS-RELATED FATIGUE AND DOCUMENTATION OF FAILURE WITH AMANTADINE OR METHYLPHENIDATE. Page 69 of 128

70 ONFI Onfi FOR NEW START PATIENTS: DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. RESERVED FOR PRESCRIBING BY NEUROLOGY. Page 70 of 128

71 ORAL DISSOLVE TABLETS PROTECTED CLASS Abilify Discmelt, clonazepam, clozapine, FazaClo, Lamictal ODT, mirtazapine, olanzapine, risperidone FOR NEW START PATIENTS: (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION THAT THE PATIENT HAS DIFFICULTY SWALLOWING OR HAS COMPLIANCE CONCERNS WITH REGULAR TABLET DOSAGE FORMS. Page 71 of 128

72 ORAP Orap FOR NEW START PATIENTS: DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. Page 72 of 128

73 ORENCIA Orencia (1) DIAGNOSIS OF AN FDA-APPROVED RHEUMATOLOGY DISORDER, AND (2) DOCUMENTATION OF MEDICAL CONTRAINDICATIONS OR FAILURE WITH ENBREL AND HUMIRA. RESERVED FOR PRESCRIBING BY RHEUMATOLOGY Page 73 of 128

74 PART B DRUGS acetylcysteine, Astagraf XL, Azasan, azathioprine, azathioprine sodium, calcitriol, CellCept, CellCept Intravenous, cyclophosphamide, cyclosporine, cyclosporine modified, dexamethasone, dexamethasone sodium phosphate, dronabinol, Emend, Engerix-B (PF), Engerix-B Pediatric (PF), Gengraf, granisetron, Granisol, heparin (porcine), heparin (porcine) in D5W, heparin, porcine (PF), hydrocortisone, Imovax Rabies Vaccine (PF), levocarnitine, levocarnitine (with sugar), lidocaine, lidocaine (PF), lidocaineprilocaine, methotrexate sodium (PF), methylprednisolone, methylprednisolone acetate, mycophenolate mofetil, Nulojix, ondansetron, ondansetron HCl, ondansetron HCl (PF), prednisolone sodium phosphate, prednisone, Prednisone Intensol, Prograf, RabAvert (PF), Rapamune, Recombivax HB (PF), Sandimmune, tacrolimus, vancomycin THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR PART D DEPENDING ON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE OF THE DRUG AND SETTING WHERE THE DRUG IS DISPENSED TO MAKE THE PART B OR PART D COVERAGE DETERMINATION. Page 74 of 128

75 Part B/D acetylcysteine, Azasan, azathioprine, azathioprine sodium, calcitriol, CellCept, CellCept Intravenous, cyclophosphamide, cyclosporine, cyclosporine modified, dexamethasone, dexamethasone sodium phosphate, dronabinol, Emend, Engerix-B (PF), Engerix-B Pediatric (PF), Gengraf, granisetron, Granisol, heparin (porcine), heparin (porcine) in D5W, heparin, porcine (PF), hydrocortisone, Imovax Rabies Vaccine (PF), levocarnitine, levocarnitine (with sugar), lidocaine, lidocaine (PF), lidocaineprilocaine, methotrexate sodium (PF), methylprednisolone, methylprednisolone acetate, mycophenolate mofetil, Nulojix, ondansetron, ondansetron HCl, ondansetron HCl (PF), prednisolone sodium phosphate, prednisone, Prednisone Intensol, Prograf, RabAvert (PF), Rapamune, Recombivax HB (PF), Sandimmune, tacrolimus, vancomycin This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. Page 75 of 128

76 PEGASYS Pegasys, Pegasys Convenience Pack, Pegasys ProClick (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) FOR TREATMENT OF HEPATITIS C, DOCUMENTATION OF HCV GENOTYPE, VIRAL LOAD AND LIVER FUNCTION TESTS, AND DOCUMENTAION OF INTOLERANCE TO OR ADVERSE EFFECTS FROM PRIOR USE OF PEGINTRON. RESERVED FOR PRESCRIBING BY GASTROENTEROLOGY, OR HEPATOLOGY, OR INFECTIOUS DISEASE SPECIALISTS. HEP C GENOTYPE 1: UP TO 48 WEEKS. HEP B AND HEP C GENOTYPES 2 OR 3: UP TO 24 WEEKS. Page 76 of 128

77 PEGINTRON PegIntron, PegIntron Redipen (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) FOR TREATMENT OF HEPATITIS C, DOCUMENTATION OF HCV GENOTYPE, VIRAL LOAD AND LIVER FUNCTION TESTS. RESERVED FOR PRESCRIBING BY GASTROENTEROLOGY, OR HEPATOLOGY, OR INFECTIOUS DISEASE SPECIALISTS. HEPATITIS C GENOTYPE 1: UP TO 48 WEEKS. HEPATITIS C GENOTYPES 2 OR 3: UP TO 24 WEEKS. Page 77 of 128

78 PERJETA Perjeta FOR NEW START PATIENTS: INITIAL CRITERIA - DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. RENEWAL CRITERIA - DOCUMENTATION THAT DISEASE PROGRESSION HAS NOT OCCURRED. SIX MONTHS, WITH APPROVAL EVERY SIX MONTHS IF RENEWAL CRITERIA ARE MET. Page 78 of 128

79 PINDOLOL pindolol (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION OF AN INADEQUATE RESPONSE OR CONTRAINDICATIONS TO TWO PREFERRED BETA-ADRENERGIC BLOCKING AGENTS, SUCH AS ATENOLOL, METOPROLOL OR PROPRANOLOL. Page 79 of 128

80 POMALYST Pomalyst FOR NEW START PATIENTS: (1) DIAGNOSIS OF MULTIPLE MYELOMA AND (2) PRIOR CHEMOTHERAPY WITH AT LEAST TWO AGENTS INCLUDING LENALIDOMIDE AND BORTEZOMIB AND (3) HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY. FOR RENEWAL: DOCUMENTATION THAT DISEASE PROGRESSION HAS NOT OCCURRED. THREE MONTHS, WITH APPROVAL EVERY THREE MONTHS IF RENEWAL CRITERIA ARE MET. Page 80 of 128

81 PRAMIPEXOLE ER Mirapex ER (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION THAT A PATIENT HAS COMPLIANCE CONCERNS WITH GENERIC PRAMIPEXOLE REGULAR TABLET. Page 81 of 128

82 PRISTIQ desvenlafaxine, Pristiq FOR NEW START PATIENTS: (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION OF AN INADEQUATE RESPONSE TO VENLAFAXINE ER AND CYMBALTA. Page 82 of 128

83 PROMACTA Promacta DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. RESTRICTED FOR PRESCRIBING BY PROVIDERS WHO ARE ENROLLED IN THE PROMACTA CARES PROGRAM. TWO MONTHS, THEN BALANCE OF CONTRACT YEAR IF POSITIVE RESPONSE. Page 83 of 128

84 PROTONIX IV pantoprazole, Protonix (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION OF: (A) FAILURE WITH ORAL FORMULARY PROTON PUMP INHIBITORS OMEPRAZOLE AND LANSOPRAZOLE, OR (B) MEDICAL CONTRAINDICATIONS TO ORAL PROTON PUMP INHIBITORS. Page 84 of 128

85 PULMONARY ARTERIAL HYPERTENSION - INJECTION epoprostenol (glycine), Remodulin, Veletri DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR PART D DEPENDING ON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE OF THE DRUG AND SETTING WHERE THE DRUG IS DISPENSED TO MAKE THE PART B OR PART D COVERAGE DETERMINATION. Page 85 of 128

86 PULMONARY ARTERIAL HYPERTENSION - NEB Tyvaso, Ventavis (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DIAGNOSIS OF PULMONARY ARTERIAL HYPERTENSION WHO GROUP 1 AND (3) MEAN PULMONARY ARTERY PRESSURE OF GREATER THAN OR EQUAL TO 25MMHG PER RIGHT HEART CATHETERIZATION AND (4) ACUTE VASODILATOR TESTING HAS BEEN DONE. THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR PART D DEPENDING ON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE OF THE DRUG AND SETTING WHERE THE DRUG IS DISPENSED TO MAKE THE PART B OR PART D COVERAGE DETERMINATION. Page 86 of 128

87 PULMONARY ARTERIAL HYPERTENSION - ORAL PREFERRED Adcirca, Letairis, Tracleer (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DIAGNOSIS OF PULMONARY ARTERIAL HYPERTENSION WHO GROUP 1 AND (3) MEAN PULMONARY ARTERY PRESSURE OF GREATER THAN OR EQUAL TO 25MMHG PER RIGHT HEART CATHETERIZATION AND (4) ACUTE VASODILATOR TESTING HAS BEEN DONE. Page 87 of 128

88 RECLAST Reclast, zoledronic acid-mannitol-water (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION OF INADEQUATE RESPONSE OR MEDICAL CONTRAINDICATION WITH TWO FORMULARY ORAL BISPHOSPHONATE MEDICATIONS. Page 88 of 128

89 RELISTOR Relistor DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. Page 89 of 128

90 REMICADE Remicade FOR RHEUMATOLOGY: (1) DIAGNOSIS OF ANKYLOSING SPONDYLITIS, RHEUMATOID ARTHRITIS, OR PSORIATIC ARTHRITIS AND DOCUMENTATION OF MEDICAL CONTRAINDICATIONS OR FAILURE WITH ENBREL AND HUMIRA, OR FOR DERMATOLOGY: (2) DIAGNOSIS OF SEVERE PSORIASIS AND DOCUMENTATION OF MEDICAL CONTRAINDICATIONS OR FAILURE WITH ENBREL AND HUMIRA, OR FOR GASTROENTEROLOGY: (3) DIAGNOSIS OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS AND DOCUMENTATION OF AN INADEQUATE RESPONSE TO CONVENTIONAL THERAPY (SUCH AS AZATHIOPRINE OR MERCAPTOPURINE), OR DIAGNOSIS OF MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE, AND DOCUMENTATION OF AN INADEQUATE RESPONSE TO CONVENTIONAL THERAPY (SUCH AS AZATHIOPRINE, METHOTREXATE OR MERCAPTOPURINE) AND DOCUMENTATION OF MEDICAL CONTRAINDICATIONS OR FAILURE WITH HUMIRA. RESERVED FOR PRESCRIBING BY DERMATOLOGY, GASTROENTEROLOGY AND RHEUMATOLOGY WITHIN THE SCOPE OF THE APPLICABLE PRESCRIBER SPECIALTY. THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR PART D DEPENDING ON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE OF THE DRUG AND SETTING WHERE THE DRUG IS DISPENSED TO MAKE THE PART B OR PART D COVERAGE DETERMINATION. Page 90 of 128

91 REQUIP XL ropinirole (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION THAT A PATIENT HAS COMPLIANCE CONCERNS WITH GENERIC ROPINIROLE REGULAR TABLET. Page 91 of 128

92 RITUXAN Rituxan RHEUMATOLOGY: (1) DIAGNOSIS OF AN FDA-APPROVED RHEUMATOLOGY DISORDER, AND (2) DOCUMENTATION THAT A PATIENT HAS TRIED AND FAILED OR HAS MEDICAL CONTRAINDICATIONS TO METHOTREXATE, OR (3) DOCUMENTATION OF AN INADEQUATE RESPONSE TO REMICADE. ONCOLOGY FOR NEW START PATIENTS: (1) DIAGNOSIS OF FDA-APPROVED INDICATIONS FOR CANCER, AND (2) DOCUMENTATION THAT A PATIENT IS BENEFITING FROM THE USE OF RITUXAN WHEN USED FOR CANCER. RESERVED FOR PRESCRIBING BY ONCOLOGY AND RHEUMATOLOGY WITHIN THE SCOPE OF THE APPLICABLE PRESCRIBER SPECIALTY. THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR PART D DEPENDING ON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE OF THE DRUG AND SETTING WHERE THE DRUG IS DISPENSED TO MAKE THE PART B OR PART D COVERAGE DETERMINATION. Page 92 of 128

93 SABRIL Sabril FOR NEW START PATIENTS: (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTED FAILURE ON TWO OTHER FORMULARY SEIZURE MEDICATIONS SUCH AS CARBAMAZEPINE, DIVALPROEX, LEVETIRACETAM, GABAPENTIN, TOPIRAMATE, AND OTHERS. Page 93 of 128

94 SEROSTIM Serostim DOCUMENTION THAT OTHER THERAPIES HAVE PROVEN INEFFECTIVE FOR HIV- INFECTED PATIENTS DIAGNOSED WITH SIGNIFICANT WASTING. Page 94 of 128

95 SIGNIFOR Signifor INITIAL: (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. RENEWAL: DOCUMENTATION OF BENEFICIAL RESPONSE. THREE MONTHS, THEN BALANCE OF CONTRACT YEAR IF RENEWAL CRITERIA ARE MET. Page 95 of 128

96 SILDENAFIL - PAH THERAPY Revatio, sildenafil (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DIAGNOSIS OF PULMONARY ARTERIAL HYPERTENSION WHO GROUP 1 AND (3) MEAN ARTERY PRESSURE OF GREATER THAN OR EQUAL TO 25 MMHG PER RIGHT HEART CATHETERIZATION AND (4) ACUTE VASODILATOR TESTING HAS BEEN DONE. Page 96 of 128

97 SIMPONI Simponi (1) DIAGNOSIS OF ANKYLOSING SPONDYLITIS, OR (2) DIAGNOSIS OF RHEUMATOID ARTHRITIS OR PSORIATIC ARTHRITIS, AND (3) DOCUMENTATION OF MEDICAL CONTRAINDICATIONS OR FAILURE WITH ENBREL AND HUMIRA. RESERVED FOR PRESCRIBING BY RHEUMATOLOGY Page 97 of 128

98 SOMATROPIN Omnitrope CRITERIA FOR CHILDREN: TREATMENT IS PRESCRIBED BY A PEDIATRIC ENDOCRINOLOGIST AND EITHER 1 OR 2 OR 3 OR 4: (1) SHORT STATURE INITIAL: A) CURRENT HEIGHT IS 2.5 OR MORE STANDARD DEVIATIONS BELOW NORMAL, OR B) TARGET ADULT HEIGHT OF 2 OR MORE STANDARD DEVIATIONS BELOW MIDPARENTAL HEIGHT, OR C) HEIGHT VELOCITY OF MINUS 2 OR MORE STANDARD DEVIATIONS FOR AGE AND TANNER STAGE, AND D) GROWTH HORMONE (GH) PROVOCATIVE TESTING (GH PEAK LESS THAN 10 MG/ML), OR E) SERUM IGF LEVELS (IGF-1 OR IGFBP-3) LESS THAN 1 STANDARD DEVIATION BELOW NORMAL, OR F) IGF GENERATION TEST (STIMULATE LEVEL 3 TIMES BASELINE OR GREATER THAN 250MG/ML). (1) SHORT STATURE RENEWAL: A) INCREASE IN HEIGHT VELOCITY OF MORE THAN 50% ABOVE BASELINE, AND B) PATIENT HEIGHT IS 5 FEET 8 INCHES OR LESS FOR BOYS OR 5 FEET 3 INCHES OR LESS FOR GIRLS, AND C) PATIENT HAS NOT ACHIEVED MATURE BONE AGE (17 OR GREATER FOR BOYS OR 15 OR GREATER FOR GIRLS), (2) PANHYPOPITUITARISM, (3) PRADER-WILLI, (4) TURNER'S SYNDROME AND BONE AGE IS 15 YEARS OR LESS AND GROWTH IS GREATER THAN 2 CM PER YEAR. CRITERIA FOR ADULTS: TREATEMENT IS PRESCRIBED BY AN ENDOCRINOLOGIST AND THE PATEINT HAS GROWTH HORMONE DEFICIENCY (GHD) WITH 1 OR 2 AND 3 AND 4 AND 5 LISTED BELOW: (1) HISTORY OF HYPOTHALAMIC OR PITUITARY DISEASE OR HISTORY OF CRANIAL IRRADIATION, OR (2) LOW IGF-1 LEVELS BASED ON AGE ADJUSTED VALUES AND SERUM GROWTH HORMONE CONCENTRATION OF LESS THAN 5NG/ML (PEAK LEVELS) FOLLOWING STIMULATION TESTING. ITT (INSULIN TOLERANCE TEST) IS THE DIAGNOSTIC TEST OF CHOICE UNLESS CONTRAINDICATED, AND (3) COMPLETE PITUITARY HORMONE FUNCTION HAS BEEN TESTED AND REPLACED WHEN APPROPRIATE, AND (4) THREE OF THE FOLLOWING: A) ALTERED BODY COMPOSITION WITH INCREASED BODY FAT MASS AND DECREASED LEAN BODY MASS, OR B) DECREASED MUSCLE STRENGTH AND EXERCISE CAPACITY, OR C) REDUCED BONE DENSITY OR PRESENCE OF A FRAGILITY FRACTURE, OR D) POOR SLEEP, OR E) IMPAIRED SENSE OF WELL BEING, AND (5) SECONDARY MEDICAL ILLNESSES THAT AFFECT GH HAVE BEEN RULED OUT. Page 98 of 128

99 RESERVED FOR PRESCRIBING BY ENDOCRINOLOGY. Page 99 of 128

100 SOMATULINE Somatuline Depot DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. Page 100 of 128

101 STELARA Stelara (1) DIAGNOSIS OF MODERATE TO SEVERE PLAQUE PSORIASIS, AND (2) DOCUMENTATION OF MEDICAL CONTRAINDICATIONS OR FAILURE WITH ENBREL AND HUMIRA. RESERVED FOR PRESCRIBING BY DERMATOLOGY Page 101 of 128

102 STIMATE Stimate DIAGNOSIS OF HEMOPHILIA A OR VON WILLEBRANDS DISEASE (TYPE 1). Page 102 of 128

103 STIVARGA Stivarga FOR NEW START PATIENTS: INITIAL CRITERIA - DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. RENEWAL CRITERIA - DOCUMENTATION THAT DISEASE PROGRESSION HAS NOT OCCURRED. THREE MONTHS, WITH APPROVAL EVERY THREE MONTHS IF RENEWAL CRITERIA ARE MET. Page 103 of 128

104 SUCRAID Sucraid DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, IF MEDICALLY NECESSARY. RESERVED FOR PRESCRIBING BY PROVIDERS SPECIALIZING IN GENETICS AND METABOLISM. Page 104 of 128

105 SYNAREL Synarel DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. Page 105 of 128

106 SYNRIBO Synribo FOR NEW START PATIENTS: (1) DIAGNOSIS OF CHRONIC OR ACCELERATED PHASE CHRONIC MYELOID LEUKEMIA (CML) AND (2) DOCUMENTED HISTORY OF RESISTANCE AND/OR INTOLERANCE TO TWO OR MORE TYROSINE KINASE INHIBITORS (TKIS). FOR RENEWAL: DOCUMENTATION THAT DISEASE PROGRESSION HAS NOT OCCURRED THREE MONTHS, WITH APPROVAL EVERY THREE MONTHS IF RENEWAL CRITERIA ARE MET. Page 106 of 128

107 TAFLINAR Tafinlar INITIAL CRITERIA: FOR NEW START PATIENTS: DIAGNOSIS OF UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATION. RENEWAL CRITERIA: DOCUMENTATION OF NO DISEASE PROGRESSION THREE MONTHS, THEN BALANCE OF CONTRACT YEAR IF RENEWAL CRITERIA ARE MET. Page 107 of 128

108 TYSABRI TYSABRI (1) DIAGNOSIS OF MULTIPLE SCLEROSIS, AND (2) DOCUMENTED FAILURE WITH COPAXONE AND REBIF. Page 108 of 128

109 VALCHLOR Valchlor THREE MONTHS, WITH APPROVAL EVERY THREE MONTHS IF RENEWAL CRITERIA ARE MET. Page 109 of 128

110 VASCEPA Vascepa (1) DIAGNOSIS OF HYPERTRIGLYCERIDEMIA WITH TRIGLYCERIDE LEVEL GREATER THAN 500 MG/DL, AND (2) INADEQUATE RESPONSE TO COMBINATION THERAPY WITH A FIBRATE (SUCH AS GEMFIBROZIL OR FENOFIBRATE) AND LOVAZA, UNLESS THE ALTERNATIVES ARE CONTRAINDICATED. Page 110 of 128

111 VICTRELIS Victrelis INITIAL: (1) DIAGNOSIS OF HEPATITIS C WITH DOCUMENTATION OF HCV GENOTYPE 1 AND VIRAL LOAD, AND (2) PRESCRIBED IN COMBINATION WITH PEGYLATED INTERFERON AND RIBAVIRIN. RENEWAL: HCV RNA TESTING AT WEEK 8 FOR DETERMINATION OF RESPONSE GUIDED THERAPY PER FDA-APPROVED DURATION. RESERVED FOR PRESCRIBING BY GASTROENTEROLOGY, OR HEPATOLOGY, OR INFECTIOUS DISEASE SPECIALISTS. 24 WEEKS, THEN UP TO AN ADDITIONAL 20 WEEKS IF RENEWAL CRITERIA ARE MET FOR FDA-APPROVED DURATION. Page 111 of 128

112 VIIBRYD Viibryd FOR NEW START PATIENTS: (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION OF AN INADEQUATE RESPONSE OR MEDICAL CONTRAINDICATION TO TWO PREFERRED ALTERNATIVE ANTIDEPRESSANTS: CITALOPRAM, ESCITALOPRAM, FLUOXETINE, PAROXETINE, SERTRALINE, VENLAFAXINE, OR CYMBALTA. Page 112 of 128

113 XALKORI Xalkori FOR NEW START PATIENTS: INITIAL CRITERIA - DIAGNOSIS OF LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE AND AN ECOG FUNCTIONAL STATUS OF 0 TO 2. RENEWAL CRITERIA - DOCUMENTATION EVERY 3 MONTHS THAT THERE HAS BEEN NO DISEASE PROGRESSION. THREE MONTHS, WITH APPROVAL EVERY THREE MONTHS IF RENEWAL CRITERIA ARE MET. Page 113 of 128

114 XELJANZ Xeljanz (1) DIAGNOSIS OF RHEUMATOID ARTHRITIS, AND (2) DOCUMENTATION OF MEDICAL CONTRAINDICATIONS OR FAILURE WITH METHOTREXATE, AND (3) DOCUMENTATION OF MEDICAL CONTRAINDICATIONS OR FAILURE WITH ENBREL AND HUMIRA. RESERVED FOR PRESCRIBING BY RHEUMATOLOGY Page 114 of 128

115 XENAZINE Xenazine DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. RESERVED FOR PRESCRIBING BY NEUROLOGY. THREE MONTHS, THEN BALANCE OF CONTRACT YEAR IF POSITIVE RESPONSE. Page 115 of 128

116 XIFAXAN Xifaxan (1) DIAGNOSIS OF HEPATIC ENCEPHALOPATHY AND DOCUMENTATION THAT SIDE EFFECTS HAVE LIMITED THE DOSE OF LACTULOSE, OR (2) DIAGNOSIS OF TRAVELER'S DIARRHEA AND DOCUMETATION OF TRIAL AND FAILURE OF, OR CONTRAINDICATIONS TO, CIPROFLOXACIN. Page 116 of 128

117 XTANDI Xtandi FOR NEW START PATIENTS: INITIAL CRITERIA - (1) DIAGNOSIS OF METASTATIC CASTRATION-RESISTANT PROSTATE CANCER AND (2) PRIOR CHEMOTHERAPY WITH DOCETAXEL, OR NOT A CANDIDATE FOR CHEMOTHERAPY. RENEWAL CRITERIA: DOCUMENTATION OF NO DISEASE PROGRESSION AND NO NEW CHEMOTHERAPY REGIMENS. SIX MONTHS, WITH APPROVAL EVERY SIX MONTHS IF RENEWAL CRITERIA ARE MET. Page 117 of 128

118 XYREM Xyrem DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. Page 118 of 128

119 ZALTRAP Zaltrap FOR NEW START PATIENTS: INITIAL CRITERIA - DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. RENEWAL CRITERIA - DOCUMENTATION THAT DISEASE PROGRESSION HAS NOT OCCURRED. THREE MONTHS, WITH APPROVAL EVERY THREE MONTHS IF RENEWAL CRITERIA ARE MET. Page 119 of 128

120 ZELBORAF Zelboraf FOR NEW START PATIENTS: INITIAL CRITERIA - (1) DIAGNOSIS OF METASTATIC OR UNRESECTABLE MELANOMA (2) DOCUMENTATION THAT THE BRAF V600 MUTATION HAS BEEN SHOWN TO BE PRESENT BY THE COBAS 4800 BRAF V600 MUTATION TEST OR SIMILAR TEST FROM A CLIA-CERTIFIED LABORATORY. RENEWAL CRITERIA - DOCUMENTATION THAT DISEASE PROGRESSION HAS NOT OCCURRED. THREE MONTHS, WITH APPROVAL EVERY THREE MONTHS IF RENEWAL CRITERIA ARE MET. Page 120 of 128

121 ZEMPLAR paricalcitol, Zemplar (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION OF FAILURE WITH CALCITRIOL. THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR PART D DEPENDING ON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE OF THE DRUG AND SETTING WHERE THE DRUG IS DISPENSED TO MAKE THE PART B OR PART D COVERAGE DETERMINATION. Page 121 of 128

122 ZIOPTAN Zioptan (PF) DOCUMENTATION THAT THE PATIENT HAS A SENSITIVITY TO PRESERVATIVES IN OTHER FORMULARY PRODUCTS SUCH AS LATANOPROST, LUMIGAN, TRAVATAN Z OR OTHER EYE DROPS FOR GLAUCOMA. Page 122 of 128

123 ZOLEDRONIC ACID zoledronic acid, Zometa DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. Page 123 of 128

124 ZORTRESS Zortress FOR NEW START PATIENTS: DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. THIS DRUG MAY BE COVERED UNDER MEDICARE PART B OR PART D DEPENDING ON THE CIRCUMSTANCES. INFORMATION MAY NEED TO BE SUBMITTED DESCRIBING THE USE OF THE DRUG AND SETTING WHERE THE DRUG IS DISPENSED TO MAKE THE PART B OR PART D COVERAGE DETERMINATION. Page 124 of 128

125 ZYFLO Zyflo, Zyflo CR (1) DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D, AND (2) DOCUMENTATION OF FAILURE WITH MONTELUKAST. Page 125 of 128

126 ZYTIGA Zytiga FOR NEW START PATIENTS: (1) DIAGNOSIS OF METASTATIC CASTRATION-RESISTANT PROSTATE CANCER AND (2) CONCURRENT USE OF PREDNISONE. FOR RENEWAL: DOCUMENTATION THAT (1) DISEASE PROGRESSION HAS NOT OCCURRED AND (2) NO OTHER CHEMOTHERAPY REGIMENS HAVE BEEN INITIATED AND (3) THE PATIENT HAS NOT EXPERIENCED UNACCEPTABLE TOXICITY SIX MONTHS, THEN BALANCE OF CONTRACT YEAR IF RENEWAL CRITERIA ARE MET. Page 126 of 128

127 ZYVOX Zyvox DIAGNOSIS OF AN FDA-APPROVED INDICATION, NOT OTHERWISE EXCLUDED FROM PART D. RESERVED FOR PRESCRIBING BY AN INFECTIOUS DISEASE SPECIALIST. Page 127 of 128

128 Drug Index INDEX \e " " \c "3" \z "1033" Page 128 of 128

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