Covered Uses All medically accepted indications not otherwise excluded from Part D.

Transcription

1 AAT DEFICIENCY Aralast NP intravenous recon soln 1,000 mg Glassia Prolastin-C intravenous recon soln Zemaira PA Details Age Other Diagnosis of severe congenital A1-PI deficiency who have clinically evident emphysema, weight, A1-PI phenotype, A1-PI baseline level Prescription must be written by a pulmonologist 6 months for initiation, 1 year for continuation 1

2 ADAPALENE adapalene topical cream adapalene topical gel 0.1 % PA Details Age Other Not approved when used to treat photo aging. Diagnosis, previous treatments, and response therapy 1 year Must have failure, intolerance, or contraindication to tretinoin 2

3 ADEMPAS Adempas PA Details Age Other Confirmation of diagnosis, documentation of response to any prior therapies Prescription must be written by pulmonologist or cardiologist 3 months initial, 1 year continuation For WHO Group 1 diagnosis, patient must have a history of taking or contraindication to sildenafil (Revatio). 3

4 AFINITOR Afinitor Afinitor Disperz PA Details Age Other DIAGNOSIS, PRIOR THERAPIES, AND TREATMENT RESPONSE Under CMS Review 3 MONTHS INITIAL, 1 YEAR CONTINUATION IN PATIENTS WITH RCC, USE OF AFINITOR IS RESERVED FOR THOSE WITH A DOCUMENTED TREATMENT FAILURE WITH NEXAVAR OR SUTENT 4

5 ALK POSITIVE TYROSINE KINASE INHIBITORS Alecensa Xalkori Zykadia PA Details Age Other Diagnosis, other treatments tried and outcome Prescribed by an oncologist 1 year Under CMS Review 5

6 ALUNBRIG Alunbrig PA Details Age Other Non-small cell lung cancer (NSCLC): Diagnosis of metastatic NSCLC. Patient has an anaplastic lymphoma kinase (ALK)-positive tumor as detected with an FDA-approved test or Clinical Laboratory Improvement Amendments-approved facility. Trial and failure or intolerance to Xalkori (crizotinib). Prescribed by or in consultation with an oncologist 3 months initial, 6 months continuation Approve for continuation of prior therapy. 6

7 AMITIZA Amitiza PA Details Age Other DIAGNOSIS, DOCUMENTED FAILURE OF 2 OF THE FOLLOWING AGENTS: FIBER PRODUCT, POLYETHYLENE GLYCOL, LACTULOSE, DOCUSATE, OR BISACODYL 1 YEAR 7

8 AMPYRA Ampyra PA Details Age Other NOT A COVERED BENEFIT IN PATIENTS WITH SEIZURE DISORDER OR A CREATININE CLEARANCE LESS THAN 50 ML/MIN EXPANDED DISABILITY SCALE SCORE, BASELINE AND FOLLOW-UP 25 FOOT WALK TEST, CREATININE CLEARANCE PRESCRIPTION MUST BE WRITTEN BY A NEUROLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION PATIENT MUST SHOW AN IMPROVEMENT IN WALKING SPEED TO CONTINUE TREATMENT 8

9 ANTIDEPRESSANTS Fetzima Trintellix Viibryd oral tablet Viibryd oral tablets,dose pack 10 mg (7)- 20 mg (23) PA Details Age DIAGNOSIS, PRIOR THERAPIES TRIED AND FAILED 1 YEAR Other MUST SEE CONTRAINDICATION TO OR FAILURE OF 2 DIFFERENT CLASSES OF GENERIC ANTIDEPRESSANTS INCLUDING SSRIS, SNRIS, TCAS, NOREPINEPHRINE-DOPAMINE REUPTAKE INHIBITORS, OR NORADRENERGIC AND SPECIFIC SEROTONERGIC ANTIDEPRESSANTS 9

10 ANTIPSYCHOTICS Abilify Maintena aripiprazole oral solution aripiprazole oral tablet aripiprazole oral tablet,disintegrating Aristada chlorpromazine oral clozapine oral tablet,disintegrating 100 mg, 12.5 mg, 25 mg clozapine oral tablet,disintegrating 150 mg, 200 mg Fanapt fluphenazine decanoate fluphenazine HCl injection Invega Sustenna Invega Trinza Latuda paliperidone oral tablet extended release 24hr 1.5 mg, 3 mg, 6 mg, 9 mg quetiapine oral tablet extended release 24 hr Rexulti Saphris (black cherry) thioridazine Versacloz Vraylar PA Details Age Other FOR BIPOLAR DISORDER OR SCHIZOPHRENIA, DOCUMENTATION OF DIAGNOSIS, TREATMENT FAILURE WITH TWO ATYPICAL ANTIPSYCHOTICS (ZIPRASIDONE, RISPERIDONE, QUETIAPINE, OLANZAPINE, CLOZAPINE), OR RATIONALE AS TO WHY ALTERNATIVES ARE NOT SUITABLE 1 YEAR 10

11 ANTI-TNF ALPHA DRUGS Cimzia Cimzia Powder for Reconst Enbrel Enbrel SureClick Humira Humira Pediatric Crohn's Start Humira Pen Humira Pen Crohn's-UC-HS Start Humira Pen Psoriasis-Uveitis Simponi subcutaneous syringe PA Details Age Other DIAGNOSIS AND OTHER THERAPIES TRIED AND FAILED, NEGATIVE TB TEST MUST BE WRITTEN BY A DERMATOLOGIST, RHEUMATOLOGIST, GASTROENTEROLOGIST, OR OPHTHALMOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION PRIOR TO RECEIVING BIOLOGIC THERAPY: FOR RHEUMATOID ARTHRITIS, PATIENT MUST HAVE A DOCUMENTED FAILURE WITH AT LEAST ONE DMARD. FOR CROHN'S DISEASE, PATIENT MUST HAVE A DOCUMENTED FAILURE WITH AT LEAST ONE NON-BIOLOGIC CONVENTIONAL THERAPY (INCLUDING BUT NOT LIMITED TO SULFASALAZINE, MESALAMINE, AZATHIOPRINE, OR METHOTREXATE). FOR PSORIASIS, PATIENT MUST HAVE TRIAL OF OR CONTRAINDICATION TO TOPICAL THERAPY AND METHOTREXATE. IN ORDER TO RECEIVE CIMZIA, SIMPONI, OR INFLIXMAB, PATIENT MUST HAVE A TRIAL OF OR CONTRAINDICATION TO ENBREL OR HUMIRA, WITH THE EXCEPTION OF INFLIXIMAB FOR FISTULIZING CROHN'S DISEASE AND ULCERATIVE COLITIS 11

12 ARANESP Aranesp (in polysorbate) injection solution 100 mcg/ml, 200 mcg/ml, 25 mcg/ml, 300 mcg/ml, 40 mcg/ml, 60 mcg/ml Aranesp (in polysorbate) injection syringe PA Details Age Other Ucontrolled 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. CKD - prescribed by a nephrologist or hematologist. Non-myeloid malignancies - prescribed by an oncologist/hematologist Initial: 3 months. Renewal: CKD-12 months, Non-myeloid malignancies - 4 months For renewal of CKD, for dialysis patients: Hb less than 11 g/dl or physician will decrease or interrupt dose and for 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). 12

13 ARCALYST Arcalyst PA Details Age Other 12 YEARS AND OLDER 1 YEAR AT A TIME 13

14 BENLYSTA Benlysta subcutaneous syringe PA Details Age Other Severe active lupus nephritis, active central nervous, use in combination with other biologics Diagnosis, autoantibody testing, prior treatments including response, and SLEDAI score. must be 18 and older Prescription must be written by a rheumatologist 6 months Failed to demonstrate adequate response to TWO standard therapies at recommended doses: corticosteroids, antimalarials, NSAIDs, and/or immunosuppressants. SLEDAI score greater than 8. 14

15 BOSULIF Bosulif oral tablet 100 mg, 400 mg, 500 mg PA Details Age Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to bosutinib. CBC and LFT lab test results are needed for continuation treatment. Prescription must be written by an oncologist 1 year Under CMS Review 15

16 CABOMETYX Cabometyx PA Details Age Other Renal cell carcinoma (RCC): Diagnosis of RCC. RCC is advanced. History of failure, contraindication, or intolerance to at least one prior antiangiogenic therapy [e.g., Nexavar (sorafenib), Sutent (sunitinib)]. Prescribed by or in consultation with an oncologist. 3 months initiation and 1 year continuation 16

17 CALQUENCE Calquence PA Details Age Other NA Documentation of diagnosis, previous treatments, and response to treatment. Prescribed by oncology 3 months initial, 6 months continuation 17

18 CAPRELSA Caprelsa oral tablet 100 mg, 300 mg PA Details Age Other HISTORY OF CONGENITAL LONG QT SYNDROME DIAGNOSIS, PRIOR THERAPIES, TREATMENT RESPONSE 18 YEARS AND OLDER PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 MONTHS FOR INITIATION, 6 MONTHS FOR CONTINUATION ECG, ELECTROLYTE(K,Mg,Ca), AND TSH MONITORING AT BASELINE, 2-4 WEEKS AND 8-12 WEEKS AFTER STARTING TREATMENT AND EVERY 3 MONTHS THEREAFTER 18

19 COMETRIQ Cometriq PA Details Age Other Diagnosis, prior therapy used, result of prior therapy. Prescription must be written by an oncologist 3 months for initiation, 6 months for continuation 19

20 CORLANOR Corlanor PA Details Age Other Ejection fraction less than or equal to 35% AND heart rate greater than 70 beats per minute AND in sinus rhythm AND on maximally tolerated betablocker OR has contraindication to beta-blocker (i.e.. allergy, severe COPD limiting beta blocker usage) Prescribed by a cardiologist. 12 months 20

21 COTELLIC Cotellic PA Details Age Other Diagnosis, other therapies tried and/or failed, and treatment response. Prescribed by an oncologist. 3 months for initiation, 6 months for continuation 21

22 DALIRESP Daliresp PA Details Age Diagnosis, prior therapies used and response to therapy, FEV1, baseline and follow-up weight assessments, baseline psychiatric evaluation Prescription must be written by pulmonologist or have had a pulmonology consult within the past 6 months 1 year Other To qualify for use, patients must have severe COPD (FEV1 less than 50% predicted) with a chronic bronchitis component and a history of exacerbations. Patients must also have concurrent use of long-acting bronchodilator and inhaled corticosteroid 22

23 DEMSER Demser PA Details Age Other Diagnosis and whether the patient is a candidate for surgery 3 months 23

24 DICLOFENAC GEL 3% diclofenac sodium topical gel 3 % PA Details Age Other Diagnosis and any prior treatments. Prescription must be written by a Dermatologist 3 months 24

25 DOPTELET Doptelet PA Details Age Other Diagnosis and platelet count Under CMS Review 1 month Patient must be scheduled to undergo a pre planned medical or dental procedure with treatment beginning 10 to 13 days prior to the scheduled procedure. Patients should undergo their procedure 5 to 8 days after the last dose. 25

26 EGRIFTA Egrifta subcutaneous recon soln 1 mg PA Details Age Other ONLY APPROVED FOR PATIENTS WITH HIV ASSOCIATED LIPODYSTROPHY. NOT INDICATED FOR WEIGHT MANAGEMENT. DIAGNOSIS, BASELINE WAIST CIRCUMFERENCE, BASELINE IGF- 1 FASTING PLASMA GLUCOSE, AND BASELINE HGAIC. MONITORING EVERY 6 MONTHS OF PARAMETERS LISTED ABOVE. MUST NOT HAVE AN ACTIVE MALIGNANCY PRESCRIPTION MUST BE WRITTEN BY AN INFECTIOUS DISEASE SPECIALIST OR ENDOCRINOLOGIST 3 MONTHS 26

27 EMEND aprepitant PA Details Age For use with highly and moderately-emetogenic chemotherapy, provide the chemotherapy regimen including drug, dose, and frequency. Ondansetron is preferred for post-operative nausea/vomiting (PONV) prophylaxis. When Emend or aprepitant is used for PONV prophylaxis, provide rationale as to why ondansetron is not a suitable alternative. 6 months Other Drug will also be reviewed for coverage under part B versus part D. 27

28 ENTRESTO Entresto PA Details Age Other History of angioedema related to previous ACE inhibitor or ARB therapy, concomitant use with aliskiren, pregnancy Patient has a diagnosis of New York Heart Association class II to IV heart failure, reduced ejection fraction less than or equal to 40%, other therapies tried, and outcome Prescription must be written by a cardiologist OR patient must have a consultation with a cardiologist within the past 12 months. 1 year Trial of or contraindication to ONE ACE inhibitor AND receiving concomitant therapy with one of the following beta blockers: carvedilol, bisoprolol, sustained-release metoprolol, unless unable to tolerate or contraindicated AND patient will discontinue use of any concomitant ACE inhibitor or ARB before initiating therapy. 28

29 EPOETIN ALFA Epogen injection solution 2,000 unit/ml, 20,000 unit/2 ml, 20,000 unit/ml, 3,000 unit/ml, 4,000 unit/ml Procrit injection solution 10,000 unit/ml, 2,000 unit/ml, 20,000 unit/ml, 3,000 unit/ml, 4,000 unit/ml, 40,000 unit/ml PA Details Age Other 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. 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 For renewal of CKD, for dialysis patients: Hb less than 11 g/dl or physician will decrease or interrupt dose and for 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]) 29

30 ERIVEDGE Erivedge PA Details Age Other PATIENTS WHO ARE CANDIDATES FOR SURGERY OR RADIATION DIAGNOSIS, PRIOR TREATMENTS, RESPONSE TO THERAPY 18 YEARS OF AGE AND OLDER PRESCRIPTION MUST BE WRITTEN BY A ONCOLOGIST OR DERMATOLOGIST 3 MONTHS FOR INITIATION, 6 MONTHS FOR CONTINUATION 30

31 ERLEADA Erleada PA Details Age Other Diagnosis, other therapies tried and outcome, fall risk assessment, and seizure history (if any) Must be prescribed by an oncologist or urologist 1 year 31

32 EXJADE Exjade PA Details Age Other myelodysplastic syndrome, renal failure, and neoplastic disease Serum ferritin, CrCl, serum transaminases and bilirubin, baseline auditory and ophthalmic examinations. For Non-Transfusion-Dependent Thalassemia Syndromes: liver iron concentration (LIC) by liver biopsy or by an FDA-cleared or approved method for identifying patients for treatment with deferasirox therapy. Dose verification 3 months For chronic transfusional iron overload due to blood transfusion :serum ferritin consistently greater than 1000 mcg/l. For NON-transfusion dependent thalassemia syndrome and chronic iron overload a LIC (liver iron concentration) of at least 5 mg Fe/g dry weight and a serum ferritin greater than 300 mcg/l on at least 2 measurements 1 month apart. For patients continuation: Current LIC is greater than 3 mg per gram of dry weight or Exjade will be withheld until the LIC reaches above 5 mg per gram of dry weight 32

33 FARYDAK Farydak PA Details Age Other Diagnosis, other therapies tried and/or failed Prescription must be written by an oncologist 3 months initial, 6 months for continuation 33

34 FASENRA Fasenra PA Details Age Other Allergen test, baseline FEV1, FEV1 following bronchodilator, asthma medical history (including medications, emergency department visits, and hospitalizations), baseline eosinophil count Must be prescribed by a Pulmonologist or Immunologist or Allergist Initiation: 3 months, continuation 1 year Under CMS Review 34

35 FERRIPROX Ferriprox oral tablet PA Details Age Other Diagnosis, length of therapy, serum ferritin concentrations and dose/weight verification, & CBC 3 months Must have a contraindication to, an inadequate response, or has been intolerant to, or experienced clinically significant adverse effects to Exjade, such as evidence of cardiac iron overload or iron-induced cardiac dysfunction with Exjade. For continuation patient must have a 20% or greater reduction in serum ferritin with an adequate dose and duration of therapy. 35

36 FULYZAQ Mytesi PA Details Age Other Use when infectious diarrhea has not been ruled out Diagnosis, use of antiretroviral therapy 3 months Infectious diarrhea needs to be ruled out prior to initiating treatment. Patient must have a history of using at least two prior treatments for diarrhea, including bismuth subsalicylate, kaolin, loperamide, or diphenoxylate/atropine. 36

37 FYCOMPA Fycompa oral suspension Fycompa oral tablet PA Details Age Other Diagnosis, other therapies tried, response to prior therapy Prescription must be prescribed by neurologist 12 months Monitor at initiation and after dose increases for serious psychiatric and/or behavioral reactions. 37

38 GATTEX Gattex 30-Vial PA Details Age Other Therapy should be discontinued in cases of intestinal malignancy. Diagnosis, other therapies tried and/or failed. Prescription must be written by a gastroenterologist 3 months for initiation, 6 months for continuation A colonoscopy of the entire colon with removal of polyps must be done before initiating therapy, medical records documenting this procedure must be submitted. 38

39 GAUCHER'S DISEASE TREATMENT Cerdelga miglustat Zavesca PA Details Age Other NOT APPROVED FOR TYPE II OR TYPE III GAUCHER'S DISEASE Under CMS Review PRESCRIPTION MUST BE WRITTEN BY GENETICIST, HEMOTOLOGIST, OR METABOLIC SPECIALIST 1 YEAR Under CMS Review 39

40 GILOTRIF Gilotrif PA Details Age Other Diagnosis, previous therapies tried and/or failed Prescription must be written by oncologist 12 months 40

41 GLEEVEC imatinib PA Details Age Other DIAGNOSIS, PRIOR THERAPIES, AND TREATMENT RESPONSE PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 MONTHS INITIAL, 6 MONTHS CONTINUATION GENETIC, HEMATOLOGIC, AND CYTOGENIC TESTS ARE REQUIRED BASED ON THE SPECIFIC INDICATION TO ASSESS APPROPRIATE USE AND ADEQUATE RESPONSE TO THERAPY 41

42 GRALISE Gralise Gralise 30-Day Starter Pack PA Covered Uses Age Other Details All medically accepted indications not otherwise excluded under Part D Diagnosis, previous treatments including dosage, outcome of previous treatment 1 year Under CMS Review 42

43 GROWTH HORMONE Norditropin FlexPro Nutropin AQ Nuspin PA Details Age Other PRESENCE OF CONTRAINDICATIONS TO THERAPY DIAGNOSIS, HEIGHT AND WEIGHT, HISTORY OF GROWTH MEASUREMENT. REPLACEMENT THERAPY IN PATIENTS WITH GROWTH HORMONE DEFICIENCY WITH DIAGNOSIS CONFIRMED BY APPROPRIATE GROWTH HORMONE STIMULATION TESTING PRESCRIPTION MUST BE WRITTEN BY ENDOCRINOLOGIST OR NEPHROLOGIST 3 MONTHS FOR INITIATION, 1 YEAR FOR CONTINUATION 43

44 HEPATITIS B Baraclude oral solution entecavir PA Details Age Other TREATMENT CONSIDERATION IS BASED ON HBEAG, HBV DNA QUANTITY, AND ALT LEVEL PRESCRIPTION MUST BE WRITTEN BY A GASTROENTEROLOGIST, HEPATOLOGIST, OR INFECTIOUS DISEASE SPECIALIST 1 YEAR 44

45 HEPATITIS C TREATMENT Harvoni Mavyret Rebetol oral solution Ribasphere oral capsule ribavirin oral capsule ribavirin oral tablet 200 mg Zepatier PA Details Age Other PATIENT WEIGHT, GENOTYPE, HCV-RNA, LEVEL OF FIBROSIS, TREATMENT HISTORY PRESCRIPTION MUST BE WRITTEN BY GASTROENTEROLOGIST, HEPATOLOGIST, OR INFECTIOUS DISEASE SPECIALIST 8-24 WEEKS. TREATMENT WILL BE APPROVED CONSISTENT WITH CURRENT AASLD-IDSA GUIDANCE. FOR COVERAGE OF HARVONI OR ZEPATIER: MUST HAVE FAILURE, INTOLERANCE, OR CONTRAINDICATION TO MAVYRET. 45

46 HEREDITARY ANGIOEDEMA Cinryze Firazyr Haegarda PA Details Age Other Diagnosis, including the results immunologic laboratory testing that show low C4 and functional C1- inhibitor levels Prescription must be written by Allergist or Immunologist 3 months initially, 12 months for continuation Prophylactic treatment with Cinryze is limited to patients who experience one or more severe attacks per month, on average. 46

47 HETLIOZ Hetlioz PA Details Age Other Diagnosis, other therapies tried and/or failed 3 months initial, 1 year continuation 47

48 HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA Juxtapid Kynamro PA Details Age Other Diagnosis, prior therapy used, results of prior therapy 3 months for initiation, 6 months for continuation Patient must have a diagnosis of homozygous familial hypercholesterolemia. Liver function tests required at baseline and at least monthly during the first year of treatment. 48

49 IBRANCE (S) Ibrance PA Details Age Other Prescription must be written by an oncologist 3 months initial, 6 months for continuation Must have a failure, contraindication, or intolerance to Kisqali 49

50 ICLUSIG Iclusig PA Details Age Other Diagnosis, prior therapy used, result of prior therapy. Prescription must be written by an oncologist or hematologist 3 months for initiation, 6 months for continuation Liver function monitoring required at baseline and 3 months after initiation 50

51 IDHIFA Idhifa PA Details Age Other Diagnosis, previous treatments, and outcome. Prescribed by or in consultation with a hematologist/oncologist. 12 months 51

52 IMBRUVICA Imbruvica oral capsule 140 mg, 70 mg Imbruvica oral tablet PA Details Age Other DIAGNOSIS, PRIOR TREATMENTS, RESPONSE TO THERAPY Under CMS Review 12 months 52

53 INCRELEX Increlex PA Details Age Other DIAGNOSIS, HEIGHT AND WEIGHT MEASUREMENTS, GH LEVEL, IGF-1 LEVEL PRESCRIPTION MUST BE WRITTEN BY ENDOCRINOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION 53

54 INHALED TOBRAMYCIN Tobi Podhaler inhalation capsule, w/inhalation device PA Details Age Other Diagnosis, therapies tried, and outcome Prescribed by Infectious disease specialist or pulmonologist 1 year 54

55 INLYTA Inlyta oral tablet 1 mg, 5 mg PA Details Age Other DIAGNOSIS, PRIOR TREATMENTS, RESPONSE TO THERAPY 18 YEARS OF AGE AND OLDER PRESCRIPTION MUST BE WRITTEN BY A ONCOLOGIST 3 MONTHS FOR INITIATION, 6 MONTHS FOR CONTINUATION 55

56 INTERFERON ALPHA Intron A injection Pegasys Pegasys ProClick subcutaneous pen injector 180 mcg/0.5 ml PA Details Age Other FOR HEPATITIS C: PATIENT WEIGHT, GENOTYPE, HCV-RNA QUANTITY AND DATE OF TEST, PRESENCE OF DIRRHOSIS (Y/N), TREATMENT HISTORY, HISTORY OF ANEMIA OR DEPRESSION. HEPATITIS B: HBEAG STATUS, HBV DNA QUANTITY, AND ALT LEVEL. OTHERS: DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED, RESPONSE TO TREATMENT Under CMS Review 1 YEAR FOR INDICATIONS OTHER THAN HEPATITIS C. HEPC APPROVALS FROM WEEKS BASED ON DRUG REGIME 56

57 INTUNIV guanfacine oral tablet extended release 24 hr PA Details Age Other DIAGNOSIS AND THERAPIES TRIED AND FAILED. 1 year 57

58 IRESSA Iressa PA Details Age Other Under CMS Review PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION GEFITINIB IS COVERED AS MONOTHERAPY 58

59 IVIG Bivigam Carimune NF Nanofiltered intravenous recon soln 6 gram Flebogamma DIF intravenous solution 10 % Gammagard Liquid Gammagard S-D (IgA < 1 mcg/ml) Gammaked injection solution 1 gram/10 ml (10 %) Gammaplex Gammaplex (with sorbitol) Gamunex-C injection solution 1 gram/10 ml (10 %) Octagam Privigen PA Details Age Other DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED, RESPONSE TO TREATMENT 3 MONTHS FOR INITIATION, 6 MONTHS FOR CONTINUATION DIAGNOSIS AND ADMINISTRATION INFORMATION WILL BE REVIEWED TO DETERMINE IF COVERAGE IS AVAILABLE AS A MEDICARE PART B OR PART D BENEFIT 59

60 JAKAFI Jakafi PA Details Age Other DIAGNOSIS, OTHER TREATMENTS TRIED AND FAILED, CBC AT BASELINE AND PERIODICALLY AFTER INITIATION, HISTORY OF RBC TRANSFUSIONS 18 YEARS AND OLDER PRESCRIBER MUST BE A HEMATOLOGIST OR ONCOLOGIST 3 MONTHS FOR INITATION, 6 MONTHS FOR CONTINUATION PATIENT MUST HAVE PALPABLE SPLENOMEGALY AT BASELINE AND SHOW A REDUCTION IN SPLEEN VOLUME AND SYMPTOM IMPROVEMENT FOR CONTINUATION OF THERAPY 60

61 JYNARQUE Jynarque PA Details Age Other History of signs or symptoms of significant liver impairment or injury Documented diagnosis of polycystic kidney disease, ultrasound results Prescribed by endocrinology or nephrology 6 months initial, 1 year continuation 61

62 KALYDECO Kalydeco PA Details Age Other Diagnosis and the presence of one or more specific gene mutations that the drug is FDA approved to treat. 3 months initially, 12 months for continuation 62

63 KEVZARA Kevzara subcutaneous syringe PA Details Age Other Diagnosis, other therapies tried and outcome, negative TB test, baseline LFTs and for continuation of therapy, CBC, and serum lipid profile at baseline and for continuation of therapy. Must be prescribed by a Rheumatologist Initiation: 3 months, continuation 1 year Must have a documented failure with two of the following TNF drugs: Humira, Enbrel, or Infliximab 63

64 KINERET Kineret PA Details Age Other Diagnosis, other therapies tried and/or failed Prescription must be written by rheumatologist or pediatrician 3 months initially, 6 months for continuation for gout is limited to patients who have tried a maximum tolerated dose of a xanthine oxidase inhibitor (i.e.: allopurinol) 64

65 KISQALI Kisqali PA Details Age Other Diagnosis, other therapies previously tried, and the outcome. Kisqali is used in combination with an aromatase inhibitor [(e.g., Femara (letrozole)]. Prescribed by or in consultation with an oncologist 3 months initial and 6 months for continuation of therapy 65

66 KORLYM Korlym PA Details Age Other Diagnosis, other therapies tried and outcome, HbA1c Prescribed by endocrinologist 1 year Must have trial of ketoconazole or metyrapone therapy or have intolerance or contraindication to these medications. Must have failed surgery or not be a candidate for surgery. For continuation of therapy patient must show an improvement in HbA1c. 66

67 KUVAN Kuvan oral powder in packet 100 mg Kuvan oral tablet,soluble PA Details Age Other DIAGNOSIS AND BASELINE AND FOLLOW UP PHENYLALANINE LEVELS. FOR CONTINUATION, MUST SHOW A 30% REDUCTION IN PHE LEVELS FROM BASELINE 2 MONTHS FOR INITIATION, 1 YEAR FOR CONTINUATION 67

68 LENVIMA Lenvima PA Details Age Other Prescription must be written by an oncologist 1 year 68

69 LEUKINE Leukine injection recon soln PA Details DIAGNOSIS Age ACUTE MYELOID LEUKEMIA (AML): GREATER OR EQUAL TO 55 YEARS OLD. Other 3 MONTHS AT A TIME 69

70 LIDOCAINE TRANSDERMAL lidocaine topical adhesive patch,medicated lidocaine topical ointment PA Details Age Other DIAGNOSIS AND OTHER THERAPIES TRIED AND FAILED 1 YEAR FOR LIDOCAINE PATCH: MUST HAVE A USED A PREVIOUS TRIAL OF GABAPENTIN FOR THE TREATMENT OF POST- HERPETIC NEURALGIA OR DIABETIC NEUROPATHY 70

71 LINZESS Linzess PA Details Age Other Diagnosis and previous treatments 1 year Must have a failure, contraindication or intolerance to Amitza 71

72 LONSURF Lonsurf PA Details Age Other Diagnosis, other therapies tried and/or failed, and treatment response Prescription must be written by an oncologist 1 year 72

73 LYNPARZA Lynparza PA Details Age Other DIAGNOSIS, PRIOR THERAPIES, GENETIC TESTING PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 months initiation, 6 months continuation Patients must have failed greater than equal to 3 prior courses of chemotherapy and have BRCA-positive or suspected BRCA-positive advanced ovarian cancer 73

74 MEDICALLY ACCEPTED USE gabapentin oral capsule gabapentin oral solution 250 mg/5 ml gabapentin oral tablet 600 mg, 800 mg Lyrica megestrol oral suspension 400 mg/10 ml (40 mg/ml), 625 mg/5 ml megestrol oral tablet topiramate oral capsule, sprinkle topiramate oral tablet zonisamide PA Details Age Other Diagnosis 1 year 74

75 MEKINIST Mekinist oral tablet 0.5 mg, 2 mg PA Details Age Other Wild-type BRAF melanoma Diagnosis, prior therapy used, result of prior therapy. Documentation of BRAF mutation, as detected using an FDA-approved test. Prescription must be written by an oncologist 1 year 75

76 METHADONE methadone oral solution methadone oral tablet PA Details Age Other Diagnosis and any prior treatments. 6 months Under CMS Review 76

77 METHAMPHETAMINE methamphetamine PA Details Age Other Diagnosis, other therapies previously tried and failed, and response to treatment 1 year For the treatment of attention deficit disorder patient must have a trial of both methylphenidate and amphetamine/dextroamphetamine or rationale as to why these treatments are not suitable. 77

78 MIRVASO Mirvaso topical gel with pump PA Details Age Other Documentation of diagnosis and other treatments tried and outcome. 1 year For the treatment of acne rosacea: doxycycline (oral) and topical metronidazole. 78

79 MOVANTIK Movantik PA Covered Uses Age Other Details All medically accepted indications not otherwise excluded from Part D Will not be approved for cancer related pain Documented diagnosis of opiate induced constipation (non-cancer pain) 1 year Patient must have a trial of or contraindication to at least two different classes of laxative agents including bulk, osmotic, or stimulant laxatives. 79

80 MULTIPLE SCLEROSIS Aubagio Avonex (with albumin) Avonex intramuscular pen injector kit Avonex intramuscular syringe kit Betaseron subcutaneous kit Extavia subcutaneous kit Gilenya oral capsule 0.5 mg glatiramer Glatopa Rebif (with albumin) Rebif Rebidose Rebif Titration Pack Tecfidera PA Covered Uses Age Other Details All medically accepted indications not otherwise excluded under Part D Diagnosis, EDSS score, relapse history, and physical or cognitive disability neurologist 1 year For Aubagio, Extavia, Tecfidera, and Rebif- must have a failure of one of the following: Avonex, Betaseron, Glatopa, Glatiramer, or Gilenya 80

81 MYALEPT Myalept PA Details Age Other Diagnosis, prior therapy used, result of prior therapy 3 months for initiation, 1 year for continuation 81

82 NATPARA Natpara PA Details Age Other DIAGNOSIS, BASELINE SERUM CALCIUM AND 25- HYDROXYVITAMIN D LEVELS MUST BE PRESCRIBED BY AN ENDOCRINOLOGIST 1 year 82

83 NERLYNX Nerlynx PA Details Age Other Diagnosis, previous treatments, and outcome. Prescribed by or in consultation with an oncologist 12 months Approve for continuation of prior therapy if treatment duration of Nerlynx has not exceeded a total of 12 months 83

84 NEUPRO Neupro PA Details Age Other Diagnosis, other therapies tried and/or failed, frequency of symptoms 1 year Patient must have a trial of or contraindication to two of the following therapies prior to coverage of Neupro: pramipexole, ropinirole, or carbidopa/levodopa. 84

85 NEXAVAR Nexavar PA Details Age Other DIAGNOSIS, PRIOR THERAPIES, AND TREATMENT RESPONSE PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION 85

86 NINLARO Ninlaro PA Details Age Other Diagnosis, other therapies tried and/or failed, and treatment response. Used in combination with Revlimid (lenalidomide) and dexamethasone. Prescription must be written by an oncologist or hematologist 3 months for initial 6 months for continuation Must have an intolerance or contraindication to Velcade 86

87 NOXAFIL Noxafil oral PA Details Age Other Diagnosis, therapies tried, and outcome Prescribed Infectious disease specialist 6 months For the treatment of aspergillosis patient must have failure of, intolerance or contraindication to vorconizole OR rationale as to why vorconizole is not suitable. 87

88 NUCALA Nucala PA Details Age Other Under CMS Review Pulmonology, immunologist, or allergist 3 months for initial, 1 year for continuation Under CMS Review 88

89 NUEDEXTA Nuedexta PA Details Age Other Diagnosis Prescription must be written by a neurologist or psychiatrist. 1 year 89

90 NUPLAZID Nuplazid oral tablet 17 mg PA Details Age Other Parkinson's disease psychosis: Diagnosis of Parkinson's disease. Patient has at least one of the following: hallucinations or delusions. 1 year 90

91 OCALIVA Ocaliva PA Details Age Other Diagnosis, other therapies tried and failed, and response to therapy, baseline alkaline phosphatase (ALP) level for initiation, and ALP levels after first 3 months of therapy and then yearly for continuation of therapy. 3 months for initial and 1 year for continuation ALP levels are still elevated with at least 12 consecutive months of Actigall/Ursodiol use (at maximum dose of mg/kg/day) unless intolerant to Acitgal/Ursodiol. Must be used in combination with Actigal/Ursodiol. If intolerant to Actigal/Ursodiol can be used as monotherapy. Must show improvement of ALP levels for continuation. 91

92 OCTREOTIDE octreotide acetate injection solution PA Details Age Other Diagnosis, other therapies tried and failed 1 year 92

93 ODOMZO Odomzo PA Details Age Other Patient has recurring disease following surgery or radiation OR patient is not a candidate for surgery or radiation therapy Prescription must be written by an oncologist or dermatologist 1 year 93

94 OPSUMIT Opsumit PA Details Age Other Confirmation of diagnosis, documentation of response to any prior therapies Prescription must be written by pulmonologist or cardiologist 3 months initial, 1 year continuation Patient must have a history of taking bosentan (Tracleer), or a contraindication to bosentan that does not apply to Opsumit. 94

95 ORENCIA Orencia subcutaneous syringe 125 mg/ml PA Details Age Other DIAGNOSIS AND OTHER THERAPIES TRIED AND FAILED, NEGATIVE TB TEST PRESCRIPTION MUST BE WRITTEN BY A RHEUMATOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION PATIENT MUST HAVE A DOCUMENTED FAILURE WITH AT LEAST ONE DMARD AND EITHER HUMIRA OR ENBREL 95

96 ORFADIN Orfadin PA Details Age Other DIAGNOSIS AND WEIGHT PRESCRIPTION MUST BE WRITTEN BY AN ENDOCRINOLOGIST, GASTROENTEROLOGIST, HEMATOLOGIST, METABOLIC SPECIALIST, OR NEPHROLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION CLOSE MONITORING OF DISEASE MARKERS (ERYTHROCYTE PBG-SYNTHASE ACTIVITY, URINE 5-ALA, SUCCINYLACETONE) DURING THE FIRST 3 MONTHS OF TREATMENT TO ENSURE NORMALIZATION 96

97 ORKAMBI Orkambi PA Details Age Other Patient has a diagnosis of cystic fibrosis (CF) AND Patient is homozygous for the F508del mutation in the CF transmembrane conductance regulator (CFTR) gene AND The presence of the mutation was documented by an FDA-cleared cystic fibrosis mutation test. 6 months initial, 12 months for continuation For renewal, Patient is benefiting from treatment (i.e., improvement in lung function [forced expiratory volume in one second [FEV1], decreased number of pulmonary exacerbations) 97

98 OTEZLA Otezla Otezla Starter oral tablets,dose pack 10 mg (4)-20 mg (4)-30 mg (47) PA Details Age Other Diagnosis, prior therapy used, result of prior therapy Must be prescribed by a Rheumatologist or Dermatologist 3 months for initiation, 1 year for continuation Patient must have failure of, intolerance or contraindication to at least one formulary TNF inhibitor (including but not limited to Humira, Enbrel, Cimzia, or Infliximab) 98

99 OXYCONTIN oxycodone oral tablet,oral only,ext.rel.12 hr PA Details Age Other DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED, RESPONSE TO TREATMENT, OTHER OPIATES CURRENTLY BEING USED 6 MONTHS Under CMS Review 99

100 PANRETIN Panretin PA Details Age Other NOT INDICATED WHEN SYSTEMIC ANTI-KS THERAPY IS REQUIRED. 6 MONTHS 100

101 PCSK9 INHIBITORS Praluent Pen Repatha Repatha SureClick PA Covered Uses Age Other Details All medically accepted indications not otherwise excluded under Part D Submission of clinical and laboratory evidence documenting heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, or clinical atherosclerotic cardiovascular disease- ASCVD (defined as history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral arterial disease presumed to be of atherosclerotic origin). Baseline LDL-C within 30 days prior to request, and documentation of other therapies tried and the outcome. Repeat LDL- C within 60 days of each prior authorization request. Prescribed by a cardiologist, endocrinologist, or lipid specialist Initial 6 months. Renewal 1 year. Member must have tried and failed at least 2 different statins including fluvastatin. Praluent/Repatha must be received with maximally tolerated statin therapy unless statin therapy cannot be used. LDL-C with in 30 days of request greater than or equal to 100mg/dL with ASCVD or LDL-C greater than or equal to 130mg/dL without ASCVD. 101

102 POMALYST Pomalyst PA Details Age Other Diagnosis, prior therapy used, result of prior therapy. Prescription must be written by an oncologist or hematologist 1 year 102

103 PROLIA Prolia PA Details Age Other PRESENCE OF ABSOLUTE CONTRAINDICATION TO THERAPY DIAGNOSIS AND OTHER THERAPIES TRIED AND FAILED 18 YEARS AND OLDER 1 YEAR PATIENT MUST HAVE A DOCUMENTED FAILURE OR CONTRAINDICATION TO A BISPHOSPHONATE AGENT. 103

104 PROMACTA Promacta PA Details Age Other Diagnosis, other therapies tried and/or failed, and platelet count INITIAL FILL FOR 6 MONTHS, 1 YEAR THEREAFTER 104

105 PROVIGIL modafinil PA Details Age Other DIAGNOSIS AND OTHER THERAPIES TRIED AND FAILED. 1 YEAR 105

106 PULMONARY FIBROSIS Esbriet Ofev PA Details Age Other liver function prescriber must be a pulmonologist. 1 year 106

107 PULMONARY HYPERTENSION Adcirca Letairis sildenafil (Pulmonary Arterial Hypertension) oral tablet 20 mg Tracleer Ventavis PA Details Age CONFIRMATION OF DIAGNOSIS OF PAH (WHO GROUP 1 OR HIGHER), DOCUMENATION OF RESPONSE TO THERAPY PRESCRIPTION MUST BE WRITTEN BY PULMONOLOGIST OR CARDIOLOGIST 1 YEAR Other Ventavis will also be reviewed for coverage under part B versus part D. Prior to coverage of sildenafil, the plan will determine whether the diagnosis meets part D requirements for approval 107

108 PURIXAN Purixan PA Details Age Other DIAGNOSIS, PRIOR TREATMENTS, RESPONSE TO THERAPY prescriber must be a oncologist or hematologist 1 year 108

109 RELISTOR Relistor oral Relistor subcutaneous solution Relistor subcutaneous syringe PA Details Age Other Diagnosis and prior therapies tried and failed 3 months for initiation, 1 year for continuation For the treatment of opioid-induced constipation associated with chronic noncancerous pain: prior trial of or contraindication to at least one class of laxative agents (including bulk, osmotic, or stimulant laxatives) AND Amitiza. For all other conditions: a trial of or contraindication to at least two different classes of laxative agents (including bulk, osmotic, or stimulant laxatives) 109

110 REVLIMID Revlimid PA Details Age Other DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED, RESPONSE TO TREATMENT 18 YEARS AND OLDER PRESCRIPTION MUST BE WRITTEN BY AN ONCOLOGIST 1 year 110

111 RUBRACA Rubraca PA Details Age Other Ovarian cancer: Diagnosis of advanced ovarian cancer. Presence of deleterious BRCA mutation as detected by an FDA-approved diagnostic test (e.g., Foundation Focus CDxBRCA Assay). History of failure, contraindication, or intolerance to two or more chemotherapies (e.g., cisplatin, carboplatin). Prescribed by or in consultation with an oncologist 12 months 111

112 RYDAPT Rydapt PA Details Age Other Acute Myeloid Leukemia (AML): Newly diagnosed acute myeloid leukemia (AML), FMS-like tyrosine kinase 3 (FLT3) mutation-positive as detected by a U.S. Food and Drug Administration (FDA)-approved test, used in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. Aggressive Systemic Mastocytosis (ASM), Systemic Mastocytosis with Associated Hematological Neoplasm (SM- AHN), Mast Cell Leukemia (MCL): Diagnosis of one of the following: aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). All indications: Prescribed by or in consultation with a hematologist or oncologist. 1 year Approve for continuation of prior therapy 112

113 SAMSCA Samsca PA Details Age Other Diagnosis, patient has a serum sodium less than 125 meq/l at baseline, OR member has less marked hyponatremia (serum sodium less than 135 meq/l at baseline) AND is symptomatic (e.g. nausea, vomiting, headache, lethargy, confusion, and baseline LFTs) Prescribed by endocrinology or nephrology 1 month Patient must have documented failure of two other therapies (e.g. fluid restriction, furosemide, demeclocycline). 113

114 SAVELLA Savella oral tablet Savella oral tablets,dose pack PA Details Age Other DIAGNOSIS OF FIBROMYALGIA, RESPONSE TO THERAPY 1 YEAR 114

115 SIGNIFOR Signifor PA Details Age Other Diagnosis, other therapies tried and failed, result of prior pituitary surgery (if performed). If not surgery was performed, provide the reason why surgery is not an option. Prescription must be written by an endocrinologist 3 months for imitation, 6 months for continuation 115

116 SIRTURO Sirturo PA Details Age Other Diagnosis, other therapies tried and/or failed. ECG and liver function tests are required at baseline and at intervals as specified in the FDA prescribing information to monitor for potentially severe adverse events. Prescription must be written by a infectious disease specialist 24 weeks Drug therapy must be directly observed. Use of Sirturo is reserved for MDR-TB where other treatment options cannot be used for safety or efficacy reasons. 116

117 SORIATANE acitretin PA Details Age Other Female patients who are pregnant or planning to become pregnant within the next three years Diagnosis, other therapies tried and/or failed Prescription must be written by dermatologist, oncologist, or transplant physician 3 months for initiation, 6 months for continuation For the treatment of psoriasis, patient must have a trial of or contraindication to topical therapy and methotrexate. For the prevention of skin cancer in solid organ transplant patients, Soriatane will be covered for patients who develop multiple (greater than 5) squamous cell carcinoma (SCC) lesions per year, aggressive SCC, or accelerated development of SCC 117

118 SPRITAM Spritam PA Details Age Other Diagnosis, therapies tried, and outcome Prescribed by Neurologist 1 year Rationale as to why generic levetiracetam is not suitable. 118

119 SPRYCEL Sprycel PA Details Age Other PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 1 year Must have a failure, intolerance or contraindication to imatinib. 119

120 STIVARGA Stivarga PA Details Age Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to regorafenib. LFT lab test results are needed for continuation treatment. Prescription must be written by an oncologist 1 year 120

121 SUPREP Suprep Bowel Prep Kit PA Details Age Other Diagnosis, other therapies tried and outcome 1 year Must have a failure, contraindication, or intolerance to at least one generic bowel prep ie. Trilyte 121

122 SUTENT Sutent PA Details Age DIAGNOSIS, PRIOR THERAPIES, AND TREATMENT RESPONSE. DOCUMENATION OF FAILURE OF IMATINIB FOR PATIENTS WITH GIST. DOCUMENTATION OF FAILURE OF VOTRIENT FOR PATIENTS WITH RENAL CELL CARCINOMA. IF NO PREVIOUS FAILURE, RATIONALE AS TO WHY PREFERRED AGENT CANNOT BE USED PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION Other GIST PATIENTS REQUIRE A FOLLOW-UP CT SCAN BETWEEN 8 AND 12 WEEKS. 122

123 SYLATRON Sylatron PA Details Age Other HISTORY OF HEPATITIS OR HEPATIC DECOMPENSATION DIAGNOSIS OF MALIGNANT MELANOMA WITH EVIDENCE OF NODAL INVOLVEMENT 18 YEARS AND OLDER PRESCRIBER MUST BE ONCOLOGIST OR DERMATOLOGIST 6 MONTHS MONITOR FOR NEUROPSYCHIATRIC DISORDERS, TOXICITY, AND NEW OR WORSENING RETINOPATHY 123

124 SYMLIN SymlinPen 120 SymlinPen 60 PA Details Age Other GASTROPARESIS OR USE OF DRUGS TO STIMULATE GASTROINTESTINAL MOTILITY HBA1C AND CURRENT DIABETES MEDICATIONS 1 YEAR 124

125 SYNRIBO Synribo PA Details Age Other Diagnosis, prior therapy used, result of prior therapy. Prescription must be written by an oncologist or hematologist 3 months for initiation, 6 months for continuation 125

126 TAFINLAR Tafinlar PA Details Age Other Wild-type BRAF melanoma Diagnosis, prior therapy used, result of prior therapy. Documentation of BRAF mutation, as detected using an FDA-approved test. Prescription must be written by an oncologist 1 year 126

127 TAGRISSO Tagrisso PA Details Age Other Diagnosis, other therapies tried and/or failed, and treatment response. For NCSLC: Tumors are positive for epidermal growth factor receptor (EGFR) T790M mutation. Prescribed by an oncologist. 1 year 127

128 TARCEVA Tarceva PA Details Age Other DIAGNOSIS, PRIOR THERAPIES, AND TREATMENT RESPONSE PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 1 year 128

129 TASIGNA Tasigna oral capsule 150 mg, 200 mg, 50 mg PA Details Age Other DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED, RESPONSE TO TREATMENT, POTENTIAL DRUG INTERACTIONS Under CMS Review PRESCRIPTION MUST BE WRITTEN BY AN ONCOLOGIST 1 year Must have a failure, intolerance or contraindication to imatinib and Sprycel. 129

130 TAVALISSE Tavalisse PA Details Age Other Diagnosis, other therapies tried, outcome, and platelet count less than 50,000/microL for at least 3 months Must be prescribed by a hematologist or oncologist 3 months Patient must have a failure, contraindication, or intolerance to at least two of the following therapies: corticosteroids, IVIG, Rituxan, or Promacta. For continuation of therapy the platelet counts must be to a level sufficient to avoid clinically important bleeding. 130

131 TAZORAC tazarotene Tazorac topical cream 0.05 % Tazorac topical gel PA Details Age Other DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED. 1 YEAR 131

132 TEKTURNA Tekturna Tekturna HCT PA Details Age DIAGNOSIS AND OTHER THERAPIES TRIED AND FAILED. 1 YEAR Other MUST SEE CONTRAINDICATION TO OR FAILURE OF 2 MEDICATIONS THAT BELONG TO DIFFERENT CLASSES OF ANTIHYPERTENSIVE MEDICATIONS. DIFFERENT CLASSES ALPHA BLOCKERS, BETA BLOCKERS, CALCIUM CHANNEL BLOCKERS, DIURETICS, ACE-INHIBITORS, ANGIOTENSIN- RECEPTOR BLOCKERS, OR VASODILATORS. 132

133 TESTOSTERONE testosterone transdermal gel in metereddose pump 12.5 mg/ 1.25 gram (1 %) testosterone transdermal gel in packet PA Details Age Other Not approved for use in females Must submit documentation that member has total testosterone level below the lower limit of normal of 300 ng/dl, is experiencing signs and symptoms associated with low testosterone, and has been evaluated for any potential contraindications to testosterone replacement therapy. Repeat total testosterone levels 3-6 months after initiation, upon dosage increase, and annually thereafter. 6 months for initiation, 1 year for continuation 133

134 TRANSMUCOSAL IMMEDIATE RELEASE FENTANYL fentanyl citrate Lazanda PA Details Age Other NOT APPROVED FOR PATIENTS WHO ARE NOT TOLERANT TO OPIOID THERAPY AND ARE NOT RECEIVING LONG ACTING OPIATE THERAPY DIAGNOSIS AND TRIAL OF FORMULARY SHORT ACTING OPIOID ANALGESICS SUCH AS OXYCODONE, MORPHINE SULFATE, OR HYDROMORPHONE 6 MONTHS AT A TIME DOCUMENTATION AS TO WHY A UNIQUE METHOD OF ADMINISTRATION IS NEEDED AND A TRADITIONAL SHORT ACTING ORAL OPIATE MEDICATION IS NOT SUITABLE. PRIOR TO COVERAGE, THE PLAN WILL DETERMINE WHETHER THE DIAGNOSIS MEETS PART D REQUIREMENTS FOR APPROVAL. 134

135 TRELEGY Trelegy Ellipta PA Details Age Other Diagnosis, other therapies tried, outcome, baseline FEV1, and ER visits/hospitalizations. 1 year Member is either currently on TRIPLE therapy with a LABA/LAMA/ICS and would benefit from once daily, single inhaler use for improved medication adherence OR failure of adequate treatment with LABA plus LAMA or ICS plus LABA. 135

136 TRELSTAR DEPOT, TRELSTAR LA Trelstar intramuscular syringe PA Details Age Other DIAGNOSIS PRESCRIPTION MUST BE WRITTEN BY AN ONCOLOGIST. 6 MONTHS AT A TIME 136

137 TRETINOIN Avita topical cream Avita topical gel tretinoin topical PA Covered Uses Age Other Details All medically accepted indications not otherwise excluded under Part D Not approved when used to treat photo aging. Diagnosis, previous treatments, and response therapy 1 year 137

138 TRIENTINE trientine PA Details Age Other Diagnosis, other therapies tried and the outcome, ferritin, LFTs baseline, serum iron, hemoglobin, and hematocrit Prescribed by or in consultation with a gastroenterologist 3 months for initiation, 6 months for continuation Must have a failure, contraindication, or intolerance to penicillamine. 138

139 TYKERB Tykerb PA Details Age Other DIAGNOSIS, PRIOR AND CURRENT THERAPIES, TREATMENT RESPONSE 18 YEARS AND OLDER PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 1 year 139

140 UCERIS budesonide oral tablet,delayed and ext.release Uceris oral PA Details Age Other Not approved for maintenance of remission or in patients with severe disease (UCDAI score = 10) Diagnosis, other therapies tried and/or failed, including anti-inflammatory and immunosuppressant drugs Prescription must be written by a gastroenterology specialist 3 months 140

141 UPTRAVI Uptravi PA Details Age Other Confirmation of diagnosis of PAH, other therapies tried, and documentation of response to therapy Prescription must be written by a cardiologist or pulmonologist 3 months for initial, 1 year for continuation Must have PAH WHO group 1. Prior to receiving treatment with Uptravi, patient must have a contraindication, intolerance to, or history of taking a PDE5 inhibitor (sildenafil or Adcirca) AND an ERA (bosentan or ambrisentan) 141

142 UREA CYCLE DISORDER Ravicti sodium phenylbutyrate oral powder PA Details Age Other 3 months for initiation, 1 year for continuation 142

143 VALCHLOR Valchlor PA Details Age Other 6 months 143

144 VELTASSA Veltassa PA Details Age Other Under CMS Review 12 months 144

145 VENCLEXTA Venclexta Venclexta Starting Pack PA Details Age Other Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL): Diagnosis of CLL or SLL with 17p deletion or TP53 mutation. Patient has received at least one prior therapy for CLL/SLL [e.g., Cytoxan (cyclophosphamide), Fludara (fludarabine), Rituxan (rituximab)]. Prescribed by or in consultation with a hematologist or oncologist 12 months 145

146 VERZENIO Verzenio PA Details Age Other NA Documentation of diagnosis, previous treatments, response to treatment, and LFTs. Prescribed by oncology 1 year Under CMS Review 146

147 VOTRIENT Votrient PA Details Age Other DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED, RESPONSE TO TREATMENT PRESCRIPTION MUST BE WRITTEN BY AN ONCOLOGIST 1 year 147

148 XATMEP Xatmep PA Covered Uses Age Other Details All medically accepted indications not otherwise excluded from Part D Diagnosis, prior treatments, response to therapy Prescription must be written by an oncologist or rheumatologist 1 year justification as to why member cannot use methotrexate tablets or injectable solution 148

149 XELJANZ Xeljanz oral tablet 5 mg Xeljanz XR PA Details Age Other Diagnosis, prior therapy used, response to prior therapy. Documentation of negative TB test. 3 months for initiation, 1 year for continuation Under CMS Review 149

150 XENAZINE tetrabenazine PA Details Age Other CONTRAINDICATED IN PATIENTS WITH HEPATIC DISEASE, THOSE TAKING MAOIS, OR WITH UNTREATED OR INADEQUATELY TREATED DEPRESSION DIAGNOSIS OF HUNTINGTONS DISEASE PRESCRIPTION MUST BE WRITTEN BY NEUROLOGIST 1 YEAR CYP2D6 GENOTYPING IS REQUIRED FOR PATIENTS WHO REQUIRE MORE THAN 50 MG PER DAY 150