Diagnosis of severe congenital A1-PI deficiency who have clinically evident emphysema, weight, A1-PI phenotype, A1-PI baseline level

Transcription

1 AAT DEFICIENCY Aralast NP intravenous recon soln 1,000 mg Glassia Prolastin-C intravenous recon soln Zemaira 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 % 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 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 Other DIAGNOSIS, PRIOR THERAPIES, AND TREATMENT RESPONSE PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST OR NEUROLOGIST 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 AIMOVIG Aimovig Autoinjector (2 Pack) Other Diagnosis, other therapies tried, and outcome. Member has been evaluated for and does not have medication overuse headache. 18 years of age or older Must be prescribed by or in consultation with a neurologist or pain specialist 1 year Patient must have an inadequate response, contraindication, or intolerance to two different chronic migraine prevention drugs. The two prerequisite drugs must be from different classes such as anticonvulsants (topiramate/valproate), beta blockers (propranolol, metoprolol), and antidepressants (nortriptyline/venlafaxine). 5

6 ALK POSITIVE TYROSINE KINASE INHIBITORS Alecensa Xalkori Zykadia Other Diagnosis, other treatments tried and outcome Prescribed by an oncologist 1 year 6

7 ALUNBRIG Alunbrig 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. 7

8 AMITIZA Amitiza Other DIAGNOSIS, DOCUMENTED FAILURE OF 2 OF THE FOLLOWING AGENTS: FIBER PRODUCT, POLYETHYLENE GLYCOL, LACTULOSE, DOCUSATE, OR BISACODYL 1 YEAR 8

9 AMPYRA Ampyra 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 9

10 ANTIDEPRESSANTS Fetzima Trintellix Viibryd oral tablet Viibryd oral tablets,dose pack 10 mg (7)- 20 mg (23) 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 10

11 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 thioridazine Vraylar 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 11

12 ANTI-TNF ALPHA DRUGS Cimzia Cimzia Powder for Reconst Enbrel Enbrel SureClick Humira Humira Pediatric Crohns Start Humira Pen Humira Pen Crohns-UC-HS Start Humira Pen Psor-Uveits-Adol HS Humira(CF) Humira(CF) Pedi Crohns Starter Humira(CF) Pen Humira(CF) Pen Crohns-UC-HS Humira(CF) Pen Psor-Uv-Adol HS Simponi subcutaneous syringe 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 12

13 HUMIRA, WITH THE EXCEPTION OF INFLIXIMAB FOR FISTULIZING CROHN'S DISEASE AND ULCERATIVE COLITIS 13

14 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 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). 14

15 ARCALYST Arcalyst Other 12 YEARS AND OLDER 1 YEAR AT A TIME 15

16 BENLYSTA Benlysta subcutaneous syringe 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. 16

17 BOSULIF Bosulif oral tablet 100 mg, 400 mg, 500 mg 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 17

18 BRAFTOVI Braftovi Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to treatment. Prescription must be written by an oncologist 3 months for initiation, 1 year for continuation 18

19 CABOMETYX Cabometyx 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 19

20 CALQUENCE Calquence Other NA Documentation of diagnosis, previous treatments, and response to treatment. Prescribed by oncology 3 months initial, 6 months continuation 20

21 CAPRELSA Caprelsa oral tablet 100 mg, 300 mg 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 21

22 COMETRIQ Cometriq Other Diagnosis, prior therapy used, result of prior therapy. Prescription must be written by an oncologist 3 months for initiation, 6 months for continuation 22

23 COPIKTRA Copiktra Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to treatment. Prescription must be written by an oncologist or hematologist 3 months for initiation, 1 year for continuation 23

24 CORLANOR Corlanor 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 24

25 COTELLIC Cotellic Other Diagnosis, other therapies tried and/or failed, and treatment response. Prescribed by an oncologist. 3 months for initiation, 6 months for continuation 25

26 DALIRESP Daliresp 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 26

27 DAURISMO Daurismo Other Diagnosis, prior therapies, and result of prior therapy. Prescription must be written by an oncologist or hematologist 1 year 27

28 DEMSER Demser Other Diagnosis and whether the patient is a candidate for surgery 3 months 28

29 DICLOFENAC GEL 3% diclofenac sodium topical gel 3 % Other Diagnosis and any prior treatments. Prescription must be written by a Dermatologist 3 months 29

30 DOPTELET Doptelet (10 tab pack) Doptelet (15 tab pack) Other Diagnosis and platelet count Must be prescribed by a hematologist, oncologist, or gastroenterologist 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. 30

31 EGRIFTA Egrifta subcutaneous recon soln 1 mg 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 31

32 EMEND aprepitant 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. 32

33 ENTRESTO Entresto 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. 33

34 EPIDIOLEX Epidiolex Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to treatment. Prescription must be written by or in consultation with a neurologist 1 year Monitor for hepatocellular injury in accordance with FDA approved label. For Lennox-Gastaut syndrome must have a failure, contraindication, or intolerance to lamotrigine and topiramate. 34

35 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 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]) 35

36 36

37 ERIVEDGE Erivedge 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 37

38 ERLEADA Erleada 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 38

39 EXJADE Exjade 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 39

40 FARYDAK Farydak Other Diagnosis, other therapies tried and/or failed Prescription must be written by an oncologist 3 months initial, 6 months for continuation 40

41 FASENRA Fasenra 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 Patient must be diagnosed with severe asthma, currently receiving inhaled and/or oral corticosteroid treatment, AND have a baseline eosinophil count of 150 cells/mcl or greater within previous 12 months. 41

42 FERRIPROX Ferriprox oral tablet 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. 42

43 FULYZAQ Mytesi 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. 43

44 FYCOMPA Fycompa oral suspension Fycompa oral tablet 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. 44

45 GATTEX Gattex 30-Vial 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. 45

46 GAUCHER'S DISEASE TREATMENT Cerdelga miglustat Zavesca Other NOT APPROVED FOR TYPE II OR TYPE III GAUCHER'S DISEASE DIAGNOSIS, WEIGHT. FOR MIGLUSTAT: RATIONALE AS TO WHY ERT IS NOT APPROPRIATE PRESCRIPTION MUST BE WRITTEN BY GENETICIST, HEMOTOLOGIST, OR METABOLIC SPECIALIST 1 YEAR USE OF MIGLUSTAT IS RESERVED FOR THOSE WHOM ENZYME REPLACEMENT THERAPY IS NOT AN OPTION 46

47 GILOTRIF Gilotrif Other Diagnosis, previous therapies tried and/or failed Prescription must be written by oncologist 12 months 47

48 GLEEVEC imatinib 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 48

49 GRALISE Gralise Gralise 30-Day Starter Pack Covered Uses Other All medically accepted indications not otherwise excluded under Part D Diagnosis, previous treatments including dosage, outcome of previous treatment 1 year Must have a documented intolerance, contraindication to, or failure of gabapentin titrated to maximum tolerated dosage or rationale as to why gabapentin cannot be used. 49

50 GROWTH HORMONE Norditropin FlexPro Nutropin AQ Nuspin 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 50

51 HEPATITIS B Baraclude oral solution entecavir 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 51

52 HEPATITIS C TREATMENT Harvoni ledipasvir-sofosbuvir Mavyret Rebetol oral solution Ribasphere oral capsule ribavirin oral capsule ribavirin oral tablet 200 mg Zepatier 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. 52

53 HEREDITARY ANGIOEDEMA Cinryze Firazyr Haegarda Takhzyro 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. 53

54 HETLIOZ Hetlioz Other Diagnosis, other therapies tried and/or failed 3 months initial, 1 year continuation 54

55 HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA Juxtapid Kynamro 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. 55

56 IBRANCE (S) Ibrance Other Prescription must be written by an oncologist 3 months initial, 6 months for continuation Must have a failure, contraindication, or intolerance to Kisqali 56

57 ICLUSIG Iclusig 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 57

58 IDHIFA Idhifa Other Diagnosis, previous treatments, and outcome. Prescribed by or in consultation with a hematologist/oncologist. 12 months 58

59 IMBRUVICA Imbruvica oral capsule 140 mg, 70 mg Imbruvica oral tablet Other DIAGNOSIS, PRIOR TREATMENTS, RESPONSE TO THERAPY Prescription must be prescribed by oncologist, hematologist, or transplant specialist 12 months 59

60 INCRELEX Increlex Other DIAGNOSIS, HEIGHT AND WEIGHT MEASUREMENTS, GH LEVEL, IGF-1 LEVEL PRESCRIPTION MUST BE WRITTEN BY ENDOCRINOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION 60

61 INHALED TOBRAMYCIN Tobi Podhaler inhalation capsule, w/inhalation device Other Diagnosis, therapies tried, and outcome Prescribed by Infectious disease specialist or pulmonologist 1 year 61

62 INLYTA Inlyta oral tablet 1 mg, 5 mg 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 62

63 INTERFERON ALPHA Intron A injection Pegasys Pegasys ProClick subcutaneous pen injector 180 mcg/0.5 ml 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 1 YEAR FOR INDICATIONS OTHER THAN HEPATITIS C. HEPC APPROVALS FROM WEEKS BASED ON DRUG REGIME 63

64 INTUNIV guanfacine oral tablet extended release 24 hr Other DIAGNOSIS AND THERAPIES TRIED AND FAILED. 1 year 64

65 IRESSA Iressa Other Diagnosis, prior therapy used, response to prior therapy PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION GEFITINIB IS COVERED AS MONOTHERAPY 65

66 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 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 66

67 JAKAFI Jakafi 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 67

68 JYNARQUE Jynarque 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 68

69 KALYDECO Kalydeco 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 69

70 KEVZARA Kevzara subcutaneous syringe 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 70

71 KINERET Kineret 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) 71

72 KISQALI Kisqali Kisqali Femara Co-Pack Other Diagnosis, other therapies previously tried, and the outcome. Prescribed by or in consultation with an oncologist 3 months initial and 6 months for continuation of therapy 72

73 KORLYM Korlym 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. 73

74 KUVAN Kuvan oral powder in packet 100 mg Kuvan oral tablet,soluble 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 74

75 LENVIMA Lenvima Other Prescription must be written by an oncologist 1 year 75

76 LEUKINE Leukine injection recon soln DIAGNOSIS ACUTE MYELOID LEUKEMIA (AML): GREATER OR EQUAL TO 55 YEARS OLD. Other 3 MONTHS AT A TIME 76

77 LIDOCAINE TRANSDERMAL lidocaine topical adhesive patch,medicated lidocaine topical ointment 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 77

78 LINZESS Linzess Other Diagnosis and previous treatments 1 year Must have a failure, contraindication or intolerance to Amitza 78

79 LONSURF Lonsurf Other Diagnosis, other therapies tried and/or failed, and treatment response Prescription must be written by an oncologist 1 year 79

80 LORBRENA Lorbrena Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to treatment. Prescription must be written by an oncologist 1 year 80

81 LYNPARZA Lynparza oral tablet 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 81

82 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 Other Diagnosis 1 year 82

83 MEKINIST Mekinist oral tablet 0.5 mg, 2 mg 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 83

84 MEKTOVI Mektovi Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to treatment. Prescription must be written by an oncologist 3 months for initiation, 1 year for continuation Must be used in combination with encorafenib. 84

85 METHADONE methadone oral solution methadone oral tablet Other Diagnosis and any prior treatments. 6 months Monitor for possible misuse, including early refill history and multiple treating physicians 85

86 METHAMPHETAMINE methamphetamine 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. 86

87 MIRVASO Mirvaso topical gel with pump Other Documentation of diagnosis and other treatments tried and outcome. 1 year For the treatment of acne rosacea: doxycycline (oral) and topical metronidazole. 87

88 MOVANTIK Movantik Covered Uses Other 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. 88

89 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 Covered Uses Other 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 89

90 MYALEPT Myalept Other Diagnosis, prior therapy used, result of prior therapy 3 months for initiation, 1 year for continuation 90

91 NATPARA Natpara Other DIAGNOSIS, BASELINE SERUM CALCIUM AND 25- HYDROXYVITAMIN D LEVELS MUST BE PRESCRIBED BY AN ENDOCRINOLOGIST 1 year 91

92 NERLYNX Nerlynx 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 92

93 NEUPRO Neupro 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. 93

94 NEXAVAR Nexavar Other DIAGNOSIS, PRIOR THERAPIES, AND TREATMENT RESPONSE PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION 94

95 NINLARO Ninlaro 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 95

96 NOXAFIL Noxafil oral 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. 96

97 NUCALA Nucala Other For patients with asthma: allergen test, baseline FEV1, FEV1 following bronchodilator, asthma medical history (including medications, emergency department visits, and hospitalizations), baseline eosinophil count. For patients with eosinophilic granulomatosis with polyangiitis: documentation of diagnosis, prior therapies, and the outcome. Pulmonology, immunologist, or allergist 3 months for initial, 1 year for continuation For patients with asthma: must be currently receiving inhaled and/or oral corticosteroid treatment, AND have a baseline eosinophil count of 300 cells/mcl or greater within previous 12 months or 150 cell/mcl within previous 6 weeks. 97

98 NUEDEXTA Nuedexta Other Diagnosis Prescription must be written by a neurologist or psychiatrist. 1 year 98

99 NUPLAZID Nuplazid Other Parkinson's disease psychosis: Diagnosis of Parkinson's disease. Patient has at least one of the following: hallucinations or delusions. 1 year 99

100 OCALIVA Ocaliva 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. 100

101 OCTREOTIDE octreotide acetate injection solution Other Diagnosis, other therapies tried and failed 1 year 101

102 ODOMZO Odomzo 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 102

103 OPSUMIT Opsumit 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. 103

104 ORENCIA Orencia subcutaneous syringe 125 mg/ml 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 104

105 ORFADIN Orfadin 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 105

106 ORKAMBI Orkambi oral granules in packet Orkambi oral tablet 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) 106

107 ORLISSA Orilissa Other Diagnosis, prior therapies, and result of prior therapy. 1 year Must have a failure, contraindication, or intolerance to a continuous hormonal contraceptive AND progestin therapy (e.g. medroxyprogesterone, norethindrone). 107

108 OTEZLA Otezla Otezla Starter oral tablets,dose pack 10 mg (4)-20 mg (4)-30 mg (47) 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) 108

109 OXERVATE Oxervate Other Diagnosis, prior therapies, and result of prior therapy. Prescription must be written by an ophthalmologist 8 weeks 109

110 OXYCONTIN oxycodone oral tablet,oral only,ext.rel.12 hr Other DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED, RESPONSE TO TREATMENT, OTHER OPIATES CURRENTLY BEING USED 6 MONTHS MONITOR FOR POTENIAL MISUSE INCLUDING EARLY REFILL HISTORY, MULTIPLE CONCURRENT LONG ACTING OPIATES OVER 3 MONTH PERIOD, AND MULTIPLE TREATING PHYSICIANS 110

111 PALYNZIQ Palynziq Other Diagnosis, prior treatments, and outcome. Baseline and follow up phenylalanine (Phe) concentrations. 3 months for initial, 1 year for continuation Must have phenylalanine (Phe) concentrations greater than 600 micromol/l on existing management, and a failure, contraindication, or intolerance to Kuvan. 111

112 PANRETIN Panretin Other NOT INDICATED WHEN SYSTEMIC ANTI-KS THERAPY IS REQUIRED. 6 MONTHS 112

113 PCSK9 INHIBITORS Praluent Pen Repatha Repatha SureClick Covered Uses Other 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. 113

114 POMALYST Pomalyst Other Diagnosis, prior therapy used, result of prior therapy. Prescription must be written by an oncologist or hematologist 1 year 114

115 PROLIA Prolia 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. 115

116 PROMACTA Promacta oral tablet Other Diagnosis, other therapies tried and/or failed, and platelet count INITIAL FILL FOR 6 MONTHS, 1 YEAR THEREAFTER 116

117 PROVIGIL modafinil Other DIAGNOSIS AND OTHER THERAPIES TRIED AND FAILED. 1 YEAR 117

118 PULMONARY FIBROSIS Esbriet Ofev Other liver function prescriber must be a pulmonologist. 1 year 118

119 PULMONARY HYPERTENSION Adcirca Letairis sildenafil (Pulmonary Arterial Hypertension) oral Tracleer Ventavis 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 119

120 PURIXAN Purixan Other DIAGNOSIS, PRIOR TREATMENTS, RESPONSE TO THERAPY prescriber must be a oncologist or hematologist 1 year 120

121 RELISTOR Relistor oral Relistor subcutaneous solution Relistor subcutaneous syringe 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) 121

122 REVLIMID Revlimid Other DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED, RESPONSE TO TREATMENT 18 YEARS AND OLDER PRESCRIPTION MUST BE WRITTEN BY AN ONCOLOGIST 1 year 122

123 RUBRACA Rubraca 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 123

124 RYDAPT Rydapt 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 124

125 SAMSCA Samsca 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). 125

126 SAVELLA Savella oral tablet Savella oral tablets,dose pack Other DIAGNOSIS OF FIBROMYALGIA, RESPONSE TO THERAPY 1 YEAR 126

127 SIGNIFOR Signifor 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 127

128 SIRTURO Sirturo 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. 128

129 SORIATANE acitretin 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 129

130 SPRITAM Spritam Other Diagnosis, therapies tried, and outcome Prescribed by Neurologist 1 year Rationale as to why generic levetiracetam is not suitable. 130

131 SPRYCEL Sprycel Other PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 1 year Must have a failure, intolerance or contraindication to imatinib. 131

132 STELARA Stelara subcutaneous Other Diagnosis, prior therapies, and result of prior therapy. TB test results Prescribed by gastroenterologist or rheumatologist 1 year For psoriasis and psoriatic arthritis: Patient must have failure of, intolerance, or contraindication to inflixmab and Otezla. For Crohn's disease: Patient must have a failure of, intolerance, or contraindication to infliximab and Humira. 132

133 STIVARGA Stivarga 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 133

134 SUPREP Suprep Bowel Prep Kit 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 134

135 SUTENT Sutent 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. 135

136 SYLATRON Sylatron 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 136

137 SYMDEKO Symdeko Other Diagnosis of CF AND homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. If the patients genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use. FEV1 at baseline and continuation, baseline LFT and continuation, review for drug interactions CYP3A inducers 12 and older Must be prescribed by a pulmonologist or doctor specializing in cystic fibrosis 6 months initial, 1 year 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) 137

138 SYMLIN SymlinPen 120 SymlinPen 60 Other GASTROPARESIS OR USE OF DRUGS TO STIMULATE GASTROINTESTINAL MOTILITY HBA1C AND CURRENT DIABETES MEDICATIONS 1 YEAR 138

139 SYNRIBO Synribo 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 139

140 TAFINLAR Tafinlar 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 140

141 TAGRISSO Tagrisso 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 141

142 TALZENNA Talzenna Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to treatment. Prescription must be written by an oncologist 1 year 142

143 TARCEVA Tarceva Other DIAGNOSIS, PRIOR THERAPIES, AND TREATMENT RESPONSE PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 1 year 143

144 TASIGNA Tasigna oral capsule 150 mg, 200 mg, 50 mg Other DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED, RESPONSE TO TREATMENT, POTENTIAL DRUG INTERACTIONS PRESCRIPTION MUST BE WRITTEN BY AN ONCOLOGIST 1 year Must have a failure, intolerance or contraindication to imatinib and Sprycel. 144

145 TAVALISSE Tavalisse 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. 145

146 TAZORAC tazarotene Tazorac topical cream 0.05 % Tazorac topical gel Other DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED. 1 YEAR 146

147 TEKTURNA Tekturna Tekturna HCT 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. 147

148 TESTOSTERONE testosterone transdermal gel in metereddose pump 12.5 mg/ 1.25 gram (1 %), mg/1.25 gram (1.62 %) testosterone transdermal gel in packet 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 148

149 TIBSOVO Tibsovo Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to treatment. Prescription must be written by an oncologist 3 months for initiation, 1 year for continuation 149

150 TRANSMUCOSAL IMMEDIATE RELEASE FENTANYL fentanyl citrate Lazanda 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. 150