AAT DEFICIENCY. Products Affected Aralast Np INJ 1000MG, 500MG Glassia. Prior Authorization Criteria Health Alliance Plan_2016_HAPFB Updated: 10/2016

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1 Prior Authorization Health Alliance Plan_2016_HAPFB Updated: 10/2016 AAT DEFICIENCY Products Affected Aralast Np INJ 1000MG, 500MG Glassia Prolastin-c Zemaira Covered Uses All FDA-approved indications not otherwise excluded from Part D. 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 Formulary ID 16286, V#21 1 Y0076_PA CRIT WEB CMS Approved 2015

2 ADAGEN Products Affected Adagen Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DOCUMENTATION OF ADA DEFICIENCY AND WHETHER THE PATIENT IS A SUITABLE CANDIDATE FOR A BONE MARROW TRANSPLANT. 1 YEAR Formulary ID 16286, V#21 2

3 ADCETRIS Products Affected Adcetris Covered Uses All FDA-approved indications not otherwise excluded from Part D. Other Diagnosis, other therapies tried and/or failed Prescription must be written by an oncologist 3 months initial, 6 months for continuation Formulary ID 16286, V#21 3

4 ADEMPAS Products Affected Adempas Covered Uses All FDA approved indications not otherwise excluded from Part D. 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). Formulary ID 16286, V#21 4

5 AFINITOR Products Affected Afinitor Afinitor Disperz Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D DIAGNOSIS, PRIOR THERAPIES, AND TREATMENT RESPONSE PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 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 Formulary ID 16286, V#21 5

6 ALECENSA Products Affected Alecensa Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Patient has a diagnosis of metastatic non-small cell lung cancer AND Patient has anaplastic lymphoma kinase (ALK)-positive disease as detected with an FDA-approved test or Clinical Laboratory Improvement Amendments-approved facility AND Patient had an inadequate response, progressed on, or had an intolerance or contraindication to XALKORI (crizotinib) Prescribed by an oncologist. 3 months for initiation, 6 months for continuation Formulary ID 16286, V#21 6

7 AMITIZA Products Affected Amitiza Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D DIAGNOSIS, DOCUMENTED FAILURE OF 2 OF THE FOLLOWING AGENTS: FIBER PRODUCT, POLYETHYLENE GLYCOL, LACTULOSE, DOCUSATE, OR BISACODYL 1 YEAR Formulary ID 16286, V#21 7

8 AMPYRA Products Affected Ampyra Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D 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 Formulary ID 16286, V#21 8

9 ANDROGEL Products Affected Testosterone TRANSDERMAL GEL 1%, 25MG/2.5GM Testosterone Pump Covered Uses All FDA-approved indications not otherwise excluded from Part D. 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 testesterone replacement therapy. Repeat total testosterone levels 3-6 months after initiation, upon dosage increase, and annually therafter. 6 months for initiation, 1 year for continuation Formulary ID 16286, V#21 9

10 ANTIDEPRESSANTS Products Affected Brintellix Fetzima Fetzima Titration Pack Trintellix Viibryd Viibryd Starter Pack Covered Uses ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D 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 Formulary ID 16286, V#21 10

11 ANTIPSYCHOTICS Products Affected Abilify INJ Abilify ORAL SOLN Abilify Discmelt Abilify Maintena Aripiprazole Aripiprazole Odt Aristada Chlorpromazine Hcl INJ Chlorpromazine Hcl ORAL TABS 10MG, 25MG Clozapine Odt Fanapt Fanapt Titration Pack Fluphenazine Decanoate INJ Fluphenazine Hcl INJ Invega Invega Sustenna Invega Trinza Latuda Paliperidone Er Rexulti Saphris Seroquel Xr Thioridazine Hcl ORAL TABS Versacloz Vraylar Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D 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 Formulary ID 16286, V#21 11

12 ANTI-TNF ALPHA DRUGS Products Affected Cimzia Enbrel Enbrel Sureclick Humira Humira Pediatric Crohns Disease Starter Pack Humira Pen Humira Pen-crohns Diseasestarter Humira Pen-psoriasis Starter Remicade Simponi Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D DIAGNOSIS AND OTHER THERAPIES TRIED AND FAILED, NEGATIVE TB TEST MUST BE WRITTEN BY A DERMATOLOGIST, RHEUMATOLOGIST, OR GASTROENTEROLOGIST 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 REMICADE, PATIENT MUST HAVE A TRIAL OF OR CONTRAINDICATION TO ENBREL OR HUMIRA, WITH THE EXCEPTION OF REMICADE FOR FISTULIZING CROHN'S DISEASE AND ULCERATIVE COLITIS Formulary ID 16286, V#21 12

13 ARANESP Products Affected Aranesp Albumin Free INJ 100MCG/0.5ML, 100MCG/ML, 10MCG/0.4ML, 150MCG/0.3ML, 200MCG/0.4ML, 200MCG/ML, 25MCG/0.42ML, 25MCG/ML, 300MCG/0.6ML, 300MCG/ML, 40MCG/0.4ML, 40MCG/ML, 500MCG/ML, 60MCG/0.3ML, 60MCG/ML Covered Uses All FDA-approved indications not otherwise excluded from Part D. 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). Formulary ID 16286, V#21 13

14 ARCALYST Products Affected Arcalyst Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. 12 YEARS AND OLDER 1 YEAR AT A TIME Formulary ID 16286, V#21 14

15 ARZERRA Products Affected Arzerra Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DIAGNOSIS OF LYMPHOCYTIC LEUKEMIA (CLL) PRESCRIPTION MUST BE WRITTEN BY AN ONCOLOGIST 1 YEAR Formulary ID 16286, V#21 15

16 BENDEKA Products Affected Bendeka Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Diagnosis, other therapies tried and/or failed, and treatment response. Prescribed by an oncologist. 3 months for initiation, 6 months for continuation Formulary ID 16286, V#21 16

17 BLINCYTO Products Affected Blincyto Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Diagnosis, other therapies, and treatment response Prescription must be writtten by an oncologist 3 months initial, 6 months continuation Formulary ID 16286, V#21 17

18 BOSULIF Products Affected Bosulif Covered Uses All FDA approved indications not otherwise excluded from Part D. 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 3 months for initiation, 6 months for continuation Formulary ID 16286, V#21 18

19 CABOMETYX Products Affected Cabometyx Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Renal cell carcinoma (RCC): Diagnosis of RCC. RCC is advanced. History of failure, contraindication, or intolerance to at least one prior anti-angiogenic therapy [e.g., Nexavar (sorafenib), Sutent (sunitinib)]. Prescribed by or in consultation with an oncologist. 3 months initiation and 1 year continuation Formulary ID 16286, V#21 19

20 CAPRELSA Products Affected Caprelsa Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D 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 Formulary ID 16286, V#21 20

21 CINQAIR Products Affected Cinqair Covered Uses All medically accepted indications not otherwise excluded from Part D. Other administration of reslizumab requires a specialized care setting and requires an experienced clinician prepared to manage anaphylaxis will not be approved for self administration Allergen test, baseline FEV1, FEV1 following bronchodilator, asthma medical history (including medications, emergency department visits, and hospitalizations), baseline eosinophil count Pulmonology or Immunologist 1 year Patient must be diagnosed with severe asthma, currently receiving inhaled and/or oral corticosteroid treatment, have a baseline eosinophil count of 400/mcL, have a contraindication, intolerance or failure of Nucala. Formulary ID 16286, V#21 21

22 COMETRIQ Products Affected Cometriq Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Diagnosis, prior therapy used, result of prior therapy. Prescription must be written by an oncologist 3 months for initiation, 6 months for continuation Formulary ID 16286, V#21 22

23 CORLANOR Products Affected Corlanor Covered Uses All medically accepted indications not otherwise excluded from Part D. 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 (ie. allergy, severe COPD limiting beta blocker usage) Prescribed by a cardiologist. 12 months Formulary ID 16286, V#21 23

24 COTELLIC Products Affected Cotellic Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Diagnosis, other therapies tried and/or failed, and treatment response. Prescribed by an oncologist. 3 months for initiation, 6 months for continuation Formulary ID 16286, V#21 24

25 CYRAMZA Products Affected Cyramza Covered Uses All FDA-approved indications not otherwise excluded from Part D. Other Diagnosis, other therapies tried and/or failed Prescription must be written by an oncologist 3 months initial, 6 months for continuation Formulary ID 16286, V#21 25

26 DAKLINZA Products Affected Daklinza Covered Uses All FDA-approved indications not otherwise excluded from Part D. Other Concomitantly use with drugs that strongly induce cytochrome P450 enzyme (CYP) 3A, such as phenytoin, carbamazepine, rifampin, and St. John s wort. Patient has a diagnosis of chronic hepatitis C virus (HCV) genotype 1, 2, or 3 infection AND Patient will use the medication in combination with SOVALDI (sofosbuvir) AND Medication will not be used in combination with OLYSIO, TECHNIVIE, HARVONI, or VIEKIRA. Must be prescribed by hepatologist, gastroenterologist, or infectious disease specialist 12 to 24 wks based on AASLD guidelines, genotype, or cirrhosis, transplant, treatment hx Formulary ID 16286, V#21 26

27 DALIRESP Products Affected Daliresp Covered Uses All FDA approved indications not otherwise excluded from Part D. 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 Formulary ID 16286, V#21 27

28 DARZALEX Products Affected Darzalex INJ 100MG/5ML Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Diagnosis, other therapies tried and/or failed, and treatment response. Prescribed by an oncologist or hematologist. 3 months for initiation, 6 months for continuation Formulary ID 16286, V#21 28

29 DEMSER Products Affected Demser Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Diagnosis and whether the patient is a candidate for surgery 3 months Formulary ID 16286, V#21 29

30 DIABETES INJECTABLE Products Affected Bydureon Bydureon Pen Byetta Victoza Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D NOT APPROVED FOR WEIGHT MANAGEMENT DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED, AND HBA1C 1 YEAR PATIENT MUST USE METFORMIN (OR OTHER ORAL FIRST-LINE AGENT, SULFONYLUREA, DPP4, OR TZD) MONOTHERAPY FOR AT LEAST 3 MONTHS WITH TITRATION TO SAFE AND EFFECTIVE MAXIMAL DOSE. Formulary ID 16286, V#21 30

31 EGRIFTA Products Affected Egrifta Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. ONLY APPROVED FOR PATIENTS WITH HIV ASSOCIATED LIPODYSTROPHY. NOT INDICATED FOR WEIGHT MANAGEMENT. DIAGNOSIS, HISTORY OF HIV-ASSOCIATED DISEASE OR MALIGNANCY, BASELINE WAIST CIRCUMFERENCE, IGF-1 FASTING PLASMA GLUCOSE, AND HGAIC. PERIODIC MONITORING (EVERY 3-6 MONTHS) OF PARAMETERS LISTED ABOVE. PRESCRIPTION MUST BE WRITTEN BY AN INFECTIOUS DISEASE SPECIALIST. 3 MONTHS Formulary ID 16286, V#21 31

32 EMEND Products Affected Emend ORAL CAPS Emend SUSR Covered Uses Other All FDA approved indications not otherwise excluded from Part D 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 is used for PONV prophylaxis, provide rationale as to why ondansetron is not a suitable alternative. 6 months Formulary ID 16286, V#21 32

33 EMPLICITI Products Affected Empliciti Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Diagnosis, other therapies tried and/or failed, and treatment response. Used in combination with Revlimid (lenalidomide) and dexamethasone. Prescribed by an oncologist or hematologist. 3 months for initiation, 6 months for continuation Formulary ID 16286, V#21 33

34 EMVERM Products Affected Emverm Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Diagnosis, prior treatments, and response to therapy 1 month Formulary ID 16286, V#21 34

35 ENTRESTO Products Affected Entresto Covered Uses All FDA-approved indications not otherwise excluded from Part D. 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 AND reduced ejection fraction less than or equal to 40% 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. Prescription must be written by a cardiologist OR patient must have a consultation with a cardiologist within the past 12 months. 1 year Formulary ID 16286, V#21 35

36 EPCLUSA Products Affected Epclusa Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Submission of medical records (e.g., chart notes, laboratory values) documenting a diagnosis of chronic hepatitis C virus, genotype, previous therapies tried. Must be prescribed by hepatologist, gastroenterologist, or infectious disease specialist 12 weeks. will be applied consistent with current AASLD/IDSA guideline. Formulary ID 16286, V#21 36

37 EPOETIN ALFA Products Affected Epogen Procrit Covered Uses All FDA-approved indications not otherwise excluded from Part D. 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]) Formulary ID 16286, V#21 37

38 ERIVEDGE Products Affected Erivedge Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D 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 3 MONTHS FOR INITIATION, 6 MONTHS FOR CONTINUATION Formulary ID 16286, V#21 38

39 EVOMELA Products Affected Evomela Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Diagnosis, prior treatments, and response to therapy Prescribed by hematology/oncology 1 month Formulary ID 16286, V#21 39

40 EXEMESTANE Products Affected Exemestane Covered Uses Other All FDA approved indications not otherwise excluded from Part D Diagnosis of breast cancer, other therapies tried and/or failed Prescription must be written by an oncologist 1 year Formulary ID 16286, V#21 40

41 EXJADE Products Affected Exjade Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DIAGNOSIS, LENGTH OF THERAPY, IRON STUDIES, AND DOSE VERIFICATION. 3 MONTHS Formulary ID 16286, V#21 41

42 FABRAZYME Products Affected Fabrazyme INJ 35MG Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. FOR MALES: ACTIVITY LEVEL OF ALPHA-GALACTOSIDASE A IN PLASMA OR IN LEUKOCYTES. FOR FEMALES: MOLECULAR STUDY INDICATING ALPHA-GALACTOSIDE A ENZYME MUTATION AND EXHIBITION OF CLINICAL MANIFESTATIONS 1 YEAR Formulary ID 16286, V#21 42

43 FARXIGA Products Affected Farxiga Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Patients with severe renal impairment, ESRD, or on dialysis Diagnosis, other therapies tried and failed, result of most recent HbA1c test, renal function (creatinine clearance) 12 months Patient must have a history of taking, contraindication to, or currently using two of the following medications: metformin, sulfonylurea (glipizide or glimepiride preferred), DPP4 inhibitor (ie: Januvia), or thiazolidinedione (ie: pioglitazone). Formulary ID 16286, V#21 43

44 FARYDAK Products Affected Farydak Covered Uses All FDA-approved indications not otherwise excluded from Part D. Other Diagnosis, other therapies tried and/or failed Prescription must be written by an oncologist 3 months initial, 6 months for continuation Formulary ID 16286, V#21 44

45 FERRIPROX Products Affected Ferriprox TABS Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DIAGNOSIS, LENGTH OF THERAPY, SERUM FERRITIN CONCENTRATIONS, AND DOSE/WEIGHT VERIFICATION 3 MONTHS PATIENT MUST HAVE A 20% OR GREATER REDUCTION IN SERUM FERRITIN WITH AN ADEQUATE DOSE AND DURATION OF THERAPY IN ORDER TO CONTINUE TREATMENT Formulary ID 16286, V#21 45

46 FULYZAQ Products Affected Fulyzaq Covered Uses All FDA approved indications not otherwise excluded from Part D. 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. Formulary ID 16286, V#21 46

47 FYCOMPA Products Affected Fycompa Covered Uses All FDA-approved indications not otherwise excluded from Part D. 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. Formulary ID 16286, V#21 47

48 GATTEX Products Affected Gattex Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Therapy should be discontinued in cases of intestinal malignancy. Diagnosis, other therapies tried and/or failed. In order to be approved for continuation of therapy, the patient must demonstrate at least a 20% reduction in parenteral fluid volume from baseline. 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. Formulary ID 16286, V#21 48

49 GAUCHER'S DISEASE TREATMENT Products Affected Cerdelga Cerezyme Elelyso Vpriv Zavesca Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D NOT APPROVED FOR TYPE II OR TYPE III GAUCHER'S DISEASE DIAGNOSIS, WEIGHT. FOR ZAVESCA: RATIONALE AS TO WHY ERT IS NOT APPROPRIATE PRESCRIPTION MUST BE WRITTEN BY GENETICIST OR HEMOTOLOGIST 1 YEAR USE OF ZAVESCA IS RESERVED FOR THOSE WHOM ENZYME REPLACEMENT THERAPY IS NOT AN OPTION Formulary ID 16286, V#21 49

50 GAZYVA Products Affected Gazyva Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Diagnosis, prior treatments, and response to therapy Prescribed by hematology/oncology 3 months for initial 1 year for continuation Formulary ID 16286, V#21 50

51 GILOTRIF Products Affected Gilotrif Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Diagnosis, previous therapies tried and/or failed Prescription must be written by oncologist 12 months Formulary ID 16286, V#21 51

52 GLEEVEC Products Affected Gleevec Imatinib Mesylate Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D 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 Formulary ID 16286, V#21 52

53 GRALISE Products Affected Gralise Gralise Starter Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Diagnosis, prior therapy used, result of prior therapy. 1 year Patient must have a previous trial of or contraindication to generic gabapentin Formulary ID 16286, V#21 53

54 GROWTH HORMONE Products Affected Norditropin Flexpro Nutropin Aq Nuspin 10 Nutropin Aq Nuspin 20 Nutropin Aq Nuspin 5 Nutropin Aq Pen Somavert Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D 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 SOMAVERT IS COVERED FOR ACROMEGALY Formulary ID 16286, V#21 54

55 HARVONI Products Affected Harvoni Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Diagnosis of Hepatitis C, genotype, previous therapies tried. Prescription must be written by a gastroenterologist, hepatologist, or infectious disease specialist 8 to 24 weeks depending on prior treatment status, presence of cirrhosis, and viral factors Note: an shortened 8 week course of therapy will be covered when appropriate, but is not mandated. Formulary ID 16286, V#21 55

56 HEPATITIS B Products Affected Baraclude SOLN Entecavir Tyzeka Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. 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 Formulary ID 16286, V#21 56

57 HEPATITIS C TREATMENT Products Affected Incivek Moderiba Rebetol SOLN Ribasphere Ribasphere Ribapak Ribatab TABS 400MG Ribavirin CAPS Ribavirin TABS Victrelis Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D PATIENT WEIGHT, GENOTYPE, HCV-RNA QUANTITY AND DATE OF TEST, PRESENCE OF DIRRHOSIS (Y/N), TREATMENT HISTORY, HISTORY OF ANEMIA OR SKIN CONDITIONS PRESCRIPTION MUST BE WRITTEN BY GASTROENTEROLOGIST, HEPATOLOGIST, OR INFECTIOUS DISEASE SPECIALIST WEEKS Formulary ID 16286, V#21 57

58 HEREDITARY ANGIOEDEMA Products Affected Cinryze Firazyr Covered Uses All FDA approved indications not otherwise excluded from Part D. 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. Formulary ID 16286, V#21 58

59 HETLIOZ Products Affected Hetlioz Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Diagnosis, other therapies tried and/or failed 3 months initial, 1 year continuation Formulary ID 16286, V#21 59

60 HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA Products Affected Juxtapid Kynamro Covered Uses All FDA approved indications not otherwise excluded from Part D. 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. Must be used in conjunction with a low fat diet and baseline lipid lowering therapies. Liver function tests required at baseline and at least monthly during the first year of treatment. Formulary ID 16286, V#21 60

61 HYDROXYPROGESTERONE Products Affected Hydroxyprogesterone Caproate INJ Covered Uses All medically accepted indications not otherwise excluded from Part D Amenorrhea: Diagnosis of primary or secondary amenorrhea. Amenorrhea is due to hormonal imbalance in the absence of organic pathology (e.g., submucous fibroids or uterine cancer) Secretory endometrium and desquamation: Used for conversion to secretory endometrium and desquamation in patients with endometrial disorder. Adenocarcinoma: Diagnosis of Stage III or IV adenocarcinoma of the uterine corpus. Other Adenocarcinoma (initial): Prescribed by or in consultation with an oncologist 6 months Formulary ID 16286, V#21 61

62 IBRANCE (S) Products Affected Ibrance Covered Uses All FDA-approved indications not otherwise excluded from Part D. Other Patient has a diagnosis of estrogen receptor positive, human epidermal growth factor receptor 2-negative advanced breast cancer and patient is a postmenopausal woman and Ibrance will be used in combination with letrozole Prescription must be written by an oncologist 3 months initial, 6 months for continuation Formulary ID 16286, V#21 62

63 ICLUSIG Products Affected Iclusig Covered Uses All FDA approved indications not otherwise excluded from Part D. 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 Formulary ID 16286, V#21 63

64 ILARIS Products Affected Ilaris Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Diagnosis, other therapies tried and/or failed Prescription must be written by rheumatologist 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 (ie: allopurinol) Formulary ID 16286, V#21 64

65 IMBRUVICA Products Affected Imbruvica Covered Uses Other All FDA-approved indications not otherwise excluded from Part D DIAGNOSIS, PRIOR TREATMENTS, RESPONSE TO THERAPY Prescription must be prescribed by oncologist or hematologist 12 months Formulary ID 16286, V#21 65

66 IMLYGIC Products Affected Imlygic Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Diagnosis, other therapies tried and/or failed, and treatment response. Prescribed by an oncologist. 3 months for initiation, 6 months for continuation Formulary ID 16286, V#21 66

67 INCRELEX Products Affected Increlex Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D DIAGNOSIS, HEIGHT AND WEIGHT MEASUREMENTS, GH LEVEL, IGF-1 LEVEL PRESCRIPTION MUST BE WRITTEN BY ENDOCRINOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION Formulary ID 16286, V#21 67

68 INLYTA Products Affected Inlyta Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D PATIENTS WHO HAVE NOT HAD A PREVIOUS TRIAL WITH AT LEAST ONE SYSTEMIC THERAPY 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 Formulary ID 16286, V#21 68

69 INTERFERON ALPHA Products Affected Intron A INJ 10MU, 18MU, 50MU, UNIT/ML Intron A W/diluent Pegasys Pegasys Proclick Pegintron Peg-intron Redipen Peg-intron Redipen Pak 4 Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D 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 PRESCRIPTION MUST BE WRITTEN BY A GASTROENTEROLOGIST, DERMATOLOGIST, ONCOLOGIST, OR HEPATOLOGIST 1 YEAR FOR INDICATIONS OTHER THAN HEPATITIS C. HEP C APPROVALS FROM WEEKS BASED ON DRUG REGIME Formulary ID 16286, V#21 69

70 INTUNIV Products Affected Guanfacine Er Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DIAGNOSIS AND THERAPIES TRIED AND FAILED. 1 year Formulary ID 16286, V#21 70

71 INVOKANA Products Affected Invokana Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Patients with severe renal impairment, ESRD, or on dialysis Diagnosis, other therapies tried and failed, result of most recent HbA1c test, renal function (creatinine clearance) 12 months Patient must have a history of taking, contraindication to, or currently using all of the following medications: metformin, sulfonylurea (glipizide or glimepiride preferred), DPP4 inhibitor (ie: Januvia), or thiazolidinedione (ie: pioglitazone). Patients at risk for volume depletion should be carefully assessed prior to and during initiation of therapy. Risk factors include: elderly, receiving diuretics or other medications that interfere with RAA system, hypotension, or dehydration. Formulary ID 16286, V#21 71

72 IRESSA Products Affected Iressa Covered Uses All FDA-approved indications not otherwise excluded from Part D. Other DOCUMENTED FAILURE WITH AT LEAST ONE CHEMOTHERAPY REGIMEN. DOCUMENTATION OF RESPONSE TO TREATMENT PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION GEFITINIB IS COVERED AS MONOTHERAPY Formulary ID 16286, V#21 72

73 IV ONCOLOGY Products Affected Kadcyla Perjeta Zaltrap INJ 100MG/4ML Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Diagnosis, prior therapy used, result of prior therapy. Prescription must be written by an oncologist 3 months for initiation, 6 months for continuation Formulary ID 16286, V#21 73

74 IVIG Products Affected Bivigam Carimune Nanofiltered INJ 6GM Flebogamma Flebogamma Dif Gamastan S/d Gammagard Liquid Gammaked Gammaplex Gamunex-c Hizentra Hyqvia Octagam INJ 10GM/100ML, 10GM/200ML, 1GM/20ML, 2.5GM/50ML, 20GM/200ML, 2GM/20ML, 5GM/100ML, 5GM/50ML Privigen Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D 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 Formulary ID 16286, V#21 74

75 JAKAFI Products Affected Jakafi Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D 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 Formulary ID 16286, V#21 75

76 KALYDECO Products Affected Kalydeco Covered Uses All FDA approved indications not otherwise excluded from Part D. 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 Formulary ID 16286, V#21 76

77 KANUMA Products Affected Kanuma Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Patient has a diagnosis of lysosomal acid lipase deficiency (LAL-D) AND Diagnosis was confirmed by an enzymatic blood (e.g., dried blood spot test) or genetic test Prescribed by or in consultation with a specialist experienced in the treatment of inborn errors of metabolism 12 months Formulary ID 16286, V#21 77

78 KERYDIN Products Affected Kerydin Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Documented diagnosis of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes. 12 months Patient must have a trial and failure of ciclopirox nail laquer solution. Formulary ID 16286, V#21 78

79 KEYTRUDA Products Affected Keytruda Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Diagnosis of unresctable or metastatic malignant melanoma 18 years and older must be an oncologist 3 months initial, 6 months continuation For patients with unresectable or metastatic malignant melanoma who have disease progression following ipilimumab or in BRAF V600 mutation-positive patients who have disease progression following ipilimumab and a BRAF inhibitor. Formulary ID 16286, V#21 79

80 KINERET Products Affected Kineret Covered Uses Other All medically accepted indications not otherwise excluded from Part D Diagnosis, other therapies tried and/or failed Prescription must be written by rheumatologist 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 (ie: allopurinol) Formulary ID 16286, V#21 80

81 KUVAN Products Affected Kuvan PACK 100MG Kuvan TBSO Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D DIAGNOSIS, DIETARY RESTRICTION, BASELINE AND FOLLOW UP PHENYLALANINE LEVELS. FOR CONTINUATION, MUST SHOW A 30% REDUCTION IN PHE LEVELS FROM BASELINE 1 MONTH FOR INITIATION, 1 YEAR FOR CONTINUATION Formulary ID 16286, V#21 81

82 KYPROLIS Products Affected Kyprolis Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Diagnosis, prior treatments, and response to therapy Prescribed by hematology/oncology 1 year Formulary ID 16286, V#21 82

83 LEMTRADA Products Affected Lemtrada Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Patients who are infected with Human Immunodeficiency Virus (HIV) Diagnosis, other treatments tried, and history of varicella or have been vaccinated for varicella zoster virus (VZV) must be a neurologist. 3 months initial, 6 months continuation Lemtrada is reserved for patients who have had an inadequate response to 2 or more previous treatments for MS. Formulary ID 16286, V#21 83

84 LENVIMA Products Affected Lenvima 10 Mg Daily Dose Lenvima 14 Mg Daily Dose Lenvima 18 Mg Daily Dose Lenvima 20 Mg Daily Dose Lenvima 24 Mg Daily Dose Lenvima 8 Mg Daily Dose Covered Uses All FDA-approved indications not otherwise excluded from Part D. Other Patient has a diagnosis of locally recurrent or metastatic, progressive differentiated thyroid cancer AND the cancer is refractory to radioactive iodine treatment Prescription must be written by an oncologist 3 months initial, 6 months continuation Formulary ID 16286, V#21 84

85 LEUKINE Products Affected Leukine INJ 250MCG Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DIAGNOSIS ACUTE MYELOID LEUKEMIA (AML): GREATER OR EQUAL TO 55 YEARS OLD. 3 MONTHS AT A TIME Formulary ID 16286, V#21 85

86 LIDODERM TRANSDERMAL Products Affected Lidocaine PTCH Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. ALSO COVERED FOR DIABETIC NEUROPATHY. DIAGNOSIS AND OTHER THERAPIES TRIED AND FAILED 1 YEAR MUST HAVE A USED A PREVIOUS TRIAL OF GABAPENTIN FOR THE TREATMENT OF POST-HERPETIC NEURALGIA OR DIABETIC NEUROPATHY Formulary ID 16286, V#21 86

87 LINZESS Products Affected Linzess Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Diagnosis and documented failure of 1 of the following agents: fiber product, polyethylene glycol, lactulose, docusate, or bisacodyl. Must also have previously used a trial of Amitza. 1 YEAR Formulary ID 16286, V#21 87

88 LONSURF Products Affected Lonsurf Covered Uses All FDA-approved indications not otherwise excluded from Part D. Other Diagnosis, other therapies tried and/or failed, and treatment response Prescription must be written by an oncologist 3 months initial, 6 months for continuation Formulary ID 16286, V#21 88

89 LYNPARZA Products Affected Lynparza Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D 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 Formulary ID 16286, V#21 89

90 MEKINIST Products Affected Mekinist Covered Uses All FDA approved indications not otherwise excluded from Part D. 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 3 months for initiation, 6 months for continuation Formulary ID 16286, V#21 90

91 MOZOBIL Products Affected Mozobil Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Diagnosis, patient weight Prescription must be written by oncologist or hematologist 1 month Formulary ID 16286, V#21 91

92 MULTIPLE SCLEROSIS Products Affected Avonex Avonex Pen Betaseron Extavia Gilenya Glatopa Rebif Rebif Rebidose Rebif Rebidose Titration Pack Rebif Titration Pack Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D EDSS SCORE, DISEASE COURSE (RRMS, SPMS), RELAPSE HISTORY, PHYSICAL OR COGNITIVE DISABILITY PRESCRIPTION MUST BE WRITTEN BY A NEUROLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION FOR COVERAGE OF GILENYA PATIENT MUST HAVE A TRIAL AND FAILURE WITH AVONEX, EXTAVIA, REBIF, OR COPAXONE Formulary ID 16286, V#21 92

93 MYALEPT Products Affected Myalept Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Diagnosis, prior therapy used, result of prior therapy 3 months for initiation, 1 year for continuation Formulary ID 16286, V#21 93

94 MYRBETRIQ Products Affected Myrbetriq Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Diagnosis, other therapies tried and failed 1 year Patient must have used prior therapy with at least two generic urinary antispasmodic agents including oxybutynin, tolterodine, or trospium Formulary ID 16286, V#21 94

95 NATPARA Products Affected Natpara Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D DIAGNOSIS, BASELINE SERUM CALCIUM AND 25- HYDROXYVITAMIN D LEVELS MUST BE PRESCRIBED BY AN ENDOCRINOLOGIST 3 MONTHS INITIAL, 6 MONTHS CONTINUATION Formulary ID 16286, V#21 95

96 NEUDEXTA Products Affected Nuedexta Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Diagnosis Prescription must be written by neurologist 1 year Formulary ID 16286, V#21 96

97 NEULASTA Products Affected Neulasta Neulasta Onpro Kit Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DIAGNOSIS AND PRIOR THERAPIES TRIED AND FAILED. 3 MONTHS USE OF NEULASTA IS RESERVED FOR PATIENTS WHO HAVE HAS INTOLERABLE ADVERSE EFFECT(S) TO FILGRASTIM THAT DO NOT CROSS-REACT WITH PEGFILGRSTIM. Formulary ID 16286, V#21 97

98 NEUPRO Products Affected Neupro Covered Uses All FDA approved indications not otherwise excluded from Part D. 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: gabapentin, a dopamine agonist (ie: pramipexole, ropinirole), or benzodiazepine (ie: lorazepam, alprazolam) Formulary ID 16286, V#21 98

99 NEXAVAR Products Affected Nexavar Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D DIAGNOSIS, PRIOR THERAPIES, AND TREATMENT RESPONSE PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION Formulary ID 16286, V#21 99

100 NINLARO Products Affected Ninlaro Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Diagnosis, other therapies tried and/or failed, and treatment response. Used in combination with Revlimid (lenalidomide) and dexamethasone. Prescribed by an oncologist or hematologist. 3 months for initiation, 6 months for continuation Formulary ID 16286, V#21 100

101 NUCALA Products Affected Nucala Covered Uses All FDA approved indications not otherwise excluded from Part D. Other Allergen test, baseline FEV1, FEV1 following bronchodilator, asthma medical history (including medications, emergency department visits, and hospitalizations), baseline eosinophil count Pulmonology or Immunologist 3 months for initial 1 year for continuation Patient must be diagnosed with severe asthma, 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. Formulary ID 16286, V#21 101

102 NUPLAZID Products Affected Nuplazid Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Parkinson's disease psychosis: Diagnosis of Parkinson's disease. Patient has at least one of the following: hallucinations or delusions. 1 year Formulary ID 16286, V#21 102

103 OCTREOTIDE Products Affected Octreotide Acetate Covered Uses All FDA-approved indications not otherwise excluded from Part D. Other Diagnosis, other therapies tried and failed 3 months for initiation, 6 months for continuation Formulary ID 16286, V#21 103

104 ODOMZO Products Affected Odomzo Covered Uses All FDA-approved indications not otherwise excluded from Part D. 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 3 months initial, 6 months for continuation Formulary ID 16286, V#21 104

105 ONIVYDE Products Affected Onivyde Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Diagnosis, other therapies tried and/or failed, and treatment response. Prescribed by an oncologist. 3 months for initiation, 6 months for continuation Formulary ID 16286, V#21 105

106 OPDIVO Products Affected Opdivo Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D DIAGNOSIS And PRIOR THERAPIES PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 months initiation, 6 months continuation For patients with diagnosis ofmalignant melanoma: Patient must have prior treatment with ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor Formulary ID 16286, V#21 106

107 OPSUMIT Products Affected Opsumit Covered Uses All FDA approved indications not otherwise excluded from Part D. 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. Formulary ID 16286, V#21 107

108 ORENCIA Products Affected Orencia Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D 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 Formulary ID 16286, V#21 108

109 ORFADIN Products Affected Orfadin ORAL CAPS 10MG, 2MG, 5MG Orfadin SUSP Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D DIAGNOSIS AND WEIGHT PRESCRIPTION MUST BE WRITTEN BY AN ENDOCRINOLOGIST. 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 Formulary ID 16286, V#21 109

110 ORKAMBI Products Affected Orkambi Covered Uses All FDA-approved indications not otherwise excluded from Part D. 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) Formulary ID 16286, V#21 110

111 OTEZLA Products Affected Otezla Covered Uses All FDA approved indications not otherwise excluded from Part D. 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 Remicade) Formulary ID 16286, V#21 111

112 OXYCONTIN Products Affected Oxycodone Hcl Er Oxycontin Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED, RESPONSE TO TREATMENT, OTHER OPIATES CURRENTLY BEING USED 6 MONTHS MONITOR FOR PROPER COMPLIANCE AND POTENIAL MISUSE INCLUDING EARLY REFILL HISTORY, MULTIPLE CONCURRENT LONG ACTING OPIATES OVER 3 MONTH PERIOD, AND MULTIPLE TREATING PHYSICIANS Formulary ID 16286, V#21 112

113 PANRETIN Products Affected Panretin Covered Uses Other ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. NOT INDICATED WHEN SYSTEMIC ANTI-KS THERAPY IS REQUIRED. 6 MONTHS Formulary ID 16286, V#21 113