AAT DEFICIENCY. Products Affected Aralast Np INJ 1000MG, 500MG Glassia Prolastin-c INJ 1000MG Zemaira

Transcription

1 AAT DEFICIENCY Aralast Np INJ 1000MG, 500MG Glassia Prolastin-c INJ 1000MG Zemaira PA Details 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 18297, V#14 1

2 ADAGEN Adagen PA Details Other DOCUMENTATION OF ADA DEFICIENCY AND WHETHER THE PATIENT IS A SUITABLE CANDIDATE FOR A BONE MARROW TRANSPLANT. 1 YEAR Formulary ID 18297, V#14 2

3 ADCETRIS Adcetris PA Details Other Diagnosis, other therapies tried and/or failed Prescription must be written by an oncologist 3 months initial, 6 months for continuation Formulary ID 18297, V#14 3

4 ADEMPAS Adempas PA Details 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 18297, V#14 4

5 AFINITOR Afinitor Afinitor Disperz PA Details Other 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 18297, V#14 5

6 ALECENSA Alecensa PA Details 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 18297, V#14 6

7 ALIQOPA Aliqopa PA Details Other Diagnosis, prior treatments, response to therapy 18 and older Presciption must written by a hematologist or oncologist 3 months initation, 6 months continuation Formulary ID 18297, V#14 7

8 ALUNBRIG Alunbrig PA Details 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. Formulary ID 18297, V#14 8

9 AMITIZA Amitiza PA Details Other DIAGNOSIS, DOCUMENTED FAILURE OF 2 OF THE FOLLOWING AGENTS: FIBER PRODUCT, POLYETHYLENE GLYCOL, LACTULOSE, DOCUSATE, OR BISACODYL 1 YEAR Formulary ID 18297, V#14 9

10 AMPYRA Ampyra PA Details 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 Formulary ID 18297, V#14 10

11 ANTIDEPRESSANTS Brintellix Fetzima Fetzima Titration Pack Trintellix Viibryd Viibryd Starter Pack PA Details 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 18297, V#14 11

12 ANTIPSYCHOTICS Abilify INJ Abilify Maintena Aristada Chlorpromazine Hcl INJ Chlorpromazine Hcl TABS Clozapine Odt Fanapt Fanapt Titration Pack Fluphenazine Decanoate INJ Fluphenazine Hcl INJ Invega Sustenna Invega Trinza Latuda Paliperidone Er Rexulti Saphris Thioridazine Hcl TABS 100MG, 10MG, 25MG, 50MG Versacloz Vraylar Formulary ID 18297, V#14 12

13 PA Details 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 Formulary ID 18297, V#14 13

14 ANTI-TNF ALPHA DRUGS Cimzia Enbrel Enbrel Mini Enbrel Sureclick Humira INJ 10MG/0.2ML, 20MG/0.4ML, 40MG/0.8ML Humira Pediatric Crohns Disease Starter Pack INJ 40MG/0.8ML Humira Pen INJ 40MG/0.8ML Humira Pen-crohns Diseasestarter Humira Pen-psoriasis Starter Remicade Renflexis Simponi Formulary ID 18297, V#14 14

15 PA Details 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 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 18297, V#14 15

16 ARANESP Aranesp Albumin Free PA Details 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 18297, V#14 16

17 ARCALYST Arcalyst PA Details Other 12 YEARS AND OLDER 1 YEAR AT A TIME Formulary ID 18297, V#14 17

18 ARZERRA Arzerra PA Details Other DIAGNOSIS OF LYMPHOCYTIC LEUKEMIA (CLL) PRESCRIPTION MUST BE WRITTEN BY AN ONCOLOGIST 1 YEAR Formulary ID 18297, V#14 18

19 AUSTEDO Austedo PA Details Other Diagnosis of Chorea associated with Huntington's disease. Prescribed by or in consultation with a neurologist initial: 3 months, Continuation: 1 year For continuation of therapy:documentation of positive clinical response to therapy. Formulary ID 18297, V#14 19

20 BAVENCIO Bavencio PA Covered Uses Other Details All medically accepted indications not otherwise excluded from Part D Diagnosis, prior therapies, and treatment response Prescribed by or in consultation with an oncologist 1 year Formulary ID 18297, V#14 20

21 BENDEKA Bendeka PA Details 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 18297, V#14 21

22 BENLYSTA Benlysta INJ 200MG/ML PA Details 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. Formulary ID 18297, V#14 22

23 BESPONSA Besponsa PA Details Other Diagnosis, prior treatments, labs including: CBC and LFT, and weight 18 and older Prescription must be written by a hematologist or oncologist 3 months initation, 6 months for continuation For patients not proceeding to HSCT, additional cycles Continuation of therapy after intiation requires evidence of a complete remission with or without complete hematologic recovery. For patients not proceeding to HSCT can receive a maximum of 6 cycles. Formulary ID 18297, V#14 23

24 BLINCYTO Blincyto PA Details Other Diagnosis, other therapies, and treatment response Prescription must be writtten by an oncologist 3 months initial, 6 months continuation Formulary ID 18297, V#14 24

25 BOSULIF Bosulif PA Details 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 18297, V#14 25

26 CABOMETYX Cabometyx PA Details 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 18297, V#14 26

27 CALQUENCE Calquence PA Details Other NA Documentation of diagnosis, previous treatments, and response to treatment. Prescribed by oncology 3 months initial, 6 months continuation Formulary ID 18297, V#14 27

28 CAPRELSA Caprelsa PA Details 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 Formulary ID 18297, V#14 28

29 CINQAIR Cinqair PA Details 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 18297, V#14 29

30 COMETRIQ Cometriq PA Details 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 18297, V#14 30

31 CORLANOR Corlanor PA Details 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 18297, V#14 31

32 COTELLIC Cotellic PA Details 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 18297, V#14 32

33 CYRAMZA Cyramza PA Details Other Diagnosis, other therapies tried and/or failed Prescription must be written by an oncologist 3 months initial, 6 months for continuation Formulary ID 18297, V#14 33

34 DAKLINZA Daklinza PA Details 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 18297, V#14 34

35 DALIRESP Daliresp PA Details 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 18297, V#14 35

36 DARZALEX Darzalex INJ 100MG/5ML PA Details 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 18297, V#14 36

37 DEMSER Demser PA Details Other Diagnosis and whether the patient is a candidate for surgery 3 months Formulary ID 18297, V#14 37

38 DICLOFENAC GEL 3% Diclofenac Sodium GEL 3% PA Details Other Diagnosis and any prior treatments. Prescription must be written by a Dermatologist 3 months Formulary ID 18297, V#14 38

39 EGRIFTA Egrifta PA Details 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 Formulary ID 18297, V#14 39

40 EMEND Aprepitant PA Details Other 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 Formulary ID 18297, V#14 40

41 EMFLAZA Emflaza PA Details Other Initial: Diagnosis of Duchenne muscular dystrophy (DMD). Patient has received genetic testing for a mutation of the dystrophin gene. One of the following: A) Documentation of a confirmed mutation of the dystrophin gene or B) Muscle biopsy confirmed an absence of dystrophin protein. Patient has had a trial and failure or intolerance to prednisone. Emflaza dose will not exceed 0.9 milligrams per kilogram of body weight once daily. Initial: Patient is 5 years of age or older Initial: Prescribed by or in consultation with a neurologist who has experience treating children 12 months (Reauth): Patient has experienced a benefit from therapy (e.g., improvement or preservation of muscle strength) Formulary ID 18297, V#14 41

42 EMPLICITI Empliciti PA Details 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 18297, V#14 42

43 ENTRESTO Entresto PA Details 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. Formulary ID 18297, V#14 43

44 EPCLUSA Epclusa PA Details 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 18297, V#14 44

45 EPOETIN ALFA Epogen INJ 10000UNIT/ML, 20000UNIT/ML, 2000UNIT/ML, 3000UNIT/ML, 4000UNIT/ML Procrit Formulary ID 18297, V#14 45

46 PA Details 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 18297, V#14 46

47 ERIVEDGE Erivedge PA Details 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 3 MONTHS FOR INITIATION, 6 MONTHS FOR CONTINUATION Formulary ID 18297, V#14 47

48 ERLEADA Erleada PA Details Other Diagnosis, other therapies tried and outcome, fall risk assessment, and seizure history (if any) Must be prescribed by an oncologist or urologist Initiation: 3 months, continuation 6 months Formulary ID 18297, V#14 48

49 EVOMELA Evomela PA Details Other Diagnosis, prior treatments, and response to therapy Prescribed by hematology/oncology 1 month Formulary ID 18297, V#14 49

50 EXJADE Exjade PA Details 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 Formulary ID 18297, V#14 50

51 EXONDYS 51 Exondys 51 PA Details Other Submission of medical records (e.g., chart notes, laboratory values) confirming the mutation of the DMD gene is amenable to exon 51 skipping and baseline dystrophin level. Prescribed by or in consultation with a physician who specializes in treatment of Duchenne muscular dystrophy 3 months for initation, 6 months for continuation For initiation: patient must be ambulatory. For continuation: demonstration of response to therapy as determined by clinician and improvement in dystrophin level. Formulary ID 18297, V#14 51

52 FABRAZYME Fabrazyme PA Details Other 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 18297, V#14 52

53 FARYDAK Farydak PA Details Other Diagnosis, other therapies tried and/or failed Prescription must be written by an oncologist 3 months initial, 6 months for continuation Formulary ID 18297, V#14 53

54 FASENRA Fasenra PA Details 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/µl or greater within previous 12 months. Formulary ID 18297, V#14 54

55 FERRIPROX Ferriprox TABS PA Details 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. Formulary ID 18297, V#14 55

56 FULYZAQ Fulyzaq Mytesi PA Details 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 18297, V#14 56

57 FYCOMPA Fycompa PA Details 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 18297, V#14 57

58 GATTEX Gattex PA Details 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. Formulary ID 18297, V#14 58

59 GAUCHER'S DISEASE TREATMENT Cerdelga Cerezyme Elelyso Miglustat Vpriv Zavesca PA Details Other 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, HEMOTOLOGIST, OR METABOLIC SPECIALIST 1 YEAR USE OF ZAVESCA IS RESERVED FOR THOSE WHOM ENZYME REPLACEMENT THERAPY IS NOT AN OPTION Formulary ID 18297, V#14 59

60 GAZYVA Gazyva PA Details Other Diagnosis, prior treatments, and response to therapy Prescribed by hematology/oncology 3 months for initial 1 year for continuation Formulary ID 18297, V#14 60

61 GILOTRIF Gilotrif PA Details Other Diagnosis, previous therapies tried and/or failed Prescription must be written by oncologist 12 months Formulary ID 18297, V#14 61

62 GLEEVEC Imatinib Mesylate PA Details 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 Formulary ID 18297, V#14 62

63 GRALISE Gralise Gralise Starter PA Covered Uses Other Details 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 failure of gabapentin titrated to maximum dosage or rationale as to why gabapentin cannot be used. Formulary ID 18297, V#14 63

64 GROWTH HORMONE Norditropin Flexpro Nutropin Aq Nuspin 10 Nutropin Aq Nuspin 20 Nutropin Aq Nuspin 5 Nutropin Aq Pen PA Details 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 Formulary ID 18297, V#14 64

65 HARVONI Harvoni PA Details Other Diagnosis of Hepatitis C, genotype, previous therapies tried. Prescription must be written by a gastroenterologist, hepatologist, or infectious disease specialist Up to 24 weeks. will be applied consistent with current AASLD- IDSA guidance. Note: an shortened 8 week course of therapy will be covered when appropriate, but is not mandated. Formulary ID 18297, V#14 65

66 HEPATITIS B Baraclude SOLN Entecavir Tyzeka PA Details 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 Formulary ID 18297, V#14 66

67 HEPATITIS C TREATMENT Moderiba Rebetol SOLN Ribasphere Ribasphere Ribapak Ribavirin CAPS Ribavirin TABS 200MG Victrelis PA Details Other PATIENT WEIGHT, GENOTYPE, HCV-RNA QUANTITY AND DATE OF TEST, PRESENCE OF CIRRHOSIS (Y/N), TREATMENT HISTORY, HISTORY OF ANEMIA OR SKIN CONDITIONS. PRESCRIPTION MUST BE WRITTEN BY GASTROENTEROLOGIST, HEPATOLOGIST, OR INFECTIOUS DISEASE SPECIALIST WEEKS Formulary ID 18297, V#14 67

68 HEREDITARY ANGIOEDEMA Cinryze Firazyr Haegarda PA Details 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 18297, V#14 68

69 HETLIOZ Hetlioz PA Details Other Diagnosis, other therapies tried and/or failed 3 months initial, 1 year continuation Formulary ID 18297, V#14 69

70 HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA Juxtapid Kynamro PA Details 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. Formulary ID 18297, V#14 70

71 HUMALOG/HUMULIN Humalog Humalog Junior Kwikpen Humalog Kwikpen Humalog MIX 50/50 Humalog MIX 50/50 Kwikpen Humalog MIX 75/25 Humalog MIX 75/25 Kwikpen Humulin 70/30 Humulin 70/30 Kwikpen Humulin N Humulin N Kwikpen Humulin R PA Details Other Diagnosis, prior treatments, outcome, hemaglobin A1c 1 year Must have a contraindication to, an inadequate response to, or has been intolerant to Novolog/Novolin. Formulary ID 18297, V#14 71

72 HUMAN CHORIONIC GONADOTROPIN Chorionic Gonadotropin INJ Novarel INJ 10000UNIT Pregnyl W/diluent Benzyl Alcohol/nacl PA Details Other Diagnosis and any prior treatments. 1 year Formulary ID 18297, V#14 72

73 HYDROXYPROGESTERONE Hydroxyprogesterone Caproate INJ 1.25GM/5ML PA Covered Uses Details 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 18297, V#14 73

74 IBRANCE (S) Ibrance PA Details Other Prescription must be written by an oncologist 3 months initial, 6 months for continuation Formulary ID 18297, V#14 74

75 ICLUSIG Iclusig PA Details 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 18297, V#14 75

76 IDHIFA Idhifa PA Details Other Diagnosis, previous treatments, and outcome. Prescribed by or in consultation with a hematologist/oncologist. 12 months Formulary ID 18297, V#14 76

77 ILARIS Ilaris INJ 150MG PA Details Other Diagnosis, other therapies tried and/or failed Prescription must be written by rheumatologist, dermatologist, or immunologist 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 18297, V#14 77

78 IMBRUVICA Imbruvica PA Details Other DIAGNOSIS, PRIOR TREATMENTS, RESPONSE TO THERAPY Prescription must be prescribed by oncologist or hematologist 12 months Formulary ID 18297, V#14 78

79 IMFINZI Imfinzi PA Details Other Urothelial carcinoma: 1) Diagnosis of locally advanced or metastatic urothelial carcinoma AND 2) One of the following: a) Patient has experienced disease progression during or following platinum-containing chemotherapy OR b) Patient has experienced disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Prescribed by or in consultation with an oncologist 3 months initial, 6 months continuation Approve for continuation of prior therapy Formulary ID 18297, V#14 79

80 INCRELEX Increlex PA Details Other DIAGNOSIS, HEIGHT AND WEIGHT MEASUREMENTS, GH LEVEL, IGF-1 LEVEL PRESCRIPTION MUST BE WRITTEN BY ENDOCRINOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION Formulary ID 18297, V#14 80

81 INGREZZA Ingrezza CAPS 40MG PA Covered Uses Other Details All medically accepted indications not otherwise excluded from Part D Documentation of diagnosis of tardive dyskinesia Prescribed by or in consultation with a neurologist or psychiatrist 1 year Formulary ID 18297, V#14 81

82 INHALED TOBRAMYCIN Tobi Podhaler PA Details Other Diagnosis, therapies tried, and outcome Prescribed by Infectious disease specialist or pulmonologist 1 year Formulary ID 18297, V#14 82

83 INLYTA Inlyta PA Details 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 Formulary ID 18297, V#14 83

84 INTERFERON ALPHA Intron A Intron A W/diluent Pegasys Pegasys Proclick Pegintron Peg-intron Redipen Peg-intron Redipen Pak 4 INJ 120MCG/0.5ML, 150MCG/0.5ML, 80MCG/0.5ML PA Details 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 PRESCRIPTION MUST BE WRITTEN BY A GASTROENTEROLOGIST, DERMATOLOGIST, ONCOLOGIST, HEPATOLOGIST, OR INFECTIOUS DISEASE SPECIALIST 1 YEAR FOR INDICATIONS OTHER THAN HEPATITIS C. HEP C APPROVALS FROM WEEKS BASED ON DRUG REGIME Formulary ID 18297, V#14 84

85 INTUNIV Guanfacine Er PA Details Other DIAGNOSIS AND THERAPIES TRIED AND FAILED. 1 year Formulary ID 18297, V#14 85

86 IRESSA Iressa PA Details 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 18297, V#14 86

87 IV ONCOLOGY Dactinomycin Kadcyla Perjeta Trisenox INJ 12MG/6ML Zaltrap PA Details 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 18297, V#14 87

88 IVIG Bivigam Carimune Nanofiltered INJ 6GM Cuvitru Flebogamma Dif Gamastan S/d Gammagard Liquid Gammagard S/d Iga Less Than 1mcg/ml Gammaked Gammaplex Gamunex-c Hizentra Hyqvia Octagam Privigen PA Details 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 Formulary ID 18297, V#14 88

89 Formulary ID 18297, V#14 89

90 JAKAFI Jakafi PA Details 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 Formulary ID 18297, V#14 90

91 KALYDECO Kalydeco PA Details 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 18297, V#14 91

92 KANUMA Kanuma PA Details 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, gastroenterologist, or lipidologist 12 months Formulary ID 18297, V#14 92

93 KERYDIN Kerydin PA Details 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 18297, V#14 93

94 KEVZARA Kevzara PA Details 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 Formulary ID 18297, V#14 94

95 KEYTRUDA Keytruda PA Details Other must be an oncologist 3 months initial, 6 months continuation Formulary ID 18297, V#14 95

96 KINERET Kineret PA Details 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 (ie: allopurinol) Formulary ID 18297, V#14 96

97 KISQALI Kisqali PA Details Other Diagnosis, other therapies previously tried, and the outcome. Kisqali is used in combination with an aromatase inhibitor [(e.g., Femara (letrozole)]. Prescribed by or in consultation with an oncologist 3 months initial and 6 months for continuation of therapy Formulary ID 18297, V#14 97

98 KUVAN Kuvan PACK 100MG Kuvan TBSO PA Details 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 Formulary ID 18297, V#14 98

99 KYMRIAH Kymriah PA Details Other Diagnosis, prior treatments, weight, patient is free of active infection or inflammatory disorders, labs including: CBC, IgG, creatinine/bun, negative pregnancy test (if applicable), and neurologic function years old Prescription must be written by a hematologist or oncologist 1 dose Formulary ID 18297, V#14 99

100 KYPROLIS Kyprolis PA Details Other Diagnosis, prior treatments, and response to therapy Prescribed by hematology/oncology 1 year Formulary ID 18297, V#14 100

101 LARTRUVO Lartruvo PA Details Other Soft Tissue Sarcoma (STS): Diagnosis of STS. All of the following: A) One of the following: 1) Disease is not amenable to curative treatment with radiotherapy or 2) Disease is not amenable to curative treatment with surgery AND B) Used in combination with doxorubicin for the first 8 cycles of treatment Prescribed by or in consultation with an oncologist 12 months Formulary ID 18297, V#14 101

102 LEMTRADA Lemtrada PA Details 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 18297, V#14 102

103 LENVIMA 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 PA Details Other Prescription must be written by an oncologist 3 months initial, 6 months continuation Formulary ID 18297, V#14 103

104 LEUKINE Leukine INJ 250MCG PA Details Other DIAGNOSIS ACUTE MYELOID LEUKEMIA (AML): GREATER OR EQUAL TO 55 YEARS OLD. 3 MONTHS AT A TIME Formulary ID 18297, V#14 104

105 LIDODERM TRANSDERMAL Lidocaine PTCH PA Details Other 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 18297, V#14 105

106 LONSURF Lonsurf PA Details 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 18297, V#14 106

107 LYNPARZA Lynparza PA Details 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 Formulary ID 18297, V#14 107

108 MAVYRET Mavyret PA Details Other Diagnosis of hepatitis c, genotype, previous therapies tried. Prescription must be written by a gastroenterologist, hepatologist, or infectious disease specialist Up to 16 weeks. criteria will be applied consistent with current aasld-idsa guidance Formulary ID 18297, V#14 108

109 MEKINIST Mekinist PA Details 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 18297, V#14 109

110 METHADONE Methadone Hcl CONC Methadone Hcl INJ Methadone Hcl SOLN Methadone Hcl TABS Methadone Hcl Intensol Methadose CONC 10MG/ML Methadose TABS Methadose Sugar-free PA Details Other Diagnosis and any prior treatments. Pain management specialist 6 months Monitor for compliance and possible misuse, including early refill history and multiple treating physicians Formulary ID 18297, V#14 110

111 METHAMPHETAMINE Methamphetamine Hcl PA Details 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. Formulary ID 18297, V#14 111

112 MIRVASO Mirvaso PA Details Other Documentatin of diagnosis and other treatments tried and outcome. 1 year For the treatment of acne rosacea: doxycycline (oral) and topical metronidazole. Formulary ID 18297, V#14 112

113 MOVANTIK Movantik PA Covered Uses Other Details All medically accepted indications not otherwise excluded from Part D Will not be approved for cancer related pain Documented diagnosis of opiate induced constipation (non-cancer pain) 1 year Patient must have a trial of or contraindication to at least two different classes of laxative agents including bulk, osmotic, or stimulant laxatives. Formulary ID 18297, V#14 113

114 MOZOBIL Mozobil PA Details Other Diagnosis, patient weight Prescription must be written by oncologist or hematologist 1 month Formulary ID 18297, V#14 114

115 MULTIPLE SCLEROSIS Aubagio Avonex Avonex Pen Betaseron Copaxone INJ 40MG/ML Extavia Gilenya Glatiramer Acetate Glatopa Rebif Rebif Rebidose Rebif Rebidose Titration Pack Rebif Titration Pack Tecfidera Tecfidera Starter Pack PA Covered Uses Other Details All medically accepted indications not otherwise excluded under Part D Diagnosis, EDSS score, relapse history, and physical or cognitive disability neurologist 1 year For Aubagio, Extavia, Gilenya, and Rebif- must have a failure of one of the following: Avonex, Betaseron, Glatopa, Copaxone 40mg, or Tecfidera Formulary ID 18297, V#14 115

116 MYALEPT Myalept PA Details Other Diagnosis, prior therapy used, result of prior therapy 3 months for initiation, 1 year for continuation Formulary ID 18297, V#14 116

117 MYLOTARG Mylotarg PA Details Other Diagnosis, prior treatments, labs including: CBC, creatinine/bun, and LFT 2 and older Prescription must be written by a hematologist or oncologist 3 months initation, 6 months for continuation Formulary ID 18297, V#14 117

118 MYRBETRIQ Myrbetriq PA Details 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 18297, V#14 118

119 NATPARA Natpara PA Details Other DIAGNOSIS, BASELINE SERUM CALCIUM AND 25- HYDROXYVITAMIN D LEVELS MUST BE PRESCRIBED BY AN ENDOCRINOLOGIST 3 MONTHS INITIAL, 6 MONTHS CONTINUATION Formulary ID 18297, V#14 119

120 NERLYNX Nerlynx PA Details 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 Formulary ID 18297, V#14 120

121 NEUPRO Neupro PA Details 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. Formulary ID 18297, V#14 121

122 NEXAVAR Nexavar PA Details Other DIAGNOSIS, PRIOR THERAPIES, AND TREATMENT RESPONSE PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION Formulary ID 18297, V#14 122

123 NINLARO Ninlaro PA Details 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 inital 6 months for continuation Must have an intolerance or contraindication to Velcade Formulary ID 18297, V#14 123

124 NOXAFIL Noxafil SUSP Noxafil TBEC PA Details 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. Formulary ID 18297, V#14 124

125 NUCALA Nucala PA Details Other Allergen test, baseline FEV1, FEV1 following bronchodilator, asthma medical history (including medications, emergency department visits, and hospitalizations), baseline eosinophil count Pulmonology, immunologist, or allergist 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 18297, V#14 125

126 NUEDEXTA Nuedexta PA Details Other Diagnosis Prescription must be written by a neurologist or psychiatrist. 1 year Formulary ID 18297, V#14 126

127 NUPLAZID Nuplazid PA Details 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 18297, V#14 127

128 OCALIVA Ocaliva PA Details 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. Formulary ID 18297, V#14 128

129 OCTREOTIDE Octreotide Acetate PA Details Other Diagnosis, other therapies tried and failed 3 months for initiation, 6 months for continuation Formulary ID 18297, V#14 129

130 ODOMZO Odomzo PA Details 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 18297, V#14 130

131 OPDIVO Opdivo INJ 100MG/10ML, 40MG/4ML PA Details Other 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 18297, V#14 131

132 OPSUMIT Opsumit PA Details 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 18297, V#14 132

133 ORENCIA Orencia INJ 125MG/ML, 250MG PA Details 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 Formulary ID 18297, V#14 133

134 ORFADIN Orfadin PA Details 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 Formulary ID 18297, V#14 134

135 ORKAMBI Orkambi PA Details 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 18297, V#14 135

136 OTEZLA Otezla PA Details 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 18297, V#14 136

137 OXYCONTIN Oxycodone Hcl Er T12A PA Details Other 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 18297, V#14 137

138 PANRETIN Panretin PA Details Other NOT INDICATED WHEN SYSTEMIC ANTI-KS THERAPY IS REQUIRED. 6 MONTHS Formulary ID 18297, V#14 138

139 PCSK9 INHIBITORS Praluent Repatha Repatha Sureclick PA Covered Uses Other Details All medically accepted indications not otherwise exlcuded 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. Formulary ID 18297, V#14 139