MEDICATION(S) ORENCIA 125 MG/ML SYRINGE, ORENCIA 50 MG/0.4 ML SYRINGE, ORENCIA 87.5 MG/0.7 ML SYRINGE, ORENCIA CLICKJECT
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- Dana Stevenson
- 5 years ago
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1 ABATACEPT ORENCIA 125 MG/ML SYRINGE, ORENCIA 50 MG/0.4 ML SYRINGE, ORENCIA 87.5 MG/0.7 ML SYRINGE, ORENCIA CLICKJECT Documentation that patient has had an inadequate response or intolerant to BOTH of the preferred TNF ALPHA INHIBITOR agents - Humira AND Enbrel RHEUMATOLOGISTS. Approved for 12 months PAGE 1 LAST UPDATED 03/2019
2 ABIRATERONE ACETATE ABIRATERONE ACETATE, ZYTIGA DOCUMENTATION TO INDICATE USE IN COMBINATION WITH PREDNISONE APPROVED FOR 12 MONTHS DURATION. PAGE 2 LAST UPDATED 03/2019
3 ACITRETIN ACITRETIN PREGNANCY DOCUMENTATION OF DIAGNOSIS DERMATOLOGIST APPROVED 12 MONTHS PAGE 3 LAST UPDATED 03/2019
4 ADALIMUMAB HUMIRA, HUMIRA PEN, HUMIRA PEN CROHN'S-UC-HS, HUMIRA PEN PSOR-UVEITS-ADOL HS, HUMIRA(CF), HUMIRA(CF) PEN, HUMIRA(CF) PEN CROHN'S-UC-HS, HUMIRA(CF) PEN PSOR-UV-ADOL HS FOR THE DIAGNOSIS OF RHEUMATOID ARTHRITIS OR THE DIAGNOSIS OF PSORIATIC ARTHRITIS, DOCUMENTATION THAT PATIENT IS CURRENTLY USING OR HAS HAD AN INADEQUATE RESPONSE TO ONE OR MORE DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS): METHOTREXATE, SULFASALAZINE, CYCLOSPORINE, HYDROXYCHLOROQUINE, OR AZATHIOPRINE.FOR THE DIAGNOSIS OF ACTIVE ANKYLOSING SPONDYLITIS, DOCUMENTATION THAT PATIENT IS CURRENTLY USING OR HAS HAD INADEQUATE RESPONSE TO ONE OR MORE NSAIDS OR DMARDS.FOR THE DIAGNOSIS OF PLAQUE PSORIASIS, DOCUMENTATION THAT PATIENT IS CURRENTLY USING OR HAS HAD INADEQUATE RESPONSE TO ONE OR MORE DMARDS, OR HIGH POTENCY TOPICAL CORTICOSTEROIDS SUCH AS CLOBETASOL, BETAMETASONE, FLUOCINONIDE, HALOBETASOL, MOMETASONE, OR VITAMIN D TOPICAL ANALOGUES SUCH AS CALCIPOTRIENE, OR TOPICAL RETINOIDS SUCH AS TAZAROTENE, OR PHOTOTHERAPY.FOR THE DIAGNOSIS OF ADULT CROHN'S DISEASE AND ULCERATIVE COLITIS, DOCUMENTATION THAT PATIENT IS CURRENTLY USING OR HAS HAD INADEQUATE RESPONSE TO ONE MORE CONVENTIONAL THERAPIES SUCH AS ORAL CORTICOSTEROIDS, AZATHIOPRINE, 6-MERCAPTOPURINE, METHOTREXATE, SULFASALAZINE, MESALAMINE, LIALDA, BALSALAZIDE, CANASA, DIPENTUM, OR PENTASA. OPHTHALMOLOGISTS, RHEUMATOLOGISTS, DERMATOLOGISTS, AND PAGE 4 LAST UPDATED 03/2019
5 GASTROINTESTINAL SPECIALISTS. Approved for 12 months PAGE 5 LAST UPDATED 03/2019
6 AFATINIB GILOTRIF DIAGNOSIS APPROVED FOR 12 MONTHS DURATION. PAGE 6 LAST UPDATED 03/2019
7 ALECTINIB ALECENSA DIAGNOSIS, AND INFORMATION ON PRIOR SYSTEMIC THERAPIES. ONCOLOGIST APPROVED FOR 12 MONTHS DURATION. PAGE 7 LAST UPDATED 03/2019
8 ALISKIREN TEKTURNA DOCUMENTATION REQUIRED TO INDICATE THAT PATIENT HAS TRIED AND FAILED ON AN ANGIOTENSIN CONVERTING ENZYME (ACE) INHIBITOR AND ANGIOTENSIN RECEPTOR (ARB) BLOCKER. Approved for 12 months PAGE 8 LAST UPDATED 03/2019
9 ALISKIREN HCT TEKTURNA HCT DOCUMENTATION REQUIRED TO INDICATE THAT PATIENT HAS TRIED AND FAILED ON AN ANGIOTENSIN CONVERTING ENZYME (ACE) INHIBITOR AND ANGIOTENSIN RECEPTOR (ARB) BLOCKER. Approved for 12 months PAGE 9 LAST UPDATED 03/2019
10 ALOSETRON ALOSETRON HCL MALE PATIENTS WILL BE EXCLUDED. DOCUMENTATION OF SEVERE DIARRHEA-PREDOMINANT IBS AND ASSOCIATED SYMPTOMS 18 YEARS AND OLDER GASTROINTESTINAL SPECIALISTS. Approved for 12 months PAGE 10 LAST UPDATED 03/2019
11 ALPHA-1 PROTEINASE INHIBITOR ARALAST NP, PROLASTIN C, ZEMAIRA LABORATORY DATA/TEST CONFIRMATION OF ALPHA-1 ANTI-TRYPSIN DEFICIENCY (LESS THAN 80 MG/DL OR LESS THAN 11UM/L OR LESS THAN 0.8G/L (35% OF NORMAL), AND ESTABLISHED AIRFLOW OBSTRUCTION WITH DOCUMENTED FORCED EXPIRATORY VOLUME IN 1 SECOND (FEV1) LESS THAN 80 PERCENT PREDICTED. For Aralast and Zemaira, History of trial and failure to Prolastim-C. FIRST APPROVAL 3 MONTHS. IF POSITIVE RESPONSE AND NO CONTRAINDICATIONS APPROVED 12 MONTHS ON RENEWAL PAGE 11 LAST UPDATED 03/2019
12 AMBRISENTAN LETAIRIS DOCUMENTATION REQUIRED TO INDICATE PATIENT HAS TRIED AND FAILED SILDENAFIL (REVATIO) AND DIAGNOSIS OF PULMONARY ARTERIAL HYPERTENSION OF WHO GROUP 1. CARDIOLOGISTS, PULMONOLOGISTS. Approved for 12 months PAGE 12 LAST UPDATED 03/2019
13 ANAKINRA KINERET FOR RHEUMATOID ARTHRITIS: DOCUMENTATION THAT THE PATIENT HAS MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND HAS AN INADEQUATE RESPONSE TO THE FOLLOWING: 1) 1 OR MORE OF THE FOLLOWING DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS): METHOTREXATE, SULFASALAZINE, CYCLOSPORINE, HYDROXYCHLOROQUINE, OR AZATHIOPRINE 2) BOTH OF THE FOLLOWING TNF-ALPHA INHIBITORS - HUMIRA AND ENBREL. FOR CRYOPYRIN-ASSOCIATED PERIODIC SYNDROMES (CAPS): DOCUMENTED DIAGNOSIS OF CAPS OR NEONATAL-ONSET MULTISYSTEM INFLAMMATORY DISEASE (NOMID) Approved for 12 months PAGE 13 LAST UPDATED 03/2019
14 ANIDULAFUNGIN ERAXIS (WATER DILUENT) LABORATORY REQUIREMENT - CULTURE AND SENSITIVITY OF FUNGAL ORGANISM. APPROVED FOR 3 MONTH. PAGE 14 LAST UPDATED 03/2019
15 ANTI-OBESITY PHENTERMINE 15 MG CAPSULE, PHENTERMINE 30 MG CAPSULE Documentation of Diagnosis, and documentation to indicate patient has previously tried and failed weight loss or management programs and/or drug therapies for weight loss. PAGE 15 LAST UPDATED 03/2019
16 ANTINEOPLASTIC AGENTS MISCELLANEOUS DAURISMO, ERLEADA, VITRAKVI, XOSPATA ALL FDA-APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D OR NCCN GUIDELINES RECOMMENDED TREATMENT REGIMENS NOT OTHERWISE EXCLUDED FROM PART D ONCOLOGIST, HEMATOLOGIST, OR IN CONSULTATION WITH ONCOLOGY/HEMATOLOGY Approved for 12 months FOR OFF-LABEL USE, NCCN GUIDELINES WILL BE USED TO DETERMINE APPROPRIATENESS OF TREATMENT PAGE 16 LAST UPDATED 03/2019
17 APREMILAST OTEZLA For the diagnosis of plaque psoriasis and psoriatic arthritis: Documentation patient has tried and failed on BOTH of the preferred TNF-alpha inhiitors: Enbrel AND Humira. Dermatology or Rheumatology Approved for 12 months PAGE 17 LAST UPDATED 03/2019
18 ARIPIPRAZOLE LAUROXIL ARISTADA ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DOCUMENTATION TO INDICATE: A) PATIENT HAS TRIED AND FAILED ORAL ANTIPSYCHOTIC THERAPY OR B) TRANSFERRED FROM HOSPITAL/FACILITY/ANOTHER PROVIDER STABILIZED ON THIS MEDICATION APPROVED FOR 12 MONTHS DURATION. PAGE 18 LAST UPDATED 03/2019
19 ARIPIPRAZOLE LAUROXIL INITIO ARISTADA INITIO ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Documentation that the patient has history of non-compliance with oral antipsychotics or difficulty swallowing oral medications. Approved for 1 month duration Documentation to indicate use in combination with one dose of oral aripiprazole. PAGE 19 LAST UPDATED 03/2019
20 ARIPRIZOLE LONG-ACTING INJECTION ABILIFY MAINTENA DOCUMENTATION TO INDICATE : 1) PATIENT HAS TRIED AND FAILED ORAL ANTIPSYCHOTIC THERAPY 2) PATIENT HAS TRANSFERRED FROM HOSPITAL/FACILITY/ANOTHER PROVIDER AND STABILIZED ON THIS MEDICATION APPROVED FOR 12 MONTHS. PAGE 20 LAST UPDATED 03/2019
21 ASENAPINE SAPHRIS ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Documentation required to indicate that patient has tried and failed two trials of formulary antipsychotics Approved for 12 months PAGE 21 LAST UPDATED 03/2019
22 ATYPICAL ANTIPSYCHOTICS ARIPIPRAZOLE 1 MG/ML SOLUTION, ARIPIPRAZOLE ODT, OLANZAPINE ODT, RISPERIDONE ODT ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. FOR ORAL DISINTEGRATING ARIPIPRAZOLE, OLANZAPINE AND RISPERIDONE, DOCUMENTATION IS REQUIRED TO INDICATE PATIENT HAS DIFFICULTY IN SWALLOWING OR TAKING ORAL FORMULATIONS. APPROVED FOR 12 MONTHS. PAGE 22 LAST UPDATED 03/2019
23 AXITINIB INLYTA ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DOCUMENTED DIAGNOSIS OF ADVANCED RENAL CELL CARCINOMA AND FAILURE OF AT LEAST 1 PRIOR SYSTEMIC THERAPY ONCOLOGISTS APPROVED FOR 6 MONTHS DURATION. PAGE 23 LAST UPDATED 03/2019
24 BECAPLERMIN REGRANEX NON-DIABETIC RELATED ULCERS. DOCUMENTATION REQUIRED TO INDICATE THE SIZE OF ULCER(S) BEFORE START OF TREATMENT AND AFTER 10 WEEKS OF TREATMENT. FOR APPROVAL FOR CONTINUATION OF THERAPY, DOCUMENTATION TO SHOW PATIENT HAS EXPERIENCED IMPROVEMENT. 16 YEARS AND OLDER SURGEONS, INTERNAL MEDICINE, ENDOCRINOLOGISTS, INFECTIOUS DISEASE SPECIALISTS, OR PODIATRISTS. APPROVED FOR 10 WEEKS FOR INITIAL, AND FOR 20 WKS FOR CONTINUATION OF THERAPY ON RENEWAL PAGE 24 LAST UPDATED 03/2019
25 BINIMETINIB MEKTOVI ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DOCUMENTATION TO INDICATE USE IN COMBINATION WITH BRAFTOVI AND DOCUMENTED BRAF V600E OR BRAF V600K MUTATION ONCOLOGIST, HEMATOLOGIST, OR IN CONSULTATION WITH ONCOLOGY/HEMATOLOGY Approved for 12 months PAGE 25 LAST UPDATED 03/2019
26 BOSENTAN TRACLEER FOR THE DIAGNOSIS OF PULMONARY ARTERIAL HYPERTENSION WITH WHO FUNCTIONAL CLASS II TO IV, DOCUMENTATION THAT THE PATIENT HAS TRIED AND FAILED ON SILDENAFIL (REVATIO) OR TREPROSTINIL (REMODULIN). FOR THE DIAGNOSIS OF IDIOPATHIC OR CONGENITAL PULMONARY ARTERIAL HYPERTENSION IN PEDIATRIC PATIENTS AGED 3 YEARS OF AGE AND OLDER: DOCUMENTATION OF DIAGNOSIS. CARDIOLOGISTS, PULMONOLOGISTS. Approved for 12 months PAGE 26 LAST UPDATED 03/2019
27 BREXPIPRAZOLE REXULTI ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Documentation required to indicate that patient has tried and failed two trials of formulary antipsychotics Approved for 12 months PAGE 27 LAST UPDATED 03/2019
28 BRIGATINIB ALUNBRIG DIAGNOSIS, AND INFORMATION ON PRIOR SYSTEMIC THERAPIES. ONCOLOGIST APPROVED FOR 12 MONTHS DURATION. PAGE 28 LAST UPDATED 03/2019
29 CABOZANTINIB CABOMETYX, COMETRIQ DIAGNOSIS APPROVED FOR 12 MONTHS DURATION. PAGE 29 LAST UPDATED 03/2019
30 CALQUENCE CALQUENCE All FDA-approved indications not otherwise excluded from Part D. DIAGNOSIS, AND INFORMATION ON PRIOR THERAPIES. Oncologist, or in consultation with an oncologist Approved for 12 months PAGE 30 LAST UPDATED 03/2019
31 CANNABIDIOL EPIDIOLEX For the diagnosis of Lennox-Gastaut syndrome: Documentation to indicate patient has tried and failed or had an intolerance or contraindication to two formulary agents such as valproate, lamotrigine, Banzel, topiramate, felbamate, or clobazam. For the diagnosis of Dravet syndrome, documentation to indicate patient has tried, failed, or had an intolerance or contraindication to two formulary antiepileptics such as valproate, clobazam, topiramate, clonazepam, levetiracetam, or zonisamide. Approved for 12 months PAGE 31 LAST UPDATED 03/2019
32 CARIPRAZINE VRAYLAR ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DOCUMENTATION REQUIRED TO DEMONSTRATE THAT PATIENT HAS TWO PREVIOUS DOCUMENTED TRIALS OF GENERIC ATYPICAL ANTIPSYCHOTICS APPROVED FOR 12 MONTHS DURATION. PAGE 32 LAST UPDATED 03/2019
33 CASPOFUNGIN CASPOFUNGIN ACETATE LABORATORY REQUIREMENT - CULTURE AND SENSITIVITY OF FUNGAL ORGANISM. APPROVED FOR 6 MONTHS. PAGE 33 LAST UPDATED 03/2019
34 CINRYZE CINRYZE DIAGNOSIS APPROVAL 12 MONTHS PAGE 34 LAST UPDATED 03/2019
35 CLOZAPINE SUSPENSION VERSACLOZ DOCMENTATION REQUIRED TO INDICATE PATIENT HAS INADEQUATE RESPONSE OR INTOLERANCE TO REGULAR RELEASE CLOZAPINE. EXPLANATION OF SPECIFIC RESULTS AND OUTCOMES WITH CLOZAPINE THERAPY REQUIRED. APPROVED FOR 12 MONTHS DURATION. PAGE 35 LAST UPDATED 03/2019
36 CLOZAPINE TBDP CLOZAPINE ODT ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DOCMENTATION REQUIRED TO INDICATE PATIENT HAS INADEQUATE RESPONSE OR INTOLERANCE TO REGULAR RELEASE CLOZAPINE. EXPLANATION OF SPECIFIC RESULTS AND OUTCOMES WITH CLOZAPINE THERAPY REQUIRED. APPROVED FOR 12 MONTHS. PAGE 36 LAST UPDATED 03/2019
37 COBIMETINIB COTELLIC DIAGNOSIS, AND INFORMATION ON PRIOR SYSTEMIC THERAPIES. ONCOLOGIST APPROVED FOR 12 MONTHS DURATION. PAGE 37 LAST UPDATED 03/2019
38 DABRAFENIB TAFINLAR DIAGNOSIS INFORMATION APPROVED FOR 12 MONTHS PAGE 38 LAST UPDATED 03/2019
39 DACOMITINIB VIZIMPRO ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. 18 YEARS OF AGE AND OLDER ONCOLOGIST, HEMATOLOGIST, OR IN CONSULTATION WITH ONCOLOGY/HEMATOLOGY Approved for 12 months FOR OFF-LABEL USE, NCCN GUIDELINES WILL BE USED TO DETERMINE APPROPRIATENESS OF TREATMENT PAGE 39 LAST UPDATED 03/2019
40 DARBEPOETIN ARANESP 10 MCG/0.4 ML SYRINGE, ARANESP 100 MCG/0.5 ML SYRINGE, ARANESP 100 MCG/ML VIAL, ARANESP 150 MCG/0.3 ML SYRINGE, ARANESP 200 MCG/0.4 ML SYRINGE, ARANESP 200 MCG/ML VIAL, ARANESP 25 MCG/0.42 ML SYRING, ARANESP 25 MCG/ML VIAL, ARANESP 300 MCG/0.6 ML SYRINGE, ARANESP 300 MCG/ML VIAL, ARANESP 40 MCG/0.4 ML SYRINGE, ARANESP 40 MCG/ML VIAL, ARANESP 500 MCG/1 ML SYRINGE, ARANESP 60 MCG/0.3 ML SYRINGE, ARANESP 60 MCG/ML VIAL ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. FOR CANCER RELATED CONDITIONS, HEMOGLOBIN LEVEL GREATER THAN 10 G/DL (PRETREATMENT LEVEL). FOR CHRONIC RENAL FAILURE CONDITIONS, HEMOGLOBIN LEVEL GREATER THAN 12 G/DL. LABORATORY TEST - COMPLETE BLOOD COUNT INDICATING HEMOGLOBIN LEVEL. APPROVED 1 YEAR FOR CANCER RELATED DIAGNOSIS OR CHRONIC RENAL FAILURE (CRF) PAGE 40 LAST UPDATED 03/2019
41 DENOSUMAB - XGEVA XGEVA FOR THE TREATMENT OF HYPERCALCEMIA OF MALIGNANCY: DOCUMENTATION OF TRIAL AND FAILURE OF A BISPHOSPHONATE. FOR THE PREVENTION OF SKELETAL- RELATED EVENTS IN PATIENTS WITH MULTIPLE MYELOMA, PATIENTS WITH BONE METASTASES FROM SOLID TUMORS, OR FOR THE TREATMENT OF GIANT CELL TUMOR OF BONE: DOCUMENTATION OF DIAGNOSIS. APPROVED FOR 12 MONTHS DURATION. PAGE 41 LAST UPDATED 03/2019
42 DENOSUMAB-PROLIA PROLIA DOCUMENTED HIGH RISK FOR FRACTURE (HISTORY OF FRACTURE OR MULTIPLE RISK FACTORS FOR FRACTURE) OR TRIED FAILED OR INTOLERANT TO ORAL BISPHOSPHONATES. LABORATORY REQUIREMENT - BONE MINERAL DENSITY TEST. Approved for 12 months PAGE 42 LAST UPDATED 03/2019
43 DEXTROMETHORPHAN/QUINIDINE NUEDEXTA DOCUMENTATION TO INDICATE PATIENT HAS A DIAGNOSIS OF PSEUDOBULBAR AFFECT DUE TO ANY CAUSE Approved for 12 months PAGE 43 LAST UPDATED 03/2019
44 DICHLORPHENAMIDE KEVEYIS Documentation of diagnosis APPROVED FOR 12 MONTHS DURATION PAGE 44 LAST UPDATED 03/2019
45 DIMETHYL FUMERATE TECFIDERA Diagnosis of relapsing remitting multiple sclerosis including patients who have experience first clinical episode and MRI features consistent with multiple sclerosis. Neurologist Approved for 12 months PAGE 45 LAST UPDATED 03/2019
46 DORNASE PULMOZYME DOCUMENTATION OF DIAGNOSIS 5 YEARS OF AGE AND OLDER APPROVE FOR 12 MONTHS DURATION PAGE 46 LAST UPDATED 03/2019
47 DRONABINOL DRONABINOL FOR CANCER CHEMOTHERAPY-INDUCED NAUSEA AND VOMITTING - DOCUMENTATION REQUIRED TO SHOW PATIENT HAS HAD AN INADEQUATE RESPONSE TO ONE OR MORE ANTINAUSEANTS SUCH AS ONDANSETRON, GRANISETRON, OR PROCHLORPERAZINE. FOR APETITE STIMULATION IN AIDS PATIENTS - DOCUMENTATION THAT TREATMENT IS FOR ANOREXIA ASSOCIATED WITH WEIGHT LOSS IN PATIENTS WITH AIDS. APPROVED FOR 12 MONTHS DURATION. PAGE 47 LAST UPDATED 03/2019
48 DRONEDARONE MULTAQ NYHA CLASS IV HEART FAILURE OR SYMPTOMATIC HEART FAILURE WITH RECENT HOSPITALIZATION. DOCUMENTATION TO INDICATE PATIENT HAS TRIED AND FAILED AMIODARONE. CARDIOLOGIST APPROVED 12 MONTHS PAGE 48 LAST UPDATED 03/2019
49 DUVELISIB COPIKTRA ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Diagnosis and documentation that the patient has tried and failed on at least two prior systemic therapies Oncology or hematology or in consultation with oncology/hematology Approved for 12 months PAGE 49 LAST UPDATED 03/2019
50 ELBASVIR/ GRAZOPREVIR ZEPATIER ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Approval may not be granted when the provider attests that the patient has a life expectancy of less than 12 months due to non-liver comorbid conditions (per AASLD-IDSA treatment guideline recommendations) Criteria applied will be consistent with current AASLD-IDSA guideline recommendations. Submission of medical records (e.g., chart notes, applicable lab values such as detectable HCV RNA viral load) documenting and confirming diagnosis of chronic hepatitis C virus infection. Documentation of genotype, liver disease status, and treatment history required. Treatment candidate must be 18 years of age or older. Gastroenterologist, Hepatologist, Infectious Disease, or Transplant Specialist Up to 16 weeks or consistent with AASLD-IDSA guidelines. Trial and failure of Mavyret when Mavyret is considered an acceptable treatment option per AASLD-IDSA guidelines or provision of medical justification to indicate why Mavyret cannot be used. PAGE 50 LAST UPDATED 03/2019
51 EMICIZUMAB HEMLIBRA Not for use in patients currently taking belimumab Documentation patient diagnosed with congenital hemophilia A and documentation of high titer (>5 bethesda units per ml) of neutralizing anti-factor VIII inhibitors. Approved for 12 months duration PAGE 51 LAST UPDATED 03/2019
52 ENCORAFENIB BRAFTOVI ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DOCUMENTATION TO INDICATE USE IN COMBINATION WITH MEKTOVI AND DOCUMENTED BRAF V600E OR BRAF V600K MUTATION ONCOLOGIST, HEMATOLOGIST, OR IN CONSULTATION WITH ONCOLOGY/HEMATOLOGY Approved for 12 months PAGE 52 LAST UPDATED 03/2019
53 ERYTHROPOIETIN EPOGEN 2,000 UNITS/ML VIAL, EPOGEN 20,000 UNITS/2 ML VIAL, EPOGEN 20,000 UNITS/ML VIAL, EPOGEN 3,000 UNITS/ML VIAL, EPOGEN 4,000 UNITS/ML VIAL, PROCRIT, RETACRIT ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. FOR CANCER RELATED CONDITIONS, HEMOGLOBIN LEVEL GREATER THAN 10 G/DL (PRETREATMENT LEVEL). FOR CHRONIC RENAL FAILURE CONDITIONS, HEMOGLOBIN LEVEL GREATER THAN 12 G/DL. LABORATORY TEST - COMPLETE BLOOD COUNT INDICATING HEMOGLOBIN LEVEL. APPROVED 1 YEAR PAGE 53 LAST UPDATED 03/2019
54 ETANERCEPT ENBREL, ENBREL MINI, ENBREL SURECLICK All medically accepted indications not otherwise excluded from Part D. DOCUMENTATION THAT PATIENT HAS HAD AN INADEQUATE RESPONSE TO ONE OR MORE DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS): METHOTREXATE, SULFASALAZINE, CYCLOSPORINE, HYDROXYCHLOROQUINE, OR AZATHIOPRINE FOR PSORIATIC OR ARTHRITIC CONDITIONS. DOCUMENTATION THAT PATIENT HAS HAD INADEQUATE RESPONSE TO ONE OR MORE NSAIDS FOR ACTIVE ANKYLOSING SPONDYLITIS. RHEUMATOLOGISTS, GASTROINTESTINAL SPECIALISTS, DERMATOLOGISTS Approved for 12 months PAGE 54 LAST UPDATED 03/2019
55 EVEROLIMUS - ZORTRESS ZORTRESS FOR THE DIAGNOSIS OF KIDNEY TRANSPLANT, DOCUMENTATION TO INDICATE MEDICATION IS PRESCRIBED IN COMBINATION WITH CYCLOSPORINE FOR THE DIAGNOSIS OF LIVER TRANSPLANT, DOCUMENTATION TO INDICATE MEDICATION IS PRESCRIBED IN COMBINATION WITH TACROLIMUS TRANSPLANT SPECIALIST APPROVED FOR 12 MONTHS DURATION. PAGE 55 LAST UPDATED 03/2019
56 EVOLOCUMAB REPATHA PUSHTRONEX, REPATHA SURECLICK, REPATHA SYRINGE ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. LABORATORY DOCUMENTATION REQUIRED - PROVIDE RECENT LDL-C LEVEL. FOR CLINICAL ATHEROSCLEROTIC CV DISEASE (ASCVD): DOCUMENTATION OF HISTORY OF ASCVD OR CV EVENT AND CURRENT LDL-C LEVEL OF GREATER THAN OR EQUAL TO 70 MG/DL AFTER TREATMENT WITH A HIGH-POTENCY STATIN (AS DEFINED IN OTHER CRITERIA), OR A CONTRAINDICATION/INTOLERANCE TO STATIN THERAPY (AS DEFINED IN ). FOR FAMILIAL HYPERCHOLESTEROLEMIA: DOCUMENTED DIAGNOSIS BY ONE OF THE FOLLOWING: A) GENETIC TEST SHOWING A LDL-RECEPTOR MUTATION, FAMILIAR DEFECTIVE APOB-100, OR A PCSK9 GAIN-OF-FUNCTION MUTATION OR B) MEETS SIMON- BROOME OR WHO/DUTCH LIPID CLINIC NETWORK CRITERIA FOR DEFINITE FAMILIAL HYPERCHOLESTEROLEMIA, AND ONE OF THE FOLLOWING: A) HAS CONCURRENT ASCVD, B) HOMOZYGOUS FH (HoFH) OR C) HETEROZYGOUS FH (HeFH). FOR HoFH, ONE OF THE FOLLOWING: A) CURRENT LDL-C LEVEL OF GREATER THAN OR EQUAL TO 100 MG/DL AFTER TREATMENT WITH A HIGH-POTENCY STATIN (SEE ) AND EZETIMIBE,B) CONTRAINDICATION/INTOLERANCE TO STATIN THERAPY (AS DEFINED IN ) AND IS TAKING EZETIMIBE, OR C) CONTRAINDICATION TO BOTH STATIN THERAPY AND EZETIMIBE. FOR HeFH, ONE OF THE FOLLOWING: CURRENT LDL- C LEVEL OF GREATER THAN OR EQUAL TO 100 MG/DL AFTER TREATMENT WITH A HIGH- POTENCY STATIN (AS DEFINED IN ), OR A CONTRAINDICATION/INTOLERANCE TO STATIN THERAPY (AS DEFINED IN OTHER CRITERIA). PAGE 56 LAST UPDATED 03/2019
57 CARDIOLOGIST, ENDOCRINOLOGIST, NEUROLOGIST, LIPID SPECIALIST FOR INITIAL THERAPY: APPROVED FOR 6 MONTHS. FOR CONTINUING THERAPY: APPROVED FOR 12 MONTHS. STATIN INTOLERANCE AS ATTESTED BY PROVIDER. FOR INADEQUATE RESPONSE WITH HIGH-INTENSITY STATIN: EVIDENCE PATIENT HAS A CURRENT LDL-C LEVEL OF 100 MG/DL OR GREATER AFTER HAVING UNDERGONE AT LEAST 3 MONTHS OF THERAPY WITH ATORVASTATIN AND ROSUVASTATIN. FOR CONTINUATION OF THERAPY: APPROVAL WILL BE CONTINGENT UPON DEMONSTRATING A DOWNWARD TREND OF LDL-C FROM BASELINE (BASED ON LDL-C LEVEL PRIOR TO STARTING PCSK9 INHIBITOR THERAPY) PAGE 57 LAST UPDATED 03/2019
58 FENTANYL CITRATE FENTANYL CIT OTFC 1,200 MCG, FENTANYL CIT OTFC 1,600 MCG, FENTANYL CITRATE OTFC 200 MCG, FENTANYL CITRATE OTFC 400 MCG, FENTANYL CITRATE OTFC 600 MCG, FENTANYL CITRATE OTFC 800 MCG All FDA-approved indications not otherwise excluded from Part D. DIAGNOSIS APPROVED FOR 6 MONTHS DURATION. PAGE 58 LAST UPDATED 03/2019
59 FILGRASTIM-AAFI NIVESTYM ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. LABORATORY TEST - COMPLETE BLOOD COUNT PANEL. Approved for 6 months duration PAGE 59 LAST UPDATED 03/2019
60 FILGRASTIM-SNDZ ZARXIO ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. LABORATORY TEST - COMPLETE BLOOD COUNT PANEL. APPROVED FOR 6 MONTHS. PAGE 60 LAST UPDATED 03/2019
61 FIRAZYR FIRAZYR DIAGNOSIS 18 AND OLDER APPROVAL 12 MONTHS PAGE 61 LAST UPDATED 03/2019
62 FOSTAMATINIB TAVALISSE DOCUMENTATION OF DIAGNOSIS AND INFORMATION ON PRIOR THERAPIES Approved for 12 months PAGE 62 LAST UPDATED 03/2019
63 GEFITINIB IRESSA ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DIAGNOSIS, AND INFORMATION ON PRIOR SYSTEMIC THERAPIES. ONCOLOGIST APPROVED FOR 12 MONTHS DURATION. PAGE 63 LAST UPDATED 03/2019
64 GEODON GEODON 20 MG/ML VIAL ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DOCUMENTATION TO INDICATE PATIENT HAS TRIED AND FAILED ORAL ANTIPSYCHOTIC THERAPY APPROVED FOR 6 MONTHS. PAGE 64 LAST UPDATED 03/2019
65 GLATIRAMER COPAXONE 40 MG/ML SYRINGE, GLATIRAMER ACETATE, GLATOPA Diagnosis of relapsing remitting multiple sclerosis including patients who have experience first clinical episode and MRI features consistent with multiple sclerosis. Neurologist Approved for 12 months PAGE 65 LAST UPDATED 03/2019
66 GLECAPREVIR/ PIBRENTASVIR MAVYRET ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Approval may not be granted when the provider attests that the patient has a life expectancy of less than 12 months due to non-liver comorbid conditions (per AASLD-IDSA treatment guideline recommendations) Criteria applied will be consistent with current AASLD-IDSA guideline recommendations. Submission of medical records (e.g., chart notes, applicable lab values such as detectable HCV RNA viral load) documenting and confirming diagnosis of chronic hepatitis C virus infection. Documentation of genotype, liver disease status, and treatment history required. Treatment candidate must be 18 years of age or older. Gastroenterologist, Hepatologist, Infectious Disease, or Transplant Specialist Up to 16 weeks or consistent with AASLD-IDSA guidelines. PAGE 66 LAST UPDATED 03/2019
67 IBRUTINIB IMBRUVICA DIAGNOSIS APPROVED FOR 12 MONTHS DURATION. PAGE 67 LAST UPDATED 03/2019
68 IDELALISIB ZYDELIG DIAGNOSIS, AND INFORMATION ON PRIOR SYSTEMIC THERAPIES. ONCOLOGIST APPROVED FOR 6 MONTHS DURATION. PAGE 68 LAST UPDATED 03/2019
69 IDHIFA IDHIFA ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test in an adult. APPROVED FOR 12 MONTHS. PAGE 69 LAST UPDATED 03/2019
70 ILOPERIDONE FANAPT ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Documentation required to indicate that patient has tried and failed two trials of formulary antipsychotics Approved for 12 months PAGE 70 LAST UPDATED 03/2019
71 IMMUNOGLOBULINS IV GAMMAGARD LIQUID, GAMMAGARD S-D, GAMMAPLEX 10 GRAM/100 ML VIAL, GAMMAPLEX 20 GRAM/200 ML VIAL, GAMMAPLEX 5 GRAM/50 ML VIAL, GAMUNEX-C 1 GRAM/10 ML VIAL, OCTAGAM Documentation of Diagnosis APPROVED FOR 6 MONTHS. PAGE 71 LAST UPDATED 03/2019
72 INTERFERON ALFA-2B INTRON A ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. HEPATITS A PATIENTS FOR HEPATITIS RELATED TREATMENT ONLY: LABORATORY LEVELS REQUIRED - VIRAL RNA LEVELS, AST/ALT LEVELS, VIRAL GENOTYPE. BIOPSY RESULTS OF LIVER IS PREFERRABLY DOCUMENTED IF AVAILABLE. FOR MALIGNANT MELAONA ONLY, MUST HAVE DOCUMENTATION OF SURGICAL INTERVENTION WITHIN 56 DAYS OF INTERFERON ALFA-2B. FOR FOLLICULAR LYMPHOMA, DOCUMENTATION THAT THERAPY WILL BE USED IN CONJUNCTION WITH ANTHRACYCLINE-CONTAINING CHEMOTHERAPY REGIMEN APPROVED FOR 12 MONTHS DURATION. PAGE 72 LAST UPDATED 03/2019
73 INTERFERON BETA 1A (AVONEX) AVONEX, AVONEX PEN Diagnosis of relapsing remitting multiple sclerosis including patients who have experience first clinical episode and MRI features consistent with multiple sclerosis. Neurologist Approved for 12 months PAGE 73 LAST UPDATED 03/2019
74 INTERFERON BETA 1A (REBIF) REBIF, REBIF REBIDOSE Diagnosis of relapsing remitting multiple sclerosis including patients who have experience first clinical episode and MRI features consistent with multiple sclerosis. Neurologist Approved for 12 months PAGE 74 LAST UPDATED 03/2019
75 INTERFERON BETA 1B BETASERON Diagnosis of relapsing remitting multiple sclerosis including patients who have experience first clinical episode and MRI features consistent with multiple sclerosis. Neurologist Approved for 12 months PAGE 75 LAST UPDATED 03/2019
76 INTERFERON GAMMA-1B ACTIMMUNE ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DOCUMENTATION OF DIAGNOSIS APPROVED FOR 12 MONTHS DURATION. PAGE 76 LAST UPDATED 03/2019
77 INTERLEUKIN 23 RECEPTOR ANTAGONISTS ILUMYA, TREMFYA For the diagnosis of plaque psoriasis: Documentation to indicate patient has tried and failed one of the preferred TNF-alpha inhibitors: Enbrel or Humira AND documentation to indicate patient has tried and failed on the Cosentyx. Dermatology or Rheumatology Approved for 12 months PAGE 77 LAST UPDATED 03/2019
78 INVEGA TRINZA INVEGA TRINZA All FDA approved indications not otherwise excluded from Part D TREATMENT WITH INVEGA SUSTENNA FOR AT LEAST 4 MONTHS, WITH LAST 2 DOSES OF INVEGA SUSTENNA BEING THE SAME DOSAGE STRENGTH BEFORE STARTING INVEGA TRINZA. USE DOSAGE COVERSION CHART FOR TRINZA DOSE. Approved for 12 months QUANTITY LIMIT EXCEPTIONS REQUIRE DOCUMENTATION TO INDICATE BOTH THE FOLLOWING: 1) GLUTEAL INJECTION HAS BEEN TRIED OR OFFERED 2) HIGHER DOSAGE STRENGTH HAS BEEN TRIED OR OFFERED. PAGE 78 LAST UPDATED 03/2019
79 ITRACONAZOLE ITRACONAZOLE, SPORANOX 10 MG/ML SOLUTION ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. FOR THE INDICATION OF ONYCHOMYCOSIS/TINEA UNGUIUM: PATIENT HAS AN INADEQUATE RESPONSE OR INABILITY TO TOLERATE TERBINAFINE. FOR ALL OTHER INDICATIONS: DOCUMENTATION OF DIAGNOSIS APPROVED FOR 6 MONTHS TO A YEAR. PAGE 79 LAST UPDATED 03/2019
80 IVABRADINE CORLANOR DOCUMENTATION REQUIRED TO SHOW PATIENT HAS DIAGNOSIS OF SYMPTOMATIC CHRONIC HEART FAILURE WITH LVEF: LEFT VENTRICULAR EJECTION FRACTION LESS THAN OR EQUAL TO 35% HR: IN SINUS RHYTHM WITH RESTING HEART RATE GREATER THAN OR EQUAL TO 70 BEATS PER MINUTE. ALSO PATIENT HAS TRIED AND FAILED MAXIMALLY TOLERATED DOSES OF BETA- BLOCKERS OR HAS A CONTRAINDICATION TO BETA-BLOCKER USE. CARDIOLOGISTS APPROVED FOR 12 MONTHS DURATION. PAGE 80 LAST UPDATED 03/2019
81 IVOSIDENIB TIBSOVO ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DOCUMENTATION TO INDICATE PATIENT HAS IDH-1 MUTATION AML. ONCOLOGIST, HEMATOLOGIST, OR IN CONSULTATION WITH ONCOLOGY/HEMATOLOGY Approved for 12 months PAGE 81 LAST UPDATED 03/2019
82 IXAZOMIB NINLARO DIAGNOSIS, AND INFORMATION ON PRIOR SYSTEMIC THERAPIES. ONCOLOGIST APPROVED FOR 12 MONTHS DURATION. PAGE 82 LAST UPDATED 03/2019
83 KALYDECO KALYDECO Patients with cystic fibrosis who are homozygous for the F508del mutation in the CFTR gene. DIAGNOSIS WITH DOCUMENTATION OF PATIENT'S CFTR GENOTYPE. TABLETS: 6 YEARS AND OLDER. GRANULES: PATIENT MUST BE 2 TO UNDER 6 YEARS OLD. Approved for 12 months PAGE 83 LAST UPDATED 03/2019
84 LANREOTIDE SOMATULINE DEPOT DOCUMENTATION TO INDICATE PATIENT HAS TRIED AND FAILED OCTREOTIDE THERAPY. APPROVED FOR 1 YEAR. PAGE 84 LAST UPDATED 03/2019
85 LAPATINIB TYKERB DOCUMENTATION REQUIRED TO INDICATE PATIENT HAS RECEIVED PRIOR THERAPY WITH AN ANTHRACYCLINE, A TAXANE AND TRASTUZUMAB AND IS USING LAPATINIB IN COMBINATION WITH CAPECITABINE OR DOCUMENTATION THAT PATIENT IS USING LAPATINIB IN COMBINATION WITH LETROZOLE. ONCOLOGISTS APPROVED FOR 12 MONTHS PAGE 85 LAST UPDATED 03/2019
86 LENVATINIB LENVIMA All FDA-approved indications not otherwise excluded from Part D. DIAGNOSIS, AND INFORMATION ON PRIOR SYSTEMIC THERAPIES. ONCOLOGIST APPROVED FOR 6 MONTHS DURATION. PAGE 86 LAST UPDATED 03/2019
87 LEVOMILNACIPRAN FETZIMA DOCMENTATION REQUIRED TO INDICATE PATIENT HAS TRIED AND FAILED VENLAFAXINE OR DULOXETINE. APPROVED FOR 12 MONTHS DURATION. PAGE 87 LAST UPDATED 03/2019
88 LIDOCAINE TRANSDERMAL PATCH LIDOCAINE 5% PATCH All medically accepted indications not otherwise excluded from Part D DIAGNOSIS Approved for 12 months PAGE 88 LAST UPDATED 03/2019
89 LOMITAPIDE JUXTAPID All FDA-approved indications not otherwise excluded from Part D. DOCUMENTATION REQUIRED INDICATING PATIENT HAS TRIED AND FAILED ONE OF THE FOLLOWING DRUGS ATORVASTATIN OR EZETIMIBE TO CONTROL HYPERCHOLESTEROLEMIA. MOST RECENT LIPID PANEL IS REQUIRED. APPROVED FOR 12 MONTHS DURATION. PAGE 89 LAST UPDATED 03/2019
90 LORLATINIB LORBRENA ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. For the diagnosis of ALK-positive metastatic NSCLC: documentation patient has progressed on crizotinib plus one other ALK inhibitor such as alectinib or ceritinib 18 YEARS OF AGE AND OLDER ONCOLOGIST, HEMATOLOGIST, OR IN CONSULTATION WITH ONCOLOGY/HEMATOLOGY Approved for 12 months FOR OFF-LABEL USE, NCCN GUIDELINES WILL BE USED TO DETERMINE APPROPRIATENESS OF TREATMENT PAGE 90 LAST UPDATED 03/2019
91 LUMACAFTOR/IVACAFTOR ORKAMBI ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. PATIENTS WHO ARE NOT HOMOZYGOUS FOR F508del MUTATION. DIAGNOSIS OF CYSTIC FIBROSIS AND DOCUMENTATION THAT PATIENT S CFTR GENOTYPE IS HOMOZYGOUS FOR F508del MUTATION 2 years of age and older PULMONOLOGIST APPROVED FOR 12 MONTHS DURATION. PAGE 91 LAST UPDATED 03/2019
92 MECASERMIN INCRELEX Documentation of Diagnosis APPROVED FOR 12 MONTHS PAGE 92 LAST UPDATED 03/2019
93 METHAMPHETAMINE METHAMPHETAMINE HCL ALL MEDICALLY-ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. EXOGENOUS OBESITY FOR USE IN ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD), DOCUMENTATION REQUIRED TO INDIATE PATIENT HAS TRIED AND FAILED ON TWO FORMULARY STIMULANTS. Approved for 12 months PAGE 93 LAST UPDATED 03/2019
94 METHYLNALTREXONE RELISTOR DOCUMENTATION REQUIRED TO INDICATE PATIENT HAS INADEQUATE RESPONSE OR INTOLERANCE TO TWO OR MORE FIRST LINE LAXATIVE AGENTS SUCH AS DOCUSATE, SENNA, LACTULOSE SYRUP, BISACODYL, MILK OF MAGNESIA, PSYLLIUM/FIBER, POLYETHYLENE GLYCOL 3350 APPROVED FOR 4 MONTHS. PAGE 94 LAST UPDATED 03/2019
95 MIDOSTAURIN RYDAPT DIAGNOSIS, AND INFORMATION ON PRIOR SYSTEMIC THERAPIES. ONCOLOGIST APPROVED FOR 12 MONTHS DURATION. PAGE 95 LAST UPDATED 03/2019
96 MIFEPRISTONE KORLYM All FDA-approved indications not otherwise excluded from Part D. PATIENTS WHO ARE PREGNANT, PATIENTS WITH DIABETES NOT ASSOCIATED WITH CUSHINGS SYNDROME DIAGNOSIS APPROVED FOR 6 MONTHS DURATION. PAGE 96 LAST UPDATED 03/2019
97 MIRABEGRON MYRBETRIQ All FDA-approved indications not otherwise excluded from Part D. DOCUMENTATION REQUIRED TO INDICATE PATIENT HAS TRIED, FAILED OR INTOLERANT TO TWO OF THE ANTIMUSCARINIC CLASS OF DRUGS SUCH AS OXYBUTYNIN, TOLTERODINE, OR DARIFENACIN. APPROVED FOR 12 MONTHS DURATION. PAGE 97 LAST UPDATED 03/2019
98 MODAFINIL MODAFINIL DIAGNOSIS APPROVED 12 MONTHS PAGE 98 LAST UPDATED 03/2019
99 MOGAMULIZUMAB POTELIGEO ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Diagnosis and documentation that the patient has tried and failed on at least one prior systemic therapy Oncology or hematology or in consultation with oncology/hematology Approved for 12 months PAGE 99 LAST UPDATED 03/2019
100 NALTREXONE INJECTABLE VIVITROL DIAGNOSIS. FOR ALCOHOL DEPENDENCE OR ABUSE, REQUIRED INFORMATION TO INDICATE PATIENT HAS FAILED TRIAL OF ORAL MEDICATION FOR ALCOHOL DEPENDENCE OR ABUSE (ACAMPROSATE, ORAL NALTREXONE, DISUFIRAM, OR GABAPENTIN), OR THE PATIENT'S CLINICAL STATUS INDICATES INSTABILITY SUCH THAT ORAL MEDICATION WILL NOT BE TAKEN CONSISTENTLY OR A TRIAL WILL LIKELY FAIL. APPROVED FOR 12 MONTHS DURATION. PAGE 100 LAST UPDATED 03/2019
101 NERLYNX NERLYNX ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy in an adult. APPROVED FOR 12 MONTHS. PAGE 101 LAST UPDATED 03/2019
102 NILOTINIB TASIGNA DOCUMENTATION OF DIAGNOSIS REQUIRED APPROVED FOR 6 MONTHS DURATION. PAGE 102 LAST UPDATED 03/2019
103 NIRAPARIB ZEJULA DIAGNOSIS, AND INFORMATION ON PRIOR SYSTEMIC THERAPIES. ONCOLOGIST APPROVED FOR 12 MONTHS DURATION. PAGE 103 LAST UPDATED 03/2019
104 OCTREOTIDE OCTREOTIDE 1,000 MCG/5 ML VIAL, OCTREOTIDE 1,000 MCG/ML VIAL, OCTREOTIDE 5,000 MCG/5 ML VIAL, OCTREOTIDE ACET 0.05 MG/ML VL, OCTREOTIDE ACET 100 MCG/ML AMP, OCTREOTIDE ACET 100 MCG/ML VL, OCTREOTIDE ACET 200 MCG/ML VL, OCTREOTIDE ACET 50 MCG/ML AMP, OCTREOTIDE ACET 50 MCG/ML VIAL, OCTREOTIDE ACET 500 MCG/ML AMP, OCTREOTIDE ACET 500 MCG/ML VL ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Documentation of diagnosis APPROVED FOR 6 MONTHS UP TO 1 YEAR. PAGE 104 LAST UPDATED 03/2019
105 OLAPARIB LYNPARZA DIAGNOSIS, AND INFORMATION ON PRIOR SYSTEMIC THERAPIES. ONCOLOGIST APPROVED FOR 6 MONTHS DURATION. PAGE 105 LAST UPDATED 03/2019
106 OMACETAXINE SYNRIBO DIAGNOSIS APPROVED FOR 12 MONTHS DURATION. PAGE 106 LAST UPDATED 03/2019
107 OMALIZUMAB XOLAIR FOR THE DIAGNOSIS OF ALLERGIC ASTHMA: DOCUMENTATION REQUIRED TO INDICATE THAT PATIENT HAS A HISTORY OF MODERATE TO SEVERE PERSISTENT ASTHMA. LABORATORY TEST REQUIRED DOCUMENTING ALLERGIC SENSITIZATION VIA SKIN TEST OR IN VITRO TESTING AND IGE LEVEL BETWEEN IU/ML PRETREATMENT. DOCUMENTATION REQUIRED TO INDICATE TRIAL AND FAILURE OF, OR INTOLERANCE TO, A TREATMENT REGIMEN THAT INCLUDES TWO OF THE FOLLOWING DRUG CLASSES: CORTICOSTEROIDS (INHALED OR ORAL, E.G., MOMETASONE, FLUTICASONE, BECLOMETHASONE, PREDNISONE, METHYLPREDNISOLONE, OR PREDNISOLONE) AND LONG-ACTING BRONCHODILATOR (E.G., FORMOTEROL, SALMETEROL, FLUTICASONE/SALMETEROL, OR BUDESONIDE/FORMOTEROL). FOR THE DIANOSIS OF CHRONIC IDIOPATHIC URTICARIA: DOCUMENTATION REQUIRED TO INDICATE TRIAL AND FAILURE OF, OR INTOLERANCE TO, TWO ANTIHISTAMINES (E.G., CETIRIZINE, LEVOCETIRIZINE, LORATADINE, DESLORATADINE, OR FEXOFENADINE). FOR PATIENTS 6 YEARS OF AGE OR OLDER DERMATOLOGISTS, IMMUNOLOGISTS, PULMONOLOGISTS, ALLERGISTS. APPROVED FOR 12 MONTHS DURATION. PAGE 107 LAST UPDATED 03/2019
108 OSIMERTINIB TAGRISSO DIAGNOSIS, AND INFORMATION ON PRIOR SYSTEMIC THERAPIES. ONCOLOGIST APPROVED FOR 12 MONTHS DURATION. PAGE 108 LAST UPDATED 03/2019
109 OXYMETHOLONE ANADROL-50 ALL MEDICALLY-ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. BREAST CANCER IN MEN, BREAST CANCER IN WOMEN WITH HYPERCALCEMIA, PROSTATE CANCER, SEVERE HEPATIC DYSFUNCTION, NEPHROSIS OR NEPHROTIC PHASE OF NEPHRITIS, PREGNANCY, OR PLANNED PREGNANCY. LABORATORY VALUE REQUIRED TO INDICATE PATIENT HAS HEMATOCRIT VALUE LESS THAN 30%. DOCUMENTATION REQUIRED THAT PATIENT WILL RECEIVE ONLY ONE ANDROGEN OR ANABOLIC AGENT, OR PRESCRIBER HAS SUBMITTED DOCUMENTATION IN SUPPORT OF THERAPY WITH MORE THAN ONE ANDROGEN OR ANABOLIC AGENT. 12 MONTHS PAGE 109 LAST UPDATED 03/2019
110 PALBOCICLIB IBRANCE All FDA-approved indications not otherwise excluded from Part D. DIAGNOSIS, AND INFORMATION ON PRIOR SYSTEMIC THERAPIES. ONCOLOGIST APPROVED FOR 6 MONTHS DURATION. PAGE 110 LAST UPDATED 03/2019
111 PALIPERIDONE PALIPERIDONE ER ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. DOCMENTATION REQUIRED TO INDICATE PATIENT HAS INADEQUATE RESPONSE OR INTOLERANCE TO REGULAR RELEASE RISPERIDONE (RISPERDAL). APPROVED FOR 12 MONTHS PAGE 111 LAST UPDATED 03/2019
112 PALIPERIDONE LONG-ACTING INJECTION INVEGA SUSTENNA All FDA-approved indications not otherwise excluded from Part D. DOCUMENTATION TO INDICATE : 1) PATIENT HAS TRIED AND FAILED ORAL ANTIPSYCHOTIC THERAPY 2) PATIENT HAS TRANSFERRED FROM HOSPITAL/FACILITY/ANOTHER PROVIDER AND STABILIZED ON THIS MEDICATION APPROVED FOR 12 MONTHS. QUANTITY LIMIT EXCEPTIONS REQUIRE DOCUMENTATION TO INDICATE BOTH THE FOLLOWING: 1) GLUTEAL INJECTION HAS BEEN TRIED OR OFFERED 2) HIGHER DOSAGE STRENGTH HAS BEEN TRIED OR OFFERED. PAGE 112 LAST UPDATED 03/2019
113 PANOBINOSTAT FARYDAK All FDA-approved indications not otherwise excluded from Part D. DIAGNOSIS, AND INFORMATION ON PRIOR SYSTEMIC THERAPIES. ONCOLOGIST APPROVED FOR 6 MONTHS DURATION. PAGE 113 LAST UPDATED 03/2019
114 PART D VS PART B ABELCET, ACETYLCYSTEINE 10% VIAL, ACETYLCYSTEINE 20% VIAL, ACYCLOVIR SODIUM, ALBUTEROL 2.5 MG/0.5 ML SOL, ALBUTEROL 5 MG/ML SOLUTION, ALBUTEROL SUL 1.25 MG/3 ML SOL, ALBUTEROL SUL 2.5 MG/3 ML SOLN, AMBISOME, AMINOSYN II 15% IV SOLUTION, AMINOSYN II WITH ELECTROLYTES, AMINOSYN 8.5%-ELECTROLYTES SOL, AMINOSYN-HBC, AMINOSYN-PF 7% IV SOLUTION, AMPHOTERICIN B, ANZEMET 100 MG TABLET, ANZEMET 50 MG TABLET, APREPITANT, AZASAN, AZATHIOPRINE, BUDESONIDE 0.5 MG/2 ML SUSP, BUDESONIDE 1 MG/2 ML INH SUSP, CALCITRIOL 0.25 MCG CAPSULE, CALCITRIOL 0.5 MCG CAPSULE, CALCITRIOL 1 MCG/ML SOLUTION, CINACALCET HCL, CLINIMIX, CLINIMIX E 2.75%-10% SOLUTION, CLINIMIX E 2.75%-5% SOLUTION, CLINIMIX E 4.25%-25% SOLUTION, CLINIMIX E 4.25%-5% SOLUTION, CLINIMIX E 5%-15% SOLUTION, CLINIMIX E 5%-20% SOLUTION, CLINIMIX E 5%-25% SOLUTION, CROMOLYN 20 MG/2 ML NEB SOLN, CYCLOPHOSPHAMIDE 25 MG CAPSULE, CYCLOPHOSPHAMIDE 50 MG CAPSULE, CYCLOSPORINE 100 MG CAPSULE, CYCLOSPORINE 25 MG CAPSULE, CYCLOSPORINE MODIFIED, CYTARABINE 20 MG/ML VIAL, DAPTOMYCIN, DEXTROSE 10%- WATER IV SOLUTION, DOXERCALCIFEROL 0.5 MCG CAP, DOXERCALCIFEROL 1 MCG CAPSULE, DOXERCALCIFEROL 2.5 MCG CAP, DOXY 100, DOXYCYCLINE HYCLATE 100 MG VL, ENGERIX-B ADULT, ENGERIX-B PEDIATRIC-ADOLESCENT, FIRMAGON, GANCICLOVIR 500 MG/10 ML VIAL, GRANISETRON HCL 1 MG TABLET, INTRALIPID, IPRATROPIUM BR 0.02% SOLN, IPRATROPIUM-ALBUTEROL, LEVALBUTEROL CONCENTRATE, LEVALBUTEROL HCL, LEVOCARNITINE 1 G/10 ML SOLN, LEVOCARNITINE 330 MG TABLET, MEPERIDINE 100 MG/ML VIAL, MEPERIDINE 25 MG/ML VIAL, MEPERIDINE 50 MG/ML VIAL, METHOTREXATE 2.5 MG TABLET, MYCOPHENOLATE 200 MG/ML SUSP, MYCOPHENOLATE 250 MG CAPSULE, MYCOPHENOLATE 500 MG TABLET, MYCOPHENOLIC ACID, NEBUPENT, NEPHRAMINE, ONDANSETRON 4 MG/5 ML SOLUTION, ONDANSETRON HCL 4 MG TABLET, ONDANSETRON HCL 8 MG TABLET, ONDANSETRON ODT, PALONOSETRON HCL, PARICALCITOL, PENTAM 300, PREMASOL, PROCALAMINE, PROSOL, RABAVERT, RAPAMUNE 1 MG/ML ORAL SOLN, RECOMBIVAX HB, SENSIPAR, SIROLIMUS, TACROLIMUS 0.5 MG CAPSULE, TACROLIMUS 1 MG CAPSULE, TACROLIMUS 5 MG CAPSULE, TRAVASOL, TREXALL, TROPHAMINE 10% IV SOLUTION, XATMEP DETAILS This drug may be covered under Medicare Part B or D depending on the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. PAGE 114 LAST UPDATED 03/2019
115 PAZOPANIB VOTRIENT DIAGNOSIS ONCOLOGIST APPROVED FOR 6 MONTHS. PAGE 115 LAST UPDATED 03/2019
116 PEGFILGRASTIM FULPHILA, NEULASTA ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. LABORATORY TEST - COMPLETE BLOOD COUNT PANEL. APPROVED FOR 6 MONTHS. PAGE 116 LAST UPDATED 03/2019
117 PEGINTERFERON ALFA-2A PEGASYS, PEGASYS PROCLICK LABORATORY LEVELS REQUIRED - HCV RNA LEVELS, AST/ALT LEVELS, VIRAL GENOTYPE. BIOPSY RESULTS OF LIVER IS PREFERRABLY DOCUMENTED IF AVAILABLE. GASTROENTEROLOGISTS, HEPATOLOGISTS, TRANSPLANT SPECIALISTS, INFECTIOUS DISEASE SPECIALISTS APPROVED FOR 6 MONTHS UP TO 1 YEAR. PAGE 117 LAST UPDATED 03/2019
118 PEGINTERFERON ALFA-2B PEGINTRON 50 MCG KIT, PEGINTRON REDIPEN LABORATORY LEVELS REQUIRED - HCV RNA LEVELS, AST/ALT LEVELS, VIRAL GENOTYPE. BIOPSY RESULTS OF LIVER IS PREFERRABLY DOCUMENTED IF AVAILABLE. GASTROENTEROLOGISTS, HEPATOLOGISTS, TRANSPLANT SPECIALISTS, INFECTIOUS DISEASE SPECIALISTS APPROVED FOR 6 MONTHS UP TO 1 YEAR. PAGE 118 LAST UPDATED 03/2019
119 PEGVISOMANT SOMAVERT LABORATORY REQUIREMENT: LIVER ENZYMES (AST/ALT) DOCUMENTATION TO INDICATE INADEQUATE RESPONSE TO SURGERY, RADIATION THERAPY OR TREATMENT WITH OCTREOTIDE OR LANREOTIDE OR DOCUMENTATION INDICATING THE ABOVE THERAPIES FOR ACROMEGALY ARE NOT APPROPRIATE. APPROVED FOR 6 MONTHS. PAGE 119 LAST UPDATED 03/2019
120 PIMAVANSERIN NUPLAZID DOCUMENTATION INDICATING TREATMENT WITH QUETIAPINE HAS BEEN INEFFECTIVE, INTOLERABLE, OR CONTRAINDICATED. Approved for 12 months PAGE 120 LAST UPDATED 03/2019
121 PIRFENIDONE ESBRIET All FDA-approved indications not otherwise excluded from Part D. DIAGNOSIS APPROVED FOR 12 MONTHS DURATION. PAGE 121 LAST UPDATED 03/2019
122 POMALIDOMIDE POMALYST FOR PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 2 PRIOR THERAPIES INCLUDING LENALIDOMIDE AND BORTEZOMIB AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY. APPROVED FOR 12 MONTHS DURATION. PAGE 122 LAST UPDATED 03/2019
123 PONATINIB ICLUSIG DIAGNOSIS APPROVED FOR 12 MONTHS DURATION. PAGE 123 LAST UPDATED 03/2019
124 PRAMLINTIDE ACETATE SYMLINPEN 120, SYMLINPEN 60 DIAGNOSIS OF GASTROPARESIS DOCUMENTATION REQUIRED TO INDICATE THAT PATIENT IS CURRENTLY USING MEAL- TIME INSULIN PREPARATIONS. RECENT LABORATORY LEVELS SUCH AS HEMOGLOBIN A1C, FASTING BLOOD GLUCOSE SHOULD BE DOCUMENTED. APPROVED FOR 12 MONTHS DURATION. PAGE 124 LAST UPDATED 03/2019
125 PREGABALIN LYRICA For the diagnosis of neuropathic pain associated with diabetic peripheral neuropathy: Documentation of trial and failure of two of the following formulary alternatives: gabapentin, one SNRI (duloxetine or venlafaxine IR/ER), or one tricyclic antidepressant. For the diagnosis of neuropathic pain associated with post herpetic neuralgia: Documentation of trial and failure of two of the following formulary alternatives: gabapentin, one tricyclic antidepressant, or lidocaine patches (PA required). For the diagnosis of fibromyalgia, documentation of trial and failure of two of the following: Gabapentin, duloxetine, tricyclic antidepressant, or cyclobenzaprine. For the diagnosis of neuropathic pain due to spinal cord injury or partial seizure disorder, documentation of diagnosis. Approved for 12 months PAGE 125 LAST UPDATED 03/2019
126 RENFLEXIS RENFLEXIS Documentation patient has tried and failed on ONE of the preferred TNF-alpha inhibitors: Enbrel or Humira. Dermatology or Rheumatology Approved for 12 months PAGE 126 LAST UPDATED 03/2019
127 RIBOCICLIB KISQALI, KISQALI FEMARA CO-PACK DIAGNOSIS, INFORMATION ON PRIOR SYSTEMIC THERAPIES. ONCOLOGIST APPROVED FOR 12 MONTHS DURATION. PAGE 127 LAST UPDATED 03/2019
128 RIFAXIMIN XIFAXAN ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. For hepatic encephalopathy, documentation required to indicate patient has tried, failed, or intolerant to lactulose. For the diagnosis of travelers diarrhea, documentation that the patient has tried, failed, or intolerant to a flouroquinolone (e.g., ciprofloxacin, levofloxacin, ofloxacin) or azithromycin. For the diagnosis of IBS-D, documentation to indicate that the patient has tried and failed on TWO of the following formulary alternatives: antidiarrheals such as loperamide, dicyclomine, or a tricyclic antidepressant. Approved for 3 days for travelers diarrhea, 12 months duration for IBS-D and hepatic encephalopathy PAGE 128 LAST UPDATED 03/2019
129 RILONACEPT ARCALYST DIAGNOSIS APPROVED FOR 1 YEAR. PAGE 129 LAST UPDATED 03/2019
130 RIOCIGUAT ADEMPAS All FDA-approved indications not otherwise excluded from Part D. DIAGNOSIS.FOR PULMONARY ARTERIAL HYPERTENSION DOCUMENTATION REQUIRED INDICATING THAT PATIENT HAS HAD PREVIOUS TREATMENT AND FAILURE ON ONE OF THE FOLLOWING DRUGS SILDENAFIL OR TADALAFIL. APPROVED FOR 12 MONTHS DURATION. PAGE 130 LAST UPDATED 03/2019
131 RISPERIDONE LONG-ACTING INJECTION RISPERDAL CONSTA All FDA-approved indications not otherwise excluded from Part D. DOCUMENTATION TO INDICATE: A) PATIENT HAS TRIED AND FAILED ORAL ANTIPSYCHOTIC THERAPY OR B) TRANSFERRED FROM HOSPITAL/FACILITY/ANOTHER PROVIDER STABILIZED ON THIS MEDICATION APPROVED FOR 12 MONTHS. PAGE 131 LAST UPDATED 03/2019
132 ROFLUMILAST DALIRESP DOCUMENTATION THAT PATIENT HAS TRIED/FAILED OR INTOLERANT TO SHORT-ACTING BRONCHODIALATORS (ALBUTEROL, COMBIVENT OR IPRATROPIUM) AND CURRENTLY RECEIVING STANDARD TREATMENT FOR COPD INCLUDING LONG-ACTING BRONCHODIALATORS/COMBO INHALERS (SPIRIVA, SALMETEROL, SYMBICORT OR ADVAIR) AND DOCUMENTED HISTORY OF COPD EXACERBATIONS Approved for 12 months PAGE 132 LAST UPDATED 03/2019
133 RUCAPARIB RUBRACA DIAGNOSIS, INFORMATION ON PRIOR SYSTEMIC THERAPIES. ONCOLOGIST APPROVED FOR 12 MONTHS DURATION. PAGE 133 LAST UPDATED 03/2019
134 SACUBITRIL/ VALSARTAN ENTRESTO Documentation to indicate patient has tried and failed or intolerant to an ACE or ARB Approved for 12 months PAGE 134 LAST UPDATED 03/2019
135 SAPROPTERIN KUVAN 100 MG TABLET Documentation of Diagnosis APPROVED FOR 12 MONTHS PAGE 135 LAST UPDATED 03/2019
136 SARGRAMOSTIM LEUKINE ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. LABORATORY TEST - COMPLETE BLOOD COUNT PANEL. APPROVED FOR 3 MONTHS. PAGE 136 LAST UPDATED 03/2019
137 SECUKINUMAB COSENTYX (2 SYRINGES), COSENTYX PEN, COSENTYX PEN (2 PENS), COSENTYX SYRINGE FOR THE DIAGNOSIS OF PLAQUE PSORIASIS - DOCUMENTATION THAT THE PATIENT HAS HAD AN INADEQUATE RESPONSE OR INTOLERANT TO ONE OF THE PREFERRED TNF ALPHA ANTAGONIST AGENTS - HUMIRA OR ENBREL. FOR ALL OTHER INDICATIONS, DOCUMENTATION THAT THE PATIENT HAS HAD AN INADEQUATE RESPONSE OR INTOLERANT TO BOTH OF THE FOLLOWING TNF ANTAGONIST AGENTS - ENBREL AND HUMIRA. RHEUMATOLOGIST OR DERMATOLOGIST Approved for 12 months PAGE 137 LAST UPDATED 03/2019
138 SELEXIPAG UPTRAVI ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Patients who are receiving Prostacyclin Analogues Diagnosis of PAH (WHO Group 1) and documentation that patient has been on an ERA and/or a PDE5I for at least 3 months 18 years old and older Cardiologist, Pulmonologist 12 MONTHS PAGE 138 LAST UPDATED 03/2019
139 SILDENAFIL SILDENAFIL DIAGNOSIS Approved for 12 months PAGE 139 LAST UPDATED 03/2019
140 SODIUM OXYBATE XYREM DOCUMENATION REQUIRED TO INDICATE PATIENT HAS TRIED AND FAILED MODAFANIL, METHYLPHENIDATE, DEXTROAMPHETAMINE/AMPHETAMINE, OR A REM SLEEP- SUPRESSING DRUG INCLUDING VENLAFAXINE, FLUOXETINE OR ATOMOXETINE. SLEEP SPECIALIST, NEUROLOGIST APPROVED FOR 1 YEAR. PAGE 140 LAST UPDATED 03/2019
141 SOFOSBUVIR/ VELPATASVIR EPCLUSA, SOFOSBUVIR-VELPATASVIR ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Approval may not be granted when the provider attests that the patient has a life expectancy of less than 12 months due to non-liver comorbid conditions (per AASLD-IDSA treatment guideline recommendations) Criteria applied will be consistent with current AASLD-IDSA guideline recommendations. Submission of medical records (e.g., chart notes, applicable lab values such as detectable HCV RNA viral load) documenting and confirming diagnosis of chronic hepatitis C virus infection. Documentation of genotype, liver disease status, and treatment history required. Treatment candidate must be 18 years of age or older. Gastroenterologist, Hepatologist, Infectious Disease, or Transplant Specialist Up to 24 weeks or consistent with AASLD-IDSA guidelines Trial and failure of Mavyret when Mavyret is considered an acceptable treatment option per AASLD-IDSA guidelines or provision of medical justification to indicate why Mavyret cannot be used. PAGE 141 LAST UPDATED 03/2019
142 SOFOSBUVIR/ VELPATASVIR/ VOXILAPREVIR VOSEVI ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Approval may not be granted when the provider attests that the patient has a life expectancy of less than 12 months due to non-liver comorbid conditions (per AASLD-IDSA treatment guideline recommendations) Criteria applied will be consistent with current AASLD-IDSA guideline recommendations. Submission of medical records (e.g., chart notes, applicable lab values such as detectable HCV RNA viral load) documenting and confirming diagnosis of chronic hepatitis C virus infection. Documentation of genotype, liver disease status, and treatment history required. Treatment candidate must be 18 years of age or older. Gastroenterologist, Hepatologist, Infectious Disease, or Transplant Specialist Up to 12 week or consistent with AASLD-IDSA guidelines Trial and failure of Mavyret when Mavyret is considered an acceptable treatment option per AASLD-IDSA guidelines or provision of medical justification to indicate why Mavyret cannot be used. PAGE 142 LAST UPDATED 03/2019
143 SOMATROPIN GENOTROPIN, NUTROPIN AQ 20 MG/2ML PEN CART, NUTROPIN AQ NUSPIN 20 INJECTOR ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Documentation of Diagnosis APPROVED FOR 12 MONTHS PAGE 143 LAST UPDATED 03/2019
144 SONIDEGIB ODOMZO ALL FDA-APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D PREGNANCY DOCUMENTATION REQUIRED TO INDICATE PATIENT HAS A DIAGNOSIS OF LOCALLY ADVANCED BASAL CELL CARCINOMA (BCC), AND THE PATIENT HAS EXPERIENCED DISEASE RECURRENCE FOLLOWING SURGERY OR RADIATION THERAPY OR THE PATIENT IS NOT A CANDIDATE FOR SURGERY OR RADIATION THERAPY. DOCUMENTED NEGATIVE PREGNANCY TEST RESULT REQUIRED FOR ALL FEMALE PATIENTS OF REPRODUCTIVE POTENTIAL. ONCOLOGIST APPROVED FOR 12 MONTHS PAGE 144 LAST UPDATED 03/2019
145 SUNITINIB MALATE SUTENT DIAGNOSIS OF ADVANCED PANCREATIC NEUROENDOCRINE TUMOR, ADVANCED RENAL CELL CARCINOMA OR GI STROMAL TUMOR (GIST). FOR PATIENT WITH DIAGNOSIS OF GIST DOCUMENTATTION REQUIRE TO INDICATED TRIED AND FAILED (OR INTOLERANT TO) IMATINIB (GLEEVEC) THERAPY. APPROVED FOR 6 MONTHS. PAGE 145 LAST UPDATED 03/2019
146 TADALAFIL ADCIRCA, ALYQ, TADALAFIL 20 MG TABLET NOT FOR USE IN ERECTILE DYSFUNCTION. DIAGNOSIS OF GROUP 1 PAH TRIED AND FAILED REVATIO (SILDENAFIL) Approved for 12 months PAGE 146 LAST UPDATED 03/2019
147 TALAZOPARIB TALZENNA ALL MEDICALLY ACCEPTED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. 18 YEARS OF AGE AND OLDER ONCOLOGIST, HEMATOLOGIST, OR IN CONSULTATION WITH ONCOLOGY/HEMATOLOGY Approved for 12 months FOR OFF-LABEL USE, NCCN GUIDELINES WILL BE USED TO DETERMINE APPROPRIATENESS OF TREATMENT PAGE 147 LAST UPDATED 03/2019
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