AAT DEFICIENCY Aralast NP intravenous recon soln 1,000 Prolastin-C intravenous recon soln mg Zemaira Glassia Other Diagnosis of severe congenital A1-PI deficiency who have clinically evident emphysema, weight, A1-PI phenotype, A1-PI baseline level Prescription must be written by a pulmonologist 6 months for initiation, 1 year for continuation 1
ADAPALENE adapalene topical cream adapalene topical gel 0.1 % Other Not approved when used to treat photo aging. Diagnosis, previous treatments, and response therapy 1 year Must have failure, intolerance, or contraindication to tretinoin 2
ADEMPAS Adempas Other Confirmation of diagnosis, documentation of response to any prior therapies Prescription must be written by pulmonologist or cardiologist 3 months initial, 1 year continuation For WHO Group 1 diagnosis, patient must have a history of taking or contraindication to sildenafil (Revatio). 3
AFINITOR Afinitor Afinitor Disperz Other DIAGNOSIS, PRIOR THERAPIES, AND TREATMENT RESPONSE PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST OR NEUROLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION IN PATIENTS WITH RCC, USE OF AFINITOR IS RESERVED FOR THOSE WITH A DOCUMENTED TREATMENT FAILURE WITH NEXAVAR OR SUTENT 4
AIMOVIG Aimovig Autoinjector (2 Pack) Other Diagnosis, other therapies tried, and outcome. Member has been evaluated for and does not have medication overuse headache. 18 years of age or older Must be prescribed by or in consultation with a neurologist or pain specialist 1 year Patient must have an inadequate response, contraindication, or intolerance to two different chronic migraine prevention drugs. The two prerequisite drugs must be from different classes such as anticonvulsants (topiramate/valproate), beta blockers (propranolol, metoprolol), and antidepressants (nortriptyline/venlafaxine). 5
ALK POSITIVE TYROSINE KINASE INHIBITORS Alecensa Zykadia Xalkori Other Diagnosis, other treatments tried and outcome Prescribed by an oncologist 1 year 6
ALUNBRIG Alunbrig Other Non-small cell lung cancer (NSCLC): Diagnosis of metastatic NSCLC. Patient has an anaplastic lymphoma kinase (ALK)-positive tumor as detected with an FDA-approved test or Clinical Laboratory Improvement Amendments-approved facility. Trial and failure or intolerance to Xalkori (crizotinib). Prescribed by or in consultation with an oncologist 3 months initial, 6 months continuation Approve for continuation of prior therapy. 7
AMITIZA Amitiza Other DIAGNOSIS, DOCUMENTED FAILURE OF 2 OF THE FOLLOWING AGENTS: FIBER PRODUCT, POLYETHYLENE GLYCOL, LACTULOSE, DOCUSATE, OR BISACODYL 1 YEAR 8
AMPYRA Ampyra Other NOT A COVERED BENEFIT IN PATIENTS WITH SEIZURE DISORDER OR A CREATININE CLEARANCE LESS THAN 50 ML/MIN EXPANDED DISABILITY SCALE SCORE, BASELINE AND FOLLOW-UP 25 FOOT WALK TEST, CREATININE CLEARANCE PRESCRIPTION MUST BE WRITTEN BY A NEUROLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION PATIENT MUST SHOW AN IMPROVEMENT IN WALKING SPEED TO CONTINUE TREATMENT 9
ANTIDEPRESSANTS Fetzima Viibryd oral tablets,dose pack 10 mg (7)- Trintellix 20 mg (23) Viibryd oral tablet DIAGNOSIS, PRIOR THERAPIES TRIED AND FAILED 1 YEAR Other MUST SEE CONTRAINDICATION TO OR FAILURE OF 2 DIFFERENT CLASSES OF GENERIC ANTIDEPRESSANTS INCLUDING SSRIS, SNRIS, TCAS, NOREPINEPHRINE-DOPAMINE REUPTAKE INHIBITORS, OR NORADRENERGIC AND SPECIFIC SEROTONERGIC ANTIDEPRESSANTS 10
ANTIPSYCHOTICS Abilify Maintena aripiprazole oral solution aripiprazole oral tablet aripiprazole oral tablet,disintegrating Aristada Aristada Initio chlorpromazine oral clozapine oral tablet,disintegrating 100 mg, 12.5 mg, 25 mg clozapine oral tablet,disintegrating 150 mg, 200 mg Fanapt fluphenazine decanoate Versacloz 50mg/ml suspension fluphenazine HCl injection Invega Sustenna Invega Trinza Latuda paliperidone oral tablet extended release 24hr 1.5 mg, 3 mg, 6 mg, 9 mg quetiapine oral tablet extended release 24 hr Rexulti Saphris thioridazine Vraylar chlorpromazine 25mg/ml ampule Other FOR BIPOLAR DISORDER OR SCHIZOPHRENIA, DOCUMENTATION OF DIAGNOSIS, TREATMENT FAILURE WITH TWO ATYPICAL ANTIPSYCHOTICS (ZIPRASIDONE, RISPERIDONE, QUETIAPINE, OLANZAPINE, CLOZAPINE), OR RATIONALE AS TO WHY ALTERNATIVES ARE NOT SUITABLE 1 YEAR 11
ANTI-TNF ALPHA DRUGS Cimzia Cimzia Powder for Reconst Enbrel Enbrel SureClick Humira Humira Pediatric Crohns Start Humira Pen Humira Pen Crohns-UC-HS Start Humira Pen Psor-Uveits-Adol HS Humira(CF) Humira(CF) Pedi Crohns Starter Humira(CF) Pen Crohns-UC-HS Humira(CF) Pen Psor-Uv-Adol HS Humira(CF) Pen subcutaneous pen injector kit 40 mg/0.4 ml Simponi subcutaneous syringe Other DIAGNOSIS AND OTHER THERAPIES TRIED AND FAILED, NEGATIVE TB TEST MUST BE WRITTEN BY A DERMATOLOGIST, RHEUMATOLOGIST, GASTROENTEROLOGIST, OR OPHTHALMOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION PRIOR TO RECEIVING BIOLOGIC THERAPY: FOR RHEUMATOID ARTHRITIS, PATIENT MUST HAVE A DOCUMENTED FAILURE WITH AT LEAST ONE DMARD. FOR CROHN'S DISEASE, PATIENT MUST HAVE A DOCUMENTED FAILURE WITH AT LEAST ONE NON-BIOLOGIC CONVENTIONAL THERAPY (INCLUDING BUT NOT LIMITED TO SULFASALAZINE, MESALAMINE, AZATHIOPRINE, OR METHOTREXATE). FOR PSORIASIS, PATIENT MUST HAVE TRIAL OF OR CONTRAINDICATION TO TOPICAL THERAPY AND METHOTREXATE. IN ORDER TO RECEIVE CIMZIA, SIMPONI, OR INFLIXMAB, PATIENT MUST HAVE A TRIAL OF OR CONTRAINDICATION TO ENBREL OR 12
HUMIRA, WITH THE EXCEPTION OF INFLIXIMAB FOR FISTULIZING CROHN'S DISEASE AND ULCERATIVE COLITIS 13
ARANESP Aranesp (in polysorbate) injection solution Aranesp (in polysorbate) injection syringe 100 mcg/ml, 200 mcg/ml, 25 mcg/ml, 300 mcg/ml, 40 mcg/ml, 60 mcg/ml Other Ucontrolled hypertension. Pure red cell aplasia that begins after ESA treatment. Pre-treatment hemoglobin level less than 10 g/dl AND Patient has adequate iron stores prior to initiation of therapy defined as ferritin more than 100 mcg/l or serum transferrin saturation greater than 20% AND other causes of anemia such as iron deficiency, folate deficiency or B12 deficiency, hemolysis, gastrointestinal bleeding, other active or occult bleeding, or underlying hematologic disease (such as sickle cell anemia, thalassemia, and porphyria) have been ruled out. CKD - prescribed by a nephrologist or hematologist. Non-myeloid malignancies - prescribed by an oncologist/hematologist Initial: 3 months. Renewal: CKD-12 months, Non-myeloid malignancies - 4 months For renewal of CKD, for dialysis patients: Hb less than 11 g/dl or physician will decrease or interrupt dose and for non-dialysis patients: Hb less than 10 g/dl or physician will decrease or interrupt dose. For renewal of non-myeloid malignancies: Concurrent myelosuppressive chemotherapy and Hb is 12g/dL or less and there is measurable response after eight weeks (defined as an increase in Hb 1 g/dl or more or a reduction in red blood cell transfusion requirements). 14
ARCALYST Arcalyst Other 12 YEARS AND OLDER 1 YEAR AT A TIME 15
BENLYSTA Benlysta subcutaneous syringe Other Severe active lupus nephritis, active central nervous, use in combination with other biologics Diagnosis, autoantibody testing, prior treatments including response, and SLEDAI score. must be 18 and older Prescription must be written by a rheumatologist 6 months Failed to demonstrate adequate response to TWO standard therapies at recommended doses: corticosteroids, antimalarials, NSAIDs, and/or immunosuppressants. SLEDAI score greater than 8. 16
BOSULIF Bosulif oral tablet 100 mg, 400 mg, 500 mg Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to bosutinib. CBC and LFT lab test results are needed for continuation treatment. Prescription must be written by an oncologist 1 year 17
BRAFTOVI Braftovi Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to treatment. Prescription must be written by an oncologist 3 months for initiation, 1 year for continuation 18
CABOMETYX Cabometyx Other Renal cell carcinoma (RCC): Diagnosis of RCC. RCC is advanced. History of failure, contraindication, or intolerance to at least one prior antiangiogenic therapy [e.g., Nexavar (sorafenib), Sutent (sunitinib)]. Prescribed by or in consultation with an oncologist. 3 months initiation and 1 year continuation 19
CALQUENCE Calquence Other NA Documentation of diagnosis, previous treatments, and response to treatment. Prescribed by oncology 3 months initial, 6 months continuation 20
CAPRELSA Caprelsa oral tablet 100 mg, 300 mg Other HISTORY OF CONGENITAL LONG QT SYNDROME DIAGNOSIS, PRIOR THERAPIES, TREATMENT RESPONSE 18 YEARS AND OLDER PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 MONTHS FOR INITIATION, 6 MONTHS FOR CONTINUATION ECG, ELECTROLYTE(K,Mg,Ca), AND TSH MONITORING AT BASELINE, 2-4 WEEKS AND 8-12 WEEKS AFTER STARTING TREATMENT AND EVERY 3 MONTHS THEREAFTER 21
CINQAIR Cinqair 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. 22
COMETRIQ Cometriq Other Diagnosis, prior therapy used, result of prior therapy. Prescription must be written by an oncologist 3 months for initiation, 6 months for continuation 23
COPIKTRA Copiktra Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to treatment. Prescription must be written by an oncologist or hematologist 3 months for initiation, 1 year for continuation 24
CORLANOR Corlanor Other Ejection fraction less than or equal to 35% AND heart rate greater than 70 beats per minute AND in sinus rhythm AND on maximally tolerated betablocker OR has contraindication to beta-blocker (i.e.. allergy, severe COPD limiting beta blocker usage) Prescribed by a cardiologist. 12 months 25
COTELLIC Cotellic Other Diagnosis, other therapies tried and/or failed, and treatment response. Prescribed by an oncologist. 3 months for initiation, 6 months for continuation 26
DALIRESP Daliresp Diagnosis, prior therapies used and response to therapy, FEV1, baseline and follow-up weight assessments, baseline psychiatric evaluation Prescription must be written by pulmonologist or have had a pulmonology consult within the past 6 months 1 year Other To qualify for use, patients must have severe COPD (FEV1 less than 50% predicted) with a chronic bronchitis component and a history of exacerbations. Patients must also have concurrent use of long-acting bronchodilator and inhaled corticosteroid 27
DAURISMO Daurismo Other Diagnosis, prior therapies, and result of prior therapy. Prescription must be written by an oncologist or hematologist 1 year 28
DEMSER Demser Other Diagnosis and whether the patient is a candidate for surgery 3 months 29
DICLOFENAC GEL 3% diclofenac sodium topical gel 3 % Other Diagnosis and any prior treatments. Prescription must be written by a Dermatologist 3 months 30
DOPTELET Doptelet (10 tab pack) Doptelet (15 tab pack) Other Diagnosis and platelet count Must be prescribed by a hematologist, oncologist, or gastroenterologist 1 month Patient must be scheduled to undergo a pre planned medical or dental procedure with treatment beginning 10 to 13 days prior to the scheduled procedure. Patients should undergo their procedure 5 to 8 days after the last dose. 31
EGRIFTA Egrifta subcutaneous recon soln 1 mg Other ONLY APPROVED FOR PATIENTS WITH HIV ASSOCIATED LIPODYSTROPHY. NOT INDICATED FOR WEIGHT MANAGEMENT. DIAGNOSIS, BASELINE WAIST CIRCUMFERENCE, BASELINE IGF- 1 FASTING PLASMA GLUCOSE, AND BASELINE HGAIC. MONITORING EVERY 6 MONTHS OF PARAMETERS LISTED ABOVE. MUST NOT HAVE AN ACTIVE MALIGNANCY PRESCRIPTION MUST BE WRITTEN BY AN INFECTIOUS DISEASE SPECIALIST OR ENDOCRINOLOGIST 3 MONTHS 32
EMEND aprepitant For use with highly and moderately-emetogenic chemotherapy, provide the chemotherapy regimen including drug, dose, and frequency. Ondansetron is preferred for post-operative nausea/vomiting (PONV) prophylaxis. When Emend or aprepitant is used for PONV prophylaxis, provide rationale as to why ondansetron is not a suitable alternative. 6 months Other Drug will also be reviewed for coverage under part B versus part D. 33
ENTRESTO Entresto Other History of angioedema related to previous ACE inhibitor or ARB therapy, concomitant use with aliskiren, pregnancy Patient has a diagnosis of New York Heart Association class II to IV heart failure, reduced ejection fraction less than or equal to 40%, other therapies tried, and outcome Prescription must be written by a cardiologist OR patient must have a consultation with a cardiologist within the past 12 months. 1 year Trial of or contraindication to ONE ACE inhibitor AND receiving concomitant therapy with one of the following beta blockers: carvedilol, bisoprolol, sustained-release metoprolol, unless unable to tolerate or contraindicated AND patient will discontinue use of any concomitant ACE inhibitor or ARB before initiating therapy. 34
EPIDIOLEX Epidiolex Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to treatment. Prescription must be written by or in consultation with a neurologist 1 year Monitor for hepatocellular injury in accordance with FDA approved label. For Lennox-Gastaut syndrome must have a failure, contraindication, or intolerance to lamotrigine and topiramate. 35
EPOETIN ALFA Epogen injection solution 2,000 unit/ml, Procrit injection solution 10,000 unit/ml, 20,000 unit/2 ml, 20,000 unit/ml, 3,000 2,000 unit/ml, 20,000 unit/ml, 3,000 unit/ml, 4,000 unit/ml unit/ml, 4,000 unit/ml, 40,000 unit/ml Other Uncontrolled hypertension. Pure red cell aplasia that begins after ESA treatment. Pre-treatment hemoglobin level less than 10 g/dl AND Patient has adequate iron stores prior to initiation of therapy defined as ferritin more than 100 mcg/l or serum transferrin saturation greater than 20% AND other causes of anemia such as iron deficiency, folate deficiency or B12 deficiency, hemolysis, gastrointestinal bleeding, other active or occult bleeding, or underlying hematologic disease (such as sickle cell anemia, thalassemia, and porphyria) have been ruled out. CKD - prescribed by a nephrologist or hematologist. Non-myeloid malignancies - prescribed by an oncologist/hematologist. Surgery - Prescribed by a surgeon. HIV - Prescribed by an infectious disease specialist. Initial: 3 months. Renewal: CKD-12 months, Non-myeloid cancers, HIV-4 months. Surgery-3 months For renewal of CKD, for dialysis patients: Hb less than 11 g/dl or physician will decrease or interrupt dose and for non-dialysis patients: Hb less than 10 g/dl or physician will decrease or interrupt dose. For renewal of non-myeloid malignancies: Concurrent myelosuppressive chemotherapy and Hb is 12g/dL or less and there is measurable response after eight weeks (defined as an increase in Hb 1 g/dl or more or a reduction in red blood cell transfusion requirements). For renewal of zidovudine-treated HIV, Hb is 12g/dL or less AND Zidovudine dose remains 4,200 mg/week or less and there is a measurable response after eight weeks (defined as an increase in Hb or a reduction in RBC transfusion requirements or documented dose escalation [up to max of 300 units/kg/dose]) 36
37
ERIVEDGE Erivedge Other PATIENTS WHO ARE CANDIDATES FOR SURGERY OR RADIATION DIAGNOSIS, PRIOR TREATMENTS, RESPONSE TO THERAPY 18 YEARS OF AGE AND OLDER PRESCRIPTION MUST BE WRITTEN BY A ONCOLOGIST OR DERMATOLOGIST 3 MONTHS FOR INITIATION, 6 MONTHS FOR CONTINUATION 38
ERLEADA Erleada Other Diagnosis, other therapies tried and outcome, fall risk assessment, and seizure history (if any) Must be prescribed by an oncologist or urologist 1 year 39
EXJADE Exjade Other myelodysplastic syndrome, renal failure, and neoplastic disease Serum ferritin, CrCl, serum transaminases and bilirubin, baseline auditory and ophthalmic examinations. For Non-Transfusion-Dependent Thalassemia Syndromes: liver iron concentration (LIC) by liver biopsy or by an FDA-cleared or approved method for identifying patients for treatment with deferasirox therapy. Dose verification 3 months For chronic transfusional iron overload due to blood transfusion :serum ferritin consistently greater than 1000 mcg/l. For NON-transfusion dependent thalassemia syndrome and chronic iron overload a LIC (liver iron concentration) of at least 5 mg Fe/g dry weight and a serum ferritin greater than 300 mcg/l on at least 2 measurements 1 month apart. For patients continuation: Current LIC is greater than 3 mg per gram of dry weight or Exjade will be withheld until the LIC reaches above 5 mg per gram of dry weight 40
FARYDAK Farydak Other Diagnosis, other therapies tried and/or failed Prescription must be written by an oncologist 3 months initial, 6 months for continuation 41
FASENRA Fasenra Other Allergen test, baseline FEV1, FEV1 following bronchodilator, asthma medical history (including medications, emergency department visits, and hospitalizations), baseline eosinophil count Must be prescribed by a Pulmonologist or Immunologist or Allergist Initiation: 3 months, continuation 1 year Patient must be diagnosed with severe asthma, currently receiving inhaled and/or oral corticosteroid treatment, AND have a baseline eosinophil count of 150 cells/mcl or greater within previous 12 months. 42
FERRIPROX Ferriprox oral tablet Other Diagnosis, length of therapy, serum ferritin concentrations and dose/weight verification, & CBC 3 months Must have a contraindication to, an inadequate response, or has been intolerant to, or experienced clinically significant adverse effects to Exjade, such as evidence of cardiac iron overload or iron-induced cardiac dysfunction with Exjade. For continuation patient must have a 20% or greater reduction in serum ferritin with an adequate dose and duration of therapy. 43
FULYZAQ Mytesi Other Use when infectious diarrhea has not been ruled out Diagnosis, use of antiretroviral therapy 3 months Infectious diarrhea needs to be ruled out prior to initiating treatment. Patient must have a history of using at least two prior treatments for diarrhea, including bismuth subsalicylate, kaolin, loperamide, or diphenoxylate/atropine. 44
FYCOMPA Fycompa oral suspension Fycompa oral tablet Other Diagnosis, other therapies tried, response to prior therapy Prescription must be prescribed by neurologist 12 months Monitor at initiation and after dose increases for serious psychiatric and/or behavioral reactions. 45
GALAFOLD Galafold Other Not covered in combination with Fabrazyme Confirmed diagnosis of Fabry disease and baseline renal function assessment Prescription must be written by a specialist in genetic disorders, or nephrologist 6 months for initiation, 1 year for continuation 46
GATTEX Gattex 30-Vial Other Therapy should be discontinued in cases of intestinal malignancy. Diagnosis, other therapies tried and/or failed. Prescription must be written by a gastroenterologist 3 months for initiation, 6 months for continuation A colonoscopy of the entire colon with removal of polyps must be done before initiating therapy, medical records documenting this procedure must be submitted. 47
GAUCHER'S DISEASE TREATMENT Cerdelga Zavesca miglustat Other NOT APPROVED FOR TYPE II OR TYPE III GAUCHER'S DISEASE DIAGNOSIS, WEIGHT. FOR MIGLUSTAT: RATIONALE AS TO WHY ERT IS NOT APPROPRIATE PRESCRIPTION MUST BE WRITTEN BY GENETICIST, HEMOTOLOGIST, OR METABOLIC SPECIALIST 1 YEAR USE OF MIGLUSTAT IS RESERVED FOR THOSE WHOM ENZYME REPLACEMENT THERAPY IS NOT AN OPTION 48
GILOTRIF Gilotrif Other Diagnosis, previous therapies tried and/or failed Prescription must be written by oncologist 12 months 49
GLEEVEC imatinib Other DIAGNOSIS, PRIOR THERAPIES, AND TREATMENT RESPONSE PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 MONTHS INITIAL, 6 MONTHS CONTINUATION GENETIC, HEMATOLOGIC, AND CYTOGENIC TESTS ARE REQUIRED BASED ON THE SPECIFIC INDICATION TO ASSESS APPROPRIATE USE AND ADEQUATE RESPONSE TO THERAPY 50
GRALISE Gralise Gralise 30-Day Starter Pack Covered Uses Other All medically accepted indications not otherwise excluded under Part D Diagnosis, previous treatments including dosage, outcome of previous treatment 1 year Must have a documented intolerance, contraindication to, or failure of gabapentin titrated to maximum tolerated dosage or rationale as to why gabapentin cannot be used. 51
GROWTH HORMONE Norditropin FlexPro Nutropin AQ Nuspin Other PRESENCE OF CONTRAINDICATIONS TO THERAPY DIAGNOSIS, HEIGHT AND WEIGHT, HISTORY OF GROWTH MEASUREMENT. REPLACEMENT THERAPY IN PATIENTS WITH GROWTH HORMONE DEFICIENCY WITH DIAGNOSIS CONFIRMED BY APPROPRIATE GROWTH HORMONE STIMULATION TESTING PRESCRIPTION MUST BE WRITTEN BY ENDOCRINOLOGIST OR NEPHROLOGIST 3 MONTHS FOR INITIATION, 1 YEAR FOR CONTINUATION 52
HEPATITIS B Baraclude oral solution entecavir Other TREATMENT CONSIDERATION IS BASED ON HBEAG, HBV DNA QUANTITY, AND ALT LEVEL PRESCRIPTION MUST BE WRITTEN BY A GASTROENTEROLOGIST, HEPATOLOGIST, OR INFECTIOUS DISEASE SPECIALIST 1 YEAR 53
HEPATITIS C TREATMENT Harvoni Ribasphere oral capsule ledipasvir-sofosbuvir ribavirin oral capsule Mavyret ribavirin oral tablet 200 mg Rebetol oral solution Zepatier Other PATIENT WEIGHT, GENOTYPE, HCV-RNA, LEVEL OF FIBROSIS, TREATMENT HISTORY PRESCRIPTION MUST BE WRITTEN BY GASTROENTEROLOGIST, HEPATOLOGIST, OR INFECTIOUS DISEASE SPECIALIST 8-24 WEEKS. TREATMENT WILL BE APPROVED CONSISTENT WITH CURRENT AASLD-IDSA GUIDANCE. FOR COVERAGE OF HARVONI OR ZEPATIER: MUST HAVE FAILURE, INTOLERANCE, OR CONTRAINDICATION TO MAVYRET. 54
HEREDITARY ANGIOEDEMA Cinryze Haegarda Firazyr Takhzyro Other Diagnosis, including the results immunologic laboratory testing that show low C4 and functional C1- inhibitor levels Prescription must be written by Allergist or Immunologist 3 months initially, 12 months for continuation Prophylactic treatment with Cinryze is limited to patients who experience one or more severe attacks per month, on average. 55
HETLIOZ Hetlioz Other Diagnosis, other therapies tried and/or failed 3 months initial, 1 year continuation 56
HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA Juxtapid Kynamro Other Diagnosis, prior therapy used, results of prior therapy 3 months for initiation, 6 months for continuation Patient must have a diagnosis of homozygous familial hypercholesterolemia. Liver function tests required at baseline and at least monthly during the first year of treatment. 57
IBRANCE (S) Ibrance Other Prescription must be written by an oncologist 3 months initial, 6 months for continuation Must have a failure, contraindication, or intolerance to Kisqali 58
ICLUSIG Iclusig Other Diagnosis, prior therapy used, result of prior therapy. Prescription must be written by an oncologist or hematologist 3 months for initiation, 6 months for continuation Liver function monitoring required at baseline and 3 months after initiation 59
IDHIFA Idhifa Other Diagnosis, previous treatments, and outcome. Prescribed by or in consultation with a hematologist/oncologist. 12 months 60
IMBRUVICA Imbruvica oral capsule 140 mg, 70 mg Imbruvica oral tablet Other DIAGNOSIS, PRIOR TREATMENTS, RESPONSE TO THERAPY Prescription must be prescribed by oncologist, hematologist, or transplant specialist 12 months 61
INCRELEX Increlex Other DIAGNOSIS, HEIGHT AND WEIGHT MEASUREMENTS, GH LEVEL, IGF-1 LEVEL PRESCRIPTION MUST BE WRITTEN BY ENDOCRINOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION 62
INHALED TOBRAMYCIN Tobi Podhaler inhalation capsule, w/inhalation device Other Diagnosis, therapies tried, and outcome Prescribed by Infectious disease specialist or pulmonologist 1 year 63
INLYTA Inlyta oral tablet 1 mg, 5 mg Other DIAGNOSIS, PRIOR TREATMENTS, RESPONSE TO THERAPY 18 YEARS OF AGE AND OLDER PRESCRIPTION MUST BE WRITTEN BY A ONCOLOGIST 3 MONTHS FOR INITIATION, 6 MONTHS FOR CONTINUATION 64
INTERFERON ALPHA Intron A injection Pegintron subcutaneous pen injector Pegasys Pegasys ProClick subcutaneous pen Pegintron Kit injector 180 mcg/0.5 ml Other FOR HEPATITIS C: PATIENT WEIGHT, GENOTYPE, HCV-RNA QUANTITY AND DATE OF TEST, PRESENCE OF DIRRHOSIS (Y/N), TREATMENT HISTORY, HISTORY OF ANEMIA OR DEPRESSION. HEPATITIS B: HBEAG STATUS, HBV DNA QUANTITY, AND ALT LEVEL. OTHERS: DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED, RESPONSE TO TREATMENT 1 YEAR FOR INDICATIONS OTHER THAN HEPATITIS C. HEPC APPROVALS FROM 12-48 WEEKS BASED ON DRUG REGIME 65
INTUNIV guanfacine oral tablet extended release 24 hr Other DIAGNOSIS AND THERAPIES TRIED AND FAILED. 1 year 66
IRESSA Iressa Other Diagnosis, prior therapy used, response to prior therapy PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION GEFITINIB IS COVERED AS MONOTHERAPY 67
IVIG Bivigam Carimune NF Nanofiltered intravenous recon soln 6 gram Flebogamma DIF intravenous solution 5, 10 % Gammagard Liquid Gammagard S-D (IgA < 1 mcg/ml) Gammaked injection solution 1 gram/10 ml (10 %) Hizentra Hyqvia Gammaplex Gammaplex (with sorbitol) Gamunex-C injection solution 1 gram/10 ml (10 %) Octagam Privigen Cuvitru 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 68
JAKAFI Jakafi Other DIAGNOSIS, OTHER TREATMENTS TRIED AND FAILED, CBC AT BASELINE AND PERIODICALLY AFTER INITIATION, HISTORY OF RBC TRANSFUSIONS 18 YEARS AND OLDER PRESCRIBER MUST BE A HEMATOLOGIST OR ONCOLOGIST 3 MONTHS FOR INITATION, 6 MONTHS FOR CONTINUATION PATIENT MUST HAVE PALPABLE SPLENOMEGALY AT BASELINE AND SHOW A REDUCTION IN SPLEEN VOLUME AND SYMPTOM IMPROVEMENT FOR CONTINUATION OF THERAPY 69
JYNARQUE Jynarque Other History of signs or symptoms of significant liver impairment or injury Documented diagnosis of polycystic kidney disease, ultrasound results Prescribed by endocrinology or nephrology 6 months initial, 1 year continuation 70
KALYDECO Kalydeco Other Diagnosis and the presence of one or more specific gene mutations that the drug is FDA approved to treat. 3 months initially, 12 months for continuation 71
KEVZARA Kevzara subcutaneous syringe Other Diagnosis, other therapies tried and outcome, negative TB test, baseline LFTs and for continuation of therapy, CBC, and serum lipid profile at baseline and for continuation of therapy. Must be prescribed by a Rheumatologist Initiation: 3 months, continuation 1 year Must have a documented failure with two of the following TNF drugs: Humira, Enbrel, or Infliximab 72
KINERET Kineret Other Diagnosis, other therapies tried and/or failed Prescription must be written by rheumatologist or pediatrician 3 months initially, 6 months for continuation for gout is limited to patients who have tried a maximum tolerated dose of a xanthine oxidase inhibitor (i.e.: allopurinol) 73
KISQALI Kisqali Kisqali Femara Co-Pack Other Diagnosis, other therapies previously tried, and the outcome. Prescribed by or in consultation with an oncologist 3 months initial and 6 months for continuation of therapy 74
KORLYM Korlym Other Diagnosis, other therapies tried and outcome, HbA1c Prescribed by endocrinologist 1 year Must have trial of ketoconazole or metyrapone therapy or have intolerance or contraindication to these medications. Must have failed surgery or not be a candidate for surgery. For continuation of therapy patient must show an improvement in HbA1c. 75
KUVAN Kuvan oral powder in packet 100 mg Kuvan oral tablet,soluble Other DIAGNOSIS AND BASELINE AND FOLLOW UP PHENYLALANINE LEVELS. FOR CONTINUATION, MUST SHOW A 30% REDUCTION IN PHE LEVELS FROM BASELINE 2 MONTHS FOR INITIATION, 1 YEAR FOR CONTINUATION 76
LENVIMA Lenvima Other Prescription must be written by an oncologist 1 year 77
LEUKINE Leukine injection recon soln DIAGNOSIS ACUTE MYELOID LEUKEMIA (AML): GREATER OR EQUAL TO 55 YEARS OLD. Other 3 MONTHS AT A TIME 78
LIBTAYO Libtayo Other Diagnosis, other therapies tried and/or failed, and response to prior therapy Prescription must be written by or in consultation with an oncologist or hematologist 1 YEAR 79
LIDOCAINE TRANSDERMAL lidocaine topical adhesive patch,medicated lidocaine topical ointment Other DIAGNOSIS AND OTHER THERAPIES TRIED AND FAILED 1 YEAR FOR LIDOCAINE PATCH: MUST HAVE A USED A PREVIOUS TRIAL OF GABAPENTIN FOR THE TREATMENT OF POST- HERPETIC NEURALGIA OR DIABETIC NEUROPATHY 80
LINZESS Linzess Other Diagnosis and previous treatments 1 year Must have a failure, contraindication or intolerance to Amitza 81
LOKELMA Lokelma Other Diagnosis of hyperkalemia, confirmed with laboratory test within the past month. 6 months for initiation, 1 year for continuation For initiation, must have a failure, contraindication, or intolerance to sodium polystyrene sulfonate. For continuation, must show response to therapy as demonstrated by normal potassium levels and patient remains at high risk for recurrence of hyperkalemia. 82
LONSURF Lonsurf Other Diagnosis, other therapies tried and/or failed, and treatment response Prescription must be written by an oncologist 1 year 83
LORBRENA Lorbrena Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to treatment. Prescription must be written by an oncologist 1 year 84
LYNPARZA Lynparza oral tablet Other DIAGNOSIS, PRIOR THERAPIES, GENETIC TESTING PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 months initiation, 6 months continuation Patients must have failed greater than equal to 3 prior courses of chemotherapy and have BRCA-positive or suspected BRCA-positive advanced ovarian cancer 85
MEDICALLY ACCEPTED USE gabapentin oral capsule megestrol oral tablet gabapentin oral solution 250 mg/5 ml topiramate oral capsule, sprinkle gabapentin oral tablet 600 mg, 800 mg topiramate oral tablet Lyrica zonisamide megestrol oral suspension 400 mg/10 ml (40 mg/ml), 625 mg/5 ml Other Diagnosis 1 year 86
MEKINIST Mekinist oral tablet 0.5 mg, 2 mg Other Wild-type BRAF melanoma Diagnosis, prior therapy used, result of prior therapy. Documentation of BRAF mutation, as detected using an FDA-approved test. Prescription must be written by an oncologist 1 year 87
MEKTOVI Mektovi Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to treatment. Prescription must be written by an oncologist 3 months for initiation, 1 year for continuation Must be used in combination with encorafenib. 88
METHADONE methadone oral solution methadone oral tablet Other Diagnosis and any prior treatments. 6 months Monitor for possible misuse, including early refill history and multiple treating physicians 89
METHAMPHETAMINE methamphetamine Other Diagnosis, other therapies previously tried and failed, and response to treatment 1 year For the treatment of attention deficit disorder patient must have a trial of both methylphenidate and amphetamine/dextroamphetamine or rationale as to why these treatments are not suitable. 90
MIRVASO Mirvaso topical gel with pump Other Documentation of diagnosis and other treatments tried and outcome. 1 year For the treatment of acne rosacea: doxycycline (oral) and topical metronidazole. 91
MOVANTIK Movantik Covered Uses Other All medically accepted indications not otherwise excluded from Part D Will not be approved for cancer related pain Documented diagnosis of opiate induced constipation (non-cancer pain) 1 year Patient must have a trial of or contraindication to at least two different classes of laxative agents including bulk, osmotic, or stimulant laxatives. 92
MULTIPLE SCLEROSIS Aubagio Avonex (with albumin) Avonex intramuscular pen injector kit Avonex intramuscular syringe kit Betaseron subcutaneous kit Extavia subcutaneous kit Gilenya oral capsule 0.5 mg glatiramer Glatopa Rebif (with albumin) Rebif Rebidose Rebif Titration Pack Tecfidera Covered Uses Other All medically accepted indications not otherwise excluded under Part D Diagnosis, EDSS score, relapse history, and physical or cognitive disability neurologist 1 year For Aubagio, Extavia, Tecfidera, and Rebif- must have a failure of one of the following: Avonex, Betaseron, Glatopa, Glatiramer, or Gilenya 93
MYALEPT Myalept Other Diagnosis, prior therapy used, result of prior therapy 3 months for initiation, 1 year for continuation 94
NATPARA Natpara Other DIAGNOSIS, BASELINE SERUM CALCIUM AND 25- HYDROXYVITAMIN D LEVELS MUST BE PRESCRIBED BY AN ENDOCRINOLOGIST 1 year 95
NERLYNX Nerlynx Other Diagnosis, previous treatments, and outcome. Prescribed by or in consultation with an oncologist 12 months Approve for continuation of prior therapy if treatment duration of Nerlynx has not exceeded a total of 12 months 96
NEUPRO Neupro Other Diagnosis, other therapies tried and/or failed, frequency of symptoms 1 year Patient must have a trial of or contraindication to two of the following therapies prior to coverage of Neupro: pramipexole, ropinirole, or carbidopa/levodopa. 97
NEXAVAR Nexavar Other DIAGNOSIS, PRIOR THERAPIES, AND TREATMENT RESPONSE PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION 98
NINLARO Ninlaro Other Diagnosis, other therapies tried and/or failed, and treatment response. Used in combination with Revlimid (lenalidomide) and dexamethasone. Prescription must be written by an oncologist or hematologist 3 months for initial 6 months for continuation Must have an intolerance or contraindication to Velcade 99
NOXAFIL Noxafil oral Other Diagnosis, therapies tried, and outcome Prescribed Infectious disease specialist 6 months For the treatment of aspergillosis patient must have failure of, intolerance or contraindication to vorconizole OR rationale as to why vorconizole is not suitable. 100
NUCALA Nucala Other For patients with asthma: allergen test, baseline FEV1, FEV1 following bronchodilator, asthma medical history (including medications, emergency department visits, and hospitalizations), baseline eosinophil count. For patients with eosinophilic granulomatosis with polyangiitis: documentation of diagnosis, prior therapies, and the outcome. Pulmonology, immunologist, or allergist 3 months for initial, 1 year for continuation For patients with asthma: must be currently receiving inhaled and/or oral corticosteroid treatment, AND have a baseline eosinophil count of 300 cells/mcl or greater within previous 12 months or 150 cell/mcl within previous 6 weeks. 101
NUEDEXTA Nuedexta Other Diagnosis Prescription must be written by a neurologist or psychiatrist. 1 year 102
NUPLAZID Nuplazid Other Parkinson's disease psychosis: Diagnosis of Parkinson's disease. Patient has at least one of the following: hallucinations or delusions. 1 year 103
OCALIVA Ocaliva Other Diagnosis, other therapies tried and failed, and response to therapy, baseline alkaline phosphatase (ALP) level for initiation, and ALP levels after first 3 months of therapy and then yearly for continuation of therapy. 3 months for initial and 1 year for continuation ALP levels are still elevated with at least 12 consecutive months of Actigall/Ursodiol use (at maximum dose of 13-15 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. 104
OCTREOTIDE octreotide acetate injection solution Other Diagnosis, other therapies tried and failed 1 year 105
ODOMZO Odomzo Other Patient has recurring disease following surgery or radiation OR patient is not a candidate for surgery or radiation therapy Prescription must be written by an oncologist or dermatologist 1 year 106
OPSUMIT Opsumit Other Confirmation of diagnosis, documentation of response to any prior therapies Prescription must be written by pulmonologist or cardiologist 3 months initial, 1 year continuation Patient must have a history of taking bosentan (Tracleer), or a contraindication to bosentan that does not apply to Opsumit. 107
ORENCIA Orencia subcutaneous syringe 125 mg/ml Other DIAGNOSIS AND OTHER THERAPIES TRIED AND FAILED, NEGATIVE TB TEST PRESCRIPTION MUST BE WRITTEN BY A RHEUMATOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION PATIENT MUST HAVE A DOCUMENTED FAILURE WITH AT LEAST ONE DMARD AND EITHER HUMIRA OR ENBREL 108
ORFADIN Orfadin Other DIAGNOSIS AND WEIGHT PRESCRIPTION MUST BE WRITTEN BY AN ENDOCRINOLOGIST, GASTROENTEROLOGIST, HEMATOLOGIST, METABOLIC SPECIALIST, OR NEPHROLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION CLOSE MONITORING OF DISEASE MARKERS (ERYTHROCYTE PBG-SYNTHASE ACTIVITY, URINE 5-ALA, SUCCINYLACETONE) DURING THE FIRST 3 MONTHS OF TREATMENT TO ENSURE NORMALIZATION 109
ORKAMBI Orkambi oral granules in packet Orkambi oral tablet Other Patient has a diagnosis of cystic fibrosis (CF) AND Patient is homozygous for the F508del mutation in the CF transmembrane conductance regulator (CFTR) gene AND The presence of the mutation was documented by an FDA-cleared cystic fibrosis mutation test. 6 months initial, 12 months for continuation For renewal, Patient is benefiting from treatment (i.e., improvement in lung function [forced expiratory volume in one second [FEV1], decreased number of pulmonary exacerbations) 110
ORLISSA Orilissa Other Diagnosis, prior therapies, and result of prior therapy. 1 year Must have a failure, contraindication, or intolerance to a continuous hormonal contraceptive AND progestin therapy (e.g. medroxyprogesterone, norethindrone). 111
OTEZLA Otezla Otezla Starter oral tablets,dose pack 10 mg (4)-20 mg (4)-30 mg (47) Other Diagnosis, prior therapy used, result of prior therapy Must be prescribed by a Rheumatologist or Dermatologist 3 months for initiation, 1 year for continuation Patient must have failure of, intolerance or contraindication to at least one formulary TNF inhibitor (including but not limited to Humira, Enbrel, Cimzia, or Infliximab) 112
OXERVATE Oxervate Other Diagnosis, prior therapies, and result of prior therapy. Prescription must be written by an ophthalmologist 8 weeks 113
OXYCONTIN oxycodone oral tablet,oral only,ext.rel.12 hr Other DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED, RESPONSE TO TREATMENT, OTHER OPIATES CURRENTLY BEING USED 6 MONTHS MONITOR FOR POTENIAL MISUSE INCLUDING EARLY REFILL HISTORY, MULTIPLE CONCURRENT LONG ACTING OPIATES OVER 3 MONTH PERIOD, AND MULTIPLE TREATING PHYSICIANS 114
PALYNZIQ Palynziq Other Diagnosis, prior treatments, and outcome. Baseline and follow up phenylalanine (Phe) concentrations. 3 months for initial, 1 year for continuation Must have phenylalanine (Phe) concentrations greater than 600 micromol/l on existing management, and a failure, contraindication, or intolerance to Kuvan. 115
PANRETIN Panretin Other NOT INDICATED WHEN SYSTEMIC ANTI-KS THERAPY IS REQUIRED. 6 MONTHS 116
PCSK9 INHIBITORS Praluent Pen Repatha SureClick Repatha Covered Uses Other All medically accepted indications not otherwise excluded under Part D Submission of clinical and laboratory evidence documenting heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, or clinical atherosclerotic cardiovascular disease- ASCVD (defined as history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral arterial disease presumed to be of atherosclerotic origin). Baseline LDL-C within 30 days prior to request, and documentation of other therapies tried and the outcome. Repeat LDL- C within 60 days of each prior authorization request. Prescribed by a cardiologist, endocrinologist, or lipid specialist Initial 6 months. Renewal 1 year. Member must have tried and failed at least 2 different statins including fluvastatin. Praluent/Repatha must be received with maximally tolerated statin therapy unless statin therapy cannot be used. LDL-C with in 30 days of request greater than or equal to 100mg/dL with ASCVD or LDL-C greater than or equal to 130mg/dL without ASCVD. 117
POMALYST Pomalyst Other Diagnosis, prior therapy used, result of prior therapy. Prescription must be written by an oncologist or hematologist 1 year 118
PROLIA Prolia Other PRESENCE OF ABSOLUTE CONTRAINDICATION TO THERAPY DIAGNOSIS AND OTHER THERAPIES TRIED AND FAILED 18 YEARS AND OLDER 1 YEAR PATIENT MUST HAVE A DOCUMENTED FAILURE OR CONTRAINDICATION TO A BISPHOSPHONATE AGENT. 119
PROMACTA Promacta Other Diagnosis, other therapies tried and/or failed, and platelet count INITIAL FILL FOR 6 MONTHS, 1 YEAR THEREAFTER 120
PROVIGIL modafinil Other DIAGNOSIS AND OTHER THERAPIES TRIED AND FAILED. 1 YEAR 121
PULMONARY FIBROSIS Esbriet Ofev Other liver function prescriber must be a pulmonologist. 1 year 122
PULMONARY HYPERTENSION Adcirca Ventavis Letairis sildenafil (Pulmonary Arterial Tyvaso Hypertension) oral Tracleer CONFIRMATION OF DIAGNOSIS OF PAH (WHO GROUP 1 OR HIGHER), DOCUMENATION OF RESPONSE TO THERAPY PRESCRIPTION MUST BE WRITTEN BY PULMONOLOGIST OR CARDIOLOGIST 1 YEAR Other Ventavis will also be reviewed for coverage under part B versus part D. Prior to coverage of sildenafil, the plan will determine whether the diagnosis meets part D requirements for approval 123
PURIXAN Purixan Other DIAGNOSIS, PRIOR TREATMENTS, RESPONSE TO THERAPY prescriber must be a oncologist or hematologist 1 year 124
RELISTOR Relistor oral Relistor subcutaneous syringe Relistor subcutaneous solution Other Diagnosis and prior therapies tried and failed 3 months for initiation, 1 year for continuation For the treatment of opioid-induced constipation associated with chronic noncancerous pain: prior trial of or contraindication to at least one class of laxative agents (including bulk, osmotic, or stimulant laxatives) AND Amitiza. For all other conditions: a trial of or contraindication to at least two different classes of laxative agents (including bulk, osmotic, or stimulant laxatives) 125
REVLIMID Revlimid Other DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED, RESPONSE TO TREATMENT 18 YEARS AND OLDER PRESCRIPTION MUST BE WRITTEN BY AN ONCOLOGIST 1 year 126
RUBRACA Rubraca Other Ovarian cancer: Diagnosis of advanced ovarian cancer. Presence of deleterious BRCA mutation as detected by an FDA-approved diagnostic test (e.g., Foundation Focus CDxBRCA Assay). History of failure, contraindication, or intolerance to two or more chemotherapies (e.g., cisplatin, carboplatin). Prescribed by or in consultation with an oncologist 12 months 127
RYDAPT Rydapt Other Acute Myeloid Leukemia (AML): Newly diagnosed acute myeloid leukemia (AML), FMS-like tyrosine kinase 3 (FLT3) mutation-positive as detected by a U.S. Food and Drug Administration (FDA)-approved test, used in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. Aggressive Systemic Mastocytosis (ASM), Systemic Mastocytosis with Associated Hematological Neoplasm (SM- AHN), Mast Cell Leukemia (MCL): Diagnosis of one of the following: aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). All indications: Prescribed by or in consultation with a hematologist or oncologist. 1 year Approve for continuation of prior therapy 128
SAMSCA Samsca Other Diagnosis, patient has a serum sodium less than 125 meq/l at baseline, OR member has less marked hyponatremia (serum sodium less than 135 meq/l at baseline) AND is symptomatic (e.g. nausea, vomiting, headache, lethargy, confusion, and baseline LFTs) Prescribed by endocrinology or nephrology 1 month Patient must have documented failure of two other therapies (e.g. fluid restriction, furosemide, demeclocycline). 129
SAVELLA Savella oral tablet Savella oral tablets,dose pack Other DIAGNOSIS OF FIBROMYALGIA, RESPONSE TO THERAPY 1 YEAR 130
SIGNIFOR Signifor Other Diagnosis, other therapies tried and failed, result of prior pituitary surgery (if performed). If not surgery was performed, provide the reason why surgery is not an option. Prescription must be written by an endocrinologist 3 months for imitation, 6 months for continuation 131
SIRTURO Sirturo Other Diagnosis, other therapies tried and/or failed. ECG and liver function tests are required at baseline and at intervals as specified in the FDA prescribing information to monitor for potentially severe adverse events. Prescription must be written by a infectious disease specialist 24 weeks Drug therapy must be directly observed. Use of Sirturo is reserved for MDR-TB where other treatment options cannot be used for safety or efficacy reasons. 132
SORIATANE acitretin Other Female patients who are pregnant or planning to become pregnant within the next three years Diagnosis, other therapies tried and/or failed Prescription must be written by dermatologist, oncologist, or transplant physician 3 months for initiation, 6 months for continuation For the treatment of psoriasis, patient must have a trial of or contraindication to topical therapy and methotrexate. For the prevention of skin cancer in solid organ transplant patients, Soriatane will be covered for patients who develop multiple (greater than 5) squamous cell carcinoma (SCC) lesions per year, aggressive SCC, or accelerated development of SCC 133
SPRITAM Spritam Other Diagnosis, therapies tried, and outcome Prescribed by Neurologist 1 year Rationale as to why generic levetiracetam is not suitable. 134
SPRYCEL Sprycel Other PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 1 year Must have a failure, intolerance or contraindication to imatinib. 135
STELARA Stelara subcutaneous Other Diagnosis, prior therapies, and result of prior therapy. TB test results Prescribed by gastroenterologist or rheumatologist 1 year For psoriasis and psoriatic arthritis: Patient must have failure of, intolerance, or contraindication to inflixmab and Otezla. For Crohn's disease: Patient must have a failure of, intolerance, or contraindication to infliximab and Humira. 136
STIVARGA Stivarga Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to regorafenib. LFT lab test results are needed for continuation treatment. Prescription must be written by an oncologist 1 year 137
SUPREP Suprep Bowel Prep Kit Other Diagnosis, other therapies tried and outcome 1 year Must have a failure, contraindication, or intolerance to at least one generic bowel prep ie. Trilyte 138
SUTENT Sutent DIAGNOSIS, PRIOR THERAPIES, AND TREATMENT RESPONSE. DOCUMENATION OF FAILURE OF IMATINIB FOR PATIENTS WITH GIST. DOCUMENTATION OF FAILURE OF VOTRIENT FOR PATIENTS WITH RENAL CELL CARCINOMA. IF NO PREVIOUS FAILURE, RATIONALE AS TO WHY PREFERRED AGENT CANNOT BE USED PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 3 MONTHS INITIAL, 1 YEAR CONTINUATION Other GIST PATIENTS REQUIRE A FOLLOW-UP CT SCAN BETWEEN 8 AND 12 WEEKS. 139
SYLATRON Sylatron Other HISTORY OF HEPATITIS OR HEPATIC DECOMPENSATION DIAGNOSIS OF MALIGNANT MELANOMA WITH EVIDENCE OF NODAL INVOLVEMENT 18 YEARS AND OLDER PRESCRIBER MUST BE ONCOLOGIST OR DERMATOLOGIST 6 MONTHS MONITOR FOR NEUROPSYCHIATRIC DISORDERS, TOXICITY, AND NEW OR WORSENING RETINOPATHY 140
SYMDEKO Symdeko Other Diagnosis of CF AND homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. If the patients genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use. FEV1 at baseline and continuation, baseline LFT and continuation, review for drug interactions CYP3A inducers 12 and older Must be prescribed by a pulmonologist or doctor specializing in cystic fibrosis 6 months initial, 1 year continuation For renewal, Patient is benefiting from treatment (i.e., improvement in lung function [forced expiratory volume in one second (FEV1)], decreased number of pulmonary exacerbations) 141
SYMLIN SymlinPen 120 SymlinPen 60 Other GASTROPARESIS OR USE OF DRUGS TO STIMULATE GASTROINTESTINAL MOTILITY HBA1C AND CURRENT DIABETES MEDICATIONS 1 YEAR 142
SYMPAZAN Sympazan oral film 10 mg, 20 mg, 5 mg Other Diagnosis, prior therapy used, result of prior therapy. 1 year Must have failure, intolerance, or contraindication to generic clobazam 143
SYNRIBO Synribo Other Diagnosis, prior therapy used, result of prior therapy. Prescription must be written by an oncologist or hematologist 3 months for initiation, 6 months for continuation 144
TAFINLAR Tafinlar Other Wild-type BRAF melanoma Diagnosis, prior therapy used, result of prior therapy. Documentation of BRAF mutation, as detected using an FDA-approved test. Prescription must be written by an oncologist 1 year 145
TAGRISSO Tagrisso Other Diagnosis, other therapies tried and/or failed, and treatment response. For NCSLC: Tumors are positive for epidermal growth factor receptor (EGFR) T790M mutation. Prescribed by an oncologist. 1 year 146
TALZENNA Talzenna Other Diagnosis, prior therapy used, result of prior therapy. If continuation, prior response to treatment. Prescription must be written by an oncologist 1 year 147
TARCEVA Tarceva Other DIAGNOSIS, PRIOR THERAPIES, AND TREATMENT RESPONSE PRESCRIPTION MUST BE WRITTEN BY ONCOLOGIST 1 year 148
TASIGNA Tasigna oral capsule 150 mg, 200 mg, 50 mg Other DIAGNOSIS, OTHER THERAPIES TRIED AND FAILED, RESPONSE TO TREATMENT, POTENTIAL DRUG INTERACTIONS PRESCRIPTION MUST BE WRITTEN BY AN ONCOLOGIST 1 year Must have a failure, intolerance or contraindication to imatinib and Sprycel. 149
TAVALISSE Tavalisse Other Diagnosis, other therapies tried, outcome, and platelet count less than 50,000/microL for at least 3 months Must be prescribed by a hematologist or oncologist 3 months Patient must have a failure, contraindication, or intolerance to at least two of the following therapies: corticosteroids, IVIG, Rituxan, or Promacta. For continuation of therapy the platelet counts must be to a level sufficient to avoid clinically important bleeding. 150