ADCIRCA. Products Affected ADCIRCA. Covered Uses All medically accepted indications not otherwise excluded from Part D.

Transcription

1 ADCIRCA ADCIRCA. Other Patient requires nitrate therapy on a regular or intermittent basis Statement of diagnosis from the physician 12/31/2017 1

2 ALUNBRIG ALUNBRIG Other Diagnosis of metastatic, ALK positive non-small cell lung cancer and have progressed or are intolerant to Xalkori (crizotinib) 18 years of age and older Prescribed by or in consultation with a oncologist 12 months 2

3 AMPYRA AMPYRA All FDA-approved indications not otherwise excluded from Part D. Other History of seizure. Moderate or severe renal impairment (creatinine clearance less than or equal to 50 ml/minute). Diagnosis of multiple sclerosis AND patient is ambulatory (able to walk at least 25 feet) AND patient has walking impairment Initial - 3 months. Renewal - 12 months For renewal, walking speed has improved from baseline. 3

4 BOSULIF BOSULIF Other Signed statement of diagnosis from the physician, hepatic panel and CBC, trial and failure ofofimiatinib or dasatinibi and documentation of a 90 day response 12/31/2017 4

5 BRIVIACT BRIVIACT Other Diagnosis of partial-onset seizures, member must have history of inadequate response, contraindication, or intolerance to levetiracetam prior to approval. 16 years of age and older Plan Year 5

6 COPAXONE COPAXONE SUBCUTANEOUS SOLUTION PREFILLED SYRINGE All FDA-approved indications not otherwise excluded from Part D. Other Diagnosis of relapsing-remitting multiple sclerosis OR diagnosis of first clinical episode with MRI features consistent with multiple sclerosis 18 years of age or older 12 months For renewal, patient has no or slowed disease progression 6

7 CYSTARAN CYSTARAN All FDA-approved indications not otherwise excluded from Part D. Other Patient has a diagnosis of cystinosis AND Patient has corneal cystine crystal accumulation Plan Year 7

8 EMPLICITI EMPLICITI INTRAVENOUS SOLUTION RECONSTITUTED 400 MG Other All medically Accepted indications not otherwise excluded from Part D Diagnosis of Multiple myeloma and used in combination with lenalidomide and dexamethasone in patients who have received 1 to 3 prior therapies. Oncologist Plan Year 8

9 ERWINAZE ERWINAZE INJECTION Other Supporting statement of diagnosis from the physician 12/31/2017 9

10 ESBRIET ESBRIET Other Appropriate diagnosis (idopathic pulmonary fibrosis [IPF]), monitoring (hepatiac function/lfts) none pulmonologist 12/31/

11 ESRD THERAPY PROCRIT Other Hemogloblin less than 10 g/dl for patients receiving Cancer Chemotherapy and Hemoglobin less than 12 and Hematacrit less than 33 for other approved FDA indications in addition to supporting statement of diagnosis from physician 3 months 11

12 FARYDAK FARYDAK Other statement of diagnosis from physician 12/31/

13 FENTANYL FENTORA BUCCAL TABLET 200 MCG, 400 MCG, 600 MCG, 800 MCG LAZANDA Other Supporting statement of diagnosis from the physician 12/31/

14 GILENYA GILENYA Other All FDA-approved indications not otherwise excluded from Part D. First clinical episode with MRI features consistent with multiple sclerosis. Recent (within the last 6 months) occurrence of: myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure. History or presence of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome, unless patient has a pacemaker. Baseline QTc interval greater than or equal to 500 ms. Receiving concurrent treatment with Class Ia or Class III anti-arrhythmic drugs (quinidine, procainamide, amiodarone, sotalol). Diagnosis of a relapsing form of multiple sclerosis or diagnosis of first clinical episode with MRI features consistent with MS AND Patient will be observed for signs and symptoms of bradycardia in a controlled setting for at least 6 hours after the first dose Initial - 6 months. Renewal - 12 months For renewal, the patient has experienced no or slowed disease progression. 14

15 GILOTRIF GILOTRIF Other Supporting statement of diagnosis of metastatic non-small cell lung cancer (NSCLC) from the physician in patients with EGFR exon 19 deletions or exon 21 (L858R) substitution as detected by an FDA-approved test OR Treatment of previously treated metastatic squamous cell NSCLC that has progressed following platinum-based chemotherapy. 12/31/

16 GONADOTROPIN chorionic gonadotropin intramuscular Other All FDA approved indications not otherwise excluded from Part D Fertility indications in females are excluded. Diagnosis of Hypogonadotrophic hypogonadism or Prepubertal cryptorchidism Plan Year 16

17 GROWTH HORMONE NORDITROPIN FLEXPRO NUTROPIN AQ NUSPIN 10 NUTROPIN AQ NUSPIN 20 Other Supporting statement of diagnosis from the physician 12/31/

18 HEPATITIS C DAKLINZA EPCLUSA HARVONI SOVALDI Other Must submit documentation of chronic hepatitis C genotype (confirmed by HCV RNA level within the last 6 months). Must submit laboratory results within 6 weeks of initiating therapy including: 1) CBC w Platelets, 2) AST/ALT, 3)Total Bilirubin, 4)Serum Albumin, 5)PT/INR, 6)Serum Creatinine, and 7)GFR. FOR GENOTYPE 1: Must include subtype, trial/failure, contraindication to, or intolerance to Harvoni prior to approval of Daklinza, Sovaldi, or Epclusa. FOR GENOTYPES 2 and 3: Must include subtype, trial/failure, contraindication to, or intolerance to Epclusa prior to approval of combination of Sovaldi and Ribavirin OR Sovaldi and Daklinza. FOR GENOTYPE 4: Must include subtype, trial/failure, contraindication to, or intolerance to Harvoni prior to approval of Epclusa. FOR GENOTYPES 5 and 6: trial/failure, contraindication to, or intolerance to Harvoni prior to approval of Epclusa or Sovaldi + PEG + Ribavirin. Patient must be age 12 or older. must be a gastroenterologist, hepatologist, or infectious disease specialist of approval per AASLD Guidelines 18

19 HRM - ADHD guanfacine hcl er METHYLPHENIDATE HCL ER ORAL TABLET EXTENDED RELEASE 24 HOUR 27 MG All FDA-approved indications not otherwise excluded from Part D. Other Verify the medication is being used for an FDA-approved diagnosis PA applies to patients 65 years or older 12 months 19

20 HRM - ANALGESICS ascomp-codeine butalbital-apap-caff-cod oral capsule mg butalbital-asa-caff-codeine indomethacin er indomethacin oral ketorolac tromethamine injection solution 15 mg/ml, 30 mg/ml ketorolac tromethamine intramuscular solution 60 mg/2ml ketorolac tromethamine oral pentazocine-naloxone hcl All FDA-approved indications not otherwise excluded from Part D. Other The drug is 1) being prescribed for an FDA-approved indication AND 2) If formulary non HRM alternatives considered safe and effective in the elderly are available, then the member had an inadequate response, intolerable side effect, or contraindication to at least 2 of the alternative(s) (ALTERNATIVES for the following diagnoses include a) ACUTE PAIN/INFLAMMATION: tramadol, tramadol/apap, morphine sulfate, hydrocodone/apap, oxycodone, oxycodone/apap, etodolac, diflunisal, fenoprofen, ibuprofen, ketoprofen, meclofenamate, nabumetone, piroxicam, sulindac, tolmetin, meloxicam, naproxen. b) OSTEOARTHRITIS: etodolac, diflunisal, fenoprofen, ibuprofen, ketoprofen, meclofenamate, nabumetone, piroxicam, sulindac, tolmetin, meloxicam, naproxen. C) GOUT: etodolac, ketoprofen, meloxicam, piroxicam, sulindac. D) HEADACHE: ibuprofen, naproxen ) AND 3) the prescribing physician attests to the medical necessity for using this high risk medication, AND 4) intent to monitor for side effects, AND 5) anticipated treatment course/duration Automatic approval if member is less than 65 years of age.prior Auth required for age 65 or older. 12/31/2017 Not covered for members if drug is available for hospice program drug benefit. 20

21 21

22 HRM - ANTI-ARRHYTHMICS digitek oral tablet 250 mcg disopyramide phosphate oral All FDA-approved indications not otherwise excluded from Part D. Other The drug is being prescribed for an FDA-approved indication AND the prescriber attests to the medical necessity for using this high risk medication AND prescriber attests to intent to monitor for side effects AND the member had an inadequate response to Digoxin 0.125mg Automatic approval if member is less than 65 years of age.prior Auth required for age 65 or older. 12/31/

23 HRM - ANTIDEPRESSANTS amitriptyline hcl oral chlordiazepoxide-amitriptyline clomipramine hcl oral doxepin hcl oral imipramine hcl oral imipramine pamoate trimipramine maleate oral Other For patients greater than or equal to 65 years, coverage determination is approved for FDA-approved indications not otherwise excluded from Part D. Automatic approval if member is less than 65 years of age.prior Auth required for age 65 or older. 12/31/

24 HRM - ANTIEMETIC DRUGS hydroxyzine hcl intramuscular hydroxyzine hcl oral syrup hydroxyzine hcl oral tablet hydroxyzine pamoate oral All FDA-approved indications not otherwise excluded from Part D. Other Documenation of prescriber attestation that benefit outweighs risk of drugs found to be high risk medications for beneficiaries age 65 and older. Automatic approval if member is less than 65 years of age.prior Auth required for age 65 or older. 12/31/2017 Must try and fail, have contraindication or intolerance to at least 2 non- HRM alternatives: Nausea/Vomiting: granisetron, ondansetron_allergic Reactions: cetirizine solution, desloratadine, levocetirizine. Part D coverage is not allowed if a hospice program drug benefit is available for the drug. 24

25 HRM - ANTIHISTAMINES cyproheptadine hcl oral tablet All FDA-approved indications not otherwise excluded from Part D. Other The drug is being prescribed for an FDA-approved indication AND If formulary non HRM alternatives (desloratadine) considered safe and effective in the elderly are available, then the member had an inadequate response, intolerable side effect, or contraindication to the alternative AND the prescribing physician attests to the medical necessity for using this high risk medication, AND intent to monitor for side effects, AND anticipated treatment course/duration Automatic approval if member is less than 65 years of age.prior Auth required for age 65 or older. 12/31/2017 NON HRM formulary alternative would be desloratadine 25

26 HRM - ANTIHYPERTENSIVE AGENTS methyldopa oral methyldopa-hydrochlorothiazide methyldopate hcl All FDA-approved indications not otherwise excluded from Part D. Other The drug is being prescribed for an FDA-approved indication AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older 12 months 26

27 HRM - ANTIPARKINSON AGENTS benztropine mesylate oral trihexyphenidyl hcl All FDA-approved indications not otherwise excluded from Part D. Other The drug is being prescribed for an FDA-approved indication AND If formulary non HRM alternatives (Levodopa/carbidopa, pramipexole, ropinirole, bromocriptine, selegiline, entacapone) considered safe and effective in the elderly are available, then the member had an inadequate response, intolerable side effect, or contraindication to at least 2 of the alternative(s) AND the prescribing physician attests to the medical necessity for using this high risk medication, AND intent to monitor for side effects, AND anticipated treatment course/duration Automatic approval if member is less than 65 years of age.prior Auth required for age 65 or older. 12/31/2017 attestation that benefit outweighs risk of drugs found to be high risk medications for beneficiaries age 65 and older 27

28 HRM - ANTIPSYCHOTICS perphenazine-amitriptyline thioridazine hcl oral All FDA-approved indications not otherwise excluded from Part D. Other The drug is being prescribed for an FDA-approved indication AND If formulary non HRM alternatives (haloperidol, quetiapine, risperidone, aripiprazole, asenapine, iloperidone, lurasidone, olanzapine, paliperidone, ziprasidone) considered safe and effective in the elderly are available, then the member had an inadequate response, intolerable side effect, or contraindication to at least 2 of the alternative(s) AND the prescribing physician attests to the medical necessity for using this high risk medication, AND intent to monitor for side effects, AND anticipated treatment course/duration Automatic approval if member is less than 65 years of age.prior Auth required for age 65 or older. 12/31/

29 HRM - ANXIOLYTICS meprobamate Other The drug is being prescribed for an FDA-approved indication AND the patient has tried at least one non-hrm alternative (listed in OTHER CRITERIA) AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older 12 months. 29

30 HRM - BARBITURATES BUTISOL SODIUM ORAL TABLET 30 MG phenobarbital oral elixir phenobarbital oral tablet All FDA-approved indications not otherwise excluded from Part D. Other Verify the medication is being used for an FDA-approved diagnosis PA applies to patients 65 years or older 12 months 30

31 HRM - CALCIUM CHANNEL BLOCKERS, DIHYDROPYRIDINE nifedipine oral All FDA-approved indications not otherwise excluded from Part D. Other The drug is being prescribed for an FDA-approved indication AND the patient has tried at least one non-hrm alternative (listed in OTHER CRITERIA) AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older 12 months extended-release nifedipine, nicardipine, amlodipine 31

32 HRM - DEMENTIA AGENTS ergoloid mesylates oral All FDA-approved indications not otherwise excluded from Part D. Other The drug is being prescribed for an FDA-approved indication AND the patient has tried and failed at least one non-hrm alternative (listed in OTHER CRITERIA) AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older 12 months donepezil, galantamine, rivastigmine, memantine 32

33 HRM - ONCOLOGY MEGACE ES megestrol acetate oral suspension 40 mg/ml, 625 mg/5ml megestrol acetate oral tablet All FDA-approved indications not otherwise excluded from Part D. Other The drug is being prescribed for an FDA-approved indication AND If formulary non HRM alternatives for diagnosis of cachexia secondary to chronic illness (dronabinol, oxandrolone) considered safe and effective in the elderly are available, then the member had an inadequate response, intolerable side effect, or contraindication to at least 2 of the alternative(s) AND the prescribing physician attestts to tthe medical necessity for using this high risk medication, AND intent to monitor for side effects, AND anticipated treatment course/duration. For treatment of cancer related diagnosis or endometrial hyperplasia, or endometriosis, requests will be automatically approved. Automatic approval if member is less than 65 years of age.prior Auth required for age 65 or older. 12/31/2017 Applies to New Starts only 33

34 HRM - ORAL ESTROGENS AND PROGESTINS estradiol oral fyavolv MENEST ORAL TABLET 0.3 MG, MG, 1.25 MG PREMARIN ORAL PREMPHASE PREMPRO All FDA-approved indications not otherwise excluded from Part D. Other The drug is being prescribed for an FDA-approved indication AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older 12 months 34

35 HRM - PLATELET INHIBITORS dipyridamole oral All FDA-approved indications not otherwise excluded from Part D. Other The drug is being prescribed for an FDA-approved indication AND the patient has tried at least one non-hrm alternative (listed in OTHER CRITERIA) AND the prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 years and older) and wishes to proceed with the originally prescribed medication. PA applies to patients 65 years or older 12 months clopidogrel, aggrenox 35

36 HRM - SEDATIVE HYPNOTIC AGENTS zaleplon zolpidem tartrate All FDA-approved indications not otherwise excluded from Part D. Other The drug is being prescribed for an FDA-approved indication AND If formulary non HRM alternatives (Rozerem (8 mg/d) considered safe and effective in the elderly is available, then the member had an inadequate response, intolerable side effect, or contraindication to the alternative AND the prescribing physician attests to the medical necessity for using this high risk medication, AND intent to monitor for side effects, AND anticipated treatment course/duration Automatic approval if member is less than 65 years of age.prior Auth required for age 65 or older. 12/31/2017 ramelteon (8 mg/d) 36

37 HRM - SKELETAL MUSCLE RELAXANTS cyclobenzaprine hcl oral tablet 10 mg, 5 mg methocarbamol injection solution 1000 mg/10ml methocarbamol oral orphenadrine citrate er orphenadrine citrate injection All FDA-approved indications not otherwise excluded from Part D. Other The drug is being prescribed for an FDA-approved indication AND the prescribing physician attests that the benefit outweighs risk of therapy, AND intent to monitor for side effects, AND anticipated treatment course/duration. Automatic approval if member is less than 65 years of age.prior Auth required for age 65 or older. 12/31/

38 HRM - SULFONYLUREAS chlorpropamide glyburide micronized glyburide oral glyburide-metformin All FDA-approved indications not otherwise excluded from Part D. Other The drug is being prescribed for an FDA-approved indication AND If formulary non HRM alternatives (glimepiride, glipizide) considered safe and effective in the elderly are available, then the member had an inadequate response, intolerable side effect, or contraindication to at least 2 of the alternative(s) AND the prescribing physician attests to the medical necessity for using this high risk medication, AND intent to monitor for side effects, AND anticipated treatment course/duration Automatic approval if member is less than 65 years of age.prior Auth required for age 65 or older. 12/31/2017 glimepiride, glipizide 38

39 HRM - UTI ANTIBACTERIALS nitrofurantoin macrocrystal oral nitrofurantoin monohyd macro All FDA-approved indications not otherwise excluded from Part D. Other The drug is being prescribed for an FDA-approved indication AND If formulary non HRM alternatives (Non-HRM alternatives: ciprofloxacin, levofloxacin, sulfamethoxazole/trimethoprim) considered safe and effective in the elderly are available, then the member had an inadequate response, intolerable side effect, or contraindication to at least 2 of the alternative(s) AND the prescribing physician attestts to tthe medical necessity for using this high risk medication, AND intent to monitor for side effects, AND anticipated treatment course/duration Automatic approval if member is less than 65 years of age.prior Auth required for age 65 or older. 12/31/

40 HYDROXYPROGESTERONE CAPROATE hydroxyprogesterone caproate intramuscular Other Breast, cervical, hepatocellular, uterine, or vaginal cancers, hepatic or thromboembolic disease, jaundice, or vaginal bleeding Supporting statement of diagnosis from physician 16 years of age and older Up to 21 weeks 40

41 IBRANCE IBRANCE Other All FDA approved indications not otherwise excluded from Part D Appropriate diagnosis (used in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer OR diagnosis of the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy.) 12/31/

42 ICLUSIG ICLUSIG Other Diagnosis of chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) in adult patients who are T315I-positive or for whom no other tyrosine kinase inhibitor therapy is indicated OR Diagnosis of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in adult patients who are T315I-positive or for whom no other tyrosine kinase inhibitor therapy is indicated Plan Year 42

43 IDHIFA IDHIFA Other Under Review with CMS Diagnosis of relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 2 mutation as detected by an FDA approved test 18 years of age and older Prescribed by or in consultation with an oncologist or hematologist 12 months 43

44 IMBRUVICA IMBRUVICA Other Supporting statement of diagnosis from the physician 12/31/

45 IMFINZI IMFINZI Other Diagnosis of locally advanced or metastatic urothelial carcinoma. Patients must have progressed on or following platinum-containing chemotherapy, OR within 12 months of neoadjuvant or adjuvant platinum containing chemotherapy 18 years of age and older Prescribed by or in consultation with a oncologist 12 months 45

46 JUXTAPID JUXTAPID ORAL CAPSULE 10 MG, 20 MG, 5 MG Other Diagnosis of homozygous familial hypercholesterolemia AND Patient has tried and had an inadequate response or intolerance to statins Plan Year 46

47 KALYDECO KALYDECO Other Supporting statement of diagnosis from the physician 12/31/

48 KANUMA KANUMA Other Diagnosis of Lysosomal acid lipase deficiency prescribed by hepatologist Plan Year 48

49 KEYTRUDA KEYTRUDA Other Diagnosis of unresectable or metastatic melanoma OR diagnosis of metastatic non-small cell lung cancer (NSCLC) in patients with PD-L1 expressing tumors who have disease progression on or after platinumcontaining chemotherapy (patients with EGFR or ALK genomic tumor aberrations should have disease progression on approved therapy for these aberrations prior to receiving Keytruda) OR recurrent or metastatic squamous cell carcinoma of the head and neck in patients with disease progression on or after platinum-containing chemotherapy OR classical hodgkin lymphoma (chl) in patients that have relapsed after 3 or more prior lines of therapy OR locally advanced or metastatic urothelial carcinoma OR unresectable or metastatic solid tumors with biomarker microsatellite instability-high (MSI-h) or mismatch repair deficient (dmmr). Plan Year 49

50 KISQALI KISQALI 200 DOSE KISQALI 400 DOSE KISQALI 600 DOSE KISQALI FEMARA 200 DOSE KISQALI FEMARA 400 DOSE KISQALI FEMARA 600 DOSE. Other Diagnosis of hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer and intended to be used in combination with an aromatase inhibitor in postmenopausal women Age 18 years and older Prescribed by or in consultation with a oncologist Plan year 50

51 KORLYM KORLYM Other Pregnancy Supporting statement of diagnosis and relevant medical information from physician 12/31/

52 KYNAMRO KYNAMRO SUBCUTANEOUS SOLUTION PREFILLED SYRINGE Other Moderate to severe liver impairment or active liver disease including unexplained persistent abnormal liver function tests. Diagnosis of homozygous familial hypercholesterolemia AND Patient has tried and had an inadequate response or intolerance to statins Initial - 6 months. Renewal - 12 months For renewal, patient has responded to therapy with a decrease in LDL levels. 52

53 LARTRUVO LARTRUVO INTRAVENOUS SOLUTION 500 MG/50ML Other All medically accepted indications not otherwise excluded from part D Diagnosis of soft tissue sarcoma (STS), histologic subtype for which an anthracycline-containing regimen is appropriate, previous treatment failure with radiotherapy or surgery and must document being used in combination with doxorubicin for the first 8 cycles. 18 years of age or older Oncologist Plan Year 53

54 LIDODERM lidocaine external patch 5 % Other Supporting statement of diagnosis from the physician 12/31/

55 LYNPARZA LYNPARZA Other Appropriate diagnosis and testing for BRCA mutation (deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA approved test) advanced ovarian cancer that has been treated with 3 or more prior lines of chemotherapy) none none 12/31/

56 MAVYRET MAVYRET Other Must submit documentation of chronic hepatitis C genotype (confirmed by HCV RNA level within the last 6 months). Must submit laboratory results within 6 weeks of initiating therapy including: 1) CBC w Platelets, 2) AST/ALT, 3)Total Bilirubin, 4)Serum Albumin, 5)PT/INR, 6)Serum Creatinine, and 7)GFR. FOR GENOTYPES 1, 4, 5 and 6: Must include subtype, trial/failure, contraindication to, or intolerance to Harvoni prior to approval of Mavyret. For GENOTYPES 2 and 3: Must include subtype, trial/failure, contraindication to, or intolerance to Mavyret prior to approval of combination of Sovaldi and Ribavirin OR Sovaldi and Daklinza 18 years of age and older must be a gastroenterologist, hepatologist, or infectious disease specialist of approval per AASLD Guidelines 56

57 MS INTERFERONS AVONEX AVONEX PEN INTRAMUSCULAR AUTO-INJECTOR KIT AVONEX PREFILLED INTRAMUSCULAR PREFILLED SYRINGE KIT BETASERON SUBCUTANEOUS KIT PLEGRIDY PLEGRIDY STARTER PACK SUBCUTANEOUS SOLUTION PEN- INJECTOR REBIF SUBCUTANEOUS SOLUTION PREFILLED SYRINGE 22 MCG/0.5ML All-FDA approved indications not otherwise excluded from Part D. Other Diagnosis of relapsing form of multiple sclerosis OR diagnosis of first clinical episode and MRI features consistent with multiple sclerosis. 12 months For renewal, patient has experienced an objective response to therapy (i.e. no or slowed progression of disease) 57

58 NERLYNX NERLYNX Other Diagnosis of early stage HER2- overexpressed breast cancer. Must be used after trastuzumab therapy. 18 years of age and older Prescribed by or in consultation with an oncologist 12 months 58

59 NORTHERA NORTHERA Other Prior authorization will be approved for the following indication(s): orthostatic dizziness, light-headedness, or the feeling that you are about to black out in adults with neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure (i.e., Parkinson disease, multiple system atrophy, pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy) Plan Year 59

60 NUCALA NUCALA Other Diagnosis of severe asthma (eosinophilic phenotype) 12 years of age or older prescribed by pulmonologist Plan Year 60

61 NUPLAZID NUPLAZID Other Diagnosis of Parkinson disease psychosis including hallucinations and/or delusions Plan Year 61

62 OPDIVO OPDIVO INTRAVENOUS SOLUTION 40 MG/4ML Other Appropriate diagnosis (BRAF V600 wild-type or BRAF V600 mutationpositive unresectable or metastatic melanoma and used as single agent OR unresectable or metastatic melanoma in combination with ipilimumab [Yervoy] OR treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy and patients with EGFR or ALK genomic tumor aberrations should have disease progression (on FDA-approved EGFR- or ALKdirected therapy) prior to receiving nivolumab OR advanced renal cell carcinoma who have received prior anti-angiogenic therapy OR recurrent or metastatic squamous cell carcinoma of the head and neck in patients with disease progression on or after platinum-based chemotherapy OR classical Hodgkin lymphoma in patients who have relapsed or progressed following autologous hematopoietic stem cell transplant (HSCT) and posttransplant brentuximab vedotin OR locally advanced or metastatic urothelial carcinoma in patients with disease progression during or following a platinum-containing therapy or disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing therapy). none none 12/31/

63 ORKAMBI ORKAMBI Other Initial Therapy: Must have diagnosis of cystic fibrosis (CF) with documented homozygous F508del mutation confirmed by FDA-approved CF mutation test. Continuation of therapy: 1. Documentation patient is tolerating and responding to medication (i.e. improved FEV1, weight gain, decreased exacerbations, etc.) Must be greater than or equal to 12 years of age Must be prescribed by, or in conjunction with, a pulmonologist or is from a CF center accredited by the Cystic Fibrosis Foundation 12/31/

64 PCSK9 INHIBITOR PRALUENT SUBCUTANEOUS SOLUTION PEN-INJECTOR REPATHA REPATHA PUSHTRONEX SYSTEM REPATHA SURECLICK All medically accepted indications not otherwise excluded form Part D FOR PRALUENT: MUST MEET CRITERIA #1 OR #3. FOR REPATHA: MUST MEET CRITERIA #1, #2 OR #3. 1. Diagnosis of heterozygous familial hypercholesterolemia (HeFH) confirmed by genotyping OR Simon Broome criteria: Total cholesterol greater than 290mg/dL or LDL cholesterol greater than 190mg/dL, PLUS ONE OF THE FOLLOWING: Tendon xanthomas in patient, or 1st degree relative (parent, sibling, child), or 2nd degree relative (grandparent, uncle, aunt) OR DNA-based evidence of LDL receptor mutation, familial defective apo B-100, or PCSK9 mutation 2. Diagnosis of homozygous familial hypercholesterolemia (HoFH) confirmed by genotyping OR diagnosis based on the following: a. History of untreated LDL-C greater than 500 mg/dl AND xanthoma before 10 years of age OR b. Documentation of HeFH in both parents 3. Diagnosis of clinical atherosclerotic cardiovascular disease (CVD) as defined as one of the following: a. acute coronary syndrome, b. history of myocardial infarction, c. stable/unstable angina, d. coronary or other arterial revascularization, e. stroke, f. transient ischemic stroke (TIA), g. peripheral arterial disease presumed to be atherosclerotic region. AND MEETS CRITERIA #4, #5, and #6, 4. Provide baseline and current LDL-C 5. LDL-C greater than or equal to 100 mg/dl 6. Used in combination with maximally tolerated high-intensity statin OR MEETS CRITERIA #7 AND #8. 7. Statin intolerant 8. LDL-C greater than or equal to 100 mg/dl CONTINUING THERAPY: 1. Documented response to Praluent or Repatha, defined as ONE of the following: a. The patient is tolerating medication b. Will continue to be used in combination with maximally tolerated statin (unless statin intolerant). Repatha: 13 years of age or older for diagnosis HoFM, Diagnosis CVD or HeFH AND Praluent or Repatha : 18 years of age or older Must be prescribed by, or in consultation with, a cardiologist, endocrinologist, or lipid specialist 64

65 Other Initial approval: 8 weeks, Renewal approval: Plan Year 65

66 PROVIGIL modafinil Other Supporting statement of diagnosis from the physician 12/31/

67 RADICAVA RADICAVA Other Sulfite hypersensitivity Diagnosis of amyotrophic lateral sclerosis and must meet all of the following: living independently, functionality retained most activities of daily living (defined as scores of 2 points or better on each individual item of the ALS Functional Rating Scale, normal respiratory function defined as percent-predicted forced vital capacity values of percent FVC greater or equal to 80 percent, disease duration of 2 years or less. 18 years of age and older Prescribed by or in consultation with a neurologist 12 months Initial: 6 months. Renewal: 12 months. For renewal, patient must meet initial criteria and not have more than a 6 point decline in the ALS Functional Rating Scale from baseline. 67

68 REGRANEX REGRANEX Other Diabetic Neuropathic Ulcers: Diabetic patient with ulcer wound. Treatment will be given in combination with ulcer wound care (eg, debridement, infection control, and/or pressure relief). Diabetic Neuropathic Ulcers: Maximum 5 months. 68

69 REVATIO sildenafil citrate intravenous sildenafil citrate oral Other Supporting statement of diagnosis from the physician 12/31/

70 REXULTI REXULTI Other All ly Accepted Indications not otherwise excluded from Part D Statement of Diagnosis from the prescriber and documented trial and failure, contraindication, or intolerance to aripiprazole 12/31/

71 RUBRACA RUBRACA ORAL TABLET 200 MG, 300 MG Other All FDA approved indications not otherwise excluded from Part D Diagnosis of Advanced Ovarian Cancer and all of the following criteria: 1. BRCA mutation positive as detected by an approved FDA laboratory test, 2. Previous trial/failure with two or more chemotherapy regimens, 3. Used as monotherapy, 4. Agreement of provider to perform a complete blood count (CBC) at baseline and monthly thereafter, 5. Women of reproductive potential must use an effective method of contraception during therapy and for 6 months after the last dose. Renewal will be based on lack of disease progression or unacceptable toxicity. 18 years of age or older Hematologist or Oncologist Plan Year 71

72 RYDAPT RYDAPT Other Angioedema Diagnosis of treatment naive FLT3 mutation-positive acute myelogenous leukemia (AML) AND Must be used in combination with standard cytarabine and daunorubicin induction and consolidation therapy OR Diagnosis of systemic mastocytosis 18 years of age and older Prescribed by or in consultation with a oncologist 12 months 72

73 SAMSCA SAMSCA Other Supporting statement of diagnosis from the physician 12/31/

74 STIVARGA STIVARGA Other Supporting statement of diagnosis from the physician 12/31/

75 TARGRETIN bexarotene All FDA-approved indications not otherwise excluded from Part D. Other Oncologist 12/31/

76 TECFIDERA TECFIDERA All FDA-approved indications not otherwise excluded from Part D. Other Diagnosis of relapsing forms of multiple sclerosis (relapsing-remitting MS or progressive-relapsing MS, or secondary-progressive MS) OR patient has experienced a first clinical episode and has MRI features consistent with multiple sclerosis 12 months For renewal, Patient had an objective response to therapy (ie no or slowed progression of disease) 76

77 TYSABRI TYSABRI All FDA-approved indications not otherwise excluded from Part D. Other History of progressive multifocal leukoencephalopathy. Diagnosis of relapsing form of multiple sclerosis and medication will be used as monotherapy and patient had an inadequate response, intolerance, or contraindication to conventional therapy with one of the following: An interferon beta product, Copaxone, Gilenya OR Diagnosis of moderate to severe active Crohn's disease and medication will not be used in combination with immunosuppressants or inhibitors of tumor necrosis factor-alfa and patient had an inadequate response, intolerance, or contraindication to any of the following: Humira, Remicade, or Cimzia. 18 years of age or older 12 months Patient and physician are registered in the TOUCH prescribing program. For renewal, patient had an objective response to therapy (e.g., decreased flare). 77

78 VEMLIDY VEMLIDY Other Must submit documenation of immune-active chronic hepatitis B per AASLD guidelines. Patient must be age 18 or over. must be a gastroenterologist, hepatologist, or infectious disease specialist Plan Year 78

79 VENCLEXTA VENCLEXTA VENCLEXTA STARTING PACK. Other CLL for patients with 17p deletion and have had at least 1 prior therapy plan year 79

80 VYXEOS VYXEOS Other Under Review with CMS Diagnosis of therapy related acute myeloid leukemia (t-aml) or acute myeloid leukemia with myelodysplasia related changes (AML-MRC). If the patient has the diagnosis of therapy related acute myeloid leukemia (t- AML), it must be newly diagnosed. 18 years of age and older Prescribed by or in consultation with an oncologist 12 months B vs D coverage determination per CMS guidelines 80

81 XALKORI XALKORI Other Supporting statement of diagnosis from the physician that establishes the cancer as anaplastic lymphoma kinase (ALK)-positive or ROS1-positive must be prescribed by an oncologist 12/31/

82 XTANDI XTANDI Other Supporting statement of diagnosis from the physician and prior trial and failure of docetaxel 12/31/

83 YONDELIS YONDELIS Other Diagnosis and lab values: ANC, platelet count, creatine phosphokinase, and left ventricular ejection fraction. 18 years of age and older Must be prescribed by an oncologist Plan Year 83

84 ZEJULA ZEJULA Other Diagnosis of recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer AND patient had a complete or partial response to platinum-based chemotherapy 18 years of age and older Prescribed by or in consultation with a oncologist or gynecologist 12 months 84

85 ZEPATIER ZEPATIER Other Must submit documentation of chronic hepatitis C genotype (confirmed by HCV RNA level within the last 6 months). Must submit laboratory results within 6 weeks of initiating therapy including: 1) CBC w Platelets, 2) AST/ALT, 3)Total Bilirubin, 4)Serum Albumin, 5)PT/INR, 6)Serum Creatinine, and 7)GFR. FOR GENOTYPE 1 and 4: Must include subtype, trial/failure, contraindication to, or intolerance to Harvoni prior to approval of Zepatier. Patient must be age 18 or over. must be a gastroenterologist, hepatologist, or infectious disease specialist of approval per AASLD Guidelines 85

86 PART B VERSUS PART D ABELCET ABRAXANE acetylcysteine inhalation solution 10 % acyclovir sodium intravenous solution adriamycin intravenous solution adrucil intravenous solution 500 mg/10ml albuterol sulfate inhalation ALDURAZYME AMBISOME AMINOSYN II INTRAVENOUS SOLUTION 10 %, 8.5 % aminosyn ii/electrolytes AMINOSYN/ELECTROLYTES INTRAVENOUS SOLUTION 7 % aminosyn/electrolytes intravenous solution 8.5 % AMINOSYN-HBC AMINOSYN-PF AMINOSYN-RF amphotericin b injection aprepitant ARCALYST ARGATROBAN INTRAVENOUS SOLUTION 125 MG/125ML ARRANON ASTAGRAF XL ATGAM AZASAN azathioprine oral AZATHIOPRINE SODIUM BAVENCIO BENLYSTA INTRAVENOUS SOLUTION RECONSTITUTED 120 MG BICNU BIVIGAM INTRAVENOUS SOLUTION 10 GM/100ML bleomycin sulfate injection solution reconstituted 30 unit busulfan calcitonin (salmon) carboplatin intravenous solution 150 mg/15ml CARIMUNE NF INTRAVENOUS SOLUTION RECONSTITUTED 6 GM CEREZYME INTRAVENOUS SOLUTION RECONSTITUTED 400 UNIT chlorpromazine hcl injection solution 50 mg/2ml chlorpromazine hcl oral tablet 10 mg cisplatin intravenous solution 100 mg/100ml cladribine intravenous solution 10 mg/10ml CLINIMIX E/DEXTROSE (2.75/10) CLINIMIX E/DEXTROSE (2.75/5) CLINIMIX E/DEXTROSE (4.25/10) CLINIMIX E/DEXTROSE (4.25/25) CLINIMIX E/DEXTROSE (4.25/5) CLINIMIX E/DEXTROSE (5/15) CLINIMIX E/DEXTROSE (5/20) CLINIMIX E/DEXTROSE (5/25) CLINIMIX/DEXTROSE (2.75/5) clinimix/dextrose (4.25/10) CLINIMIX/DEXTROSE (4.25/20) CLINIMIX/DEXTROSE (4.25/25) CLINIMIX/DEXTROSE (4.25/5) CLINIMIX/DEXTROSE (5/15) CLINIMIX/DEXTROSE (5/20) CLINIMIX/DEXTROSE (5/25) clofarabine COSMEGEN CROMOLYN SODIUM INHALATION CYCLOPHOSPHAMIDE ORAL CAPSULE cyclosporine intravenous cyclosporine modified cyclosporine oral capsule CYRAMZA cytarabine (pf) injection solution 100 mg/ml cytarabine injection solution dacarbazine intravenous solution reconstituted 200 mg 86

87 daunorubicin hcl intravenous injectable DEPO-PROVERA INTRAMUSCULAR SUSPENSION 400 MG/ML dexrazoxane intravenous solution reconstituted 250 mg dextrose intravenous solution 10 %, 5 % DOXIL doxorubicin hcl intravenous solution doxorubicin hcl liposomal dronabinol ELAPRASE ELIGARD ELITEK EMEND INTRAVENOUS SOLUTION RECONSTITUTED 150 MG EMEND ORAL SUSPENSION RECONSTITUTED ENGERIX-B INJECTION ENVARSUS XR epirubicin hcl intravenous solution 200 mg/100ml ERBITUX INTRAVENOUS SOLUTION 100 MG/50ML ETOPOPHOS etoposide intravenous solution 500 mg/25ml FABRAZYME INTRAVENOUS SOLUTION RECONSTITUTED 35 MG FASLODEX INTRAMUSCULAR SOLUTION 250 MG/5ML FIRMAGON FLEBOGAMMA DIF INTRAVENOUS SOLUTION 5 GM/50ML fluconazole in sodium chloride intravenous solution mg/100ml-%, mg/200ml-% fluorouracil intravenous solution 2.5 gm/50ml FOLOTYN INTRAVENOUS SOLUTION 40 MG/2ML FREAMINE HBC GAMASTAN S/D INTRAMUSCULAR INJECTABLE GAMMAGARD INJECTION SOLUTION 2.5 GM/25ML GAMMAGARD S/D LESS IGA GAMMAKED INJECTION SOLUTION 1 GM/10ML GAMMAPLEX INTRAVENOUS SOLUTION 10 GM/100ML, 10 GM/200ML, 20 GM/200ML, 5 GM/50ML GAMUNEX-C INJECTION SOLUTION 1 GM/10ML ganciclovir sodium gengraf oral capsule 100 mg, 25 mg gengraf oral solution granisetron hcl intravenous solution 0.1 mg/ml, 1 mg/ml granisetron hcl oral hepatamine HERCEPTIN INTRAVENOUS SOLUTION RECONSTITUTED 440 MG idarubicin hcl intravenous solution 10 mg/10ml ifosfamide intravenous solution reconstituted 1 gm IMOVAX RABIES ipratropium bromide inhalation ipratropium-albuterol irinotecan hcl intravenous solution 100 mg/5ml JEVTANA KEPIVANCE KYPROLIS LEUCOVORIN CALCIUM INJECTION SOLUTION RECONSTITUTED 100 MG leucovorin calcium injection solution reconstituted 350 mg levalbuterol hcl inhalation nebulization solution 1.25 mg/0.5ml LEVOLEUCOVORIN CALCIUM INTRAVENOUS SOLUTION levoleucovorin calcium intravenous solution reconstituted 50 mg lincomycin hcl injection melphalan hcl mesna methotrexate oral methotrexate sodium (pf) injection solution 1 gm/40ml methotrexate sodium injection solution 50 mg/2ml 87

88 methotrexate sodium injection solution reconstituted metoprolol tartrate intravenous solution cartridge METRONIDAZOLE IN NACL INTRAVENOUS SOLUTION MG/100ML-% MIRCERA INJECTION SOLUTION PREFILLED SYRINGE 100 MCG/0.3ML, 50 MCG/0.3ML, 75 MCG/0.3ML mitomycin intravenous solution reconstituted 20 mg, 40 mg MITOMYCIN INTRAVENOUS SOLUTION RECONSTITUTED 5 MG MUSTARGEN mycophenolate mofetil mycophenolate mofetil hcl mycophenolate sodium NAGLAZYME NEBUPENT NEPHRAMINE NIPENT NULOJIX nutrilipid intravenous emulsion 20 % ondansetron ondansetron hcl injection solution 4 mg/2ml, 4 mg/2ml (2ml syringe) ondansetron hcl oral oxaliplatin intravenous solution 100 mg/20ml paclitaxel intravenous concentrate 300 mg/50ml PARICALCITOL INTRAVENOUS SOLUTION 5 MCG/ML paricalcitol oral plenamine premasol intravenous solution 6 % PRIVIGEN INTRAVENOUS SOLUTION 20 GM/200ML PROCALAMINE PROGRAF INTRAVENOUS PROLASTIN-C INTRAVENOUS SOLUTION RECONSTITUTED 1000 MG PROLEUKIN PROSOL PULMICORT PULMOZYME RABAVERT RAPAMUNE ORAL SOLUTION RECOMBIVAX HB SANDIMMUNE ORAL SIMULECT INTRAVENOUS SOLUTION RECONSTITUTED 20 MG sirolimus oral SYNDROS tacrolimus oral tazicef injection solution reconstituted 2 gm TECENTRIQ TETANUS-DIPHTHERIA TOXOIDS TD THIOTEPA INJECTION THYMOGLOBULIN tobramycin inhalation toposar intravenous solution 1 gm/50ml TOPOTECAN HCL INTRAVENOUS SOLUTION RECONSTITUTED TORISEL TRAVASOL TREANDA INTRAVENOUS SOLUTION RECONSTITUTED 100 MG TRELSTAR MIXJECT TREXALL TRISENOX VECTIBIX INTRAVENOUS SOLUTION 100 MG/5ML VENTAVIS vinblastine sulfate intravenous solution vincasar pfs vincristine sulfate intravenous vinorelbine tartrate intravenous solution 50 mg/5ml XATMEP ZANOSAR zoledronic acid intravenous concentrate zoledronic acid intravenous solution 5 mg/100ml ZOMETA INTRAVENOUS SOLUTION ZORTRESS 88

89 Details This drug may be covered under Medicare Part B or D depending upon the circumstances. may need to be submitted describing the use and setting of the drug to make the determination. 89

90 Index INDEX \e " " \c "2" \h "A" \z "1033" 90