ALPHA1-PROTEINASE INHIBITOR

Transcription

1 Ally Rx D-SNP Current as of Nov. 1, 2018 ALPHA1-PROTEINASE INHIBITOR ARALAST NP INTRAVENOUS RECON SOLN 1,000 MG GLASSIA PROLASTIN-C INTRAVENOUS RECON SOLN ZEMAIRA PA Documentation of diagnosis, lab results, spirometry results Other Indefinite as long as member is eligible. Member has a predicted FEV1 value between 30% and 65% ANDa serum alph1-antitrypsin (AAT) level less than 11 mmol/l Updated: 10/2018 1

2 ALPHA1-PROTEINASE INHIBITOR ARALAST NP INTRAVENOUS RECON SOLN 1,000 MG GLASSIA PROLASTIN-C INTRAVENOUS RECON SOLN ZEMAIRA PA Documentation of diagnosis, lab results, spirometry results Other Indefinite as long as member is eligible. Member has a predicted FEV1 value between 30% and 65% ANDa serum alph1-antitrypsin (AAT) level less than 11 mmol/l 1

3 AMPYRA AMPYRA dalfampridine PA Moderate to severe renal impairment (CrCL less than or equal to 50ml/min), patient not able to walk 25 feet in 8-45 seconds. Documentation of diagnosis, lab results, and patient progress notes to include results of timed 25 foot walk Other Neurologist Initially for 3 months Continuation requests may be approved open ended based on response.. Patient must have experienced an improvement in walking speed or other objective measure of walking ability since starting Ampyra. 2

4 ANTIBIOTIC OXAZOLIDINONE linezolid linezolid 600 mg/300 ml-0.9% nacl linezolid in dextrose 5% SIVEXTRO PA Covered Uses All medically accepted indications not otherwise excluded from Part D. Documentation of diagnosis and previous treatments Prescribed or recommended by Infectious Disease Specialist Requested acute need 6 to 28 days, longer for refractory disease Other 3

5 ANTIFUNGALS itraconazole oral capsule itraconazole oral solution PA SPORANOX ORAL SOLUTION Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Documentation of diagnosis, past medication history, and recent culture data. Onychomycosis 12 weeks. Systemic infection up to 1 year. For onychomycosis: documentation of diagnosis confirmed by fungal diagnostic test (KOH preparation, fungal culture or nail biopsy) within the past year and a documented trial, inadequate response or contraindication to oral terbinafine. For systemic fungal infection: diagnosis of a systemic fungal infection including, but not limited to blastomycosis, histoplasmosis, or aspergillosis. For dermatologic infections: documentation of diagnosis and documented trial, inadequate response or contraindication to oral or topical antifungal agent such as terbinafine, ketoconazole, nystatin cream, ciclopirox cream. 4

6 ANTI-HEPATITIS C AGENTS EPCLUSA HARVONI MAVYRET PA VOSEVI ZEPATIER Other Documentation of hepatitis C virus diagnosis, genotype, cirrhosis status, and medical history Gastroenterologist, hepatologist, or infectious disease specialist. will be authorized consistent with current FDA, AASLD, or IDSA guidelines. Previous trial with Harvoni, Epclusa, Vosevi, Mavyret or Zepatier as appropriate according to AASLD-IDSA clinical hepatitis C guidelines. 5

7 ANTI-MIGRAINE AGENTS (CGRP INHIBITORS) AIMOVIG 70 MG/ML AUTOINJECTOR AIMOVIG AUTOINJECTOR (2 PACK) PA Documentation of diagnosis and previous treatments Other Indefinite as long as member is eligible The patient has had a trial (4 weeks), inadequate response, or valid contraindication, with two conventional products for migraine prophylaxis: a) Antiepileptic b) Antidepressant c) Beta-blocker d) Calcium-channel blocker or e) ACE/ARB 6

8 ANTINEOPLASTICS AFINITOR AFINITOR DISPERZ ALECENSA ALUNBRIG ORAL TABLET 180 MG, 30 MG, 90 MG ALUNBRIG ORAL TABLETS,DOSE PACK bexarotene BOSULIF ORAL TABLET 100 MG, 400 MG, 500 MG BRAFTOVI ORAL CAPSULE 50 MG, 75 MG CABOMETYX CALQUENCE CAPRELSA ORAL TABLET 100 MG, 300 MG COMETRIQ ORAL CAPSULE 100 MG/DAY(80 MG X1-20 MG X1), 140 MG/DAY(80 MG X1-20 MG X3), 60 MG/DAY (20 MG X 3/DAY) COTELLIC CYRAMZA DARZALEX EMPLICITI ERIVEDGE ERLEADA FARYDAK GILOTRIF GLEOSTINE IBRANCE ICLUSIG IDHIFA imatinib IMBRUVICA ORAL CAPSULE 140 MG, 70 MG IMBRUVICA ORAL TABLET INLYTA ORAL TABLET 1 MG, 5 MG IRESSA JAKAFI KEYTRUDA KISQALI KISQALI FEMARA CO-PACK LARTRUVO LENVIMA ORAL CAPSULE 10 MG/DAY (10 MG X 1), 12 MG/DAY (4 MG X 3), 14 MG/DAY(10 MG X 1-4 MG X 1), 18 MG/DAY (10 MG X 1-4 MG X2), 20 MG/DAY (10 MG X 2), 24 MG/DAY(10 MG X 2-4 MG X 1), 4 MG, 8 MG/DAY (4 MG X 2) LONSURF ORAL TABLET MG, MG LYNPARZA ORAL CAPSULE LYNPARZA ORAL TABLET MEKINIST ORAL TABLET 0.5 MG, 2 MG MEKTOVI NERLYNX NINLARO ODOMZO oxaliplatin intravenous recon soln 100 mg PERJETA POMALYST RUBRACA ORAL TABLET 200 MG, 250 MG, 300 MG RYDAPT SPRYCEL ORAL TABLET 100 MG, 140 MG, 20 MG, 50 MG, 70 MG, 80 MG STIVARGA SUTENT SYLATRON SYLVANT SYNRIBO TAFINLAR ORAL CAPSULE 50 MG, 75 MG TAGRISSO TARCEVA ORAL TABLET 100 MG, 150 MG, 25 MG TASIGNA TECENTRIQ THALOMID ORAL CAPSULE 100 MG, 150 MG, 200 MG, 50 MG TIBSOVO 7

9 TREANDA INTRAVENOUS RECON SOLN TYKERB VENCLEXTA ORAL TABLET 10 MG, 100 MG, 50 MG VENCLEXTA STARTING PACK VERZENIO VOTRIENT XALKORI XTANDI PA YONDELIS YONSA ZEJULA ZELBORAF ZOLINZA ZYDELIG ZYKADIA ZYTIGA ORAL TABLET 250 MG, 500 MG Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Documentation of diagnosis. Oncologist or hematologist Indefinite as long as member is eligible. The listed anti-cancer agents will be covered when being used for a FDA approved indication or an off-label indication that is supported by one of the approved compendia as specified by Medicare Part D guidelines. The currently recognized compendia are: 1) American Hospital Formulary Service Drug (AHFS DI), 2) United States Pharmacopeia - Drug (USP DI), 3) Thomson Micromedex DRUGDEX System, 4) National Comprehensive Cancer Network Drugs and Biological Compendium (NCCN) and 5) Elsevier Gold Standard's Clinical Pharmacology. 8

10 CARBAGLU CARBAGLU PA Documentation of diagnosis Indefinite as long as member is eligible. Other 9

11 CAYSTON CAYSTON PA Other Documentation of diagnosis, laboratory data and documentation of previous treatments. 7 years or older Pulmonologist, Infectious Disease Specialist or specialist in Cystic Fibrosis Initially for 6 months. Continuation requests may be approved for 6 months based on response. Documentation that inhaled bronchodilator is administered prior to Cayston. Member has had a trial, an inadequate response, or contraindication to inhaled an tobramycin nebulizer solution. 10

12 CHOLBAM CHOLBAM PA Covered Uses All medically accepted indications not otherwise excluded from Part D. Documentation of diagnosis, lab results, and patient progress notes Other Initially for 3 months Continuation requests may be approved indefinitely. Continuation requests require 1) body weight increased by 10% or is stable at more than or equal to 50th percentile, 2) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 50U/L or baselinelevels are reduced by 80%, 3) Must not have evidence of cholestasis on liver biopsy. 11

13 CIALIS CIALIS ORAL TABLET 2.5 MG, 5 MG PA Other Not covered for sexual dysfunction unrelated to BPH. information to support the diagnosis of benign prostatic hyperplasia (BPH). Indefinite as long as member is eligible. 12

14 COLONY STIMULATING FACTORS FULPHILA GRANIX LEUKINE INJECTION RECON SOLN NEULASTA SUBCUTANEOUS SYRINGE NEUPOGEN PA NIVESTYM SUBCUTANEOUS SYRINGE 300 MCG/0.5 ML, 480 MCG/0.8 ML ZARXIO INJECTION SYRINGE 300 MCG/0.5 ML, 480 MCG/0.8 ML Other Documentation of diagnosis. All diagnosis 6 mos. 13

15 CYSTIC FIBROSIS AGENT KALYDECO ORAL GRANULES IN PACKET KALYDECO ORAL TABLET PA ORKAMBI ORAL GRANULES IN PACKET ORKAMBI ORAL TABLET SYMDEKO Other Documentation of diagnosis and confirmation of the mutation as detected by a FDA-cleared test. Kalydeco - patients 2 years of age and older. Orkambi - patients 6 years of age and older. Indefinite as long as member is eligible. 14

16 DARAPRIM DARAPRIM PA Other Megaloblactic anemia due to folate deficiency. Documentation of diagnosis and any concomitant therapy. 1 year 15

17 DERMATOLOGICAL PRODUCTS (RETINOIDS AND ACNE MEDS) adapalene topical cream adapalene topical gel avita TAZORAC tretinoin topical cream tretinoin topical gel 0.01 %, % PA Other Documentation of diagnosis, confirmation of non-cosmetic indication. Indefinite as long as member is eligible. 16

18 DIFICID DIFICID PA Other Documentation of Clostridium Difficile Associated Diarrhea diagnosis, medical records or pharmacy claims documenting previous drug treatments. Infectious Disease Specialist or Gastroenterologist. 10 days. Member must have a documented prior trial or contraindication with metronidazole and vancomycin. Approval will be granted if member has been receiving Dificid as an inpatient during hospitalization and needs to complete the course of therapy as an outpatient. 17

19 DUCHENNE MUSCULAR DYSTROPHY EMFLAZA PA Covered Uses ALL FDA APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D. Diagnosis confirmed by abnormal dystrophin presence or mutation or dystrophin gene. Serum creatinine kinase activity 10x upper limit or normal. Baseline 6 minute walk test. Prior three month trial of prednisone. 5 years or greater Other Initial request approval will be 4 months. Continuation approval will be indefinitely if eligible. Patient has experienced a clinical benefit from therapy (e.g., improvement or preservation of muscle strength) 18

20 EGRIFTA EGRIFTA SUBCUTANEOUS RECON SOLN 1 MG PA Documentation of a diagnosis Other Initial 6 months. Continuation requests will be approved indefinitely as long as member is eligible. Continuation criteria: member must show improvement in visceral adipose tissue by waist circumference or computed tomography scan AND improvement in lipid and triglyceride levels. 19

21 ENBREL ENBREL SUBCUTANEOUS RECON SOLN ENBREL SUBCUTANEOUS SYRINGE 25 MG/0.5ML (0.51), 50 MG/ML (0.98 ML) ENBREL SURECLICK PA Other Documentation of diagnosis and documentation of previous treatments. Dermatologist or Rheumatologist. Indefinite as long as member is eligible. Ankylosing Spondylitis: Member has tried, had an inadequate response to, or valid contraindication with one conventional treatment including: NSAIDs, COX-2 inhibitors or sulfasalazine. Plaque Psoriasis: Member has had a trial, inadequate response, or valid contraindication to treatment with one conventional treatment including: topical therapies (e.g., phototherapy, steroids, vitamin D analogs) or systemic therapies (e.g., acitretin, cyclosporine, methotrexate). Polyarticular Juvenile Idiopathic Arthritis: Member has had a trial, inadequate response, or valid contraindication to treatment with one disease-modifying antirheumatic drug: azathioprine, hydroxychloroquine, or methotrexate. Psoriatic or Rheumatoid Arthritis: Member has had a trial, inadequate response, or valid contraindication to treatment with one disease-modifying antirheumatic drug: sulfasalazine, hydroxychloroquine, methotrexate or leflunomide. 20

22 FLECTOR FLECTOR PA Other Documentation of diagnosis. 12 months 21

23 FORTEO FORTEO TYMLOS PA Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Documentation of a diagnosis, previous treatments, history of bone fracture, and bone density status. 2 years criteria: member had a documented, unsatisfactory response or intolerance to oral bisphosphonate therapy OR has multiple risk factors or history of osteoporotic fracture(s). 22

24 GATTEX GATTEX 30-VIAL PA Other Documentation of diagnosis and medical records. Gastroenterologist 1 year records are needed to confirm member dependence on total parental/iv nutrition. 23

25 GLP-1 RECEPTOR AGONISTS OZEMPIC TANZEUM PA TRULICITY Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Confirmation of a diabetes type 2 diagnosis, HgbA1C value and documentation (prescription claims records or medical records) supporting an adequate trial of metformin. Indefinite as long as member is eligible. Maybe approved if the following criteria are met: 1) Member has a diagnosis of diabetes mellitus type II AND 2) Member has an HgbA1C value greater than 7.0% AND 3) Member had a recent (within 2 years) clinical trial, inadequate response, or a valid contraindication to a maximum dose of metformin (Maximum metformin daily dose varies by product (2000mg-2550mg/day).) 24

26 GROWTH HORMONE NORDITROPIN FLEXPRO PA Covered Uses All medically accepted indications not otherwise excluded from Part D. Documentation of diagnosis, patient progress notes including growth curves for children and pertinent lab/genetic testing results to confirm growth hormone deficiency (such as 2 provocative growth hormone stimulation tests or IGF-1 and other pituitary hormone values if stimulation tests are not done). Genetic testing as needed to verify diagnosis of Prader - Willi, Turner or Noonan syndromes. Other Endocrinologist for growth hormone deficiency indications Ped: Initial: 6mo, Reauth: 6mo. Adult: Initial: 6mo, Reauth: indefinite based on clinical response Member must be diagnosed with one of the following: 1) child with a proven* GH deficiency 2) adult with a proven* GH deficiency 3) child with height less than 3rd percentile for chronological age with chronic renal insufficiency 4) Prader-Willi Syndrome confirmed by appropriate genetic testing 5) child with short stature associated with Turners syndrome 6) child with short stature associated with Noonan syndrome) 7) AIDS-related wasting. *Proven GH deficiency (GHD) is defined as an abnormal response to TWO provocative stimulation tests, such as L-dopa, clonidine, glucagon, propranolol, arginine or insulin. (For children, abnormal response is defined as less than 10ng/ml and 5ng/ml or less for adults. Adults may alternatively demonstrate 3 other pituitary hormone deficiencies. GHD stimulation testing is not necessary for conditions 1-7 above, or for those members with a history of surgery or irradation in the region of the hypothalamus and pituitary. It is also not necessary for children who have evidence of additional pituitary hormone deficiencies, pituitary stalk agenosis, empty sella or supra-sellar mass lesion is documented with short stature. CRITERIA FOR CONTINUATION OF GROWTH HORMONE COVERAGE IN CHILDREN: 1) Patient continues to be under the appropriate care and re-evaluations of a 25

27 PA specialist knowledgeable in the management of growth hormone deficiency and has had a documented positive clinical response to treatment. 26

28 HEREDITARY ANGIOEDEMA AGENTS CINRYZE FIRAZYR PA Confirmation of diagnosis by genetic testing or normal C1q laboratory levels. Patient has previously tried at least one prior therapy including 17 alpha-alkylated androgens or an anti-fibrinolytic agent. Other Allergist, immunologist or hematologist. Initial 3 months. Continuation requests will be approved one year. criteria: Member experiences one or more severe HAE attacks monthly AND symptoms must include airway swelling, severe abdominal pain, facial swelling, nausea and vomiting or painful facial distortion. Continuation approval may be considered if the following criterion is met: 1) documented decrease in HAE attack frequency OR 2) documented improvement in severity or duration of attacks. 27

29 HETLIOZ HETLIOZ PA Documentation of diagnosis and any previous treatments. Other Sleep Specialist or Neurologist. Initial coverage for 3 months, continuation coverage is for 1 year For initial therapy: 1) diagnosis of Non-24 Hour Sleep-Wake Disorder, AND 2) diagnosis of total blindness in both eyes (eg, nonfunctioning retinas), AND 3) unable to perceive light in both eyes. For continuation, must meet at least one of the following: 1) increased total nighttime sleep, OR 2) decreased daytime nap duration. 28

30 HIGH RISK MEDICATIONS - SKELETAL MUSCLE RELAXANTS carisoprodol cyclobenzaprine oral tablet 10 mg, 5 mg PA Other Only applies to members 65 years of age or older. Authorization will be for 21 days. Prior authorization only applies to members 65 years of age and older who will be evaluated for appropriate use of high risk medication. Use will only be approved if prescribing provider has assessed risk versus benefit in using this medication in this member and has confirmed that he/she believes it is in member's best interest to initiate/continue therapy. 29

31 HUMIRA HUMIRA PEDIATRIC CROHN'S START SUBCUTANEOUS SYRINGE KIT 40 MG/0.8 ML, 80 MG/0.8 ML, 80 MG/0.8 ML-40 MG/0.4 ML HUMIRA PEN HUMIRA PEN CROHN'S-UC-HS START SUBCUTANEOUS PEN INJECTOR KIT 40 MG/0.8 ML, 80 MG/0.8 ML PA HUMIRA PEN PSORIASIS-UVEITIS SUBCUTANEOUS PEN INJECTOR KIT 40 MG/0.8 ML, 80 MG/0.8 ML-40 MG/0.4 ML HUMIRA SUBCUTANEOUS SYRINGE KIT 10 MG/0.1 ML, 10 MG/0.2 ML, 20 MG/0.2 ML, 20 MG/0.4 ML, 40 MG/0.4 ML, 40 MG/0.8 ML KEVZARA SUBCUTANEOUS SYRINGE Other Documentation of diagnosis and previous treatments. Dermatologist, Gastroenterologist, Ophthalmologist, or Rheumatologist. Indefinite as long as member is eligible. criteria: Ankylosing Spondylitis: Trial, inadequate response, or valid contraindication with one conventional treatment including: NSAIDs, COX-2 inhibitors or sulfasalazine. Crohn's Disease and Ulcerative Colitis: Trial, inadequate response, or valid contraindication with one conventional treatment including: immunosuppressant, corticosteroid, or aminosalicylate. Hidradenitis Suppurativa (acne inversa): Trial, inadequate response, or valid contraindication with one conventional treatment including: topical antibiotic, systemic antibiotic, intralesional corticosteroid. Plaque Psoriasis: Trial, inadequate response, or valid contraindication with one conventional treatment including: topical therapies or systemic therapies. Polyarticular Juvenile Idiopathic Arthritis: Trial, inadequate response, or valid contraindication with one DMARD. Psoriatic or Rheumatoid Arthritis: Trial, inadequate response, or valid contraindication with one DMARD. Uveitis: Trial, inadequate 30

32 PA response, or valid contraindication with one conventional treatment including: immunosuppressant, DMARD, or corticosteroid.(immunosuppressant ex. methotrexate, azathioprine, 6- mercaptopurine)(corticosteroids ex. prednisone, hydrocortisone, budesonide)(aminosalicylates ex. sulfasalazine, mesalamine)(topical antibiotics ex. clindamycin)(systemic antibiotics ex. tetracycline, doxycycline, minocycline)(intralesional corticosteroids ex. triamcinolone)(topical therapies ex. phototherapy, steroids, vitamin D analogs)(systemic therapies ex. acitretin, cyclosporine, methotrexate)(dmard ex. Sulfasalazine, hydroxychloroquine, methotrexate, leflunomide) 31

33 HUNTINGTON DISEASE AGENTS AUSTEDO tetrabenazine oral tablet 12.5 mg, 25 mg PA Documentation that the patient is being treated for chorea associated with Huntington's disease Neurologist Indefinite as long as member is eligible. Other 32

34 IMMUNOSUPPRESSIVE, ANTI-INFLAMMATORY AGENTS ACTEMRA SUBCUTANEOUS CIMZIA CIMZIA POWDER FOR RECONST COSENTYX (2 SYRINGES) COSENTYX PEN (2 PENS) ORENCIA ORENCIA CLICKJECT OTEZLA OTEZLA STARTER SILIQ SIMPONI ARIA SIMPONI SUBCUTANEOUS PEN INJECTOR SIMPONI SUBCUTANEOUS SYRINGE 100 MG/ML, 50 MG/0.5 ML STELARA SUBCUTANEOUS TALTZ AUTOINJECTOR TALTZ SYRINGE XELJANZ XELJANZ XR PA Other Documentation of diagnosis and previous treatments. Documentation of recent (within previous year) negative tuberculin (TB) test. Rheumatologist, Gastroenterologist or Dermatologist Indefinite as long as member is eligible. criteria: Ankylosing Spondylitis: Trial, inadequate response, or valid contraindication with Humira and Enbrel. Crohn's Disease and Ulcerative Colitis: Trial, inadequate response, or valid contraindication with Humira. Plaque Psoriasis: Trial, inadequate response, or valid contraindication with Humira and Enbrel. Polyarticular Juvenile Idiopathic Arthritis: Trial, inadequate response, or valid contraindication with Humira and Enbrel. Psoriatic or Rheumatoid Arthritis: Trial, inadequate response, or valid contraindication with Humira and Enbrel. 33

35 INCRELEX INCRELEX PA Closed epiphyses Documentation of diagnosis, patient progress notes including growth measurements/charts and pertinent lab test results including basal IGF-1 values or documentation supporting growth hormone (GH) gene deletion and development of neutralizing antibodies to GH. Other Pediatric Endocrinologist Initial request 1 year. Continuation requests will be approved annually based on ephipysis status. for mecasermin may be approved when the following conditions are met: 1. The member is a child with a diagnosis of growth failure with severe primary IGFD or with growth hormone (GH) gene deletion who has developed neutralizing antibodies to GH and, 2. The members height standard deviation score less than or equal to -3.0 for age and sex and, 3. The members basal IGF-1 standard deviation score less than or equal to and, 4. The member has normal or elevated growth hormone (GH)and confirmation that epiphyses open. Continuation requests approved upon confirmation that epiphysis are not closed AND growth rate velocity equal or greater to 2.5 cm/year. 34

36 INHALED TOBRAMYCIN AGENTS BETHKIS TOBI PODHALER INHALATION CAPSULE, W/INHALATION DEVICE PA tobramycin in % nacl Documentation of diagnosis, past medication history, and recent culture data. Other 12 months Member has sputum cultures positive for or colonization history of Pseudomonas aeruginosa. For TOBI Podhaler and Bethkis: member has had a trial, an inadequate response, or contraindication to generic tobramycin nebulization solution. 35

37 INTERFERONS INTRON A INJECTION PEGASYS PROCLICK PEGASYS SUBCUTANEOUS SOLUTION PEGASYS SUBCUTANEOUS SYRINGE PEGINTRON PEGINTRON REDIPEN PA Other Documentation of viral genotype and abscense of ascites, hepatic encephalopathy, variceal bleeding, or other clinical signs of decompensation for chronic hepatitis C indication. For any other FDA approved indication (ex. hepatitis B or hairy cell leukemia) only documentation of diagnosis is required. Hep C approved consistent to AASLD/IDSA guidance. Other FDA indications approved indefinitely. 36

38 IRON CHELATING AGENTS EXJADE FERRIPROX JADENU JADENU SPRINKLE PA Other Documentation of a diagnosis. Hematologist 1 year 37

39 KINERET KINERET PA Documentation of diagnosis and previous treatments Indefinite as long as member is eligible. Other RHEUMATOID ARTHRITIS: 1) Confirmation of diagnosis and 2) Documented trial, inadequate response or valid contraindication with one or more Disease Modifying Anti-rheumatic Drug (DMARDS) such as hydroxychloroquine, leflunomide, methotrexate or sulfasalazine AND a trial, contraindication, or intolerance to Humira or Enbrel. CRYOPYRIN- ASSOCIATED PERIODIC SYNDROME: 1) Confirmation of diagnosis. 38

40 KUVAN KUVAN PA Other Documentation of diagnosis and lab values Specialist knowledgeable in the management of PKU Initial request 1 year. Continuation requests will be approved annually based on clinical response. Initial criteria: Documentation of baseline blood Phe level measured within 2 weeks of Kuvan initiation request. Continuation criteria: Patient continues to be under the appropriate care and re-evaluations of a specialist knowledgeable in the management of PKU AND member has had a documented positive clinical response to treatment. Dosing is within the range of 5 to 20 mg/kg/day. 39

41 LANREOTIDE SOMATULINE DEPOT PA Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Diagnosis of acromegaly in those where surgery or radiotherapy produced an inadequate response or is not an option, diagnosis of poorly differentiated (high-grade) neuroendocrine tumors/large or small cell neuroendocrine tumors, diagnosis of carcinoid tumors, or diagnosis of pancreatic endocrine tumors (islet cell tumors). Indefinite as long as member is eligible. 40

42 LIDODERM/LIDOCAINE PATCH lidocaine topical adhesive patch,medicated PA Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Documentation of diagnosis. Indefinite as long as member is eligible. 41

43 MULTIPLE SCLEROSIS AGENTS AUBAGIO BETASERON SUBCUTANEOUS KIT PLEGRIDY REBIF (WITH ALBUMIN) REBIF REBIDOSE SUBCUTANEOUS PEN INJECTOR 22 MCG/0.5 ML, 44 PA MCG/0.5 ML, 8.8MCG/0.2ML-22 MCG/0.5ML (6) REBIF TITRATION PACK ZINBRYTA Other Documentation of diagnosis and previous treatments Neurologist Indefinite as long as member is eligible. will be provided if there is a documented clinical trial, inadequate response or valid contrindication to prior treatment with Avonex, Extavia, Copaxone, Glatopa, Gilenya or Tecfidera. 42

44 MYALEPT MYALEPT PA Concomitant diagnosis of HIV, infectious liver disease, or acquired lipodystrophy with hematologic abnormalities. Documentation of diagnosis and required laboratory monitoring. Member has been diagnosis of congenital or acquired generalized lipodystrophy AND member has clinical manifestations present consistent with leptin deficiency including: diabetes mellitus (HBA1c more than 6.5%) OR hypertriglyceridemia (a fasting level more than 500 mg/dl) Other Initial: 1 year. Reauthorization: 1 year with documented evidence of clinical beneficial response Continuation criteria: 1) Member is responding to and tolerating treatment AND 2) Member does not have anti-metreleptin antibodies AND 3) member has achieved or maintained a decrease in baseline laboratory levels at time of diagnoses including: a. HbA1c (more than or equal to 2% decrease) OR b. fasting triglyceride level (more than or equal to 184 mg/dl decrease) 43

45 NOXAFIL NOXAFIL ORAL SUSPENSION NOXAFIL ORAL TABLET,DELAYED RELEASE (DR/EC) PA Other Documentation of diagnosis and previous treatments. Excluded for members who are younger than 13 years old Infectious disease provider, Pulmonologist, Hematologist or Oncologist for 1 month for oropharyngeal candiasis or 6 months for all other indications. Members with diagnosis of oropharyngeal candidiasis that have tried and failed at least 2 weeks of therapy with, or is not a candidate for, fluconazole or itraconazole. Also, prophylactic use against Aspergillus and Candida infection in individuals that are immunosuppressed due to hematopoietic stem cell transplant secondary to graft-versus host disease or hematologic malignancy with prolonged neutropenia secondary to chemotherapy. 44

46 NUEDEXTA NUEDEXTA PA Covered Uses Other All FDA-approved indications not otherwise excluded from Part D. Documentation of diagnosis. Neurologist Indefinite as long as member is eligible. 45

47 PCSK-9 INHIBITORS PRALUENT PEN REPATHA PUSHTRONEX REPATHA SURECLICK REPATHA SYRINGE PA Other Documentation of diagnosis,, previous drug treatments and required laboratory monitoring. For Heterozygous familial hypercholesterolemia (HeFH): attestation of genetic testing, Simon-Broome criteria for Familial Hypercholesterolemia or WHO Dutch Lipid Clinic Network diagnostic score of 8 or higher. For Homozygous familial hypercholesterolemia (HoFH): genetic testing showing at least one LDL receptor-defective mutation OR clinical diagnosis on the basis of an untreated LDL-C plasma concentration more than 500 mg/dl (more than 13 mmol) AND either the presence of tendon xanthomas before the age of 10 years OR evidence of HeFH in both parents. must be a cardiologist, endocrinologist, or lipid specialist. Initial: 1 year. Reauthorization: 1 year with documented evidence of clinical beneficial response Member is intolerant, on high-intensity statin therapy or maximally tolerated statin therapy and is not at LDL-C level goal. 46

48 PROLIA PROLIA PA Other Documentation of a diagnosis, bone density status, history of bone fracture and previous treatments. 1 year 47

49 PROMACTA PROMACTA ORAL TABLET 12.5 MG, 25 MG, 50 MG, 75 MG PA Documentation of diagnosis, lab results with current platelet count, previous treatments. Chronic ITP: 1)documentation of trial with corticosteroids or immunoglobulin 2)platelet count less than 30,000/mcL. Hepatitis C associated thrombocytopenia: 1) member has been prescribed interferon for treatment of chronic hepatitis C 2) platelet count less than 75,000/mcL. Severe aplastic anemia, initial: 1) trial with one immunosuppressant 2)platelet count less than 30,000/mcL. Other Hematologist, Oncologist, Gastroenterologist or Infectious Disease Specialist. Chronic ITP or severe aplastic anemia: 6 mo. Hepatitis C associated thrombocytopenia: up to 48 wk Severe aplastic anemia, continuation: 1) platelet count of at least 20,000/mcL above baseline, or stable counts with transfusion independence for a minimum of 8 weeks OR 2) Hemoglobin increase by greater than 1.5g/dl or reduction in greater than or equal to 4 unitsof RBC transfusions for 9 consecutive weeks OR 3)ANC increase of 100% or an ANC increase greater than 500/mcL. 48

50 PULMONARY ARTERIAL HYPERTENSION ADCIRCA ADEMPAS OPSUMIT ORENITRAM REVATIO ORAL SUSPENSION FOR RECONSTITUTION sildenafil (antihypertensive) oral tadalafil (antihypertensive) UPTRAVI ORAL TABLET 1,000 MCG, 1,200 MCG, 1,400 MCG, 1,600 MCG, 200 MCG, 400 MCG, 600 MCG, 800 MCG UPTRAVI ORAL TABLETS,DOSE PACK PA Other Documentation of diagnosis. Indefinite as long as member is eligible. Documentation of diagnosis of pulmonary arterial hypertension. 49

51 PULMONARY FIBROSIS AGENTS ESBRIET ORAL CAPSULE ESBRIET ORAL TABLET PA OFEV Other Documentation of diagnosis. Prescribed by or in consultation with a Pulmonologist. Indefinite as long as member is eligible. Esbriet (pirfenidone) is not to be used in conjunction with Ofev (nintedanib). 50

52 PULMOZYME PULMOZYME PA Documentation of diagnosis Initially for 1 year. Continuation requests may be approved for one year based on clinical response Other 51

53 QUININE SULFATE quinine sulfate PA Covered Uses All medically accepted indications not otherwise excluded from Part D. Other is excluded for treatment of leg cramps. Documentation of diagnosis. 7 to 10 days. will be approved for diagnosis of uncomplicated Plasmodium falciparum malaria or babesiosis. 52

54 RAVICTI RAVICTI PA Documentation of diagnosis Patient is 2 months of age or older Other Initial approval 1 year. Continuation requests approved indefinite as long as member is eligible. criteria: 1) Member has had a trial, inadequate response, or valid contraindication to sodium phenylbutyrate (Buphenyl) therapy. Continuation criteria: 1) member has had a documented positive clinical response to treatment. 53

55 REGRANEX REGRANEX PA Covered Uses All medically accepted indications not otherwise excluded from Part D. Documentation of diagnosis, adequate blood supply to ulcer and persistence of good ulcer care. Initial approval 3 months. Continuation requests will be approved for 3 months. Other Regranex gel is covered when the following conditions are met: 1) Member has chronic lower extremity diabetic neuropathic ulcers extending into the subcutaneous tissue or beyond, and 2) Ulcer has adequate tissue blood supply (determined by a transcutaneous oxygen pressure of TcpO2 greater than 30mm Hg or verified with Doppler flow). Continuation criteria: Ulcer decreased in size by 30%. 54

56 REVLIMID REVLIMID ORAL CAPSULE 10 MG, 15 MG, 2.5 MG, 20 MG, 25 MG, 5 MG PA Documentation of diagnosis and previous treatments Oncologist or hematologist One year. Other 55

57 SAMSCA SAMSCA PA Documentation of diagnosis Other 30 days. Therapy must be initiated in hospital setting 56

58 SANDOSTATIN/OCTREOTIDE octreotide acetate SANDOSTATIN LAR DEPOT INTRAMUSCULAR PA SUSPENSION,EXTENDED REL RECON Covered Uses All medically accepted indications not otherwise excluded from Part D. Documentation of diagnosis. Other Initial request 1 year. Continuation requests will be approved annually based on clinical response. ly accepted indications include: Metastatic carcinoid or neuroendocrine tumors, Vasoactive Intestinal Peptide secreting tumors (VIPomas) associated with profuse, watery diarrhea, Acromegaly, Meningioma (CNS cancers), Neuroendocrine Tumors of the Pancreas, Thymic cancer and thymomas. 57

59 SOLARAZE diclofenac sodium topical gel 3 % PA Other Documentation of diagnosis. Indefinite as long as member is eligible. 58

60 STRENSIQ STRENSIQ PA Documentation of diagnosis, laboratory data Indefinite as long as member is eligible. Other 59

61 TESTOSTERONE REPLACEMENT ANDRODERM TRANSDERMAL PATCH 24 HOUR 2 MG/24 HOUR, 4 MG/24 HR ANDROGEL TRANSDERMAL GEL IN METERED-DOSE PUMP MG/1.25 GRAM (1.62 %) ANDROGEL TRANSDERMAL GEL IN PACKET 1.62 % (20.25 MG/1.25 GRAM), 1.62 % (40.5 MG/2.5 GRAM) DEPO-TESTOSTERONE INTRAMUSCULAR OIL 200 MG/ML testosterone cyp 200 mg/ml sdv, latex-free testosterone cypionate intramuscular oil 200 mg/ml testosterone enanthate testosterone transdermal gel in metereddose pump 12.5 mg/ 1.25 gram (1 %) testosterone transdermal gel in packet PA Diagnosis of primary hypogonadism (congenital or acquired) or secondary (hypogonadotropic) hypogonadism (congenital or acquired) in males. Serum testosterone level. Indefinite as long as member is eligible. Other 60

62 TRANSMUCOSAL IMMEDIATE-RELEASE FENTANYL (TIRF) fentanyl citrate PA Other Documentation of diagnosis and previous treatments Indefinite as long as member is eligible. 61

63 TYSABRI TYSABRI PA Other Documentation of diagnosis and previous treatments. Verification that Tysabri is not being used concurrently with other medications (for treatment of MS). 18 years of age or older Must by prescribed by, or in consultation with a neurologist or gastroenterologist. Initial: 12 weeks. Continuation: 1year Continuation requests may be approved when member has had a documented positive clinical response to treatment. 62

64 VORICONAZOLE voriconazole oral suspension for reconstitution PA voriconazole oral tablet Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Documentation of diagnosis and other first-line medications tried (as appropriate) unless contraindicated. Infectious Disease Specialist or Pulmonologist. Initial coverage for 1 month for esophageal candidiasis and 6 months for any other indication. Voriconazole coverage will be approved if the following conditions are met: 1) treatment of Invasive Aspergillus OR 2) treatment of fungal infections caused by Scedosporium apiospermum or Fusarium spp intolerant of, or refractory to, other therapy 3) treatment of esophageal candidiasis and has had trial with one other systemic antifungal agent including nystatin, clotrimazole, or fluconazole OR 4)treatment of Candidemia in non-neutropenic patients and has had trial with one other systemic antifungal agent including nystatin, clotrimazole, or fluconazole OR 5) treatment of Candida Infections in the abdomen, kidney, bladder wall or wounds or disseminated infections in skin 63

65 WAKEFULNESS PROMOTING AGENTS armodafinil oral tablet 150 mg, 200 mg, 250 mg, 50 mg PA modafinil Other Documentation of diagnosis Indefinite for narcolepsy and obstructive sleep apnea. Shift work sleep disorder, 1 year. : 1) diagnosis of narcolepsy confirmed by sleep lab evaluation 2)diagnosis of obstructive sleep apnea (OSA) confirmed by polysomnography 3) diagnosis of shift work disorder (SWD) and a letter from patient's employer is required stating that the patient is working variable, alternating or 3rd shift. For continuation requests for shift work disorder, requests are reviewed annually to review the member's work schedule. 64

66 XGEVA XGEVA PA Other Documentation of diagnosis. Oncologist 1 year 65

67 XYREM XYREM PA Documentation of diagnosis, other medications and medical records Other Neurologist, Pulmonologist, or Sleep Specialist Initial approval 3 months. Continuation requests approved Indefinite as long as member is eligible. criteria: records to confirm 1) member does not concomitantly take with sedative hypnotic treatment, CNS depressants, or alcohol AND 2) does not have a succinic semialdehyde dehydrogenase deficiency. Continuation criteria: Demonstrated reduction in symptoms of excessive daytime sleepiness or frequency of cataplexy attacks. 66

68 INDEX A ACTEMRA SUBCUTANEOUS adapalene topical cream adapalene topical gel ADCIRCA ADEMPAS AFINITOR... 7, 8 AFINITOR DISPERZ... 7, 8 AIMOVIG 70 MG/ML AUTOINJECTOR 6 AIMOVIG AUTOINJECTOR (2 PACK).. 6 ALECENSA... 7, 8 ALUNBRIG ORAL TABLET 180 MG, 30 MG, 90 MG... 7, 8 ALUNBRIG ORAL TABLETS,DOSE PACK... 7, 8 AMPYRA... 2 ANDRODERM TRANSDERMAL PATCH 24 HOUR 2 MG/24 HOUR, 4 MG/24 HR ANDROGEL TRANSDERMAL GEL IN METERED-DOSE PUMP MG/1.25 GRAM (1.62 %) ANDROGEL TRANSDERMAL GEL IN PACKET 1.62 % (20.25 MG/1.25 GRAM), 1.62 % (40.5 MG/2.5 GRAM)60 ARALAST NP INTRAVENOUS RECON SOLN 1,000 MG... 1 armodafinil oral tablet 150 mg, 200 mg, 250 mg, 50 mg AUBAGIO AUSTEDO avita B BETASERON SUBCUTANEOUS KIT.. 42 BETHKIS bexarotene... 7, 8 BOSULIF ORAL TABLET 100 MG, 400 MG, 500 MG... 7, 8 BRAFTOVI ORAL CAPSULE 50 MG, 75 MG... 7, 8 C CABOMETYX... 7, 8 CALQUENCE... 7, 8 CAPRELSA ORAL TABLET 100 MG, 300 MG... 7, 8 CARBAGLU... 9 carisoprodol CAYSTON CHOLBAM CIALIS ORAL TABLET 2.5 MG, 5 MG. 12 CIMZIA CIMZIA POWDER FOR RECONST CINRYZE COMETRIQ ORAL CAPSULE 100 MG/DAY(80 MG X1-20 MG X1), 140 MG/DAY(80 MG X1-20 MG X3), 60 MG/DAY (20 MG X 3/DAY)... 7, 8 COSENTYX (2 SYRINGES) COSENTYX PEN (2 PENS) COTELLIC... 7, 8 cyclobenzaprine oral tablet 10 mg, 5 mg.. 29 CYRAMZA... 7, 8 D dalfampridine... 2 DARAPRIM DARZALEX... 7, 8 DEPO-TESTOSTERONE INTRAMUSCULAR OIL 200 MG/ML 60 diclofenac sodium topical gel 3 % DIFICID E EGRIFTA SUBCUTANEOUS RECON SOLN 1 MG EMFLAZA EMPLICITI... 7, 8 ENBREL SUBCUTANEOUS RECON SOLN ENBREL SUBCUTANEOUS SYRINGE 25 MG/0.5ML (0.51), 50 MG/ML (0.98 ML) ENBREL SURECLICK EPCLUSA... 5 ERIVEDGE... 7, 8 ERLEADA... 7, 8 ESBRIET ORAL CAPSULE ESBRIET ORAL TABLET EXJADE F FARYDAK... 7, 8 fentanyl citrate

69 FERRIPROX FIRAZYR FLECTOR FORTEO FULPHILA G GATTEX 30-VIAL GILOTRIF... 7, 8 GLASSIA... 1 GLEOSTINE... 7, 8 GRANIX H HARVONI... 5 HETLIOZ HUMIRA PEDIATRIC CROHN'S START SUBCUTANEOUS SYRINGE KIT 40 MG/0.8 ML, 80 MG/0.8 ML, 80 MG/0.8 ML-40 MG/0.4 ML HUMIRA PEN HUMIRA PEN CROHN'S-UC-HS START SUBCUTANEOUS PEN INJECTOR KIT 40 MG/0.8 ML, 80 MG/0.8 ML HUMIRA PEN PSORIASIS-UVEITIS SUBCUTANEOUS PEN INJECTOR KIT 40 MG/0.8 ML, 80 MG/0.8 ML-40 MG/0.4 ML HUMIRA SUBCUTANEOUS SYRINGE KIT 10 MG/0.1 ML, 10 MG/0.2 ML, 20 MG/0.2 ML, 20 MG/0.4 ML, 40 MG/0.4 ML, 40 MG/0.8 ML I IBRANCE... 7, 8 ICLUSIG... 7, 8 IDHIFA... 7, 8 imatinib... 7, 8 IMBRUVICA ORAL CAPSULE 140 MG, 70 MG... 7, 8 IMBRUVICA ORAL TABLET... 7, 8 INCRELEX INLYTA ORAL TABLET 1 MG, 5 MG 7, 8 INTRON A INJECTION IRESSA... 7, 8 itraconazole oral capsule... 4 itraconazole oral solution... 4 J JADENU JADENU SPRINKLE JAKAFI... 7, 8 K KALYDECO ORAL GRANULES IN PACKET KALYDECO ORAL TABLET KEVZARA SUBCUTANEOUS SYRINGE KEYTRUDA... 7, 8 KINERET KISQALI... 7, 8 KISQALI FEMARA CO-PACK... 7, 8 KUVAN L LARTRUVO... 7, 8 LENVIMA ORAL CAPSULE 10 MG/DAY (10 MG X 1), 12 MG/DAY (4 MG X 3), 14 MG/DAY(10 MG X 1-4 MG X 1), 18 MG/DAY (10 MG X 1-4 MG X2), 20 MG/DAY (10 MG X 2), 24 MG/DAY(10 MG X 2-4 MG X 1), 4 MG, 8 MG/DAY (4 MG X 2)... 7, 8 LEUKINE INJECTION RECON SOLN.. 13 lidocaine topical adhesive patch,medicated linezolid... 3 linezolid 600 mg/300 ml-0.9% nacl... 3 linezolid in dextrose 5%... 3 LONSURF ORAL TABLET MG, MG... 7, 8 LYNPARZA ORAL CAPSULE... 7, 8 LYNPARZA ORAL TABLET... 7, 8 M MAVYRET... 5 MEKINIST ORAL TABLET 0.5 MG, 2 MG... 7, 8 MEKTOVI... 7, 8 modafinil MYALEPT N NERLYNX... 7, 8 NEULASTA SUBCUTANEOUS SYRINGE NEUPOGEN NINLARO... 7, 8 68

70 NIVESTYM SUBCUTANEOUS SYRINGE 300 MCG/0.5 ML, 480 MCG/0.8 ML NORDITROPIN FLEXPRO NOXAFIL ORAL SUSPENSION NOXAFIL ORAL TABLET,DELAYED RELEASE (DR/EC) NUEDEXTA O octreotide acetate ODOMZO... 7, 8 OFEV OPSUMIT ORENCIA ORENCIA CLICKJECT ORENITRAM ORKAMBI ORAL GRANULES IN PACKET ORKAMBI ORAL TABLET OTEZLA OTEZLA STARTER oxaliplatin intravenous recon soln 100 mg 7, 8 OZEMPIC P PEGASYS PROCLICK PEGASYS SUBCUTANEOUS SOLUTION PEGASYS SUBCUTANEOUS SYRINGE PEGINTRON PEGINTRON REDIPEN PERJETA... 7, 8 PLEGRIDY POMALYST... 7, 8 PRALUENT PEN PROLASTIN-C INTRAVENOUS RECON SOLN... 1 PROLIA PROMACTA ORAL TABLET 12.5 MG, 25 MG, 50 MG, 75 MG PULMOZYME Q quinine sulfate R RAVICTI REBIF (WITH ALBUMIN) REBIF REBIDOSE SUBCUTANEOUS PEN INJECTOR 22 MCG/0.5 ML, 44 MCG/0.5 ML, 8.8MCG/0.2ML-22 MCG/0.5ML (6) REBIF TITRATION PACK REGRANEX REPATHA PUSHTRONEX REPATHA SURECLICK REPATHA SYRINGE REVATIO ORAL SUSPENSION FOR RECONSTITUTION REVLIMID ORAL CAPSULE 10 MG, 15 MG, 2.5 MG, 20 MG, 25 MG, 5 MG RUBRACA ORAL TABLET 200 MG, 250 MG, 300 MG... 7, 8 RYDAPT... 7, 8 S SAMSCA SANDOSTATIN LAR DEPOT INTRAMUSCULAR SUSPENSION,EXTENDED REL RECON sildenafil (antihypertensive) oral SILIQ SIMPONI ARIA SIMPONI SUBCUTANEOUS PEN INJECTOR SIMPONI SUBCUTANEOUS SYRINGE 100 MG/ML, 50 MG/0.5 ML SIVEXTRO... 3 SOMATULINE DEPOT SPORANOX ORAL SOLUTION... 4 SPRYCEL ORAL TABLET 100 MG, 140 MG, 20 MG, 50 MG, 70 MG, 80 MG 7, 8 STELARA SUBCUTANEOUS STIVARGA... 7, 8 STRENSIQ SUTENT... 7, 8 SYLATRON... 7, 8 SYLVANT... 7, 8 SYMDEKO SYNRIBO... 7, 8 T tadalafil (antihypertensive)

71 TAFINLAR ORAL CAPSULE 50 MG, 75 MG... 7, 8 TAGRISSO... 7, 8 TALTZ AUTOINJECTOR TALTZ SYRINGE TANZEUM TARCEVA ORAL TABLET 100 MG, 150 MG, 25 MG... 7, 8 TASIGNA... 7, 8 TAZORAC TECENTRIQ... 7, 8 testosterone cyp 200 mg/ml sdv, latex-free testosterone cypionate intramuscular oil 200 mg/ml testosterone enanthate testosterone transdermal gel in metered-dose pump 12.5 mg/ 1.25 gram (1 %) testosterone transdermal gel in packet tetrabenazine oral tablet 12.5 mg, 25 mg.. 32 THALOMID ORAL CAPSULE 100 MG, 150 MG, 200 MG, 50 MG... 7, 8 TIBSOVO... 7, 8 TOBI PODHALER INHALATION CAPSULE, W/INHALATION DEVICE tobramycin in % nacl TREANDA INTRAVENOUS RECON SOLN... 8 tretinoin topical cream tretinoin topical gel 0.01 %, % TRULICITY TYKERB... 8 TYMLOS TYSABRI U UPTRAVI ORAL TABLET 1,000 MCG, 1,200 MCG, 1,400 MCG, 1,600 MCG, 200 MCG, 400 MCG, 600 MCG, 800 MCG UPTRAVI ORAL TABLETS,DOSE PACK V VENCLEXTA ORAL TABLET 10 MG, 100 MG, 50 MG... 8 VENCLEXTA STARTING PACK... 8 VERZENIO... 8 voriconazole oral suspension for reconstitution voriconazole oral tablet VOSEVI... 5 VOTRIENT... 8 X XALKORI... 8 XELJANZ XELJANZ XR XGEVA XTANDI... 8 XYREM Y YONDELIS... 8 YONSA... 8 Z ZARXIO INJECTION SYRINGE 300 MCG/0.5 ML, 480 MCG/0.8 ML ZEJULA... 8 ZELBORAF... 8 ZEMAIRA... 1 ZEPATIER... 5 ZINBRYTA ZOLINZA... 8 ZYDELIG... 8 ZYKADIA... 8 ZYTIGA ORAL TABLET 250 MG, 500 MG