Ally Rx D-SNP Current as of r 1, 2017

Transcription

1 Ally Rx D-SNP Current as of r 1, 2017 AMPYRA AMPYRA 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 Neurologist Initially for 3 months Continuation requests may be approved open ended based on response.. Other Continuation of treatment: A positive response is defined as a 20% improvement in walking speed or an improvement in functional impairment and activities of daily living. 1 /1/2017 1

2 ANTIBIOTIC linezolid SIVEXTRO PA Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Documentation of diagnosis and previous treatments Infectious Disease Specialist Requested acute need 6 to 28 days, longer for refractory disease 2

3 ANTIFUNGALS itraconazole SPORANOX ORAL SOLUTION PA 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 trial with oral terbinafine, pertinent lab/microbiology test results such as positive KOH, PAS, biopsy with a positive methenamine silver stain or fungal culture positive for a typical skin/nail pathogen. Concomitant conditions as identified by any of the following: pain surrounding nail, soft tissue involvement, diabetes mellitus, peripheral vascular disease, immunosuppression, concurrent cancer chemotherapy, concurrent chronic oral corticosteroid use, history of solid organ transplant, HIV, or severe peripheral vascular disease. For systemic fungal infection: diagnosis of a systemic fungal infection including, but not limited to blastomycosis, histoplasmosis, or aspergillosis. for retreatment of the onychomycosis shall not be granted unless a time period of 12 months or more has elapsed since the initial authorization. 3

4 ANTI-HEPATITIS C AGENTS DAKLINZA EPCLUSA HARVONI MAVYRET OLYSIO SOVALDI TECHNIVIE VIEKIRA PAK VIEKIRA XR VOSEVI ZEPATIER PA Other Documentation of hepatitis C virus diagnosis, genotype, cirrhosis status, and medical history Gastroenterologist, hepatologist, or infectious disease specialist. will be applied consistent with current AASLD/IDSA guidance. will be applied consistent with current AASLD/IDSA guidance. 4

5 ANTINEOPLASTICS AFINITOR AFINITOR DISPERZ ALECENSA ALUNBRIG bexarotene BOSULIF ORAL TABLET 100 MG, 500 MG CABOMETYX CAPRELSA COMETRIQ COTELLIC CYRAMZA DARZALEX EMPLICITI ERIVEDGE FARYDAK GILOTRIF GLEOSTINE IBRANCE ICLUSIG IDHIFA imatinib IMBRUVICA INLYTA IRESSA JAKAFI KEYTRUDA KISQALI KISQALI FEMARA CO-PACK LARTRUVO LENVIMA LONSURF LYNPARZA ORAL CAPSULE LYNPARZA ORAL TABLET MEKINIST NERLYNX NINLARO ODOMZO PERJETA POMALYST RUBRACA ORAL TABLET 200 MG, 300 MG RYDAPT SPRYCEL STIVARGA SUTENT SYNRIBO TAFINLAR TAGRISSO TARCEVA TASIGNA TECENTRIQ THALOMID TYKERB VENCLEXTA VENCLEXTA STARTING PACK VOTRIENT XALKORI XTANDI YONDELIS ZEJULA ZELBORAF ZOLINZA ZYDELIG ZYKADIA ZYTIGA ORAL TABLET 250 MG, 500 MG PA Covered Uses All medically accepted indications not otherwise excluded from Part D. 5

6 PA Other Documentation of diagnosis. Oncologist or hematologist Initial: 6 mos, then indefinitely as long as member is eligible based on clinical response 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. 6

7 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. 7

8 COLONY STIMULATING FACTORS GRANIX LEUKINE INJECTION RECON SOLN NEULASTA SUBCUTANEOUS SYRINGE NEUPOGEN ZARXIO PA Covered Uses Other All FDA-approved indications not otherwise excluded from Part D. All FDA-approved indications not otherwise excluded from Part D, treatment of chemotherapy-induced febrile neutropenia (FN), mobilization of and following transplantation of peripheral blood progenitor cells (PBPC), following bone marrow transplantation (BMT), acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), severe chronic neutropenia (congenital, cyclic, or idiopathic), leukemic relapse following allogeneic stem cell transplantation, myelodysplastic syndromes (MDS), agranulocytosis, aplastic anemia, HIV-related neutropenia. Documentation of diagnosis. All diagnosis 6 mos. 8

9 CYSTIC FIBROSIS AGENT KALYDECO ORKAMBI PA Other Documentation of diagnosis and confirmation of the mutation as detected by a FDA-cleared test. Indefinite as long as member is eligible. 9

10 DARAPRIM DARAPRIM PA Other Megaloblactic anemia due to folate deficiency. Documentation of diagnosis and any concomitant therapy. 1 year 10

11 DERMATOLOGICAL PRODUCTS (RETINOIDS AND ACNE MEDS) adapalene topical cream adapalene topical gel avita TAZORAC tretinoin microspheres topical gel with pump tretinoin topical cream tretinoin topical gel 0.01 %, % PA Other Confirmation of non-cosmetic indication. Indefinite as long as member is eligible. 11

12 DIFICID DIFICID PA Other Documentation of Clostridium Difficile Associated Diarrhea diagnosis AND 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/or vancomycin. 12

13 DUCHENNE MUSCULAR DYSTROPHY EMFLAZA PA Other 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 Initial request approval will be 4 months. Continuation approval will be indefinitely if eligible. Continuation requests require continuous use of therapy for 4 months, and a 20 meter improvement in the 6 minute walk test from baseline. 13

14 ENBREL ENBREL ENBREL SURECLICK PA Other Documentation of diagnosis and documentation of previous treatments. Dermatologist or Rheumatologist. Indefinite as long as member is eligible. 14

15 FAMILIAL HYPERCHOLESTEROLEMIA JUXTAPID KYNAMRO PA Other Documentation of diagnosis, laboratory data and previous treatments. Initially for 6 months. Continuation requests may be approved for 6 months based on response. will be approved if the following criteria are met: 1)Prescribed by a physician who is enrolled in the REMS Program 2)Documentation confirming a clinical or laboratory diagnosis of homozygous familial hypercholesterolemia 3)Member has documented trial, inadequate response, intolerance or contraindication with one or more hyperlipidemia agents. 15

16 FLECTOR FLECTOR PA Other Documentation of diagnosis. Indefinite as long as member is eligible. 16

17 FORTEO FORTEO 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 17

18 GATTEX GATTEX ONE-VIAL PA Other Documentation of diagnosis and medical records. Gastroenterologist 1 year records are needed to confirm member dependence on total parental/iv nutrition. 18

19 GLP-1 RECEPTOR AGONISTS TANZEUM TRULICITY PA 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% despite an adequate trial of metformin at maximally tolerated doses OR documentation that the member has a contraindication or intolerance to metformin. (Maximum metformin daily dose varies by product (2000mg-2550mg/day).) 19

20 GROWTH HORMONE NORDITROPIN FLEXPRO NUTROPIN AQ NUSPIN PA Covered Uses All medically accepted indications not otherwise excluded from Part D. Other 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. Endocrinologist for growth hormone deficiency indications Ped: Initial: 6mo, Reauth: 6mo. Adult: Initial: 6mo, Reauth: indefinite based on clinical response 1. Member must be, a. is a child with a proven* GH deficiency or, b. is an adult with a proven* GH deficiency, or c. is a child with height less than 3rd percentile for chronological age with chronic renal insufficiency or, d. has Prader-Willi Syndrome confirmed by appropriate genetic testing or, e. is a child with short stature associated with Turners syndrome or, f. is a child with short stature associated with Noonan syndrome ) or, g. has 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 c-g 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. Radiologic 20

21 PA evidence shows epiphysis has not yet closed (applies to children over age 10). 21

22 GROWTH HORMONE RELEASING FACTOR ANALOG EGRIFTA SUBCUTANEOUS RECON SOLN 1 MG PA Other Documentation of a diagnosis. Indefinite as long as member is eligible. 22

23 HEREDITY ANGIOEDEMA BERINERT INTRAVENOUS KIT CINRYZE FIRAZYR RUCONEST PA Other 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. Allergist, immunologist or hematologist. 1 year 23

24 HETLIOZ HETLIOZ PA Other Documentation of diagnosis and any previous treatments. Sleep Specialist or Neurologist. Initial coverage for 3 months, continuation coverage is for 1 year For patients currently on Hetlioz therapy, must meet at least one of the following criteria for continnuation: 1) increased total nighttime sleep, OR 2) decreased daytime nap duration. 24

25 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. 25

26 HUMIRA HUMIRA HUMIRA PEN HUMIRA PEN CROHN'S-UC-HS START HUMIRA PEN PSORIASIS-UVEITIS PA Other Documentation of diagnosis and previous treatments. Dermatologist, Gastroenterologist, Ophthalmologist, or Rheumatologist. Indefinite as long as member is eligible. 26

27 ILARIS ILARIS (PF) SUBCUTANEOUS RECON SOLN PA Other Documentation of diagnosis. Indefinite as long as member is eligible. 27

28 IMMUNOSUPPRESSIVE, ANTI-INFLAMMATORY AGENTS ACTEMRA INTRAVENOUS SOLUTION 400 MG/20 ML (20 MG/ML), 80 MG/4 ML (20 MG/ML) ACTEMRA SUBCUTANEOUS CIMZIA CIMZIA POWDER FOR RECONST COSENTYX COSENTYX PEN ORENCIA ORENCIA CLICKJECT OTEZLA OTEZLA STARTER ORAL TABLETS,DOSE PACK 10 MG (4)-20 MG (4)-30 MG (47) SIMPONI ARIA SIMPONI SUBCUTANEOUS PEN INJECTOR SIMPONI SUBCUTANEOUS SYRINGE 50 MG/0.5 ML STELARA SUBCUTANEOUS SYRINGE TALTZ AUTOINJECTOR (3 PACK) 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. 1) For psoriatic arthritis and plaque psoriasis: Documented clinical failure, inadequate response or valid contraindication with Enbrel OR Humira AND Otezla. 2) For Ankylosing spondylitis, juvenile idiopathic arthritis, and rheumatoid arthritis: Documented clinical failure, inadequate response or valid contraindication with Enbrel AND Humira. 3) For Crohn's disease (adult and pediatric), and ulcerative arthritis: Documented clinical failure, inadequate response or valid contraindication with Humira. 28

29 INCRELEX INCRELEX PA Covered Uses All medically accepted indications not otherwise excluded from Part D. Other 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. Endocrinologist 1 year 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 -3.0 and, 4. The member has normal or elevated growth hormone (GH)and confirmation that epiphyses open. 29

30 INTERFERONS INTRON A INJECTION PEGASYS PEGASYS PROCLICK PEGINTRON SUBCUTANEOUS KIT 50 MCG/0.5 ML 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. duration will be applied consistent with current AASLD/IDSA guidance or FDA indications. 30

31 IRON CHELATING AGENTS EXJADE FERRIPROX JADENU JADENU SPRINKLE PA Other Documentation of a diagnosis. Hematologist 1 year 31

32 KINERET KINERET PA Other Documentation of diagnosis and previous treatments Indefinite as long as member is eligible. will be provided for the listed approved indications when the following criteria are met. RHEUMATOID ARTHRITIS: 1) Confirmation of diagnosis and 2) Documented trial, inadequate response or valid contraindication with one or more Disease Modifying Antirheumatic 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. 32

33 KUVAN KUVAN PA Other Documentation of diagnosis. Dosing is within the range of 5 to 20 mg/kg/day. Initial approval: Documented response to therapy as defined by greater than or equal to 30% reduction in baseline Phe level AND patient is under the appropriate care and reevaluations of a specialist knowledgeable in the management of PKU. Extended Approval: Documented maintenance response of greater than or equal to 30% reduction in baseline Phe level AND patient continues to be under the appropriate care and re-evaluations of a specialist knowledgeable in the management of PKU. 1 year 33

34 LIDODERM/LIDOCAINE PATCH lidocaine topical adhesive patch,medicated PA Other Documentation of diagnosis. Indefinite as long as member is eligible. 34

35 MULTIPLE SCLEROSIS AGENTS AUBAGIO BETASERON SUBCUTANEOUS KIT PLEGRIDY SUBCUTANEOUS PEN INJECTOR PLEGRIDY SUBCUTANEOUS SYRINGE 125 MCG/0.5 ML REBIF (WITH ALBUMIN) REBIF REBIDOSE REBIF TITRATION PACK PA Other Documentation of diagnosis and previous treatments Neurologist Indefinite as long as member is eligible. Documentation of multiple sclerosis (MS) diagnosis and medical record or prescription drug claims history documenting prior drug treatments. will be provided if there is a documented clinical trial, inadequate response or valid contrindication to prior treatment with interferon beta-1a (Avonex),interferon beta-1b (Extavia), glatiramer acetate (Copaxone) OR dimethyl fumarate (Tecfidera). 35

36 NOXAFIL NOXAFIL ORAL PA Other Documentation of diagnosis and previous treatments. Excluded for members who are younger than 13 years old Infectious disease provider or hematologist/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. 36

37 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. 37

38 PCSK-9 INHIBITORS REPATHA PUSHTRONEX REPATHA SURECLICK REPATHA SYRINGE PA Other Diagnosis of one of the following: Clinical atherosclerotic cardiovascular disease, Heterozygous Familial Hypercholesterolemia (HeHF)confirmed by genetic testing or Dutch Lipid Clinical Network or MedPed and WHO per 2011 ESC/EAS guidelines OR Homozygous Familial Hypercholesterolemia (HoFH) confirmed by either: genetic testing or history of untreated low-density lipoprotein cholesterol (LDL-C)greater than 500 mg/dl with either a) presence of xanthomas before the age of 10 years of age or b) evidence of heterozygous familial hypercholesterolemia in both parents. Documentation of previous drug treatments and required laboratory monitoring. must be a cardiologist, endocrinologist, or lipid specialist. Initial: 1 year. Reauthorization: 1 year with documented evidence of clinical beneficial response For atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH): patient is intolerant, on highintensity statin therapy or maximally tolerated statin therapy, is not at LDL-C level goal, and will be continued (as tolerated) on high intensity statin therapy while on PCSK9 inhibitor.for homozygous familial hypercholesterolemia (HoFH): patient is intolerant, on high-intensity or maximally tolerated lipid lowering therapy (such as statins and/ or Zetia), is not at LDL-C level goal, and will be continued (as tolerated)on high intensity ipid lowering therapy while on PCSK9 inhibitor. 38

39 PROLIA PROLIA PA Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Documentation of a diagnosis, previous treatment, history of bone fracture and bone density status. 1 year 39

40 PULMONARY ARTERIAL HYPERTENSION ADCIRCA ORENITRAM REVATIO ORAL SUSPENSION FOR RECONSTITUTION sildenafil oral 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. 40

41 PULMONARY FIBROSIS AGENTS ESBRIET ORAL CAPSULE ESBRIET ORAL TABLET OFEV PA 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). 41

42 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. 42

43 REGRANEX REGRANEX PA Covered Uses All medically accepted indications not otherwise excluded from Part D. Other Documentation of diagnosis, adequate blood supply to ulcer and persistence of good ulcer care. 3 month intervals Regranex (becaplermin) 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), and 3) Member or members provider has been practicing good ulcer care 8 weeks prior to initiation of treatment. Good ulcer care includes, but is not limited to the following: adequate blood supply has been determined as outlined above, serum albumin level greater than 2g/dL, initial sharp debridement and ongoing debridement if necessary, pressure relief, infection control and maintenance of a moist wound environment. 43

44 REVLIMID REVLIMID PA Other Documentation of diagnosis and previous treatments Oncologist or hematologist One year. 44

45 SANDOSTATIN/OCTREOTIDE octreotide acetate injection solution SANDOSTATIN LAR DEPOT INTRAMUSCULAR SUSPENSION,EXTENDED REL RECON PA Other Documentation of diagnosis. Endocrinologist for acromegaly use. 1 year 45

46 SOLARAZE diclofenac sodium topical gel 3 % PA Other Documentation of diagnosis. Indefinite as long as member is eligible. 46

47 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 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 PA Other 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. 47

48 TRANSMUCOSAL IMMEDIATE-RELEASE FENTANYL (TIRF) ABSTRAL FENTANYL CITRATE PA Other Documentation of diagnosis and previous treatments Indefinite as long as member is eligible. 48

49 VORICONAZOLE VFEND voriconazole oral PA 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. Vfend coverage will be approved if the following conditions are met: patient has a documented infection of invasive aspergillosis OR patient has a documented infection of Scedosporium apiospermum, Fusarium species OR.patient has documented esophageal candidiasis or candidemia AND patient has a trial with at least one other systemic antifungal agent OR.patient is at high risk of developing invasive Aspergillus or Candida due to being severely immunocompromised 49

50 WAKEFULNESS PROMOTING AGENTS armodafinil modafinil oral tablet 100 mg, 200 mg PA Covered Uses All medically accepted indications not otherwise excluded from Part D. Other 1) Diagnosis of narcolepsy confirmed by sleep lab evaluation OR 2)Diagnosis of obstructive sleep apnea (OSA) confirmed by polysomnography OR 3) Diagnosis of shift work disorder (SWD) Indefinite for narcolepsy and obstructive sleep apnea. Shift work sleep disorder, 1 year. For continuation requests for shift work disorder, requests are reviewed annually to review the member's work schedule. 50

51 XGEVA XGEVA PA Other Documentation of diagnosis. Oncologist 1 year 51

52 ZINBRYTA (DACLIZUMAB) ZINBRYTA PA Covered Uses Other All FDA-approved indications not otherwise excluded from Part D. 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 contraindication to prior treatment with 2 preferred agents including Avonex, Extavia, Copaxone, Glatopa, Gilenya or Tecfidera. 52

53 PART B VERSUS PART D ABELCET INTRAVENOUS SUSPENSION acetylcysteine solution acyclovir sodium intravenous solution adrucil intravenous solution 500 mg/10 ml albuterol sulfate inhalation solution for nebulization 0.63 mg/3 ml, 1.25 mg/3 ml, 2.5 mg /3 ml (0.083 %), 5 mg/ml AMBISOME INTRAVENOUS SUSPENSION FOR RECONSTITUTION AMINOSYN 7 % WITH ELECTROLYTES INTRAVENOUS PARENTERAL SOLUTION aminosyn 8.5 %-electrolytes intravenous parenteral solution AMINOSYN II 10 % INTRAVENOUS PARENTERAL SOLUTION AMINOSYN II 15 % INTRAVENOUS PARENTERAL SOLUTION AMINOSYN II 8.5 % INTRAVENOUS PARENTERAL SOLUTION AMINOSYN II 8.5 %-ELECTROLYTES INTRAVENOUS PARENTERAL SOLUTION AMINOSYN-HBC 7% INTRAVENOUS PARENTERAL SOLUTION AMINOSYN-PF 10 % INTRAVENOUS PARENTERAL SOLUTION AMINOSYN-PF 7 % (SULFITE-FREE) INTRAVENOUS PARENTERAL SOLUTION AMINOSYN-RF 5.2 % INTRAVENOUS PARENTERAL SOLUTION amphotericin b injection recon soln ANZEMET ORAL TABLET aprepitant oral capsule aprepitant oral capsule,dose pack ARANESP (IN POLYSORBATE) INJECTION SOLUTION 100 MCG/ML, 200 MCG/ML, 25 MCG/ML, 300 MCG/ML, 40 MCG/ML, 60 MCG/ML ARANESP (IN POLYSORBATE) INJECTION SYRINGE azathioprine oral tablet azathioprine sodium injection recon soln BAVENCIO INTRAVENOUS SOLUTION BETHKIS INHALATION SOLUTION FOR NEBULIZATION bleomycin injection recon soln 30 unit BONIVA INTRAVENOUS SYRINGE BROVANA INHALATION SOLUTION FOR NEBULIZATION budesonide inhalation suspension for nebulization CARIMUNE NF NANOFILTERED INTRAVENOUS RECON SOLN 6 GRAM CELLCEPT ORAL CAPSULE CELLCEPT ORAL SUSPENSION FOR RECONSTITUTION CELLCEPT ORAL TABLET CESAMET ORAL CAPSULE cromolyn inhalation solution for nebulization cyclophosphamide oral capsule cyclosporine modified oral capsule 100 mg, 25 mg CYCLOSPORINE MODIFIED ORAL CAPSULE 50 MG cyclosporine modified oral solution cyclosporine oral capsule dronabinol oral capsule EMEND ORAL CAPSULE EMEND ORAL CAPSULE,DOSE PACK EMEND ORAL SUSPENSION FOR RECONSTITUTION ENGERIX-B (PF) INTRAMUSCULAR SYRINGE ENGERIX-B PEDIATRIC (PF) INTRAMUSCULAR SUSPENSION ENGERIX-B PEDIATRIC (PF) INTRAMUSCULAR SYRINGE ENVARSUS XR ORAL TABLET EXTENDED RELEASE 24 HR FREAMINE HBC 6.9 % INTRAVENOUS PARENTERAL SOLUTION GAMASTAN S/D INTRAMUSCULAR SOLUTION 53

54 GAMMAGARD LIQUID INJECTION SOLUTION GAMMAGARD S-D (IGA < 1 MCG/ML) INTRAVENOUS RECON SOLN GAMMAPLEX (WITH SORBITOL) INTRAVENOUS SOLUTION GAMMAPLEX INTRAVENOUS SOLUTION GAMUNEX-C INJECTION SOLUTION 1 GRAM/10 ML (10 %) ganciclovir sodium intravenous recon soln gengraf oral capsule gengraf oral solution granisetron hcl oral tablet HEPATAMINE 8% INTRAVENOUS PARENTERAL SOLUTION ibandronate intravenous solution IMFINZI INTRAVENOUS SOLUTION INTRALIPID INTRAVENOUS EMULSION 20 %, 30 % ipratropium bromide inhalation solution ipratropium-albuterol inhalation solution for nebulization levalbuterol hcl inhalation solution for nebulization mycophenolate mofetil hcl intravenous recon soln mycophenolate mofetil oral capsule mycophenolate mofetil oral suspension for reconstitution mycophenolate mofetil oral tablet mycophenolate sodium oral tablet,delayed release (dr/ec) NEBUPENT INHALATION RECON SOLN NEPHRAMINE 5.4 % INTRAVENOUS PARENTERAL SOLUTION NULOJIX INTRAVENOUS RECON SOLN NUTRILIPID INTRAVENOUS EMULSION ondansetron hcl (pf) injection solution ondansetron hcl (pf) injection syringe ondansetron hcl oral solution ondansetron hcl oral tablet ondansetron oral tablet,disintegrating pamidronate intravenous solution PERFOROMIST INHALATION SOLUTION FOR NEBULIZATION premasol 10 % intravenous parenteral solution premasol 6 % intravenous parenteral solution PRIVIGEN INTRAVENOUS SOLUTION PROCRIT INJECTION SOLUTION 10,000 UNIT/ML, 2,000 UNIT/ML, 20,000 UNIT/ML, 3,000 UNIT/ML, 4,000 UNIT/ML, 40,000 UNIT/ML PROGRAF INTRAVENOUS SOLUTION PROSOL 20 % INTRAVENOUS PARENTERAL SOLUTION PULMOZYME INHALATION SOLUTION RAPAMUNE ORAL SOLUTION RAPAMUNE ORAL TABLET 1 MG, 2 MG RECOMBIVAX HB (PF) INTRAMUSCULAR SUSPENSION 10 MCG/ML, 40 MCG/ML RECOMBIVAX HB (PF) INTRAMUSCULAR SYRINGE SANDIMMUNE INTRAVENOUS SOLUTION SANDIMMUNE ORAL SOLUTION sirolimus oral tablet tacrolimus oral capsule tobramycin in % nacl inhalation solution for nebulization TRAVASOL 10 % INTRAVENOUS PARENTERAL SOLUTION TROPHAMINE 10 % INTRAVENOUS PARENTERAL SOLUTION TROPHAMINE 6% INTRAVENOUS PARENTERAL SOLUTION vancomycin intravenous recon soln 1,000 mg, 10 gram, 500 mg VENTAVIS INHALATION SOLUTION FOR NEBULIZATION VYXEOS INTRAVENOUS RECON SOLN XATMEP ORAL SOLUTION zoledronic acid-mannitol-water intravenous piggyback ZORTRESS ORAL TABLET Details 54

55 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. 55

56 Index A ABELCET ABSTRAL acetylcysteine ACTEMRA INTRAVENOUS SOLUTION 400 MG/20 ML (20 MG/ML), 80 MG/4 ML (20 MG/ML) ACTEMRA SUBCUTANEOUS acyclovir sodium adapalene topical cream adapalene topical gel ADCIRCA adrucil AFINITOR... 5 AFINITOR DISPERZ... 5 albuterol sulfate ALECENSA... 5 ALUNBRIG... 5 AMBISOME AMINOSYN 7 % WITH ELECTROLYTES aminosyn 8.5 %-electrolytes AMINOSYN II 10 % AMINOSYN II 15 % AMINOSYN II 8.5 % AMINOSYN II 8.5 %-ELECTROLYTES 53 AMINOSYN-HBC 7% AMINOSYN-PF 10 % AMINOSYN-PF 7 % (SULFITE-FREE). 53 AMINOSYN-RF 5.2 % amphotericin b AMPYRA... 1 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)47 ANZEMET aprepitant ARANESP (IN POLYSORBATE) armodafinil AUBAGIO avita azathioprine azathioprine sodium B BAVENCIO BERINERT INTRAVENOUS KIT BETASERON SUBCUTANEOUS KIT.. 35 BETHKIS bexarotene... 5 bleomycin BONIVA BOSULIF ORAL TABLET 100 MG, 500 MG... 5 BROVANA budesonide C CABOMETYX... 5 CAPRELSA... 5 CARIMUNE NF NANOFILTERED carisoprodol CELLCEPT CESAMET CIALIS ORAL TABLET 2.5 MG, 5 MG... 7 CIMZIA CIMZIA POWDER FOR RECONST CINRYZE COMETRIQ... 5 COSENTYX COSENTYX PEN COTELLIC... 5 cromolyn cyclobenzaprine oral tablet 10 mg, 5 mg.. 25 cyclophosphamide cyclosporine cyclosporine modified CYCLOSPORINE MODIFIED CYRAMZA... 5 D DAKLINZA... 4 DARAPRIM DARZALEX

57 DEPO-TESTOSTERONE INTRAMUSCULAR OIL 200 MG/ML 47 diclofenac sodium topical gel 3 % DIFICID dronabinol E EGRIFTA SUBCUTANEOUS RECON SOLN 1 MG EMEND EMFLAZA EMPLICITI... 5 ENBREL ENBREL SURECLICK ENGERIX-B (PF) ENGERIX-B PEDIATRIC (PF) ENVARSUS XR EPCLUSA... 4 ERIVEDGE... 5 ESBRIET ORAL CAPSULE ESBRIET ORAL TABLET EXJADE F FARYDAK... 5 FENTANYL CITRATE FERRIPROX FIRAZYR FLECTOR FORTEO FREAMINE HBC 6.9 % G GAMASTAN S/D GAMMAGARD LIQUID GAMMAGARD S-D (IGA < 1 MCG/ML) GAMMAPLEX GAMMAPLEX (WITH SORBITOL) GAMUNEX-C ganciclovir sodium GATTEX ONE-VIAL gengraf GILOTRIF... 5 GLEOSTINE... 5 granisetron hcl GRANIX... 8 H HARVONI... 4 HEPATAMINE 8% HETLIOZ HUMIRA HUMIRA PEN HUMIRA PEN CROHN'S-UC-HS START HUMIRA PEN PSORIASIS-UVEITIS I ibandronate IBRANCE... 5 ICLUSIG... 5 IDHIFA... 5 ILARIS (PF) SUBCUTANEOUS RECON SOLN imatinib... 5 IMBRUVICA... 5 IMFINZI INCRELEX INLYTA... 5 INTRALIPID INTRON A INJECTION ipratropium bromide ipratropium-albuterol IRESSA... 5 itraconazole... 3 J JADENU JADENU SPRINKLE JAKAFI... 5 JUXTAPID K KALYDECO... 9 KEYTRUDA... 5 KINERET KISQALI... 5 KISQALI FEMARA CO-PACK... 5 KUVAN KYNAMRO L LARTRUVO... 5 LENVIMA... 5 LEUKINE INJECTION RECON SOLN... 8 levalbuterol hcl lidocaine topical adhesive patch,medicated linezolid

58 LONSURF... 5 LYNPARZA ORAL CAPSULE... 5 LYNPARZA ORAL TABLET... 5 M MAVYRET... 4 MEKINIST... 5 modafinil oral tablet 100 mg, 200 mg mycophenolate mofetil mycophenolate mofetil hcl mycophenolate sodium N NEBUPENT NEPHRAMINE 5.4 % NERLYNX... 5 NEULASTA SUBCUTANEOUS SYRINGE... 8 NEUPOGEN... 8 NINLARO... 5 NORDITROPIN FLEXPRO NOXAFIL ORAL NUEDEXTA NULOJIX NUTRILIPID NUTROPIN AQ NUSPIN O octreotide acetate injection solution ODOMZO... 5 OFEV OLYSIO... 4 ondansetron ondansetron hcl ondansetron hcl (pf) ORENCIA ORENCIA CLICKJECT ORENITRAM ORKAMBI... 9 OTEZLA OTEZLA STARTER ORAL TABLETS,DOSE PACK 10 MG (4)-20 MG (4)-30 MG (47) P pamidronate PEGASYS PEGASYS PROCLICK PEGINTRON SUBCUTANEOUS KIT 50 MCG/0.5 ML PERFOROMIST PERJETA... 5 PLEGRIDY SUBCUTANEOUS PEN INJECTOR PLEGRIDY SUBCUTANEOUS SYRINGE 125 MCG/0.5 ML POMALYST... 5 premasol 10 % premasol 6 % PRIVIGEN PROCRIT PROGRAF PROLIA PROSOL 20 % PULMOZYME Q quinine sulfate R RAPAMUNE REBIF (WITH ALBUMIN) REBIF REBIDOSE REBIF TITRATION PACK RECOMBIVAX HB (PF) REGRANEX REPATHA PUSHTRONEX REPATHA SURECLICK REPATHA SYRINGE REVATIO ORAL SUSPENSION FOR RECONSTITUTION REVLIMID RUBRACA ORAL TABLET 200 MG, 300 MG... 5 RUCONEST RYDAPT... 5 S SANDIMMUNE SANDOSTATIN LAR DEPOT INTRAMUSCULAR SUSPENSION,EXTENDED REL RECON sildenafil oral SIMPONI ARIA SIMPONI SUBCUTANEOUS PEN INJECTOR SIMPONI SUBCUTANEOUS SYRINGE 50 MG/0.5 ML

59 sirolimus SIVEXTRO... 2 SOVALDI... 4 SPORANOX ORAL SOLUTION... 3 SPRYCEL... 5 STELARA SUBCUTANEOUS SYRINGE STIVARGA... 5 SUTENT... 5 SYNRIBO... 5 T tacrolimus TAFINLAR... 5 TAGRISSO... 5 TALTZ AUTOINJECTOR (3 PACK) TALTZ SYRINGE TANZEUM TARCEVA... 5 TASIGNA... 5 TAZORAC TECENTRIQ... 5 TECHNIVIE... 4 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 THALOMID... 5 tobramycin in % nacl TRAVASOL 10 % tretinoin microspheres topical gel with pump tretinoin topical cream tretinoin topical gel 0.01 %, % TROPHAMINE 10 % TROPHAMINE 6% TRULICITY TYKERB... 5 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 vancomycin VENCLEXTA... 5 VENCLEXTA STARTING PACK... 5 VENTAVIS VFEND VIEKIRA PAK... 4 VIEKIRA XR... 4 voriconazole oral VOSEVI... 4 VOTRIENT... 5 VYXEOS X XALKORI... 5 XATMEP XELJANZ XELJANZ XR XGEVA XTANDI... 5 Y YONDELIS... 5 Z ZARXIO... 8 ZEJULA... 5 ZELBORAF... 5 ZEPATIER... 4 ZINBRYTA zoledronic acid-mannitol-water ZOLINZA... 5 ZORTRESS ZYDELIG... 5 ZYKADIA... 5 ZYTIGA ORAL TABLET 250 MG, 500 MG