SelectHealth Advantage 2015 Prior Authorization Criteria

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1 ACROMEGALY Somatuline Depot, Somavert 1. Pt has had surgical resection of the pituitary gland OR is not a candidate for surgery/radiation therapy, 2. Patient has tried at least ONE of the following: a. Bromocriptine, b. Cabergoline, c. Octreotide Endocrinologist or consult

2 ACTEMRA Actemra 1. For rheumatoid arthritis dx: a. Pt has previous trial on at least ONE of the following: i. Enbrel, ii. Humira, b. Pt has previous trial on Cimzia, 2. For juvenile rheumatoid arthritis dx: a. Pt has failed on at least ONE of the following: i. methotrexate, ii. leflunomide, iii. hydroxychloroquine, iv. sulfasalazine, v. injectable gold, vi. oral gold, vii. azathioprine, viii. penicillamine, ix. cyclosporine, b. Pt has previous trial on at least ONE of the following: a. Enbrel, b. Humira Rheumatologist

3 ACTHAR H.P. Acthar 1. For Infantile Spasms: a. Dx is confirmed by EEG, b. Pt has tried at least ONE of the following: i. Prednisone, ii. Prednisolone, iii. Hydrocortisone, iv. Dexamethasone, c. Pt has tried at least ONE of the following: i. Vigabatrin, ii. Cosyntropin, 2. For MS: Pt has failed at least TWO courses of treatment with Solu-Medrol for two different multiple sclerosis exacerbations, 3. For Nephrotic Syndrome: a. Pt has tried at least TWO corticosteroids, b. Pt has tried at least ONE of the following: i. Cyclophosphamide, ii. Cyclosporine, 4. For Rheumatic Disorders: a. Pt has tried at least ONE oral corticosteroid, b. Pt has tried at least ONE oral DMARD, 5. For Dermatologic Disorders: a. Pt has failed therapy with methylprednisolone Infantile Spasms: 24 months old or younger 1. Infantile Spasms: Neurologist, 2. MS: Neurologist, 3. Nephrotic Syndrome: Nephrologist, 4. Rheumatic Disorders: Rheumatologist, 5. Dermatologic Disorders: Dermatologist 1 mo

4 ACTIMMUNE Actimmune 1. Hypersensitivity to Actimmune or E. coli derived products

5 ADEMPAS Adempas 1. PAH: a. Pt has previous failure on sildenafil, 2. CTPH: a. Pt has failed endarterectomy OR b. Pt considered inoperable for pulmonary endarterectomy AND c. Pt been compliant on full anticoagulation for at least 90 days 18 years old or older Specialist in pulmonary hypertension

6 ALIMTA Alimta 1. For mesothelioma: a. Unresectable disease OR not candidate for surgery, b. Used in combination with cisplatin or carboplatin, 2. For NSCLC a. Initial: used in combo with cisplatin or carboplatin, b. Maintenance tx: Used after failure of four cycles of platinum-based first-line chemotherapy, c. After prior chemotherapy: Alimta used as single chemotherapeutic agent

7 AMIFOSTINE Amifostine 1. For ovarian cancer: a. Pt receiving treatment with a cisplatin-containing regimen, 2. For head and neck cancer: a. Pt is undergoing post-operative radiation treatment, b. At least 75% of both parotid glands are in the radiation field Oncologist or Nephrologist

8 AMPHOB Ambisome, Amphotericin B 1. For use of brand Ambisome: Pt must have previous failure or contraindication to generic Amphotericin B, 2. If using for empiric therapy: a. Patient must be febrile AND neutropenic BvsD determination

9 AMPYRA Ampyra 1. Pt confined to wheelchair, 2. Hx of seizures, 3. Moderate to severe renal impairment (CrCl is less than 50 ml/min) 1. Initial: a. Currently taking at least one other MS drug, b. EDSS score between 3.5 and 6.0, c. Documented 25 foot walk time, 2. Reauth: Same as 1.a and 1.b above AND improvement in 25 foot walk time Neurologist Initial: 2 mo, Reauth:

10 ANDROGENS Androderm, Axiron, Testosterone 1. Total tesosterone level below 300 ng/dl, 2. Pt experiences at least ONE of the following: malaise, fatigue, lethargy, muscle loss, depression, decreased libido, 3. Previous trial on Androgel If request NOT for Androgel: Previous trial of Androgel,

11 APO B Juxtapid, Kynamro Pt has none of the following health conditions or health concerns: a. Congestive heart failure, b. History of significant renal or hepatic disease, c. Alcohol abuse 1. Pt has untreated, fasting LDL cholesterol greater than 500 mg/dl AND triglycerides less than 300 mg/dl, 2. Pt meets a OR b AND c of the following: a. Pt has documented mutations in both alleles of the LDL receptor or of other genes known to affect LDL receptor function, b. Both of pt's parents have a hx of untreated total cholesterol of greater than 250 mg/dl, c. Pt has xanthomas present before age 10, 3. Pt abides by a low-fat diet in addition to all other lipid-lowering therapies, 4. Patient has failed or is currently taking at least ONE of the following: a. Atorvastatin 40 mg or higher, b. Rosuvastatin 20mg or higher, c. Simvastatin 40mg or higher, AND ONE of the following: a. Niacin, b. Ezemitibe, c. Gemfibrozil, d. Fenofibrate, e. Cholestyramine, f. Colesevelam, g. Colestipol, 5. Pt previously failed lipid apheresis therapy. Specialist in lipid disorders 1. Initial: 6 mo, 2. Reauthorization: 12 mo

12 APOKYN Apokyn 1. Pt suffering from end of dose wearing off episodes, 2. Apokyn initiated with a concomitant antiemetic (not a 5HT3) Neurologist

13 ARCALYST Arcalyst 1. Combination use with a TNF-inhibitor

14 ARZERRA Arzerra 1. For refractory chronic leukemia dx: Pt is refractory to BOTH fludarabine and alemtuzumab, 2. For untreated chronic lymphocytic leukemia: a. Used in combination with chlorambucil, b. Fludarabine-based therapy is inappropriate for the pt Oncologist

15 AUBAGIO Aubagio Combination therapy with other MS agents 1. initial: a. LFT within last 6 months, b. CBC within last 6 months, c. Tuberculosis screening, d. No live vaccination within previous 2 months, 2. If pt is female: negative pregnancy test AND reliable contraception method is being used, 3. Previous trial on at least ONE of the following: a. Extavia, b. Gilenya, c. Rebif Neurologist

16 AVASTIN Avastin 1. For metastatic, colon, or rectal cancer dx: Used in combination with 5-flurouracil OR capecitabine, 2. For NSCLC dx: Used in combination with carboplatin/paclitaxel OR erlotinib, 3. For glioblastoma multiforme: Previous failure on temozolomide, 4. For RCC dx: Used in combination with interferon alpha, 5. For cervical cancer dx: Used in combination with paclitaxel/cisplatin OR paclitaxel/topotecan

17 BELEODAQ Beleodaq Oncologist

18 BOSULIF Bosulif 1. Pt's CML is in chronic phase, accelerated phase, or blast phase, 2. Pt has previous failure or intolerance to Gleevec (imatinib) Oncologist

19 CANCIDAS Cancidas 1. For invasive aspergillosis: a. Pt has failure on at least ONE other systemic antifungal, 2. If using for empiric therapy: a. Patient must be febrile AND neutropenic BvsD determination

20 CAPASTAT Capastat Sulfate Pt has previous failure on at least ONE of the following: 1. Isoniazid, 2. Rifampin, 3. Ethambutol, 4. Pyrazinamide Infectious Disease Specialist 10 Months BvsD determination

21 CAPRELSA Caprelsa Oncologist, Hematologist, Endocrinologist

22 CERDELGA Cerdelga 1. Pt was diagnosed by a Clinical Biomedical Geneticist, 2. Pt is unable to use intravenous enzyme replacement, 3. The CYP2D6 genotype has been determined

23 CHORIONIC GONADOTROPIN Chorionic Gonadotropin Fertillity Use For hypogonadism dx: Pt previously failed on testosterone replacement therapy

24 CIMZIA Cimzia Combination therapy with TNF antagonist 1. RA dx: Pt has failed on at least ONE of the following: a. methotrexate, b. leflunomide, c. hydroxychloroquine, d. sulfasalazine, e. injectable gold, f. oral gold, g. azathioprine, h. penicillamine, i. cyclosporine, 2. All dx: Pt has failed at least ONE of the following: a. Enbrel, b. Humira Rheumatologist, Gastroenterologist

25 CINRYZE Cinryze 1. Dx is verified by low C1-INH and/or low C1-INH functional levels on two separate occasions, 2. Therapy is required as follows: a. Pt has history of 2 or more facial, laryngeal, and/or gastroinestinal HAE attacks per month, AND b. Pt is compliant with trigger avoidance, AND c. Pt has tried or has contraindication to a 6 months trial of attenuated androgen therapy OR a. Pt is scheduled to undergo a major medical procedure that requires propylaxis, 3. Reauth: Pt has had a significant decrease in the frequency of attacks per month OR had a significant decrease in the severity or duration of attacks Allergist, Immunologist 6 Months

26 COMETRIQ Cometriq Diagnosis of indolent medullary thyroid cancer Oncologist

27 COSENTYX Cosentyx (2 Syringes), Cosentyx Pen 1. Plaque psoriasis involves 10% or more of the body surface area, 2. If less than 10% of body surface area there is scalp, palmer, foot, or groin involvement causing significant disability, 3. Pt has failed therapy of at least 12 weeks with at least ONE of the following: i. methotrexate, ii. cyclosporine, iii. acitretin, 4. Pt has failed treatment with Enbrel OR Humira Dermatologist

28 CRESEMBA Cresemba Cresemba is initiated incident to a hospitalization Infectious Disease Specialist 6 Months

29 CUBICIN Cubicin 1. For complicated bacterial skin and skin structure infections: Pt has had a positive culture within the past month for ANY of the following (mark all that apply): a. Staphylococcus aureus (MSSA or MRSA), b. Streptococcus pyogenes, c. Streptococcus agalactia, d. Streptococcus dysgalactiae subspecies equisimilis, e. Enterococcus faecalis (vancomycin susceptible strains only), 2. For blood stream infections: Pt has had a positive culture within the past month for Staphylococcus aureus (MSSA or MRSA) Infectious Disease Specialist 2 Months BvsD determination

30 CYRAMZA Cyramza Combination therapy Pt has experienced disease progression on or after prior chemotherapy Oncologist

31 CYSTARAN Cystaran 1. Initial: Pt has corneal cysteine accumulation that has been confirmed by slit-lamp photography, 2. Reauth: Pt had a reduction of 1 or more units in the Corneal Cystine Crystal Score (CCCS) after 6 months of treatment with Cystaran. Corneal Specialist 6 Months

32 CYSTIC FIBROSIS Bethkis, Cayston, Tobi Podhaler, Tobramycin Pt has had at least ONE positive culture for Pseudomonas aeruginosa Pulmonologist, Infectious Disease Specialist BvsD determination

33 DAKLINZA Daklinza 1. Pt has cirrhosis, 2. Pt had a previous liver transplant, 3. Pt has HCV/HIV co-infection, 4. Previous therapy with sofosbuvir Used in combination with sofosbuvir Gastroenterologist, Infectious Disease Specialist, Transplant Specialist 12 Weeks

34 DALVANCE Dalvance Chart notes and bacterial susceptibility reports have been submitted showing need for medication Infectious Disease Specialist 14 Days BvsD determination

35 DIFICID Dificid 1. Pt has had a positive C. difficile toxin assay within the past month, 2. Pt has tried as least TWO of the following treatments: a. Metronidazole for days, b. Vancomycin for days, c. Vancomycin extended taper, d. Rifaximin for 14 days. Gastroenterologist, Infectious Disease Specialist

36 ENDOTHELIN ANTAGONIST Letairis, Opsumit, Tracleer 1. Exclusion of all secondary causes of pulmonary hypertension, 2. Must be dx with PAH with WHO class II, III, or IV Pulmonoligist, Cardiologist

37 ERIVEDGE Erivedge 1. For basal cell carcinoma: a. Pt has lesions that are greater than or equal to 10 mm in diameter, b. Pt has recurring lesions after radiation therapy OR radiation therapy is contraindicated or inappropriate, c. Pt has recurring lesions after surgical excision OR surgery is contraindicated or inappropriate Dermatologist, Oncologist

38 ERWINAZE Erwinaze 1. Erwinaze is used in combination with chemotherapy for treatment, 2. Pt has demonstrated a hypersensitivity to an E. Coli derived asparaginase Oncologist

39 EVZIO Evzio 1. Initial: a. Pt's use of opioids is limited to legally prescribed medications for legitamate medical conditions, b. Pt is at a high risk for opioid overdose, c. Must meet ONE of the following: i. The current prescription contains sufficient doses to manage ONE overdose event, ii. Pt is prescribed and taking methadone tablets for pain, iii. Pt has experienced an opioid overdose in the past, 2. Reauth: a. Pt experienced an overdose that required administration of Evzio, b. Emergency medical care was immediately sought after Evzio was administered, c. Pt's use of opioids was limited to legally prescribed prescription medications for a legitimate medical condition, d. The current prescription contains sufficient doses to manage ONE overdose event, e. A Narcotics Abuse Specialist has been consulted Addiction Specialist (if 1.c.i, 1.c.ii, and 1.c.iii are not met)

40 FARYDAK Farydak 1. Used in combination with bortezomib and dexamethasone, 2. Pt has previous trial on at least TWO regimens including bortezomib and an immunomodulatory agent Oncologist, Hematologist

41 FENTANYL Abstral, Fentanyl Citrate, Fentora, Lazanda Non-cancer pain use 1. Must have documented maintenance therapy with a long-acting opioid, 2. Documented failure with a short-acting opioid for breakthrough pain Oncologist, Pain Specialist 6 Months Previous trial on generic fentanyl citrate

42 FIRAZYR Firazyr 1. For HAE type I and II and aquired angioedema: Dx has been verified by low C1-INH and/or low C1-INH function levels on two separate occasions, 2. For HAE with normal C1-INH: Pt has failed a trial with high-dose non-sedating antihistamines for at least 3 months to rule-out idiopathic angioedema Allergist, Immunologist Initial: 3 mo, Reauth: 1 year

43 FLECTOR Flector Pt has failed at least a 14-day trial with an oral NSAID in combination with a PPI

44 FOLOTYN Folotyn Treatment with prior systemic therapy Oncologist

45 FORTEO Forteo 1. Treatment for longer than 2 years, 2. Increased baseline risk for osteosarcoma 1. For osteoporosis dx: a. T-score less than or equal to -2.5, b. Pt meets at least ONE of the follwing: 1. Must have previous trial on bisphosphonate therapy and experienced a fragility fracture, ii.pt is intolerant to bisphosphonate therapy due to musculoskeletal pain, iii. GFR less than 35 ml/min AND pt is at high risk for fracture based on FRAX score

46 GILOTRIF Gilotrif The tumor has an epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation Oncologist

47 GROWTH HORMONE Saizen 1. All medically accepted indications not otherwise excluded from Part D For Ped GHD: Male at bone age of 16 yo, Female at bone age of 14 yo, 2. Growth velocity is less than 2 cm/yr, 3. Fusion of epiphyses 1. Ped GHD: Initial: a. Meet criteria i, ii, iii, iv, AND either iv(a), or iv(b), or v: i) Ht more than 2 SD below the pop mean OR less than 3rd percentile, ii) Ht velocity less than 4cm/yr OR less than 5th percentile of bone age and gender for at least 6 mo iii) Evidence of other causes of growth failure have been ruled out AND iv) (a) Failure of at least TWO stim tests (peak GH concentration less than 10mcg/L) OR iv) (b) IGF-1 2 SD or more below the mean standardized for bone age AND IGF-BP3 is in the lowest quartile for bone age and gender AND other causes of low IGF have been excluded, OR v) Pt has more than 3 pituitary hormone deficiencies requiring replacement therapy, Reauth: Growth velocity of 4cm/year or more, 2. Adult GHD: Initial: a. Pts must meet any of the criteria i-ii: i) Pt has GH deficiency as a result of hypothalamic or pituitary disease or is dxed with acquired GH deficiency (1) Secondary to any of the following: (a) Pituitary tumor, (b) Pituitary surgical damage, (c) Hypothalamic disease, (d) Pituitary irradiation, (e) Pituitary trauma, (f) Sheehan s syndrome, (g) Autoimmune hypophytis, (h) Hypophytis associated with an inflammatory condition, (i) Deficiency of 3 or more anterior pituitary hormones AND (2) Pt is receiving active supplementation of deficient hormones as necessary AND (3) (a) Pt has a low IGF-1 level and other causes of low IGF have been excluded OR (b) Pt has failed standardized provocative testing as demonstrated by serum GH conc less than 5mcg/L when measured by RIA or less than 2.5mcg/L when measured by IRMA, ii) Adult dxed with childhood GHD (1) Retesting using the parameters in 2(i)(3)(b) indicates GHD persists OR (2) Pt is dxed with panhypopituitarism and IGF-I deficiencies exist as outlined in 2(i)(3)(c), Reauth: Continued efficacy both clinically and by lab testing. Ped GHD AND Adult GHD: Endocrinologist

48 1. Ped GHD: Initial: 6 mo, Reauth: 12 mo, 2. HIV wasting: 12 wks LIFETIME, 3. All others: 1. Chronic Renal Insufficiency: a. Meet ALL of the following: i) Pt dxed with CRI AND has not yet received renal transplant, ii) Existing metabolic disorders have been corrected, iii) Ht more than 2 SD below the population mean OR less than 3rd percentile, iv) Height velocity less than 4cm/yr or less than 10th percentile of normal for age and gender, 2. Turner Syndrome: a. Meet ALL of the following: i) Dx of TS confirmed by blood karotype or fibroblast studies, ii) Ht of female pt plotted on TS-specific growth curve AND pt is less than 5th percentile of normal growth curve for girls, 3. Prader-Willi Syndrome: a. Meet ALL of the following: i) Dx of PWS confirmed by appropriate genetic testing, ii) Ht more than 2 SD below the pop mean OR less than 3rd percentile, iii) Ht velocity less than 3cm/yr or less than 10th percentile of normal for age and gender, 4. Small for Gestational Age: a. Meet ALL of the following: i) Dx of SGA as defined as one of the following: (1) Birth weight of less than 2,500g at gestational age of greater than 37 weeks, (2) OR birth weight or length less than 3rd percentile for gestational age, ii) Pt has failed to catch up in ht by 2 yo, 5. AIDS-Related Wasting: a. Meet ALL of the following: i) Involuntary weight loss of more than 10% pre-illness body weight or a BMI less than 20, ii) Failure to respond to dronabinol (Marinol ) OR megesterol acetate (Megace ), iii) Chronic diarrhea (defined as more than 3 loose stools/day for more than 30 days) OR Chronic weakness and documented fever (30 days, intermittent or constant) in the absence of concurrent illness or condition other than HIV infection that would otherwise explain the symptoms.

49 HALAVEN Halaven 1. Previous failure of at least TWO chemotherapeutic regimens, 2. Previous treament includes an anthracycline AND a taxane Oncologist

50 HARVONI Harvoni 1. Chart notes showing genotype, 2. Pt has previous trial on Viekira Gastroenterologist, Infectious Disease Specialist, Transplant Specialist Maximum 24 weeks

51 HEPATITIS C Pegasys, Pegasys Proclick, Pegintron, Pegintron Redipen 1. Previous treatment with a protease inhibitor, 2. For treatment without protease inhibitor: prior treatment with pegylated interferon 1. For Hep C dx (includes Incivek and Victrelis): a. Initial: i. HCV genotype, ii. HCV RNA viral load, b. For reauth: i. Genotype 1: 1) Interferon: No detectable HCV-RNA at treatment week 24, 2) Victrelis: HCV-RNA is 100 IU/ml or less at treatment week 12 and patient is undetectable at week 24, 3) Incivek: HCV-RNA is 1000 IU/mL or less at treatment week 12, ii. Genotype 4, 5, and 6: 2 log reduction in HCV RNA compared to baseline, iii. Genotype 2,3: No reauth available, 2. For Hep B dx (does not include Incivek and Victrelis): a. Pre-treatment HBV DNA levels are greater than 20,000 IU/ml, b. Must be used as monotherapy Gastroenterologist, Infectious Disease Interferon: Initial: 24 Wks, Re: 24 Wks, Incivek: 12 Wks, Victrelis: Initial: 24 Wks, Re: 8-20 Wks 1. Pegylated interferon and Victrelis: For reauth: Must provide HCV viral load at 24 weeks, 2. Peg-Intron, Victrelis, and Incivek must be accompanied by letter of medical necessity explaining why the preferred agents Pegasys, Olysio, and Sovaldi cannot be used

52 HETLIOZ Hetlioz 1. Pt is totally blind without light perception, 2. Pt has previous trial on Rozerem, 3. Pt has previous tiral on at least ONE of the following: a. zolpidem, b. zolpidem ER, c. zaleplon Sleep specialist

53 HRM Cyclobenzaprine Hcl, Diphenhydramine Hcl, Duavee, Ergoloid Mesylates, Phenobarbital, Thioridazine Hcl 1. Approved for 64 years of age and younger, years and older use OTHER criteria If the patient is 65 years of age or older, the benefit of therapy with the prescribed medication outweighs the potential risk.

54 IBRANCE Ibrance Prior therapy for metastatic disease Used in combination with letrozole Oncologist

55 ICLUSIG Iclusig 1. CML dx: Pt's CML is in chronic phase, accelerated phase, or blast phase, 2. All dx: Pt has previous trial on Gleevec Oncologist, Hematologist

56 ILARIS Ilaris Combination therapy with TNF antagonist 1. For all dx EXCEPT CAPS: Pt has had prior trial on BOTH of the following: 1. Kineret, 2. Actemra Rheumatologist 6 Months

57 IMBRUVICA Imbruvica Pt has failed at least ONE prior therapy Oncologist, Hematologist

58 INCRELEX Increlex 1. Height standard deviation score of less than -3 based on age and gender, 2. Basal IGF-1 standard deviation score of less than -3 based on age and gender, 3. Normal or elevated growth hormone levels, 4. Pt must have open epiphyses, 5. Gh stimulation test of greater than 10 mcg/l. 2 years old or older Endocrinologist or consult

59 INLYTA Inlyta Pt has failed prior systemic therapy Oncologist

60 ISTODAX Istodax Pt received at least ONE previous systemic therapy Oncologist

61 IVIG Bivigam, Carimune Nf Nanofiltered, Flebogamma Dif, Gamastan S-D, Gammagard Liquid, Gammaked, Gammaplex, Gamunex-C, Octagam, Privigen 1. All medically accepted indications not otherwise excluded from Part D 1. For Kawasaki disease dx: IF pt after 10 days of illness: persistent fever without explanation OR aneurysms and ongoing systemic inflammation, 2. For HIV dx: CD4 count of less than 200 cells/ml, 3. For blistering disease dx: failure on at least TWO of the following: azathioprine, mycophenolate, cyclophosphmaide, cyclosporine, methotrexate, 4. For Thrombo dx: platelet count less than 20,000, 5. For CLL dx: hypogammaglobulinemia shown by less than 500 mg/dl, 6. For Transplant dx: within 100 days of transplant OR hypogammaglobulinemia after 100 days, 7. For stiff person dx: Failure on corticosteroids, 8. For RRMS dx: Failure to at least TWO fo the following: Betaseron, Avonex, Rebif, Copaxone, Gilenya, 9. For Dermatomyositis dx: Failure to IV steroids AND failure to azathoprine OR methotrexate For Kawasaki disease dx: less than 18 years old BvsD determination

62 IXEMPRA Ixempra 1. Ixempra monotherapy: Previous failure to ALL the following: anthracycline, taxane, capecitabine, 2. Ixempra in combination with capecitabine: Previous failure to BOTH anthracycline AND taxane Initial: 6 mo, Reauth: plan year

63 JAKAFI Jakafi 1. For polycythemia dx: a. Pt had inadequate response or is intolerant to hydroxyurea, 2. For all dx: a. Pt has enlarged spleen shown by MRI or CT, b. Platelet count greater than or equal to 50X10(9)/L Oncologist, Hematologist

64 JEVTANA Jevtana 1. Previous treatment with docetaxel-containing regimen, 2. Combination therapy with prednisone Oncologist, Urologist

65 KALYDECO Kalydeco 1. Pt is being managed at a cystic fibrosis clinic, 2. Pt genotyped by an FDA-cleared CF mutation test, 3. Pt has ONE of the following mutations: a. G551D, b. G551S, c. S549R, d. G1244E, e. S1251N, f. G1349D, g. S1255P, h. G178R, i. S549N 6 years old or older Pulmonologist

66 KEPIVANCE Kepivance 1. Pt will be undergoing a bone marrow transplant, 2. Pt will be undergoing total-body irradiation, 3. Pt's chemotherapy regimen consists of at least ONE medication that is predicted to result in greater than WHO Grade 3 mucositis, 4. The patien will NOT be receiving a high dose of melphalan preparative regimen Hematologist, Oncologist BvsD determination

67 KEYTRUDA Keytruda 1. Pt has previous trial on Yervoy and experienced disease progression within 24 weeks following the last dose of Yervoy, 2. Pt did NOT experience an immune-mediated adverse reaction to Yervoy requiring use of corticosteroids, 3. Pt is NOT positive for BRAF V600E or V600K mutation OR 4. Pt is BRAF V600E or V600K mutation positive AND has previously tried at least ONE of the following: a. Mekinist, b. Tafinlar, c. Zelboraf Oncologist, Hematologist BvsD determination

68 KINERET Kineret 1. For rheumatoid arthritis dx: a. Pt has previous trial on at least ONE of the following: i. Enbrel, ii. Humira, b. Pt has previous trial on Cimzia, 2. For juvenile rheumatoid arthritis dx: a. Pt has failed on at least ONE of the following: i. methotrexate, ii. leflunomide, iii. hydroxychloroquine, iv. sulfasalazine, v. injectable gold, vi. oral gold, vii. azathioprine, viii. penicillamine, ix. cyclosporine, b. Pt has previous trial on at least ONE of the following: a. Enbrel, b. Humira

69 KORLYM Korlym Pt using long-term corticosteroid 1. Pt has previously failed surgery or chemotherapy to correct Cushing's disease OR is ineligible for surgery, 2. Pt with type II diabetes diagnosis, 3. HgA1c is 8.0% or greater, 4. Pt has treatment failure with at least TWO of the following: a. Insulin, b. metformin, c. meglitinides, d. sulfonylureas, e. thiazolidinediones, f. DPP4 inhibitors, g. GLP-1 agonists, 5. If pt is female: a. Pt has negative pregnancy test within past 14 days, b. Pt is currently using non-hormonal form of birth control Endocrinologist Initial: 6 months, Reauth:

70 LENVIMA Lenvima 1. Tumor is refractory to treatment with radioactive iodine, 2. Used as monotherapy

71 LIDODERM Lidocaine

72 LYNPARZA Lynparza Combination therapy Pt has previous trial on at least TWO prior lines of chemotherapy Oncologist

73 MEKINIST Mekinist Previous use of Zelboraf OR Tafinlar 1. Pt is BRAF(V600E or V600K) mutation positive, 2. Monotherapy or in combination with Tafinlar Oncologist, Hematolgist, Dermatologist

74 MS Avonex, Avonex Administration Pack, Avonex Pen Previous trial on at least ONE of the following: 1. Extavia, 2. Gilenya, 3. Rebif Neurologist

75 MYALEPT Myalept 1. Pt has baseline leptin levels of less than 8 ng/ml for males OR less than 12 ng/ml for females, 2. Pt has ONE of the following: a. Diagnosis of diabetes and is being treated with Metformin AND at least one other antidiabetic agent, b. Diagnosis of hypertriglyceridemia and is being treated with at least ONE antihyperlipidemic agent, 3. Reauth: a. Pt has been screened for the presence of anti-metreleptin antibodies, b. If presence of antimetreleptin antibodies, pt must still be receiving benefit from Myalept therapy, c. Pt shows improvement in hemoglobin A1c OR fasting triglyceride level Endocrinologist Initial: 6 months, Reauth:

76 NAFCILLIN Nafcillin, Nafcillin Sodium BvsD determination

77 NEXAVAR Nexavar 1. Used as monotherapy, 2. For HCC dx: Treatment for unresectable tumor or recurrent disease, 3. For thyroid cancer dx: Tumor is refractory to treatment with radioactive iodine

78 NUEDEXTA Nuedexta Pt has score of 13 or greater on Center for Neurologic Study-Liability Scale (CNS-LS) for pseudobulbar affect (PBA) Neurologist 6 Months

79 OCTREOTIDE Octreotide Acetate 1. For acromegaly: a. Has patient failed at least TWO of the following: i. Surgical resection, ii. Pituitary irradiation, iii. Bromocriptine, b. Pt has elevated levels of growth hormone and IGF-1, 2. For carcinoid: a. Pt is suffering from severe diarrhea and flushing episodes associated with disease, 3. For VIPoma: a. Pt has profuse water diarrhea associated with disease Endocrinologist or Oncologist 1. For acromegaly: 6 mo, 2. For others: Plan year BvsD determination

80 OLYSIO Olysio 1. Previous treatment with a protease inhibitor, 2. Genotype 1a: Screening revealed presence of the NS3 Q80K polymorphism 1. Used in combination with pegylated interferon-alfa and ribavirin OR 2. Used in combination with Sovaldi Gastroenterolgist, Infectious Disease Specialist, Transplant Specialist 12 Weeks

81 ONCASPAR Oncaspar 1. Oncaspar is being used in combination with chemotherapy AND 2. Oncaspar is being used first-line OR 3. Pt has demonstrated a past hypersensitivity to L-asparaginase therapy Oncologist

82 OPDIVO Opdivo 1. Pt has autoimmune disease or a medical condition that requires immunosuppression, 2. Pt has symtopmatic interstitial lung disease, 3. Pt has untreated brain metastesis 1. For melanoma dx: a. Pt has previous trial on Yervoy and experienced disease progression within 24 weeks following the last dose of Yervoy, b. Pt did NOT experience an immune-mediated adverse reaction to Yervoy requiring use of corticosteroids, c. Pt is NOT positive for BRAF V600E or V600K mutation OR d. Pt is BRAF V600E or V600K mutation positive AND has previously tried at least ONE of the following: a. Mekinist, b. Tafinlar, c. Zelboraf, 2. For NSCLC dx: a. Pt has failed treatment with a platinum-based chemotherapy regimen, b. Oncologist, Hematologist BvsD determination

83 ORENCIA Orencia 1. Pt has failed treament with Enbrel OR Humira, 2. Pt has failed treatment with Cimzia Rheumatologist or consult

84 ORFADIN Orfadin 1. Pt's plasma tyrosine level is greater than 200 microcol/l

85 ORKAMBI Orkambi 1. Initial: a. Patient is being managed at a cystic fibrosis clinic, b. Pt's ppfev1 is between 40% and 90%, c. Pt has a homozygous mutation for the F508del mutation in the CTFR gene., 2. Reauth: a. Pt has been reassessed since starting therapy, b. Pt's ppfev1 increased since starting therapy 12 years older or older Pulmonologist Initial: 3 mo, Reauth: 1 year

86 OTEZLA Otezla 1. Pt has previous trial on Enbrel OR Humira, 2. Pt has previous trial on Cimzia Rheumatologist, Dermatologist

87 PAH Adcirca, Revatio, Sildenafil 1. Exclusion of all secondary causes of pulmonary hypertension, 2. Must be dx with PAH with WHO class II or III Pulmonoligist, Cardiologist Adcirca requests: previous trial on sildenafil

88 PLEGRIDY Plegridy, Plegridy Pen 1. Pt has previous trial on Avonex AND 2. Pt has previous trial on at least ONE of the following: a. Aubagio, b. Betaseron, c. Copaxone, d. Extavia, e. Gilenya, f. Rebif, g. Tecfidera, h. Tysabri Neurologist

89 POMALYST Pomalyst 1. Pt has tried BOTH of the following: a. Revlimid, b. Velcade, 2. Pt has demonstrated disease progression within 60 days of completion of prior therapy Oncologist, Hematologist

90 PRIMAXIN Imipenem-Cilastatin Sodium Pt has had a positive culture within the past month indicating a MRSA infection 1. For infections of the lower respiratory tract, urinary tract, intra-abdominal, gynecologic, bone and joint, skin and skin structure, polymicrobic infections, or bacterial septicemia: Pt has had a positive culture within the past month for ANY of the following (mark all that apply): a. Staphylococcus aureus (MSSA), b. Streptococcus spp., c. Escherichia coli, d. Klebsiella spp., e. Enterobacter, f. Pseudomonas aeruginosa, g. Other resistant gram-negative bacilli, h. Other anaerobes, 2. Pt must meet ONE of the following: a. Pt has a CrCl greater than or equal to 5 ml/minute/1.73 m2, b. Pt will be on hemodialysis within 48 hours of therapy, 3. Pt has failed at least ONE previous antibacterial and/or other antimicrobial therapy Infectious Disease Specialist 1 Month BvsD determination

91 PROLIA Prolia 1. For Osteoporosis: a. Must meet at least ONE of the following: i. Pt has experienced a fragility fracture AND Pt has intolerance or contraindication on oral or IV bisphosphonate therapy, OR ii. WHO fracture risk score completed AND Pt qualifies for pharmacologic treatment with a 10 year hip fracture probability of greater than 3% OR a 10 year major osteoporosis-related all fracture probability of greater than 20% AND Pt has intolerance or contraindication on oral or IV bisphosphonate therapy, OR iii. WHO fracture risk score completed AND Pt qualifies for pharmacologic treatment with a 10 year hip fracture probability of greater than 3% OR a 10 year major osteoporosis-related all fracture probability of greater than 20% AND Pt had a decline in bone mineral density (BMD) of greater than 10% while on IV bisphosphonate therapy for at least 2 years AND Pt has been compliant on calcium and vitamin D supplementation AND Other causes of low BMD have been evaluated, 2. For Nonmetastatic prostate cancer: a. Pt has a BMD T-score at the lumbar spine, total hip or femoral neck of -1.0 or less OR b. Pt had an osteoporotic fracture, 3. For Women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer: a. Pt has a BMD T-score at the lumbar spine, total hip or femoral neck between -1.0 and -2.5

92 PROMACTA Promacta 1. For ITP dx: a. Previous failure to corticosteroids, immunoglubulins, OR splenectomy, b. Initial: Evidence of bleeding OR platelet count less than 20,000/microL, c. For reauth: Platelet count less than 400,000/microL, 2. For Hep C with Thrombocytopenia dx: a. Platelet count less than 75,000/microL, b. Pt is not receiving concurrent protease inhibitor treatment Oncologist, Hematologist, Gastroenterologist, Hepatologist 6 Months

93 PULMONARY FIBROSIS Esbriet, Ofev 1. Initial: a. All other causes of IPF have been eliminated, b. Diagnosis has been confirmed via high-resolution computed tomography scan and/or lung biopsy, c. Pt Forced Vital Capacity (FVC) is between 50-79% predicted value, d. Pt carbon monoxide diffusing capacity is between 30-79% predicted value, e. Liver function test has been completed prior to initiating therapy, f. Patient is not a current smoker, g. FOR OFEV: Patient is not receiving anticoagulation therapy, 2. Reauth: a. A repeat liver function teast has been performed after 3 months of therapy has been completed Pulmonoligist Initial: 3 mo, Reauth: 1 year

94 PURIXAN Purixan 1. Used in conjunction with a combination chemotherapy treatment regimen for ALL, 2. Pt has previous failure on mercaptopurine tablets Oncologist, Hematologist

95 RAVICTI Ravicti Diagnosis of hyperammonemia OR N-acetylglutamate synthase deficiency 1. Pt has been compliant with dietary protein restriction OR amino acid supplementation, 2. Previous trial on sodium phenylbutyrate 2 years old or older Medical Geneticist, Metabolic Specialist

96 RCC Afinitor, Afinitor Disperz 1. Previous failure on either Sutent or Nexavar, 2. For SEGA or TS dx: Patient must require therapeutic intervention and not be a candidate for surgical resection

97 RELISTOR Relistor 1. Pt has advanced illness, 2. Pt has tried at least TWO of the following: a. Miralax, b. Lactulose, c. Senna, d. Bisacodyl, e. Milk of Magnesia BvsD determination

98 REMICADE Remicade 1. For rheumatoid arthritis, psoriatic arthritis, Crohn's, ankylosing spondylitis dxs : a. Pt has previous trial on at least ONE of the following: i. methotrexate, ii. leflunomide, iii. hydroxychloroquine, iv. sulfasalazine, v. injectable gold, vi. oral gold, vii. azathioprine, viii. penicillamine, ix. cyclosporine, b. Pt has previous trial on at least ONE of the following: a. Enbrel, b. Humira, 2. For Crohn's dx: a. Pt has previous trial on at least ONE of the following: i. Enbrel, ii. Humira, b. Pt has previous trial on Cimzia, 3. For ulcerative colitis and plaque psoriasis dxs: Pt has previous trial on at least ONE of the following: a. Enbrel, b. Humira, 4. For ankylosing spondylitis dxs: Pt has previous trial on Cimzia Rheumatologist, Gastroenterologist, OR Dermatologist BvsD determination

99 REVLIMID Revlimid

100 SABRIL Sabril 1. For solution: Must be used as monotherapy for infantile spasms, 2. For tablets: a. Must be used as adjunctive therapy, b. Must have tried at least TWO of the following: i. Banzel, ii. Carbamazepine, iii. Celontin, iv. Depakene, v. Depakote, vi. Dilantin, vii. Divalproex, viii. Epitol, ix. Equetro, x. Ethosuximide, xi. Felbamate, xii. Gabitril, xiii. Keppra, xiv. Lamictal, xv. Lamotrigine, xvi. Levetiracetam, xvii. Lyrica, xviii. Mysoline, xix. Oxcarbazepine, xx. Peganone, xxi. Phenytoin, xxii. Potiga, xxiii. Stavzor, xxiv. Tegretol, xxv. Topamax, xxvi. Topiramate, xxvii. Trileptal, xxviii. Valproic Acid, xxix. Vimpat, xxx. Zonegran, xxxi. Zonisamide Neurologist Periodic vision testing

101 SIGNIFOR Signifor, Signifor Lar 1. Initial: a. Pt is NOT a candidate for pituitary surgery, b. If pt previously had pituitary surgery: Pt continues to have 24-hour urinary free crotisol levels of: i. 90 micrograms or greater if male, ii. 67 micrograms or greater if female, 2. Reauth: a. Pt's 24-hour urinary free cortisol level is: i. 60 micrograms or lower if male, ii. 45 micrograms or lower if female OR has decreased by at least 50% from initial Signifor therapy Endocrinologist Initial: 2 mo, Reauth:

102 SIMPONI Simponi, Simponi Aria Combination treatment with TNF antagonist 1. For rheumatoid arthritis, psoriatic arthritis dxs: a. Pt has previous trial on at least ONE of the following: i. methotrexate, ii. leflunomide, iii. hydroxychloroquine, iv. sulfasalazine, v. injectable gold, vi. oral gold, vii. azathioprine, viii. penicillamine, ix. cyclosporine, b. Pt has previous trial on at least ONE of the following: a. Enbrel, b. Humira, 2. For ankylosing spondylitis dx: a. Pt has previous trial on at least ONE of the following: i. Enbrel, ii. Humira, b. Pt has previous trial on Cimzia, 3. for ulcerative colitis dx: Pt have previous trial on at least ONE of the following: a. Enbrel, b. Humira Rheumatologist, Gastroenterologist

103 SIRTURO Sirturo Pt has previous failure on at least TWO of the following: 1. Ethambutol, 2. Streptomycin, 3. Pyrazinamide, 4. Amikacin/kanamycin, 5. Cycloserine/terizidone, 6. Ethionamide, 7. Capreomycin, 8. Levofloxacin, 9. Moxifloxacin, 10. Ofloxacin Pulmonologist, Infectious Disease Specialist 6 Months

104 SIVEXTRO Sivextro Chart notes and bacterial susceptibility reports have been submitted showing need for medication 1 month

105 SOVALDI Sovaldi 1. Genotype 1 and 4: a. Used in combination with pegylated interferon-alfa and ribavirin OR b. Used in combination with Olysio, 2. Liver transplant: Pt is a candidate for liver transplant and on the transplant waiting list, 3. Pt must display at least ONE of the following: a. Extrahepatic complications of HCV as shown by any of the following: i. HCV-related renal disease, ii. Vasculitis, iii. Porphyria cutanea tarda, b. Status post liver transplant for HCV, c. HCV with chronic kidney disease (greater than or equal to stage 2), d. Status post renal transplantation Gastroenterolgist, Infectious Disease Specialist, Transplant Specialist 1. Genotype 1, 2, 4: 12 Weeks, 2. Genotype 3: 24 Weeks, 3. Liver transplant: 48 Weeks

106 SPRYCEL Sprycel 1. For blast or chronic phase CML dx : Previous trial on Gleevec, 2. For ALL dx: Resistance or intolerance to at least ONE prior therapy, 3. Efficacy testing will be conducted in accordance with NCCN recommended treatment guidelines, 4. After failure of treatment per NCCN CML guideline testing patient does NOT have a T315I mutation based BCR-ABL kinase domain testing Oncologist, Hematologist

107 STELARA Stelara Treatment initiation during an active infection 1. For PsA dx: a. Pt has failed treatment with Enbrel OR Humira, b. Pt has failed treatment with Cimzia, 2. For plaque psoriasis dx: a. Plaque psoriasis involves 10% or more of the body surface area, b. If less than 10% of body surface area there is scalp, palmer, foot, or groin involvement causing significant disability, c. Pt has failed therapy of at least 12 weeks with at least ONE of the following: i. methotrexate, ii. cyclosporine, iii. acitretin, d. Pt has failed treatment with Enbrel OR Humira Dermatologist or consult

108 STIMULANTS Modafinil, Nuvigil 1. For OSAHS dx: Pt has history of CPAP in which pt showed compliance with CPAP, 2. For SWSD dx: 1. Expressed symptoms of excessive sleepiness for at least 3 months 2. The work shift meets at least ONE of the following: a. Six (6) or more hours of the shift between 10pm and 8am, b. Twelve (12) or less hours per shift, c. Five (5) or more alternative shifts per month, d. Three (3) or more consecutive shifts per month Sleep specialist

109 STIVARGA Stivarga Oncologist

110 SUTENT Sutent Sutent used as combination therapy with other chemotherapies 1. For GIST dx: Disease progression or intolerance to Gleevec, 2. For pnet dx: Tumor is unresectable locally advanced or metastatic

111 SYLATRON Sylatron 1. Pt has stage III melanoma with previous surgical resection, 2. Surgical resection (including lymphadenectomy) were less than 84 days prior to request Oncologist or Dermatologist

112 SYNAGIS Synagis 1. For less than 2 years of age: a. Pt with CLD requiring medical therapy (such as supplemental oxygen, bronchodilator, diuretic or corticosteroid therapy) within 6 months before start of RSV season, To meet a dx of CLD with a recent history of oxygen use, infants should have the following: i. Required supplemental oxygen for at least 28 postnatal days to be classified as having mild, moderate, or severe BPD/CLD according to United States National Institute of Child Health and Human Development (NICHD), b. 2nd season authorization: Pt continues to require medical therapy for respiratory or cardiac dysfunction, 2. Infants born at 32 weeks of gestation or before with or without CLD: a. Gestational age and chronologic age at start of season, b. Born less than 29 weeks GA and less than 12 months of age during the RSV season, c. Born 29 to 32 weeks GA and less than 6 months of age before start of RSV season, 3. Infants with a gestational age 32 weeks 0 days to 34 weeks 6 days, with one of the risk factors below: a. Daycare attendance, b. Sibling(s) younger than 5 years of age, 4. Infants less than one (1) year of age with severe neuromuscular disease or congenital abnormalities of the airways that compromise handling of respiratory secretions, 5. Children less than 24 months (2 years) old with hemodynamically significant congenital heart disease who have any of the following: a. Are receiving medication to control congestive heart failure (diuretics, antihypertensives), b. Diagnosed with moderate to severe pulmonary hypertension, c. Diagnosed with cyanotic heart disease 2 years old or younger

113 BvsD determination

114 SYNERCID Synercid 1. For complicated bacterial skin and skin structure infections: Pt has had a positive culture within the past month for either of the following (mark all that apply): a. Staphylococcus aureus (MSSA only), b. Streptococcus pyogenes Infectious Disease Specialist 1 Month BvsD determination

115 SYNRIBO Synribo Pt has resistance and/or intolerance to TWO or more of the following: 1. Gleevec, 2. Sprycel, 3. Tasigna, 4. Bosulif Hematologist, Oncologist BvsD determination

116 TAFINLAR Tafinlar Disease progression with Zelboraf OR Mekanist Pt is BRAF(V600E or V600K) mutation positive Oncologist, Hematologist, Dermatologist

117 TARCEVA Tarceva 1. For NSCLC dx: a. Pt with EGFR mutation, b. Tarceva is not used in combination with platinum-based chemotherapy, 2. For pancreatic cancer dx: Combination with gemcitabine

118 TASIGNA Tasigna Documented resistance or intolerance to gleevec for chronic phase or accelerated phase CML

119 TECFIDERA Tecfidera 1. Pt has failed at least TWO of the following: a. Aubagio, b. Avonex, c. Betaseron, d. Copaxone, e. Extavia, f. Gilenya, g. mitoxantrone, h. Rebif, i. Tysabri, 2. Pt has normal CBC (within last 6 months) Neurologist

120 TECHNIVIE Technivie 1. Pt has cirrhosis, 2. Previous therapy with sofosbuvir 1. Used in combination with ribavirin, 2. Intolerance to Viekira Pak without dasabuvir Gastroenterologist, Infectious Disease Specialist, Transplant Specialist 12 Weeks

121 TEFLARO Teflaro 1. For acute bacterial skin and skin structure infections: Pt has had a positive culture within the past month for ANY of the following (mark all that apply): a. Staphylococcus aureus (MSSA and MRSA), b. Streptococcus pyogenes, c. Streptococcus agalactiae, d. Escherichia coli, e. Klebsiella pneumonia, f. Klebsiella oxytoca, 2. For community-acquired bacterial pneumonia: Pt has had a positive culture within the past month for ANY of the following (mark all that apply): a. Staphylococcus aureus (MSSA only), b. Streptococcus pneumoniae, c. Haemophilus influenzae, d. Escherichia coli, e. Klebsiella pneumonia, f. Klebsiella oxytoca Infectious Disease Specialist 1 Month BvsD determination

122 THIOTEPA Thiotepa Oncologist

123 TORISEL Torisel Combination chemotherapy

124 TREANDA Treanda For NHL dx: Disease progression during or within six months of treatment with rituximab OR rituximab-containing regimen

125 TROKENDI Topiramate Er, Trokendi Xr Pt has previous failure on immediate release topiramate, 2. Pt has previous failure with at least ONE other antiepileptic drug 2 years old or older Neurologist

126 TYGACIL Tygacil 1. For complicated bacterial skin and skin structure infections: Pt has had a positive culture within the past month for ANY of the following (mark all that apply): a. Staphylococcus aureus (MSSA or MRSA), b. Escherichia coli, c. Enterococcus faecalis (vancomycin susceptible strains only), d. Enterobacter cloacae, e. Klebsiella pneumonia, f. Bacteroides fragilis, g. Streptococcus agalactia, h. S.pyogenes, i. S.anginosus group (including S. anginosus, S. intermedius, and S. constellatus), 2. For community acquired bacterial pneumonia: Pt has had a positive culture within the past month for ANY of the following (mark all that apply): a. Streptococcus pneumonia (penicillin-susceptible isotales), b. Haemophilus influenza (betalactamase negative isolates), c. Legionella pneumophila, 3. For complicated bacterial intra-abdominal infections: Pt has had a positive culture within the past month for ANY of the following (mark all that apply): a. Staphylococcus aureus (MSSA or MRSA), b. Escherichia coli, c. Enterococcus faecalis (vancomycin susceptible strains only), d. Enterobacter cloacae, e. Klebsiella pneumonia, f. K.oxytoca, g. Bacteroides fragilis, h. B.thetaiotaomicron, i. B.uniformis, j. B.fragilis, k. Citrobacter freundii, l. Clostridium perfringens, m. Peptostreptococcus micros 18 years old or older Infectious Disease Specialist 1 Month

127 BvsD determination TYKERB Tykerb 1. For advanced or metastatic HER-2 positive breast cancer dx: a. Previous failure on anthracycline, taxane, and trastuzumab AND b. Combination therapy with capecitabine OR c. Combination therapy with trastuzumab, 2. For postmenopausal HER-2 receptor hormone receptor positive breast cancer dx: Combination therapy with aromatase inhibitor

128 TYSABRI Tysabri 1. For MS: a. Pt has been compliant on at least ONE of the following: i. Avonex, ii. Betaseron, iii. Copaxone, iv. Rebif, b. Anti-natalizumab assay is required after 12 weeks and 24 weeks of therapy, 2. For Crohn's: a. Pt has tried at least ONE of the following: i. Humira, ii. Remicade Neurologist, Gastroenterologist Initial: 12 Weeks, Reauth: 6 Months

129 VALCHLOR Valchlor Pt has previous trial on at least ONE previous skin directed therapy of the following: 1. Topical corticosteroid, 2. Topical carmustine, 3. Topical retinoid, 4. Radiation therapy, 5. Phototherapy Oncologist, Dermatologist

130 VASODILATORS Orenitram Er, Remodulin, Tyvaso, Ventavis 1. For NYHA functional class II or III: Previous trial on at least one of the following: Adcirca, Letairis, Opsumit, sildenafil, Tracleer, 2. Presence of functional class IV Pulmonologist, Cardiologist

131 VELCADE Velcade For mantle cell lymphoma dx: Pt has failed prevous chemotherapy Oncologist

132 VERSACLOZ Versacloz 1. Pt has had an inadequate response to at least TWO antipsychotic medications, a. At least one medication must be a long-acting depot, OR 2. Pt has medical condition that prohibits the use of tablets Psychiatrist

133 VIEKIRA Viekira Pak 1. Chart notes showing genotype Gastroenterologist, Infectious Disease Specialist, Transplant Specialist Maximum 24 weeks

134 VIRAZOLE Virazole 1. Pt has had an RSV infection confirmed or quantified by antibody, antigen, or viral RNA assays in the last month, 2. Pt has an underlying compromising condition (i.e. prematurity, cardiopulmonary disease, or immunosuppression) 3 years old or younger Infectious Disease Specialist 7 Days

135 XALKORI Xalkori Combination therapy with other chemotherapy agents NSCLC must be anaplastic lymphoma kinase (ALK)-positive Oncologist

136 XELJANZ Xeljanz Combination with biologic DMARD or potent immunosuppressant 1. Pt has failed treament with Enbrel OR Humira, 2. Pt has failed treatment with Cimzia Rheumatologist or consult

137 XENAZINE Tetrabenazine, Xenazine Neurologist

138 XGEVA Xgeva 1. Use in pt with multiple myeloma 1. Must meet at least ONE of the following: a. Pt has giant cell tumor of the bone that is unresectable or where surgical resection is likely to result in severe morbidity, b. Pt has a diagnosis of bone metasteses related to a solid tumor, c. Pt has a diagnosis of metastatic breast or prostate cancer, d. Pt has severe renal impairment (CrCl less than 35mL/min), e. Pt has previously been treated with Zometa or Aredia and had disease progression OR adverse reaction to the treatment Oncologist BvsD determination

139 XIFAXAN Xifaxan 1., 2. Diarrhea or Mixed Type Irritable Bowel Syndrome, 3. Clostridium difficile infection 1. For traveler's diarrhea dx: Previous trial on sulfamethoxazole-trimethoprim, azithromycin, ciprofloxacin, or levofloxacin, 2. For hepatic encephalopathy dx: Previous failure on lactulose therapy, 3. For irritable bowel syndrome dx: Failure on at least ONE antispasmodic therapy AND at least ONE antibiotic therapy, 4. For Clostridium difficile dx: Failure on at least TWO other antibiotic therapies Gastroenterologist OR Infectious Disease Specialist

140 XOLAIR Xolair 1. FEV1 baseline between 40 and 80% of predicted, 2. Pt has been taking for at least 3 months on at least ONE of the following: a. Medium dose ICS and inhaled long-acting bronchodilator, b. Medium dose ICS and leukotriene antagonist, c. Medium dose ICS and theophylline, d. High dose ICS and inhaled long-acting bronchodilator, e. Low dose ICS and inhaled long-acting bronchodilator, 3. Pt has had need for frequent intermittent use of oral corticosteroids, 4. Pt has at least ONE of the following: 1 ER visit or hospitalization for asthma within past 6 months OR Need for frequent office visits due to asthma evaluation, 5. Pt's IgE level is greater than or equal to 30, 6. Pt is less than 330 lbs Allergist, Pulmonologist Pt weighs 330 lbs or less

141 XTANDI Xtandi 1. Pt's prostate cancer is castration resistant, 2. Pt has previous trial on Zytiga therapy Oncologist, Urologist

142 XYREM Xyrem 1. Narcolepsy dx confirmed by PSG and MSLT tests, 2. Pt must have at least ONE of the following: a. Pt exhibits symptoms of cataplexy OR b. Pt has previous treatment with Provigil or Nuvigil Board certified in Sleep, Pulmonology, or Neurology

143 ZELBORAF Zelboraf 1. Combination therapy, 2. Disease progression with prior Mekinist or Tafinlar therapy Pt is BRAF(V600E or V600K) mutation positive Oncologist, Hematologist

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