Drugs Requiring Prior Authorization. Olysio. Subsys. Prolia. Tecfidera

Transcription

1 Abstral Acthar Hp Adcirca Adempas Affinitor Amitiza Amitriptyline Ampyra Androgel Androderm Androxy Aranesp Arcalyst Aubagio Avonex Bosulif Bydureon Byetta Cimzia Cinryze Clomipramine Cometriq Copaxone Cyclobenzaprine Cyproheptadine Daliresp Diphenhydramine Doxepin Dysport Epogen Erivedge Fentanyl Oral Fentora Forteo Fulyzaq Gattex Genotropin Gilenya Giltorif Hetlioz Humatrope Iclusig Imbruvica Imipramine Incivek Increlex Infergen Inlyta Intron-A Jakafi Juxtapid Kalydeco Kineret Korlym Kuvan Kynamro Lazanda Letairis Lidocaine Transdermal Patch Linzess Drugs Requiring Prior Authorization Megace Remodulin Megestrol Revlimid Mekinist Saizen Menest Samsca Modafinil Sancuso Mozobil Serostim Namenda Sildenafil Nexavar Simponi Norditropin Sirturo Nuedexta Somavert Nutropin Sovaldi Nutropin Aq Sprycel Nuvigil Stelara Olysio Subsys Omnitrope Surmontil Opsumit Sutent Orencia Sylatron Orenitram Sylvant Otezla Symlin Oxandrolone Tabloid Pegasys Tafinlar Peg-Intron Tarceva Pomalyst Targretin Procrit Tasigna Prolia Tecfidera Promacta Testim Ravicti Tev-Tropin Rebif Thalomid Regranex Thioridazine Relistor Tracleer Remicade Treanda Tyvaso Vecamyl Vectibix Ventavis Victoza Victrelis Votrient Xalkori Xeljanz Xenazine Xgeva Xolair Xtandi Xyrem Yervoy Zaleplon Zelboraf Zolinza Zorbtive Zykadia Zytiga 1 of 107 H5883_T_PAlist CMS Approved

2 Acthar HP. 2 of 107 H5883_T_PAlist CMS Approved

3 Adempas. 3 of 107 H5883_T_PAlist CMS Approved

4 Afinitor. Prescriber is an oncologist Coverage is not provided when Affinitor is used in combination with Nexavar or Sutent 4 of 107 H5883_T_PAlist CMS Approved

5 Amitzia Diagnosis: 1. Chronic idiopathic constipation (CIC) in adults or 2. Opioid-induced constipation in adults with chronic, non-cancer pain or 3. Irritable bowel syndrome (IBS) with constipation in women 18 years of age and older Prescribed by or in consultation with a dermatologist or oncologist. Documentation of trial/failure within the last 12 months of: 1. A fiber laxative and 2. One of the following: a stimulant laxative or an osmotic laxative 5 of 107 H5883_T_PAlist CMS Approved

6 Ampyra Patients with a history of seizure or moderate to severe renal impairment defined by a CrCl of 50ml/min or less Initial requests require documentation of a 25 foot timed walk test. Renewal requests require documentation of improvement in walking distance of a 25 foot timed walk test compared to pretreatment. Prescriber is a neurologist Initial approval is Three Months Renewal approvals are for one year Initial coverage is provided to improve walking distance in patients with a diagnosis of multiple sclerosis who have the ability to walk a timed 25 foot walk test. Renewal criteria: documentation that the member has shown an improvement in walking distance of a 25 foot timed walk test compared to pretreatment. 6 of 107 H5883_T_PAlist CMS Approved

7 Trandermal Androgens Androgel, Androderm, Testim, Testipel, Testosterone Documentation of androgen deficiency syndrome confirmed by two morning testosterone levels less than 300 ng/dl and at least 2 clinical signs or symptoms specific to androgen deficiency 7 of 107 H5883_T_PAlist CMS Approved

8 Androxy 8 of 107 H5883_T_PAlist CMS Approved

9 Arcalyst 12 years of age and older 9 of 107 H5883_T_PAlist CMS Approved

10 Aubagio Prescriber is a neurologist Requires documentation of a trial/failure of either Glatiramer or an Interferon beta product. 10 of 107 H5883_T_PAlist CMS Approved

11 Avonex. Multiple Sclerosis (MS): 1. Relapsing forms of MS or 2. High risk of developing clinically definite MS defined by both of the following: a) Recent history of a first clinical demyelinating event AND b) MRI-detected brain lesions consistent with MS Lifetime 11 of 107 H5883_T_PAlist CMS Approved

12 Bosulif. Diagnosis of chronic, accelerated, or blast phase Philadelphia chromosomepositive (Ph+) chronic myelogenous leukemia (CML) 12 of 107 H5883_T_PAlist CMS Approved

13 Cimzia Requires documentation of diagnosis and medication history or intolerance(s) Crohn's Disease: Prescribed or recommended by a gastroenterologist RA: Prescribed or recommended by a rheumatologist. Rheumatoid arthritis requires the member has tried and failed Humira or Enbrel, except if not tolerated due to documented clinical side effects. Crohn's disease, requires: 1) Treatment with an adequate course of systemic corticosteroids (e.g., 40 mg to 60 mg prednisone per day for 7 to 14 days) has been ineffective or is contraindicated or 2) The patient has been unable to taper off an adequate course of systemic corticosteroids without experiencing worsening of disease or 3) The patient is experiencing breakthrough disease (e.g., active disease flares) while stabilized for at least 2 months on an immunomodulatory medication (such as azathioprine, mercaptopurine, cyclosporine, or methotrexate) and 4) Adalimumab (Humira ) is not effective after at least an initial 3-dose induction period, except if not tolerated due to documented clinical side effects. 13 of 107 H5883_T_PAlist CMS Approved

14 Cinryze Prescribed by an immunologist, allergist, or rheumatologist 14 of 107 H5883_T_PAlist CMS Approved

15 Cometriq Diagnosis of progressive, metastatic medullary thyroid cancer 15 of 107 H5883_T_PAlist CMS Approved

16 Copaxone Multiple Sclerosis (MS): 1. Relapsing forms of MS OR 2. High risk of developing clinically definite MS defined by both of the following: a) Recent history of a first clinical demyelinating event AND b) MRI-detected brain lesions consistent with MS Lifetime 16 of 107 H5883_T_PAlist CMS Approved

17 HIGH RISK IN THE ELDERLY MEDICATION Cyclobenzaprine Authorization is required for members 65 years of age and older When used for treating fibromyalagia, requires: Trial/failure of two safer alternatives (gabapentin, pregabalin, duloxetine, nortriptyline, tramadol, tizandine or baclofen) (unless not appropriate or contraindicated for the intended use). For all other indications, at least one safer alternative (tizanidine or baclofen) should be tried and failed (unless not appropriate or contraindicated for the intended use). 17 of 107 H5883_T_PAlist CMS Approved

18 Daliresp Diagnosis and patient medication history Coverage is provided for the treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis in patients with a history of exacerbations and patient is receiving: 1. inhaled long-acting beta-2 agonist [for example, Formoterol, Salmeterol] AND 2. inhaled long-acting anticholinergic agent [for example, Tiotropium] AND 3. inhaled corticosteroid [for example, Fluticasone] OR 4. Patient experienced intolerance or has contraindications to use of these medications 18 of 107 H5883_T_PAlist CMS Approved

19 Dysport Will not be covered for cosmetic purposes 19 of 107 H5883_T_PAlist CMS Approved

20 Erythropoesis Stimulating Agents: Arnesp, Epogen, Procrit Anemia due to folate, vitamin B12, iron deficiencies, hemolysis, bleeding, or bone marrow fibrosis. Anemia associated with treatment of acute and chronic myelogenous leukemias or erythroid cancers. Anemia due to cancer treatment in patients with uncontrolled hypertension. Anemia not associated with cancer treatment or renal disease under inclusions. Anemia associated only with radiotherapy. Prophylactic use to prevent chemotherapy induced anemia. Prophylactic use to reduce tumor hypoxia. Erythropoietin-type resistance due to neutralizing antibodies. Hemoglobin less than 13 for prophylactic use during some major surgeries Hemoglobin less than 12mg/dl for remaining covered uses Three Months Erythropoesis stimulating agents are subject to Part B vs Part D review 20 of 107 H5883_T_PAlist CMS Approved

21 Erivedge Prescribed by or in consultation with a dermatologist or oncologist 21 of 107 H5883_T_PAlist CMS Approved

22 Estrogens (Menest) Authorization is required for members 65 years of age and older Oral Estrogen (Menest) will be approved when used as part of a cancer treatment regimen. For all other uses, Menest will be approved if two of the following safer alternatives as been tried and failed or are not appropriate or contraindicated. Safer alternatives include: e.g., SSRIs, venlafaxine ER, Premarin vaginal cream, Estrace vaginal creams, Estring or Femring Vaginal Rings, Vagifem vaginal tablets 22 of 107 H5883_T_PAlist CMS Approved

23 Forteo Coverage is not provided for hypocalcemia 1) A Diagnosis of: a. Postmenopausal women with osteoporosis, or b. Glucocorticoid induced osteoporosis, or c. Males with primary or hypogonadal osteoporosis, all of who are at high risk for fracture 2) Bone mineral density that is 2.5 standard deviations or more below the mean (t-score at or below -2.5) One year with maximum two years of therapy Forteo is subject to Part B vs Part D review. Coverage approval requires: Trial and failure to at least one bisphosphonate except when: 1. Contraindication to an oral and intravenous bisphosphonate (such as a stricture or aclasia, inability to stand or sit upright for at least 30 minutes and increased risk of aspiration) 2. Documented intolerance to a bisphosphonate 23 of 107 H5883_T_PAlist CMS Approved

24 Fulyzaq 24 of 107 H5883_T_PAlist CMS Approved

25 Gattex Lifetime 25 of 107 H5883_T_PAlist CMS Approved

26 Gilenya Prescribed by a neurologist Requires documentation of trial/failure of either Glatiramer or an Interferon beta product. 26 of 107 H5883_T_PAlist CMS Approved

27 Giltorif 27 of 107 H5883_T_PAlist CMS Approved

28 Growth Hormone: Genotropin, Humatrope, Increlex, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Somavert, Tev-Tropin, Zorbtive Covered for the replacement of endogenous growth hormone in adults with growth hormone deficiency of childhood onset or adult onset. Covered if initial diagnosis based on two growth hormone stimulation tests and that the patient does not have edema, arthralgias, or carpal tunnel syndrome. Serostim is covered for aids wasting cachexia. Norditropin is covered for Noonan syndrome, Turner syndrome, and adult growth hormone deficiency. Nutropin is covered for Turner syndrome, and adult growth hormone deficiency. Omnitrope and Saizen are covered for adult growth hormone deficiency. Zorbtive is covered for the treatment of short-bowel syndrome in patients receiving specialized nutritional support. Somavert is covered for acromegaly. 28 of 107 H5883_T_PAlist CMS Approved

29 Hetlioz June 1, 2014 Documentation of patient visual capabilities Llifetime 29 of 107 H5883_T_PAlist CMS Approved

30 Hepatitis Treatments: Infergen, Intron-A, Pegasys, Pegasys proclick, Peg-Intron Peg-Intron Redipen Documentation of concomitant Ribavarin use (or contraindications) is required when requesting initial use for Hepatitis C. Documentation of viral genotype is required for Hepatitis C. Documentation of response to therapy is required for requests for continuation of therapy for Hepatitis C Initiation Of Therapy: 12 weeks Continuation Therapy: 24 to 48 weeks 30 of 107 H5883_T_PAlist CMS Approved

31 High Risk in the Elderly Medications: Diphenhydramine Prior authorization is required for formulary high risk medications for members 65 years of age and older Requires documentation of intolerance, contraindications, or trial with failure with at least one other safer formulary alternative. Diphenhydramine is approved if patient has failed or is intolerant to at least one other safer alternative sedative agent such as Trazodone or Rozeram or if patient has failed or is intolerant to at least one other safer alternative antihistamine such as fexofenadine. 31 of 107 H5883_T_PAlist CMS Approved

32 High Risk in the Elderly Medications: Tricyclic Antidepressants: Amitriptyline, Clomipramine, Doxepin, Imipramine, Surmontil. Authorization is required for formulary high risk medications for members 65 years of age and older High Risk Tricyclic Antidepressants are approved if patient has a history of use. For patients initiating therapy, the high risk tricyclic antidepressant is approved if at least one of the suggested alternatives (nortriptyline, desipramine, citalopram, escitalopram, mirtazapine, sertraline, venlafaxine) with less sedation and fewer anticholinergic effects have been tried and failed or is not appropriate or contraindicated for the intended use. 32 of 107 H5883_T_PAlist CMS Approved

33 High Risk in the Elderly Medications Megace (Megesterol). Authorization is required for formulary high risk medications for members 65 years of age and older Megace (megesterol) is approved if at least one of the suggested alternatives (mirtazipine, oxandrolone or dronabinol) have been tried and failed or are not appropriate or contraindicated for the intended use. 33 of 107 H5883_T_PAlist CMS Approved

34 High Risk in the Elderly Medications: Zaleplon Authorization is required for formulary high risk medications for members 65 years of age and older Lunesta (Zaleplon) is approved if at least one of the suggested alternatives, (low dose Trazodone (25-50mg) or Rozerem), has been tried and failed or is not appropriate or contraindicated for the intended use. 34 of 107 H5883_T_PAlist CMS Approved

35 High Risk in the Elderly Medications Thioridiazine Prior authorization is required for formulary high risk medications for members 65 years of age and older Requires documentation of intolerance, contraindications, or trial with failure with at least one other safer formulary alternative. Thioridizine is covered for patients who have a history of use. For patients initiating therapy, thioridizine is covered if patient has a failure of or intolerance to at least one other safer alternative antipsychotics such as Abilify or Seroquel. 35 of 107 H5883_T_PAlist CMS Approved

36 High Risk in the Elderly Medications: Cyproheptadine. Authorization is required for formulary high risk medications for members 65 years of age and older Cyproheptadine is approved if at least one suggested alternative such as a second generation antihistamine (e.g., Cetirizine, Desloratadine, Loratadine, Fexofenadine) or low dose Trazodone (25-50mg) or Rozerem, if using for sleep, have been tried and failed or not appropriate or contraindicated for the intended use. 36 of 107 H5883_T_PAlist CMS Approved

37 Iclusig 37 of 107 H5883_T_PAlist CMS Approved

38 Imbruvica 38 of 107 H5883_T_PAlist CMS Approved

39 Injectable Diabetic Medications: Byetta, Bydureon, Victoza, Symlin Not covered for non Type 2 diabetes diagnosis. Not covered for weight loss in patients with or without diabetes. Requires documentation of diagnosis and medication history or intolerance(s). Lifetime Byetta, Bydureon, Victoza: Approved as adjunctive therapy to improve glycemic control in patients who have a diagnosis of Type II Diabetes Mellitus and are currently taking or have tried and failed at least One of the following: Metformin, a Sulfonylurea, or a Thiazolidinedione, or One of the following: a combination of metformin and a sulfonylurea or a combination of Metformin and a Thiazolidinedione. In addition to the above criteria the patient must have a hemoglobin A1c of greater than 7 per cent. Symlin is covered for patients that have failed intensive treatment with insulin monotherapy and for concurrent use with an insulin product 39 of 107 H5883_T_PAlist CMS Approved

40 Inlyta Coverage is not provided for combination use with other tyrosine kinase inhibitors such as Sorafenib, Sunitinib Coverage for the treatment of renal cell carcinoma is provided after failure with one prior systemic therapy 40 of 107 H5883_T_PAlist CMS Approved

41 Jakafi Prescribed by a hematologist / oncologist 41 of 107 H5883_T_PAlist CMS Approved

42 Juxtapid Requires documentation of diagnosis of homozygous familial hypercholesterolemia. Lifetime Requires trial and failure of Kynamro 42 of 107 H5883_T_PAlist CMS Approved

43 Kalydeco Diagnosis of Cystic Fibrosis and confirmed G551D mutation 43 of 107 H5883_T_PAlist CMS Approved

44 Kineret Requires documentation of diagnosis and medication history or intolerance(s). Prescribed by a rheumatologist Rheumatoid arthritis: requires a treatment failure or contraindication to Enbrel or Humira. 44 of 107 H5883_T_PAlist CMS Approved

45 Korlym 45 of 107 H5883_T_PAlist CMS Approved

46 Kynamro Requires documentation of diagnosis of homozygous familial hypercholesterolemia. Lifetime 46 of 107 H5883_T_PAlist CMS Approved

47 Lidocaine Transdermal Patch 47 of 107 H5883_T_PAlist CMS Approved

48 Linzess 18 years of age and older Chronic idiopathic constipation (CIC) requires documentation of failure within the last 12 months of use of a fiber laxative and one of the following: a stimulant laxative or an osmotic laxative. Drug-induced constipation must be ruled out. 48 of 107 H5883_T_PAlist CMS Approved

49 Mekinist Confirmation of the presence of BRAF V600E or V600K mutation in tumor specimen 49 of 107 H5883_T_PAlist CMS Approved

50 Modafinil, Nuvigil Nuvigil: Requires a treatment failure or contraindication to modafinal 50 of 107 H5883_T_PAlist CMS Approved

51 Mozobil Requires documentation of diagnosis and that granulocyte colony stimulating factor is administered concomitantly, and documentation of poor response to apheresis with granulocyte colony stimulating factor alone. Duration requested up to one month 51 of 107 H5883_T_PAlist CMS Approved

52 Namenda Coverage is not provided for diagnosis of Autism Lifetime 52 of 107 H5883_T_PAlist CMS Approved

53 Narcotic Analgesics: Abstral, Fentanyl Citrate Oral Transmucosal, Fentora, Lazanda, Onsolis, Subsys Requires documentation of diagnosis and medication history Covered for cancer or cancer related diagnosis in patients already receiving long acting opioids 53 of 107 H5883_T_PAlist CMS Approved

54 Nexavar Hepato-cellular carcinoma: Prescribed by an oncologist, hepatologist, or gastroenterologist All other indications: Prescribed by an oncologist 54 of 107 H5883_T_PAlist CMS Approved

55 Nuedexta Requires diagnosis of pseudobulbar affect (PBA). Coverage is provided for the treatment of pseudobulbar affect in patients with underlying neurologic condition. 55 of 107 H5883_T_PAlist CMS Approved

56 Olysio Chronic Hepatitis C genotype 1 with compensated liver disease (including cirrhosis) 18 years and older 12 weeks For interferon eligible patients: must be used in combination with peg-interferon alpha and ribavirin. for interferon ineligble patients: may be used in combination with Sovaldi with or without ribavirin. 56 of 107 H5883_T_PAlist CMS Approved

57 Orencia Verification that the patient has been evaluated for TB and treated accordingly Rheumatoid Arthritis: 18 years and older. Prescribed by a rheumatologist Coverage is provided if: 1) Failed methotrexate or one DMARD and 2) Failure to at least one preferred biologic (Enbrel or Humira) 57 of 107 H5883_T_PAlist CMS Approved

58 Orenitram Lifetime 58 of 107 H5883_T_PAlist CMS Approved

59 Otezla Requires documentation of diagnosis and medication history or intolerance(s). Requires verification that the patient has been evaluated for TB and has been treated accordingly. Coverage is provided if: 1) Failed methotrexate or one DMARD and 2) Failure to at least one preferred biologic (Enbrel or Humira) 59 of 107 H5883_T_PAlist CMS Approved

60 Oxandrolone Weight gain not related to AIDS wasting/cachexia Diagnosis of bone pain due to osteoporosis Or Diagnosis of AIDS wasting/cachexia 60 of 107 H5883_T_PAlist CMS Approved

61 Pomalyst Diagnosis of multiple myeloma Coverage is provided if: 1) Patient has received at least two prior therapies including Lenalidomide and Bortezomib and 2) Demonstrated disease progression on or within 60 days of completion of the last therapy. 61 of 107 H5883_T_PAlist CMS Approved

62 Prolia Coverage is not provided for hypocalcemia Diagnosis: 1.Postmenopausal osteoporosis with a high risk of fracture or 2. Males with risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer or to increase bone mass for osteoporosis or 3. Female at high risk of fracture receiving adjuvant aromatase inhibitor therapy for nonmetastatic breast cancer Prolia is subject to Part B versus Part D review Requirements: Patient has tried and failed at least one bisphosphonate except when: 1. Contraindication to a bisphosphonate (oral and intravenous) such as a stricture or aclasia, inability to stand or sit upright for at least 30 minutes and increased risk of aspiration 2. Documented intolerance to a bisphosphonate 62 of 107 H5883_T_PAlist CMS Approved

63 Promacta Requires documentation of diagnosis, medication history or intolerance(s), platelet counts. 18 years of age and older Prescribed or recommended by a hematologist, hepatologist or gastroenterologist. Initiation of therapy: 12 weeks Continuation therapy: Initial Coverage approval requires: 1) Treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) at risk for bleeding who have had insufficient response to corticosteroids, immune globulin, or splenectomy; or 2) Treatment of thrombocytopenia in patients with chronic hepatitis C in order to allow and maintain interferon-based therapy Renewal of therapy is covered for patients who meet the following criteria: Recent platelet count of 30,000 to 150,000 mcl. 63 of 107 H5883_T_PAlist CMS Approved

64 Hepatitis Therapies: Incivik, Victrelis Coverage is not provided in situations where patients have previously not responded to therapy that included either Boceprevir or Telaprevir. Diagnosis: Chronic hepatitis C, genotype 1 with compensated liver disease (including cirrhosis) and recent HCV-RNA level. Renewal for Victrelis: Detectable HCV-RNA level/viral load or HCV-RNA level/viral load greater than or equal to 100 IU/ml after total treatment week 12 and 24. Covered for patients 18 years of age or older Incivek: 12 weeks. Victrelis: Initial: 12 weeks. 1st Renewal: 12 weeks. 2nd Renewal: 20 weeks. Incivek and Victrelis: Coverage is provided in situations where patients are receiving combination therapy with either Boceprevir or Telaprevir and a Peg interferon alfa product with Ribavirin. Victrelis: Incivek must be contraindicated or not recommended do the patients' clinical history (history of severe skin reactions or dermatologic conditions, moderate to severe hepatic impairment, drug-drug interactions not associated with boceprevir) 64 of 107 H5883_T_PAlist CMS Approved

65 Pulmonary Agents: Adcirca, Letairis, Opsumit, Sildenafil Citrate 20mg, Remodulin, Tracleer, Tyvaso, Ventavis Coverage for Sildenafil and Adcirca is not provided in situations where patients are receiving nitrate therapy. 65 of 107 H5883_T_PAlist CMS Approved

66 Ravicti 66 of 107 H5883_T_PAlist CMS Approved

67 Rebif Multiple Sclerosis (MS): 1. Relapsing forms of MS OR 2. High risk of developing clinically definite MS defined by both of the following: a) Recent history of a first clinical demyelinating event AND b) MRI-detected brain lesions consistent with MS Lifetime 67 of 107 H5883_T_PAlist CMS Approved

68 Regranex Requires documentation of adequate tissue oxygenation at the site of the neuropathic diabetic ulcer, and that there is a full thickness ulcer (for example stage three or four) extending through the dermis into subcutaneous tissue. In addition, requires documentation that the patient is participating in a comprehensive wound care treatment plan including such modalities as debridement, pressure relief (for example, non weight bearing) and infection control. 68 of 107 H5883_T_PAlist CMS Approved

69 Relistor Three Months Requires adequate treatment consisting of 5 days duration of treatment of agents for constipation, including at least any two of the following: Bulk laxatives, saline laxatives or osmotic laxatives. Coverage may not be provided if there are contraindications to Methylnaltrexone therapy. 69 of 107 H5883_T_PAlist CMS Approved

70 Revlimid Prescribed by or in consultation with an oncologist or hematologist 70 of 107 H5883_T_PAlist CMS Approved

71 Remicade Verification that the patient has been evaluated for TB and treated accordingly Crohn's Disease: 6 years and older All other indications: 18 years and older 71 of 107 H5883_T_PAlist CMS Approved

72 Remodulin 72 of 107 H5883_T_PAlist CMS Approved

73 Samsca Documentation that patient does not have underlying liver disease One Month 73 of 107 H5883_T_PAlist CMS Approved

74 Sancuso Sancuso is not covered for hyperemesis gravidarum, nausea and vomiting of pregnancy and post-operative nausea and vomiting. Covered if treatment with generic Ondansetron and oral Granisetron is not effective or is not tolerated. 74 of 107 H5883_T_PAlist CMS Approved

75 Kuvan (Sapropterin hydrochloride) Initial approval requires documentation of dietary restrictions and diagnosis. For renewal requires documentation in reduction of phenylalanine from baseline. Initial - 2 months Authorization will be extended for 1 year if documented response after initial therapy Renewal criteria: after initial therapy of 2 months, a 30% or greater reduction in phenylalanine from baseline 75 of 107 H5883_T_PAlist CMS Approved

76 Simponi Requires documentation of diagnosis and medication history or intolerance(s). Requires verification that the patient has been evaluated for TB and treated accordingly. Rheumatoid Arthritis Trial and failure with Humira or Enbrel, except if not tolerated due to documented clinical side effects. Psoriatic Arthritis requires trial and failure of Humira or Enbrel, except if not tolerated due to documented clinical side effects. Alkylosing spondylitis, requires trial and failure of Humira or Enbrel, except if contraindicated or not tolerated due to documented clinical side effects. Ulcerative Colitis requires trial and failure of Humira except if contraindicated or not tolerated due to documented clinical side effects. 76 of 107 H5883_T_PAlist CMS Approved

77 Sirturo Diagnosis Must be used in combination with at least 3 other agents 77 of 107 H5883_T_PAlist CMS Approved

78 Sovaldi none Initial: Documentation of chronic hepatitis C genotype 1-6, including patients with hepatocellular carcinoma awaiting liver transplant. Renewal: HCV RNA level at 24 weeks and documentation of hepatocellular carcinoma awaiting liver transplant. 18 years and older none Initial: 24 weeks, Renewal: 24 weeks For patients with genotype 1, 4, 5 and 6 who are interferon eligible: must be used in combination with peg-interferon alpha and ribavirin. For patients with genotype 1 who are interferon ineligible may be used in combination with Olysio with or without ribavirin or with ribavirin alone. For patients with genotype 4 who are interferon ineligible must be used in combination with ribavirin. For patients with genotype 2 or 3, and patients with hepatocellular carcinoma: must be used in combination with ribavirin. 78 of 107 H5883_T_PAlist CMS Approved

79 Sprycel Prescribed by oncologist 79 of 107 H5883_T_PAlist CMS Approved

80 Stelara Not covered for diagnosis of Crohn's disease or Psoriatic Arthritis Requires documentation of diagnosis and medication history or intolerance(s). Requires verification that the patient has been evaluated for TB and has been treated accordingly. Covered for treatment of Psoriasis when there is documented: 1. Trial and failure of at least one other oral systemic agent for psoriasis unless all are contraindicated. (E.g. cyclosporine, methotrexate, acitretin). 2. A trial and failure any one of the following: a) Infliximab (Remicaide) after at least an initial induction period (5 mg/kg on weeks 0,2, 6), except if not tolerated due to documented clinical side effects -orb) Humira -or- Enbrel after at least a 12 week treatment course, except if not tolerated due to documented clinical side effects. 80 of 107 H5883_T_PAlist CMS Approved

81 Sutent Prescribed by oncologist 81 of 107 H5883_T_PAlist CMS Approved

82 Sylatron Prescribed by oncologist 82 of 107 H5883_T_PAlist CMS Approved

83 Sylvant 83 of 107 H5883_T_PAlist CMS Approved

84 Tabloid Prescribed by oncologist or hematologist 84 of 107 H5883_T_PAlist CMS Approved

85 Tafinlar Confirmation of the presence of BRAF V600E mutation in tumor specimen 85 of 107 H5883_T_PAlist CMS Approved

86 Tarceva Prescribed by oncologist 86 of 107 H5883_T_PAlist CMS Approved

87 Targretin Prescribed by oncologist or dermatologist 87 of 107 H5883_T_PAlist CMS Approved

88 Tasigna 88 of 107 H5883_T_PAlist CMS Approved

89 Ticfidera Lifetime 89 of 107 H5883_T_PAlist CMS Approved

90 Thalomid 90 of 107 H5883_T_PAlist CMS Approved

91 Treanda 91 of 107 H5883_T_PAlist CMS Approved

92 Vecamyl 92 of 107 H5883_T_PAlist CMS Approved

93 Victibex Prescribed by an oncologist 93 of 107 H5883_T_PAlist CMS Approved

94 Votrient Documentation of advanced renal cell carcinoma Prescribed by an oncologist 94 of 107 H5883_T_PAlist CMS Approved

95 Regranex Requires adequate tissue oxygenation at the site of the neuropathic diabetic ulcer, and that there is a full thickness ulcer (for example stage three or four) extending through the dermis into subcutaneous tissue. Requires that the patient is participating in a comprehensive wound care treatment plan including such modalities as debridement, pressure relief (for example, non weight bearing) and infection control. 95 of 107 H5883_T_PAlist CMS Approved

96 Xalkori Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (alk)-positive as detected by a FDA-approved test. 96 of 107 H5883_T_PAlist CMS Approved

97 Xeljanz Requires documentation of diagnosis and medication history or intolerance(s). Prescribed or recommended by a rheumatologist Requires a treatment failure or contraindication to Enbrel and Humira. 97 of 107 H5883_T_PAlist CMS Approved

98 Xenazine Coverage for Xenazine will not be provided for patients who have hepatic function impairment, patients who are actively suicidal or who have untreated or inadequately treated depression, or patients taking monoamine oxidase inhibitors or reserpine. Lifetime 98 of 107 H5883_T_PAlist CMS Approved

99 Xgeva 99 of 107 H5883_T_PAlist CMS Approved

100 Xolair 12 years of age and older Prescribed by a pulmonologist or allergist/immunologist 100 of 107 H5883_T_PAlist CMS Approved

101 Xtandi Coverage is provided for the treatment of metastatic castration-resistant prostate cancer where the patient has had prior treatment with docetaxel. Prescribed or recommended by an oncologist or urologist 101 of 107 H5883_T_PAlist CMS Approved

102 Xyrem 102 of 107 H5883_T_PAlist CMS Approved

103 Yervoy. Prescribed by an oncologist 103 of 107 H5883_T_PAlist CMS Approved

104 Zelboraf Will not be covered in combination with Yervoy Diagnosis of unresectable or metastatic melanoma with BRAF V600E mutation as detected by a FDA-approved test. Prescribed by an oncologist 104 of 107 H5883_T_PAlist CMS Approved

105 Zolinza. Prescribed by an oncologist or hematologist 105 of 107 H5883_T_PAlist CMS Approved

106 Zykadia. 106 of 107 H5883_T_PAlist CMS Approved

107 Zytiga 107 of 107 H5883_T_PAlist CMS Approved