ACNE-TOPICAL. Products Affected. Details. Prior Authorization Criteria Simply Health Care Plans 2013 Last Updated: 11/19/2012

Transcription

1 Prior Authorization Simply Health Care Plans 2013 Last Updated: 11/19/2012 ACNE-TOPICAL Aczone Adapalene Tretinoin EXTERNAL CREA Tretinoin EXTERNAL GEL Age Other Cosmetic uses Diagnosis Greater than or equal to 12 years old 1 year None

2 ACTEMRA Actemra INJ 200MG/10ML All FDA-approved indications not otherwise excluded from part D. Age Other Diagnosis of moderate to severe, active adult rheumatoid arthritis. 2) Inadequate response to at least ONE of the following medications (Sub-Q TNFinhibitors) OR does the patient have a contraindication to ALL of the following medications: Humira, Cimzia, Enbrel, Simponi. Lifetime None 2

3 ADHD/NARCOLEPSY Adderall Xr Amphetamine/dextroamphetamine ORAL TABS Daytrana Dextroamphetamine Sulfate Dextroamphetamine Sulfate Er Focalin Xr ORAL CP24 10MG, 15MG, 20MG Metadate CD ORAL CPCR 10MG, 20MG, 60MG Metadate Er Methamphetamine Hcl Methylphenidate Hcl Methylphenidate Hcl Er TBCR 20MG Methylphenidate Hydrochloride Strattera Age Other ADHD: Diagnosis, drugs tried and failed: patient must try generic ADHD drug first. Narcolepsy: Submission of sleep study confirming the diagnosis of narcolepsy. Greater than or equal to 3 years old (amphetamines), greater than or equal to 6 years old (methylphenidates, strattera) 1 year None 3

4 AFINITOR Afinitor Age Other 1 year Failure of treatment with sunitinib or sorafenib. 4

5 AMPYRA Ampyra Age Other 1. Diagnosis of MS 2. Moderate walking disability associated with MS, but mantains the ability to walk. 3.Trial and failure to physical therapy. Lifetime None 5

6 ANTIFUNGAL Cancidas INJ 70MG Ciclopirox Nail Lacquer Itraconazole Noxafil Terbinafine Hcl TABS Vfend IV Voriconazole ORAL TABS. Age Other Confirmation by positive fungal culture or positive KOH test AND at least one of the following must apply: diabetic patient, immunocompromised status - AIDS/immunosuppressive therapy/chemotherapy, onychomycosis of fingernails, significant impairment of mobility or significant pain. Diagnosis of onychomycosis. twelve weeks None 6

7 ANTINEOPLASTIC Ixempra Kit INJ 45MG Votrient Age Other Ixempra: In combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or in patients whose cancer is taxaneresistant and for whom further anthracycline therapy is contraindicated, as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine. Torisel/Votrient: For the treatment of advanced renal cell carcinoma. oncologist, hematologist 1 year None 7

8 APOKYN Apokyn Age Other Contraindicated with concurrent use of apomorphine with drugs of the 5HT antagonist class (e.g. ondansetron, granisetron, dolasetron, palonosetron,and alosetron). Approved for the acute, intermittent treatment of hypomobility, offepisodes (end-of-dose wearing off and unpredictable on/off episodes) associated with advanced Parkinson disease. Greater than or equal to 18 years old None 1 year None 8

9 ARALASP Aralast Np INJ 400MG. Age Other Diagnosis 1 Year Subject to Part B vs D review 9

10 ARANESP Aranesp Albumin Free INJ 100MCG/ML, 200MCG/ML, 25MCG/ML, 300MCG/0.6ML, 40MCG/ML, 500MCG/ML, 60MCG/ML Age Anemia Due to Chronic Renal Failure (Initial): Hct less than 33% or Hgb less than 11 gm/dl. Verification of iron evaluation for adequate iron stores. CRF (Reauthorization): Verification that average Hct was below 36% over a 3-month period. Verification of iron evaluation for adequate iron stores. One of the following: Hct reached target range (30% to 36%), decrease in blood transfusion, or Hgb is 1 g/dl or greater from pretreatment level. Anemia in cancer patients on chemotherapy (Initial): Verification that other causes of anemia have been ruled out. Verification of iron evaluation for adequate iron stores. Hct less than 30% or Hgb less than 10 gm/dl. Verification that the cancer is a non-myeloid malignancy. Verification that the patient is concurrently on chemotherapy, will be on concomitant chemotherapy for 2 months, or that the anemia is caused by cancer chemotherapy. Chemotherapy (Reauthorization): Hct less than 36% or Hgb less than 12 gm/dl. Hct reached target range (30% to 36%), decrease in blood transfusion, or Hgb is 1 g/dl or greater from pretreatment level. Verification that the patient is concurrently on chemotherapy, will be on concomitant chemotherapy for 2 months, or that the anemia is caused by cancer chemotherapy. Refractory anemia in Myelodysplastic Syndrome (Initial): Hct less than 33% or Hgb less than 11 g/dl.serum erythropoietin of 500 mu/ml or less, or diagnosis of transfusion-dependent MDS. Verification of adequate iron stores. MDS (Reauthorization): Verification that average Hct was below 36% over a 3 month period. One of the following: verification that Hct reached target (30% to 36%), or decrease in blood transfusion, or Hgb increase 1 g/dl or more from pre-treatment level. Chemotherapy-Induced Anemia: Hb/Hct levels collected within prior two weeks of request. All other uses Hb/Hct levels collected within prior 30 days of request. 10

11 Other Chemo, MDS (Initial): 3 mo. CRF (Initial): 6 mo. CRF (Reauth), MDS (Reauth):12 mo. 1) Trial of procrit (Preferred Agent First), and 2) Subject to Part B vs D coverage review for Always Considered ESRD Related Drug 11

12 ARZERRA Arzerra INJ 100MG/5ML Age Other Diagnosis FDA approved age oncologist, hematologist 12 months none 12

13 AVASTIN Avastin INJ 100MG/4ML Age Other Non-Small Cell Lung Cancer: Squamous cell histology. History of hemoptysis. CNS metastases. Colorectal Cancer: Diagnosis of metastatic colorectal cancer. Used in combination with 5-FU, or oxaliplatin plus capecitabine, or capecitabine. Non-Small Cell Lung Cancer: Diagnosis of unresectable locally advanced recurrent or metastatic NSCLC. Used in combination with paclitaxel and carboplatin. Renal Cell Cancer: Diagnosis of metastatic renal cell cancer. Used in combination with interferon-alpha or refractory to either interferon alpha or interleukin-2. Breast Cancer: Diagnosis of metastatic breast cancer. Used in combination with paclitaxel. Age-related Macular Degeneration: Failure to FDA-approved therapies or likely to have greater benefit from the use of intravitreal bevacizumab. Renal Cell Cancer, Breast Cancer: Prescribed by or in consultation with an oncologist. ARMD: Prescribed or recommended by retina specialist Lifetime Subject to Part B vs. Part D review (not limited to new starts only). If the drug is determined to be Part D, the Prior Authorization criteria applies to new starts only. Approve for continuation of prior therapy. 13

14 BARBITURATE Phenobarbital ELIX Phenobarbital ORAL TABS 16.2MG, 30MG, 32.4MG, 64.8MG, 97.2MG. Age Other Diagnosis of epilepsy AND failure/intolerance/contraindication to at least one non-barbiturate/non-benzodiazepine medication (non-high risk alternative) 1 year Considered a?high risk medication? in patients 65 years of age and older. Approval requires a failure/intolerance/contraindication to at least one non-barbiturate/non-benzodiazepine alternative. 14

15 BENZODIAZEPINE Clonazepam Clonazepam Odt Clorazepate Dipotassium Diazepam GEL 10MG Diazepam ORAL TABS Diazepam SOLN. Age Other Diagnosis of epilepsy AND failure/intolerance/contraindication to at least one non-barbiturate/non-benzodiazepine medication (non-high risk alternative) 1 year Considered a?high risk medication? in patients 65 years of age and older. Approval requires a failure/intolerance/contraindication to at least one non-barbiturate/non-benzodiazepine alternative. 15

16 BOTOX Botox INJ 100UNIT. Age Other Cosmetic use. Diagnosis 1 Year 16

17 CALCIUM RECEPTOR ANTAGONISTS Sensipar Age Other Diagnosis, calcium, ipth, PTH 1 year None 17

18 CARBAGLU Carbaglu. Age Other Diagnosis of acute hyperammonemia and/or maintenance of chronic hyperammonemia due to deficiency of hepatic N-acetyl glutamate (NAGS). Health care provider experienced in the treatment of metabolic disorders. Initial approvals will be for 6 months. Subsequent approvals will be approved 12 months. None 18

19 CAYSTON Cayston Age Other Diagnosis of Cystic Fibrosis, documented infection with Pseudomonas aeruginosa, and patient also taking a bronchodilator. 7 years of age or older 6 months None 19

20 CELLCEPT (ORAL) Cellcept SUSR Mycophenolate Mofetil Age Other Transplant: Patient received a renal (kidney), cardiac (heart), or hepatic (liver) transplant. Patient received a bone marrow/stem cell transplant. Lupus nephritis: Diagnosis of lupus nephritis. Failure to combination therapy with corticosteroids and cyclophosphamide. Obliterative Bronchiolitis: Diagnosis of obliterative bronchiolitis following lung transplantation. 1 year Subject to Part B vs. Part D review (not limited to new starts only). If the drug is determined to be Part D, the Prior Authorization criteria applies to new starts only. 20

21 CHANTIX Chantix Chantix Starting Month Pak Age Other Approved as an aid to smoking cessation treatment, patient enrolled in any smoking cessation support program 3 months initially None 21

22 CHORIONIC GONADOTROPIN Pregnyl W/diluent Benzyl Alcohol/nacl Age Other 6 months None 22

23 CIMZIA Cimzia INJ 200MG/ML Age Other Patients are excluded if they have an active infection or are on concurrent biologic response modifier. Diagnosis: Chron's Ds / Rheumatoid arthritis, moderately to severe. Patient must demonstrate inadequate response to at least 1 conventional therapy for Crohn's disease (i.e., prednisone, budesonide, sulfasalazine, azathioprine, mesalamine, infliximab or adalimumab). Patient must demonstrate inadequate response to Enbrel and Humira therapy for Rheumatoid arthritis. Patient must be evaluated for latent TB with a PPD test and be treated if positive. Patient must also be assessed for the risk of hepatitis B and if appropriate, be tested. Approve for those 18 years of age or older 1 year 23

24 CINRYZE Cinryze. Age Other Prophylaxis against angioedema attacks in patients with Hereditary Angioedema (HAE). Equal or older than 9 years of age 1 year The requested dose cannot exceed 2 vials (1000 units) every 3 days 24

25 DEGARELIX Firmagon INJ 120MG Age Other Failure to an LHRH agonist 1 year Subject to part B vs. Part D review. 25

26 DIFICID Dificid. Age Other Diagnosed with severe Clostridium difficile-associated diarrhea with a positive results of a C.difficile toxin study in adult patients who have failed oral vancomycin therapy. Greater or equal to 18 years of age 10 days initially, continuation of therapy up to another 10 days None 26

27 ENBREL Enbrel Age Other Concurrent use of anakinra. Rheumatoid Arthritis: Dx of mod-to-sev RA. Failed MTX or 2 DMARDs for 3 mo. Juvenile Idiopathic Arthritis: Dx of mod-to-sev polyarticularcourse JIA. Failed NSAID or steroid and methotrexate for three months. PsA: Dx of active PsA. Failed MTX or 2 DMARDs for 3 mo. Ankylosing Spondylitis: Dx of AS. Failed 2 NSAIDs for 3 mo. Plaque Psoriasis: Dx mod-to-sev chronic (greater than 6 months) plaque psorisis. Failed systemic therapy with one of the following: MTX, cyclosporine, acitretin, hydroxyurea, sulfasalazine, 6-thioguanine, or mycophenolate. Reauthorization: demonstration of clinical response to therapy. RA, PsA, AS, Plaque Psoriasis: 18 years and older. JIA: 2 years and older. RA (Initial), JIA (Initial), PsA (Initial), AS (Initial): Prescribed or recommended by a rheumatologist. Plaque Psoriasis (Initial): Prescribed or recommended by a dermatologist. Initial Auth: 12 months for all except Plaque Psoriasis: 3 mo. Reauth: All uses: 12 mo. Plaque Psoriasis (Reauth) Enbrel dosage is 50 mg or less per week or less. All diagnoses: Verification that the pt has been evaluated for TB and treated accordingly. 27

28 ENZYME REPLACEMENT Aldurazyme Fabrazyme INJ 35MG Naglazyme Age Other Diagnosis Greater than or equal to 18yo (or FDA approved age) 1 year None 28

29 EPOETIN ALFA Procrit Age Anemia Due to Chronic Renal Failure: Hct less than 33% or Hgb less than 11 gm/dl. CRF (Reauth): Avg Hct was below 36% over 3-mo. 1 of the following: Hct reached target (30% to 36%), decr in blood transfusion, or Hgb is 1 g/dl or greater from pre-tx level. HIV: Anemia is d/t zidovudine tx or d/t HIV infection. Hgb less than 12 g/dl or Hct less than 36%. PtD- HIV (Reauth): Hct was below 36% over 3 mo. 1 of the following: Hct reached target (30% to 36%), decr in blood transfusion, or Hgb is 1 g/dl or greater from pre-tx level. Chemo: Verify other causes of anemia have been ruled out. Hct less than 30% or Hgb less than 10 gm/dl. Cancer is a non-myeloid malignancy. Concurrently on chemo, will be on concomitant chemo for 2 mo or anemia is caused by cancer chemo. Chemo (Reauth): Hct less than 36% or Hgb less than 12 gm/dl. Hct reached target (30% to 36%), decr in blood transfusion, or Hgb is 1 g/dl or greater from pre-tx level. Concurrently on chemo will be on concomitant chemo for 2 mo or anemia is caused by cancer chemo. Pre-op: Hgb greater than 10 to less than 13 g/dl scheduled to undergo elective, non-cardiac/vascular surgery to reduce blood transfusions or at high risk for perioperative transfusions with expected blood loss of 2 units or greater. MDS: Hct less than 33% or Hgb less than 11 g/dl. Serum erythropoietin of 500 mu/ml or less, or dx of transfusion-dependent MDS. MDS (Reauth): Avg Hct was below 36% over a 3 mo. 1 of the following: Hct reached target (30% to 36%), or decr in blood transfusion, or Hgb incr 1 g/dl or more from pre-tx level. HCV: Hgb less than 11 g/dl or Hct less than 33%. Is concurrently on ribavirin and interferon or peg-interferon alfa for the tx of HCV and the anemia is d/t tx. HCV (Reauth): Avg Hct was below 36% over a 3 mo. Hct reached target (30% to 36%), decr in blood transfusion, or Hgb is 1 g/dl or greater from pre-tx level. All uses: Verify Fe evaluation for adequate Fe stores. 29

30 Other Pre-op: 1 mo. Chemo, HCV, MDS: 3 mo. HCV (Reauth): 3 mo CRF, HIV: 6 mo. Other reauth: 12 mo. Subject to Part B vs. D review (not limited to new starts only. CRF: Patient is on dialysis (covered under Part B). 30

31 ERBITUX Erbitux INJ 100MG/50ML Age Other Head and Neck Cancer: Confirmed diagnosis of locally or regionally advanced squamous cell carcinoma of the head and neck or recurrent or metastatic squamous cell head and neck cancer. Used in combination with radiation therapy, or after failure of platinum-based chemotherapy. Colorectal Cancer: Confirmed diagnosis of metastatic carcinoma of the colon or rectum. Used in combination with irinotecan-based chemotherapy or intolerance to irinotecan-based chemotherapy or failure of irinotecan or oxaliplatin-based chemotherapy regimens. Tumor expresses wild-type KRAS gene. Lifetime Approve for continuation of prior therapy. 31

32 ERIVEDGE Erivedge. Age Other 1. Diagnosis of metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation 2. Gender, If female, evidence of negative pregnancy test provided 18 years of age or older Oncologist 12 months 32

33 EXJADE Exjade ORAL TBSO 250MG, 500MG Age Other Diagnosis, Sr Cr, LFTs, Ferritin Greater than or equal to 2 yo 1 year None 33

34 FENTANYL Abstral SUBLINGUAL SUBL 100MCG, 200MCG, 800MCG Fentanyl Citrate Oral Transmucosal Fentora BUCCAL TABS 200MCG, 400MCG, 800MCG Onsolis BUCCAL FILM 200MCG, 400MCG Age Other Cancer Pain: Confirmed diagnosis of malignant pain. Failure or contraindication to an immediate-release opioid. Demonstrated tolerance to opioids. Lifetime 34

35 FORTEO Forteo Age Other Osteoporosis: History of Paget's disease, bone metastases of skeletal malignancies, radiation therapy, metabolic bone disease other than osteoporosis. Concurrent use of bisphosphonate. Osteoporosis: BMD T score of -3.0 or less and a previous fracture resulting from minimal trauma, or both of the following: failure to a formulary bisphosphonate and patient has a history of fracture resulting from minimal trauma or BMD T score of -2.5 or less. Osteoporosis: 2 years. Subject to Part B vs. Part D review. Remove. Not on BvD global list. 35

36 GILENYA Gilenya Age Other Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS). Trial and failure OR contraindication to one of the following medications: Avonex, Betaseron, Copaxone, Extavia, Rebif 1 year None 36

37 GLEEVEC Gleevec Age Other Chronic Myeloid Leukemia (Adults): Diagnosis of Philadelphia chromosome positive CML. CML (Children): Diagnosis of Philadelphia chromosome positive (Ph+) chronic phase CML. Acute Lymphoblastic Leukemia: Adult patients with Philadelphia chromosome positive ALL. Myelodysplastic/myeloproliferative diseases: Adults diagnosed with MDS/MPD diseases associated with platelet-derived growth factor receptor gene rearrangements. Aggressive systemic mastocytosis: Adults diagnosed with aggressive systemic mastocytosis. Patient is without the D816V c-kit mutation or c-kit mutation status unknown. Hypereosinophilic syndrome and chronic eosinophilic leukemia: Adults diagnosed with HES or CEL. Dermatofibrosarcoma protuberans: Adults with unresectable, recurrent and/or metastatic DFSP. Gastrointestinal Stromal Tumors: Patients with a confirmed diagnosis of unresectable and/or metastatic GIST. Lifetime Approve for continuation of prior therapy. 37

38 GROWTH HORMONES Genotropin Genotropin Miniquick INJ 0.2MG, 0.4MG, 0.8MG, 1MG Humatrope INJ 6MG Increlex Norditropin Flexpro Norditropin Nordiflex Pen Nutropin Aq Pen INJ 10MG/2ML Omnitrope INJ 5MG/1.5ML Saizen Click.easy Tev-tropin : Growth Hormone Deficiency (GHD) in Children, Prader-Willi Syndrome (PWS) or Small for Gestational Age (SGA), Turner Syndrome (TS) or Noonan Syndrome (NS). COGHDA: Males with bone age greater than 17 yrs or females with bone age greater than 15 years, closed epiphyses on bone radiograph, growth velocity less than 2 cm/year during previous year of treatment unless COGHD criteria are met. GHD (Child): Dx GH deficiency based on 2 GH stimulation tests or low IGF-1 levels. Demonstrate growth failure based on growth velocity or ht shorter than 2 SD below the mean ht for age. PWS, SGA: Dx of PWS confirmed by genetic testing or Dx of SGA confirmed by birth wt of less than 2500g at gestation of more than 37 wks or at birth wt or length below the 3rd percentile for gestational age who failed to catch up by 2 yrs of age. TS, NS: Tx of short stature in females w/bone age less than 15 yrs associated w/ts or NS or for tx of short stature in males w/bone age less than 17 yrs associated w/ns. GRCRF: Dx of chronic renal insufficiency. Ht shorter than or equal to 2 SD below the median age for children or where growth velocity falls to below 4.5 cm/yr. GHD (Child), PWS, SGA, TS, NS, GRCRF (Reauth): Incr in growth velocity of at least 2 cm/yr during previous yr of tx. Males w/bone age less than 17 yrs or females w/bone age less than 15 yrs. ISS: Ht less than or equal to 2.25 SD below the mean ht for age. Growth velocity less than the 25th percentile for bone age. Verify open epiphyses on last bone age radiograph. Absence of comorbid conditions that should be observed or treated by other means. ISS (Reauth): Incr in growth velocity of at least 4.5 cm/yr during previous yr of tx. Males w/bone age less than 17 yrs or females w/bone age less than 15 yrs. AOGHD: Pts who have GHD alone or multiple hormone deficiencies b/c of pituitary disease/insult, hypothalamic disease, surgery, 38

39 or radiation tx. IGF-1 level less than 77 mcg/l or 2 SD below the mean value, matched by age and gender. COGHDA: Childhood onset in pts who were GH deficient during childhood who have GH deficiency confirmed as an adult before replacement tx w/gh is started. Persistent deficiency of GH documented by GH stimulation tests. IGHDA: Documented deficiency of GH documented by 2 GH stimulation tests. Age Other GH Deficiency (Child), Turner Syndrome or Noonan Syndrome (Initial), GRCRF, ISS (Initial), AOGH, Childhood Onset GH Deficiency in Adults, Isolated GH Deficiency in Adults: Prescribed by an endocrinologist. All uses: 1 year. None 39

40 HEPATITIS C PROTEASE INHIBITORS Incivek Victrelis. Age Other 1)Diagnosis of chronic hepatitis c 2)viral genotype 1a or 1b 3)Child plough score 4)Concurrent peginterferon alpha therapy 5)Concurrent ribavirin therapy Greater or equal to 18 yo Infectious disease physician, gastroenterologist, hepatologist, or transplant physician 1 year None 40

41 HEXALEN Hexalen Age Other Diagnosis of ovarian cancer, cancer has progressed or recurred following first-line tx with a cisplatin or alkylating agent-based combination Oncologist 1 year Approve for continuation of prior therapy. 41

42 HIGH RISK MEDICATIONS Carisoprodol TABS 350MG Carisoprodol/aspirin Carisoprodol/aspirin/codeine Cenestin Chlordiazepoxide/amitriptyline Chlorpropamide Chlorzoxazone Cyclobenzaprine Hcl ORAL TABS 10MG, 5MG Cyclobenzaprine Hcl Er Cyproheptadine Hcl Dicyclomine Hcl Diphenhydramine Hcl CAPS 50MG Diphenoxylate/atropine Dipyridamole ORAL TABS Estropipate Hydroxyzine Hcl Hydroxyzine Pamoate Ketorolac Tromethamine INJ 15MG/ML, 30MG/ML Ketorolac Tromethamine TABS Macrodantin CAPS 25MG Menest Meperidine Hcl INJ 100MG/ML, 25MG/ML, 50MG/ML Meperidine Hcl ORAL TABS Meprobamate Methocarbamol Nifedipine Nitrofurantoin Macrocrystalline CAPS 50MG Nitrofurantoin Monohydrate Orphenadrine Citrate Orphenadrine Citrate Er Orphenadrine/asa/caffeine Pentazocine/acetaminophen Phenadoz Premarin ORAL TABS Premphase Prempro Promethazine Hcl Promethazine Vc Promethegan RECTAL SUPP 25MG, 50MG Thioridazine Hcl Trimethobenzamide Hcl CAPS. Age or patient provides a reason why any ONE unrestricted formulary alternative (listed on ""Other "" section)can not be tried, OR pt has already tried and failed any ONE alternative medication, OR MD has been made aware that the incoming drugs is a high risk medications and wishes to proceed with originally prescribed medication. None None 42

43 Other 1 year Formulary Alternative Medications per class include but are NOT limited to: ANALGESICS: (Mild Pain) ibuprofen, naproxen, or meloxicam. (Moderate/severe Pain) tramadol, morphine sulfate, hydrocodone/apap, oxycodone, oxycodone/apap, Oxycontin, Avinza. NSAIDs: ibuprofen, naproxen, nabumetone, meclofenamate, sulindac. ANTI-EMETICS: ondansetron, granisetron. ANXIOLYTICS: buspirone. ANTIHISTAMINES: fexofenadine, Clarinex, levocetirizine. ANTIPSYCHOTICS: risperidone, Abilify, Fanapt, Geodon, Invega, Latuda, Seroquel, Zyprexa. DIHYDROPYRIDINES: nifedipine extended-release. ORAL ESTROGENS: estradiol patch. ADHD AMPHETAMINES: Strattera, Vyvanse. ANTIDIARRHEAL: loperamide. SKELETAL MUSCLE RELAXANTS: tizanidine, baclofen. Zanaflex. UTI ANTIBACTERIALS: sulfamethoxazole/trimethoprim, ciprofloxacin. VASODILATORS: Aggrenox, Plavix. SULFONYLUREAS: glimepiride, glyburide, Glycron, glipizide 43

44 HORMONAL AGENTS Eligard Emcyt Lupron Depot INJ 22.5MG, 3.75MG, 30MG, 45MG, 7.5MG Lupron Depot-ped INJ 11.25MG, 15MG Synarel Trelstar Depot Mixject Trelstar La Mixject Age Other Diagnosis gynecologist, or endocrinologist, or oncologist 1 year Subject to Part B vs. Part D review. 44

45 HUMIRA Humira Age Other Concurrent use of anakinra Moderate to severe active RA: Dx of mod-to-sev RA. Failed MTX or 2 DMARDs for 3 mo. Juvenile Idiopathic Arthritis: Dx of mod-to-sev polyarticular-course JIA. Failed NSAID or steroid and methotrexate for three months. Psoriatic Arthritis: Dx of active PsA. Failed MTX or 2 DMARDs for 3 mo. Ankylosing Spondylitis: Dx of AS. Failed 2 NSAIDs for 3 mo. Plaque Psoriasis: Dx mod-to-sev plaque psorisis. Failed systemic therapy. Crohn's disease: Dx of mod-to-sev CD. Failed one conventional therapy. Reauthorization: demonstration of clinical response to therapy. RA, PsA, CD, AS, Plaque Psoriasis: 18 years and older. JIA: 4 years and older. RA, PsA, AS, JIA: Prescribed or recommended by a rheumatologist. Plaque Psoriasis: Prescribed or recommended by a dermatologist. CD: Prescribed or recommended by a gastroenterologist. Initial Auth: 12 months for all except Plaque Psoriasis: 4 mo. Reauth for all 12 mo. RA: Authorization is for 40 mg every other week unless documented treatment failure to Humira every other week dosing, then Humira may be approved for every week dosing if other criteria met. Plaque Psoriasis: Humira dosage is 80mg (initial dose) then 40 mg every other week starting 1 week after the initial dose. All diagnoses: Verification that the patient has been evaluated for TB and treated accordingly. 45

46 INLYTA Inlyta. Age Other 1. Diagnosis of advanced renal cell carcinoma (RCC) 2. Tried and failed one other systemic therapy for RCC 18 years of age or older Oncologist Initial - 6 months, Continuation - Lifetime Alternatives-Nexavar, Sutent, Afinitor, Gleevec, or Votrient 46

47 INTERFERON Actimmune Age Other CBC, LFTs, TSH, HCV RNA viral load, HepBAg, HBV DNA, CT, MRI, or biopsy. initially up to 3 months, continuation of therapy up to 1 year For Actimmune: Chronic granulomatous disease, OR Malignant osteopetrosis 47

48 INTRON-A Intron-a INJ UNIT/ML Intron-a W/diluent INJ 10MU Covered Uses Age Other Hep B - HBeAg positive: HBsAg positive for at least 6 months. HBV DNA level greater than 100,000 copies/ml. Compensated liver disease. One of the following: persistent ALT 2 times ULN or moderate to severe hepatitis or fibrosis on biopsy. Hep B - HBeAg negative: HBsAg positive for at least 6 months. HBV DNA level of 2000 IU/mL or more or 11,200 copies/ml. Compensated liver disease. One of the following: persistent ALT 2 times ULN or moderate to severe hepatitis or fibrosis on biopsy. Hep C - Treatment Naive Patients (monotherapy): For patients with Chronic Hepatitis C with compensated liver disease with positive HCV antibody and HCV RNA. Hep C - Treatment Naive Patients (in combination with ribavirin): For patients with Chronic Hepatitis C with compensated liver disease with positive HCV antibody and HCV RNA. Hep C - Continuation of Therapy: For genotypes 2,3,5, or 6: loss of detectable HCV RNA from serum or 100 fold drop or more in HCV RNA level. Non-Hepatitis Diagnoses: Diagnosis of one of the following: Malignant Melanoma, Hairy cell leukemia, Stage III or IV follicular Non-Hodgkin's Lymphoma, condylomata acuminata, AIDS-related Kaposi's sarcoma, Multiple Myeloma. Acute Hep C: Patients with acute hepatitis C. Hep B - HBeAg positive, Hep B - HBeAg negative: 1 year of age or older. Hep C - Treatment Naive Patients, Non-Hepatitis Diagnoses, Acute Hep C: 18 years old and older. Hep C - Treatment Naive Patients (in combination with ribavirin): 3 years of age and older. HepB+:: 6mo.(-):1yr.HepC:(2,3,5,6) 6mo(1,4,HIV/HCV):12mo.AcuteHepC,HCL,Kaposi:6mo.warts:3wk.Other:1yr Approve for continuation of prior therapy for neoplastic diseases. 48

49 49

50 JAKAFI Jakafi. Age Other 1) Diagnosis of intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential. 2)For continuation of therapy - respond to Jakafi therapy with spleen reduction or symptom improvement Equal or older than 18 years of age Oncologist Initial - 6month: continuation 6 months None 50

51 JEVTANA Jevtana Age Other Patient has been previously treated with a Taxotere (docetaxel) containing treatment regimen AND is being treated with prednisone in combination with Jevtana 1 year Subject to Part B vs. Part D review. Remove. Not on BvD global list. 51

52 KALYDECO Kalydeco. Age Other 1. Diagnosis of cystic fibrosis, 2. Results of a CF mutation test to detect the presence of the G551D mutation 6 years of age or older Pulmonologist Initial - 6 months, Continuation - Lifetime 52

53 KINERET Kineret Age Other Concurrent use of TNF-blockers or Orencia RA (Initial): Diagnosis of moderate to severe active RA. Treatment and failure with Enbrel and Humira. RA (Reauthorization): Submission of chart documentation demonstrating positive clinical response. RA: 18 years or older RA: Prescribed or recommended by a rheumatologist. RA (Initial): 12 months. RA (Reauth): 1 year. None 53

54 KUVAN Kuvan Age Other Diagnosis, phenylalanine levels 3 months initially none 54

55 LEUKINE Leukine INJ 250MCG Age Other BMSCT: For patients with non-myeloid malignancies undergoing myeloablative chemotherapy followed by autologous or allogeneic BMT, or for mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis, or for peripheral stem cell transplant patients who have received myeloablative chemotherapy. AML: For patients with AML following induction or consolidation chemotherapy. NDDC: Patient is receiving NCI's Breast Intergroup, INT C9741 dose dense chemotherapy protocol for primary breast cancer or a dose-dense regimen for which the incidence of febrile neutropenia is unknown.cfn: Patient is receiving a chemotherapy regimen associated with more than 20% incidence of febrile neutropenia, or patient is receiving chemotherapy regimen associated with 10-20% incidence of febrile neutropenia and has risk factors associated with chemotherapyinduced infection, febrile neutropenia or neutropenia. FN: For patients receiving myelosuppressive anticancer drugs associated with neutropenia. Patient has febrile neutropenia at high risk for infection-associated complications or has a history of febrile neutropenia during a previous course of chemotherapy. HIVN: HIV-infected patients with an ANC less than or equal to 1,000 cells/mm3 with or without one or more risk factors for developing chronic neutropenia. AML: greater than or equal to 55 years old. BMSCT,NDDC,CFN,FN,AML: 3 mo. HIVN: 6 mo None 55

56 LOTRONEX Lotronex Age Other IBS (Initial): Male gender. IBS (Initial): Confirmed diagnosis of (IBS) with diarrhea predominant symptoms for at least 6 months. Failure to an antispasmodic and an antidiarrheal agent. IBS (Reauth): Recurrence of diarrhea-predominant IBS. Documentation of positive clinical response while on Lotronex. IBS (Initial): 18 years and older. IBS (Initial): Verification that physician has enrolled in the GlaxoSmithKline Prescribing Program. IBS (Initial): 12 weeks IBS (Reauthorization): 6 months. None 56

57 LUMIGAN Lumigan SOLN 0.01% Age Other Cosmetic uses Diagnosis 1 year None 57

58 LUMIZYME / MYOZYME Myozyme. Age Other 1 year None 58

59 MS AGENTS Avonex Betaseron Copaxone Extavia Rebif Rebif Titration Pack Tysabri Age Other Diagnosis of a relapsing form of multiple sclerosis (MS), Crohn disease (Tysabri only) Lifetime, except Tysabri ( 2 years). For Tysabri: Restricted Distribution Program (TOUCH) Betaseron: Trial of Rebif (Preferred Agent First) 59

60 NEULASTA Neulasta Age Other For patients receiving myelosuppressive anticancer drugs associated with neutropenia. 3 months None 60

61 NEUMEGA Neumega. Age Other Allergic or hypersensitivity reaction. Diagnosis 1 Year 61

62 NEUPOGEN Neupogen INJ 300MCG/0.5ML, 480MCG/0.8ML, 480MCG/1.6ML Age Other BMSCT: To decrease the incidence of infection, as manifested by febrile neutropenia for pts with non-myeloid malignancies undergoing myeloablative chemo followed by autologous or allogeneic BMT, or for mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. AML: For pts with AML following induction or consolidation chemotherapy for reducing the time to neutrophil recovery and the duration of fever. FN: For patients receiving myelosuppressive anticancer drugs associated with neutropenia. SCN: For chronic administration to reduce the incidence and duration of sequelae of neutropenia (eg, fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia. SCN 12 months, all others 3 months None 62

63 NEXAVAR Nexavar Age Other Diagnosis of renal cell carcinoma with relapse following surgical excision, or diagnosis of renal cell carcinoma with medically or surgically unresectable tumor, or diagnosis of Stage IV renal cell carcinoma, or diagnosis of unresectable hepatocellular carcinoma. Oncologist 6 months Approve for continuation of prior therapy. 63

64 ORENCIA Orencia. Age Other Diagnosis 6 years of age and older. 1 year Treatment and failure with Enbrel and Humira 64

65 OXANDRIN Oxandrolone Age Other Cosmetic use, drug abuse and dependence Diagnosis of weight gain associated with AIDS wasting and cachexia due to a chronic disease, to offset the protein catabolism associated with prolonged administration of corticosteroids, or for the relief of the bone pain frequently accompanying osteoporosis. 1 year None 65

66 PANRETIN Panretin. Age Other Diagnosis of AIDS-related Kaposi's sarcoma, Cutaneous 1 Year 66

67 PEGASYS Pegasys Pegasys Proclick INJ 135MCG/0.5ML Age Hep B - HBeAg positive: HBsAg positive for at least 6 months. HBV DNA level greater than 100,000 copies/ml. Compensated liver disease and one of the following: ALT 2 times ULN or moderate-to-severe hepatitis or fibrosis on biopsy. Hep B - HBeAg negative: HBsAg positive for at least 6 months. HBV DNA level of 2000 IU/mL or more or 11,200 copies/ml. Compensated liver disease and one of the following: ALT 2 times ULN or moderate-to-severe hepatitis or fibrosis on biopsy. Hep C - Treatment Naive Patients: Chronic Hepatitis C with compensated liver disease. Positive HCV antibody HCV RNA. HCV RNA level measurement. Genotype test result. For patients who have not previously been treated with interferon. Hep C - Continuation of Therapy: For genotypes 5 or 6: loss of detectable HCV RNA from serum or 100 fold drop or more in HCV RNA level. For genotype 1: undetectable HCV RNA after 24 weeks of therapy and one of the following: HCV RNA more than 50 IU/mL at 4 weeks into treatment or less than 100 fold drop or detectable HCV RNA 12 weeks into therapy. For genotype 3: baseline HCV RNA more than 600,000 IU/mL and steatosis or advanced fibrosis on liver biopsy. Hep C Retreatment: Retreatment in patients who have failed or relapsed following standard or pegylated interferon monotherapy, or for nonresponders or relapsers who have significant fibrosis or cirrhosis who have undergone previous regimens of treatment using non-pegylated interferon, or retreatment in patients with genotype 2 or 3 who have relapsed following 6 month treatment of pegylated interferon plus ribavirin combination therapy. Used in combination with ribavirin. Hep B - HBeAg positive, Hep B - HBeAg negative, Hep C - Treatment Naive Patients: 18 years and older 67

68 Other HepB:1yr. HepC(5,6):12 wk, (2,3): 24wk, (1,4,HIV/HCV):48wk.con't(1,3):24wk, (5,6):36wk.Retreat:1yr None 68

69 PEG-INTRON Peg-intron INJ 50MCG/0.5ML Peg-intron Redipen Sylatron Age Other Hepatitis C - Treatment Naive Patients: Chronic Hepatitis C with compensated liver disease. Positive HCV antibody HCV RNA. HCV RNA level measurement. Genotype test result. For patients who have not previously been treated with interferon. Hep C (Continuation): For genotypes 5 or 6: loss of detectable HCV RNA from serum or 100 fold drop or more in HCV RNA level. For genotype 1: undetectable HCV RNA after 24 weeks of therapy and one of the following: HCV RNA more than 50 IU/mL at 4 weeks into treatment or less than 100 fold drop or detectable HCV RNA 12 weeks into therapy. For genotype 3: baseline HCV RNA more than 600,000 IU/mL and steatosis or advanced fibrosis on liver biopsy. Hep C (Retreatment): Retreatment in patients who have failed or relapsed following standard or pegylated interferon monotherapy, or for nonresponders or relapsers who have significant fibrosis or cirrhosis who have undergone previous regimens of treatment using non-pegylated interferon, or retreatment in patients with genotype 2 or 3 who have relapsed following 6 month treatment of pegylated interferon plus ribavirin combination therapy. Used in combination with ribavirin. Hepatitis C - Treatment Naive Patients: 3 years and older. Type5,6: 12 wk, type2,3: 24wk, type1,4,hiv/hcv: 48wk.Con't: type1,3: 24wk type5,6: 36wk.Retreat: 1yr None 69

70 POTIGA Potiga. Age Other Diagnosis of partial-onset seizures,member currently taking a first-line antiepileptic (e.g., carbamazepine, valproate, lamotrigine, topiramate, etc.) 18 years of age or older Neurologist 12 months 70

71 PROGRAF (ORAL) Tacrolimus ORAL CAPS 1MG, 5MG Age Other Severe uveitis: Failure to one corticosteroid. Transplant: Patient received a renal (kidney), cardiac (heart), lung, pancreas, small bowel, hepatic (liver) transplant, or bone marrow/stem cell transplant. 1 year Subject to Part B vs. Part D review (not limited to new starts only). Approve for continuation of prior therapy if Part D. 71

72 PROLASTIN Prolastin-c. Age Other Diagnosis 1 Year Subject to Part B vs D review 72

73 PROLEUKIN Proleukin Age Other Metastatic Renal Cell Carcinoma or Metastatic Melanoma: Measurable, histologically confirmed metastatic renal cell carcinoma or metastatic melanoma. Good neurologic or ambulatory performance status. Adequate organ function: normal cardiac stress test results, FEV1 greater than 2 L on pulmonary function tests, creatinine concentration 1.5 mg/dl or less or calculated creatinine clearance of greater than 60 ml/min, bilirubin concentration of 1.5 mg/dl or less, SGOT/AST less than 150 IU or 4x upper limit of normal. Platelet count greater than or equal to 100,000 / mcl. Hemoglobin greater than or equal to 10 g/dl. WBC greater than or equal to 3,500 / mcl. At least 7 weeks since prior therapy and complete recovery from therapy-related side effects. Metastatic Renal Cell Carcinoma or Metastatic Melanoma: 18 years and older Metastatic Renal Cell Carcinoma or Metastatic Melanoma: three months All uses: For continuation of prior therapy. Metastatic Renal Cell Carcinoma or Metastatic Melanoma: Administered in a hospital setting. Additional courses of treatment should be given to patients only if there is some tumor shrinkage following the last course and if retreatment is not contraindicated. 73

74 PROLIA Prolia Age Other Diagnosis. Initial therapy: Bone mineral density (DXA or DEXA) T score of negative 2.5 or less AND Patient is at high risk for osteoporotic fracture (Personal history of fracture as an adult, history of osteoporotic fracture in a first degree relative, concurrent use of systemic corticosteroids for at least three months duration, concurrent cigarette smoking, or body weight less than 127 pounds) AND treatment failure to at least one of the following: risendronate, alendronate, ibandronate, or raloxifene. Approved for continuation of therapy. Initial and continuation 1 year Subject to Part B vs. Part D review 74

75 PROMACTA Promacta Age Other Diagnosis of chronic ITP, platelet count less than 30 x 109/L. Greater than or equal to 18 yo (or FDA approved age) Must be registered in Promacta CARES Prescribing Program 6 months None 75

76 PROVIGIL/NUVIGIL Nuvigil Age Other SWSD (Initial): Symptoms do not meet criteria for any other sleep disorder producing insomnia or excessive sleepiness. Documented Diagnosis of one of the Following: Narcolepsy, Idopathic Hypersonia, Obstructive Sleep Apnea with Failure of CPAP, Shift work sleep disorder (SWSD) excessive sleepiness, Multiple Sclerosis and myotonic dystrophy. Greater than or equal to 17 yo (Nuvigil), greater than or equal to 16 yo (Provigil) OSAHS, SWSD: 3 months, Reauthorization: Lifetime NUVIGIL: plan restricts Nuvigil 50 mg to a dose of two tablets per day. For higher doses, please use Nuvigil 150 mg or Nuvigil 250 mg tablets. PROVIGIL: plan restricts Provigil 100 mg to a dose of one tablet per day. For higher doses, please use the Provigil 200 mg tablet. 76

77 PULMONARY ARTERY HYPERTENSION Adcirca Letairis Revatio TABS Tracleer Ventavis SOLN 10MCG/ML Age Other PAH: Patients with a confirmed diagnosis of pulmonary arterial hypertension (modified WHO Group I) which is symptomatic. 1 year Ventavis only: Subject to Part B vs. Part D review. Tracleer only: Trial of Letairis First. 77

78 PULMOZYME Pulmozyme. Age Other Diagnosis 1 Year Subject to Part B vs D review 78

79 RANEXA Ranexa Age Other Patients taking strong inhibitors of CYP3A, patients taking inducers of CYP3A, and those with clinically significant hepatic impairment. Requires concurrent use with at least one medication of the following: amlodipine, beta blockers, or long-acting nitrates 1 year None 79

80 REGRANEX Regranex Age Other Diabetic Neuropathic Ulcers: Diabetic patient with ulcer wound. Debridement being performed as needed. At least two of the following are present: Stage III or IV wound, wound at least 1 cm x 1 cm, longstanding wound that does not heal with standard care, or patients at high risk for amputation (peripheral neuropathy, peripheral vascular disease, skin or nail abnormalities, previous foot ulcer amputation). Diabetic Neuropathic Ulcers: Maximum 6 months. None 80

81 RELISTOR Relistor INJ 12MG/0.6ML Age Other Diagnosis of opioid induced constipation with life expectancy less than 6 months. Patient must not have had laxation for at least 48 hours. Patient failed at least 1 laxative at the maximum recommended dose. 4 months None 81

82 REMICADE Remicade Age Other RA, PsA: Used in combination with anakinra. Diagnosis of Rheumatoid Arthritis, Crohns, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis, Ulcerative Colitis. Liver function tests, CBC, tuberculin test. regarding concomitant immunosuppressants (e.g. methotrexate or corticosteroids). RA, PsA, AS, Plaque Psoriasis, FCD, UC: 18 years and older. Crohn's Disease: 6 years and older. RA,AS, PsA: Prescribed or recommended by a rheumatologist. Crohn's Disease, Fistulizing Crohn's Disease, UC: Prescribed by a gastroenterologist or by gastroenterologist consult. Plaque Psoriasis: Prescribed or recommended by a dermatologist. Sarcoidosis: Prescribed or recommended by a pulmonologist. 1 year None 82

83 REVLIMID Revlimid ORAL CAPS 10MG, 15MG, 25MG, 5MG Age Other MDS: Diagnosis of myelodysplastic syndrome associated with a deletion 5q cytogenic abnormality and patient is transfusion dependent. OR Diagnosis of myelodysplastic syndrome without deletion 5q cytogenic abnormality and failure of initial treatment with epoetin alfa or darbopoetin alfa, hypomethylating agents (e.g., Vidaza, Dacogen), or immunosuppressive therapy (e.g., antithymocyte golbulin, cyclosporine). Multiple Myeloma: Used in combination with dexamethasone. Chronic Lymphocytic Leukemia: Relapsed or refractory to one prior therapy for CLL. MDS, Multiple Myeloma, CLL: Prescribed by an oncologist or hematologist or by oncology or hemoatology consult. MDS, Multiple Myeloma: 6 months. Approve for continuation of prior therapy. 83

84 RIBAVIRIN Ribapak TABS 400MG Ribasphere Ribavirin Age Other Hepatitis C: Adults with a diagnosis of Hepatitis C with compensated liver disease, and verification of concurrent use with an alfa interferon product. 48 weeks None 84

85 RILUTEK Rilutek Age Other Diagnosis of amyotrophic lateral sclerosis (ALS), LFTs Greater than or equal to 18 years 1 year None 85

86 RITUXAN Rituxan. Chronic Lymphocytic Leukemia, Immune or idiopathic thrombocytopenic purpura, Waldenstroms macroglobulinemia Age Other Non-Hodgkin's Lymphoma: As first-line treatment of diffuse large B-cell, CD20-positive, non-hodgkins lymphoma in combination with CHOP or other anthracycline-based chemotherapy regimens, or as first-line treatment of follicular, CD20-positive, B-cell non-hodgkin's lymphoma in combination with CVP chemotherapy, or for the treatment of low-grade, CD20-positive, B-cell non-hodgkin's lymphoma in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy, or confirmed diagnosis of relapsed or refractory, low grade or follicular CD20-positive, B-cell non-hodgkins lymphoma. RA (Initial): Diagnosis of moderate-to-severe active RA. Used in combination with methotrexate. Failure to a TNF antagonist. RA (Reauthorization): Documented positive clinical response. RA: 18 years and older. RA: Prescribed by a rheumatologist. All uses except RA: 1 year. RA: One month None 86

87 SAMSCA Samsca TABS 15MG Age Other Diagnosis of Hyponatremia, hypervolemic or euvolemic. Equal or older than 18 years of age 1 year None 87

88 SANDOSTATIN Octreotide Acetate Sandostatin Lar Depot Age Other Acromegaly: Inadequate response to surgery and/or radiotherapy, or who are not a surgical and/or radiotherapy candidate. Diagnosis of acromegaly by one of the following: serum GH level greater than 1 ng/ml after a 2- hour oral glucose tolerance test, or elevated serum IGF-1 levels as compared to normal reference values by age and gender. Carcinoid tumors: diagnosis of metastatic carcinoid tumor, for symptomatic treatment of severe diarrhea or flushing. Vasoactive Intestinal Peptide Tumors: Diagnosis of metastatic vasoactive intestinal peptide tumor, for symptomatic treatment of diarrhea associated with vasoactive intestinal peptide tumor. Cancer Chemotherapy Induced Diarrhea. Acromegaly: long-term approval. Tumors: 6 mo. Chemo-induced diarrhea, AIDS-related Diarrhea: 3 mo. None 88

89 SIMPONI Simponi Age Other Diagnosis. Ankylosing spondylitis: For the treatment of adults with active ankylosing spondylitis. Psoriatic arthritis: For the treatment of adults with active psoriatic arthritis, used alone or in combination with methotrexate. Rheumatoid arthritis: For the treatment of adults with moderately to severely active rheumatoid arthritis (RA), in combination with methotrexate. 1 year Treatment and failure with Enbrel and Humira 89

90 SIMVASTATIN 80MG Simvastatin TABS 80MG Vytorin TABS 10MG; 80MG Age Other 1)Documented History of use of the simvastatin 80mg containing product for a period longer than 12 months. 2) Confiramtion that member has not experienced myopathy or rhabdomyolysis related symptoms Lifetime None 90

91 SOMATULINE Somatuline Depot INJ 120MG/0.5ML, 60MG/0.2ML Age Other Acromegaly: Patients who require long-term treatment due to inadequate response to surgery and/or radiotherapy, or who are not a surgical and/or radiotherapy candidate. Diagnosis of acromegaly by one of the following: serum GH level greater than 1 ng/ml after a 2-hour oral glucose tolerance test, or elevated serum IGF-1 levels as compared to normal reference values by age and gender. Indefinite, long term therapy (open-ended) None 91

92 SOMAVERT Somavert Age Other Acromegaly (Initial): Inadequate response to surgery and/or radiation therapy or not a candidate for surgery or radiation. Inadequate response or intolerance to octreotide, or lanreotide, or IGF-1 value greater than 900 ng/ml. Acromegaly (Reauth): Serum IGF-1 level within the age-adjusted normal range. Acromegaly (Initial): 12 weeks. Acromegaly (Reauth): indefinite None 92

93 SORIATANE Soriatane. Age Other Acitretin must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. Ethanol must not be ingested by female patients either during treatment or for 2 months after cessation of therapy. Diagnosis. Contraception-Acitretin must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. Ethanol must not be ingested by female patients either during treatment or for 2 months after cessation of therapy. Must be greater than or equal to 18 yo (or FDA approved age). Must be dermatologist Approve up to 1 year. None 93

94 SPORANOX (SOLUTION) Sporanox SOLN Age Other Diagnosis of oropharyngeal or esophageal candidiasis. 12 weeks None 94

95 SPRYCEL Sprycel Age Other CML: Diagnosis of Philadelphia chromosome positive or BCR-ABL positive chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia. Failure to Gleevec. ALL: Diagnosis of Philadelphia chromosome-positive acute lymphoblastic leukemia. Failure to Gleevec requirement does not apply to newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. Lifetime Approve for continuation of prior therapy. 95

96 STELARA Stelara Age Other For the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Treatment and failure with Enbrel and Humira Approve for those patients 18 years of age or older 1 year Subject to Part B vs. Part D review 96

97 SUTENT Sutent Age Other GIST: Disease progression on or intolerance to Gleevec. Renal Cell Carcinoma: Diagnosis of renal cell carcinoma with relapse following surgical excision, or diagnosis of renal cell carcinoma with medically or surgically unresectable tumor, or diagnosis of Stage IV renal cell carcinoma. Oncologist 1 year Approve for continuation of prior therapy. 97

98 TARCEVA Tarceva Age Other Patients diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Pancreatic Cancer: Patient diagnosed with locally advanced, unresectable or metastatic pancreatic cancer. Used in combination with gemcitabine. Reauthorization: Patient has not experienced disease progression. Oncologist 6 months Approve for continuation of prior therapy. 98

99 TARGRETIN Targretin. Age Other Definitive diagnosis of cutaneous T-cell lymphoma (CTCL) 1 Year Approve for continuation of therapy 99

100 TASIGNA Tasigna Age Other Chronic Myelogenous Leukemia: Diagnosis of Philadelphia chromosome positive chronic or accelerated phase chronic myeloid leukemia and failure to Gleevec. Failure to Gleevec requirement does not apply to newly diagnosed CM 1 year Approve for continuation of prior therapy. 100

101 TAXOTERE Taxotere INJ 80MG/4ML. Age Other Diagnosis Lifetime 101

102 TESTOSTERONE (INJECTABLE) Testosterone Cypionate Testosterone Enanthate Age Other Diagnosis of male hypogonadism with a pre-treatment total testosterone level below normal physiological value (less than 280 ng/dl), or pretreatment free testosterone below normal reference value. Diagnosis of delayed puberty in males. Diagnosis of Metastatic breast cancer, Female (testosterone enanthate) Hypogonadism: 1 year. Delayed puberty: 6 months None 102