ACNE PRODUCTS. Affected Drugs: Epiduo Retin-A Tretinoin. Covered Uses: All FDA-approved indications not otherwise excluded from Part D

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1 ACNE PRODUCTS Epiduo Retin-A Tretinoin Exclusion Criteria: Esthetic purposes N/A N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 1 of 148

2 ACTEMRA Actemra Exclusion Criteria: 1) Active infection (including TB) 2) Concurrent therapy with other biologic agent(s) 1) Rheumatoid Arthritis: a. Document previous use of one or more of the following tumor necrosis factor antagonists: Humira, Cimzia and/or Orencia. 2) Latent tuberculosis test result. 3) Negative Hepatitis B test or currently on treatment. 4) For Systemic Juvenile Idiopathic Arthritis: patient must have failed or be intolerant to Humira or Orencia. 1) Rheumatologist 2) Dermatologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 2 of 148

3 ACTIMMUNE Actimmune Exclusion Criteria: N/A 1) Provide CBC results 1) Endocrinologist 2) Orthopedist, 3) Hematologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 3 of 148

4 ADAGEN Adagen Exclusion Criteria: 1) Bone marrow transplantation 2) Severe Thrombocytopenia with Platelet less than 10,000 1) Plasma adenosine deaminase (ADA) 2) Red blood cell deoxyadenosine nucleotide (datp) 3) CBC with Platelet 1) Specialist in metabolic or genetic disorders TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 4 of 148

5 ADCIRCA Adcirca Exclusion Criteria: 1) Patient requires nitrate therapy on a regular or intermittent basis. 1) Diagnosis of Pulmonary Arterial Hypertension, WHO Group 1 2) Cardiac catheterization results: a. Mean pulmonary artery pressure (mmhg) AND b. Pulmonary capillary wedge pressure (mmhg) 3) Acute vasodilator testing result (required for patients with Idiopathic Pulmonary Arterial Hypertension ONLY). Age Restrictions: 18 years of age or older 1) Pulmonologist 2) Cardiologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 5 of 148

6 ADEMPAS Adempas Exclusion Criteria: 1) Pregnancy 2) Co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form 3) Concomitant administration with phosphodiesterase (PDE) inhibitors, including specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE inhibitors (such as dipyridamole or theophylline). 1) Diagnosis of Pulmonary Arterial Hypertension, WHO Group 1 2) Cardiac catheterization results: a. Mean pulmonary artery pressure (mmhg) AND b. Pulmonary capillary wedge pressure (mmhg) 3) Acute vasodilator testing result (required for patients with Idiopathic Pulmonary Arterial Hypertension ONLY) 4) Document previous use of: Adcirca, Sildenafil or Ventavis Age Restrictions: 18 years of age or older 1) Pulmonologist 2) Cardiologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 6 of 148

7 ADVAIR Advair Diskus Advair HFA Exclusion Criteria: N/A N/A N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 7 of 148

8 AFINITOR Afinitor Afinitor Disperz Exclusion Criteria: N/A 1) Advanced renal cell carcinoma: Document failure of treatment with sunitinib or sorafenib 2) Subependymal Giant Cell Astrocytoma: Document the following: a. Patient is not candidate for curative surgical resection 3) Progressive neuroendocrine tumors of pancreatic origin: a. Document that is unresectable, locally advanced or metastatic 4) Renal angiomyolipoma and TS: a. Document patient not requiring immediate surgery 5) Postmenopausal women with advanced hormone receptor-positive, HER2negative breast cancer: a. Document the stage of breast cancer b. Document the patient s results: hormone receptor positive and HER2 negative c. Document failure of treatment with letrozole or anastrozole 1) Hematologist 2) Oncologist 3) Urologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 8 of 148

9 ALIMTA Alimta Exclusion Criteria: 1) Patients with squamous cell non-small cell lung cancer 2) Creatinine clearance (CRCL) less than 45 ml/min 1) CBC with differential 2) CMP 3) CRCL 1) Hematologist 2) Oncologist Other Criteria: Part D vs. Part B evaluation also applies (*) TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 9 of 148

10 ALPHA-1 PROTEINASE INHIBITOR, HUMAN 50 MG/ML Prolastin-C Exclusion Criteria: 1) Immunoglobulin A (IgA) deficiency with antibodies against IgA 2) Alpha-1-proteinase-associated liver disease 1) Serum alpha1-antitrypsin (AAT) levels (less than 11 mcmol/l) 2) FEV1 levels (less than 80%) 3) Provide Hepatitis B immunization dates Age Restrictions: 18 years of age or older N/A Other Criteria: Part D vs. Part B evaluation also applies (*) TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 10 of 148

11 AMITIZA Amitiza Exclusion Criteria: N/A N/A N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 11 of 148

12 ANABOLIC STEROIDS Oxandrolone 1). 2) HIV-wasting Exclusion Criteria: 1) Known or suspected nephrosis (the nephrotic phase of nephritis). 2) Known or suspected hypercalcemia. 3) Known or suspected carcinoma of the breast in women with hypercalcemia. 4) Known or suspected carcinoma of the prostate or breast in male patients. 5) Pregnancy N/A N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 12 of 148

13 ARANESP Aranesp (Albumin Free) Exclusion Criteria: 1) Uncontrolled hypertension 2) Hemoglobin levels less than or equal to 10g/dL 3) Cancer patients receiving myelosuppressive chemotherapy 4) Zidovudine induced anemia greater than 4200 units/ week. 1) Initial prescription: a. Hgb is less than 10 g/dl b. CBC c. Total iron binding capacity d. Iron levels e. Ferritin levels f. Vitamin B12 level g. Folate level h. Serum creatinine i. BUN. 2) For reauthorizations: a. Patient who received erythropoietin in previous month: an increase in Hgb of at least 1g/dL after at least 12 weeks of therapy b. Documentation of adequate iron stores c. Patient is receiving supplemental iron. Adequate iron stores: serum ferritin is at least 100 mg/ml or transferrin saturation is at least 20%. N/A Coverage Duration: 12 weeks Other Criteria: 1) Part D vs. Part B evaluation also applies (*) 2) For patients with chronic kidney disease not on dialysis, reduce or interrupt the dose if the hemoglobin level approaches or exceeds 10 g/dl 3) For all patients reduce the dose if the hemoglobin rises by 1g/dL in any 2 week period TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 13 of 148

14 ARCALYST Arcalyst Exclusion Criteria: 1) Active or chronic infection 2) Concurrent therapy live vaccines or TNF. 1) Patient has a diagnosis of cryopyrin-associated periodic syndromes (CAPS), including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). 2) For positive latent TB, patient must have completed or receiving treatment for LTBI prior to initiating Arcalyst. Age Restrictions: 12 years of age and older 1) Rheumatologist 2) Immunologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 14 of 148

15 AUBAGIO Aubagio Exclusion Criteria: 1) Concomitant use with leflunomide 2) Severe Hepatic Impairment 3) Pregnancy N/A 1) Neurologist Other Criteria: 1) Document previous use of Gilenya and/or Tecfidera TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 15 of 148

16 BARACLUDE Baraclude Entecavir Exclusion Criteria: 1) Hepatic decompensation (Child-Pugh score greater than 6 [class B or C]) 1) For Hepatitis B: a. Hepatitis B surface antigen (HBsAg) 1) Gastroenterologist 2) Infectologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 16 of 148

17 BOSULIF Bosulif Exclusion Criteria: N/A N/A 1) Hematologist 2) Oncologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 17 of 148

18 BRILINTA Brilinta Exclusion Criteria: 1) Not to be used in patients with active pathological bleeding. N/A N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 18 of 148

19 BUPHENYL Sodium Phenylbutyrate Exclusion Criteria: N/A 1) Results of plasma ammonia levels N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 19 of 148

20 BUPRENORPHINE Buprenorphine HCl Buprenorphine HCl-Naloxone HCl Suboxone Exclusion Criteria: N/A 1) If the patient has been receiving Suboxone (buprenorphine-naloxone) or buprenorphine there is documentation that the patient is not receiving other opioids. Age Restrictions: 18 years of age or older N/A Other Criteria: 1) Quantity of up to 120 units/30 day supply allowed for Suboxone TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 20 of 148

21 CAPRELSA Caprelsa Exclusion Criteria: Congenital Long QT syndrome N/A 1) Hematologist/Oncologist 2) Endocrinologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 21 of 148

22 CAYSTON Cayston Exclusion Criteria: N/A 1) Diagnosis of cystic fibrosis with infection with pseudomonas aeruginosa in the lungs 2) FEV1 must be more than 25% or less than 75% predicted Age Restrictions: 7 years of age and older Pulmonologist Coverage Duration: 6 months Other Criteria: The recommended dose of Cayston for both adults and pediatric patients 7 years of age and older is one single-use vial (75 mg of aztreonam) reconstituted with 1 ml of sterile diluent administered 3 times a day for a 28-day course (followed by 28 days off Cayston therapy) TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 22 of 148

23 CHANTIX Chantix Chantix Continuing Month Pak Chantix Starting Month Pak Exclusion Criteria: 1) If patient is currently taking branded Zyban, branded Zyban will be discontinued while patient is taking Chantix. 1) Patient will be observed for neuropsychiatric symptoms (e.g. changes in behavior, hostility, agitation, depressed mood, and suicide related events, including ideation, behavior, and attempted suicide) while taking Chantix. 2) If the patient is currently taking Chantix, the patient's treatment, including the use of Chantix, has resulted in smoking cessation. N/A Coverage Duration: 6 months TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 23 of 148

24 CHORIONIC GONADOTROPIN Chorionic Gonadotropin Exclusion Criteria: 1) Precocious puberty 2) Pregnancy (Novarel(R)) 3) Prostate cancer or other androgen-dependent neoplasm N/A N/A Other Criteria: Part D vs. Part B evaluation also applies (*) TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 24 of 148

25 CIMZIA Cimzia Cimzia Prefilled Exclusion Criteria: 1) Concurrent use with another biological response modifier 1) Tuberculin Skin test 2) Rheumatoid arthritis: a. Document contraindication, intolerance or inadequate response to oral treatment with a DMARDs 3) Crohn's Disease: a. Document failure or intolerance to conventional therapy that includes corticosteroids, sulfasalazine, mesalamine, azathioprine, balsalazide osalazine, or 6- mercaptopurine. 1) Gastroenterologist 2) Rheumatologist Other Criteria: Part D vs. Part B evaluation will only apply to the powder for reconstitution (*) TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 25 of 148

26 COMETRIQ Cometriq (100 mg Daily Dose) Cometriq (140 mg Daily Dose) Cometriq (60 mg Daily Dose) Exclusion Criteria: N/A N/A 1) Hematologist 2) Oncologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 26 of 148

27 COSENTYX Cosentyx Exclusion Criteria: N/A 1) Documented diagnosis for moderate to severe plaque psoriasis 2) Failure or clinically significant adverse effects to ONE of the following therapies either alone or in combination unless contraindicated a. Methotrexate at a dose of 15-20mg/week b. If methotrexate is contraindicated, failure or clinically significant adverse effects to PUVA Therapy or UVB, or cyclosporine or Soriatane (acitretin). Age Restrictions: 18 years of age or older 1) Dermatologist 2) Rheumatologist Other Criteria: Diagnosis of moderate to severe: at least 5% BSA or crucial body areas such as the hands, feet, face, or genitals. TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 27 of 148

28 CYSTAGON Cystagon Exclusion Criteria: N/A N/A 1) Nephrologist 2) Pediatric nephrologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 28 of 148

29 DEMEROL Demerol Meperidine HCl Exclusion Criteria: N/A 1) Diagnosis N/A Coverage Duration: One month Other Criteria: Part D vs. Part B evaluation also applies for procedures (*) TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 29 of 148

30 EFFIENT Effient Exclusion Criteria: 1) Not to be used in patients with active pathological bleeding or a history of transient ischemic attack or stroke N/A N/A Other Criteria: 1) Use only in patients of 75 years or more if at high risk (diabetes, history of MI) 2) Reduce the dose to 5 mg once daily if the patient weight less than 60 kg. TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 30 of 148

31 ELIQUIS Eliquis Exclusion Criteria: 1) Active pathological bleeding. 1) Diagnosis 2) For patients with non-valvular atrial fibrillation: a. Creatinine Clearance (CRCL) N/A Other Criteria: 1) Reduction of Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation: 5 mg taken orally twice daily. 2) Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery: 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery. 3) Dosage Adjustments: a. In patients with nonvalvular atrial fibrillation: The recommended doses 2.5 mg twice daily in patients with any 2 of the following characteristics: i. Age equal or greater than 80 years ii. Body weight equal or less than 60 kg iii. Serum creatinine equal or greater than 1.5 mg/dl. TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 31 of 148

32 ENBREL Enbrel Enbrel SureClick Exclusion Criteria: N/A 1) Latent tuberculosis test result. If positive must be on treatment 2) Negative Hep B test or currently on treatment 3) Rheumatoid arthritis: a. Document previous use of at least one of the following tumor necrosis factor antagonists Humira, Cimzia or Orencia 4) Plaque Psoriasis: a. 5% BSA or crucial body areas b. Document previous use following of tumor necrosis factor antagonists: Humira 5) Ankylosing Spondylitis: a. Document previous use of one or more of the following tumor necrosis factor antagonists: Humira or Cimzia 6) Psoriatic Arthritis: a. Document previous use of one or more of the following tumor necrosis factor antagonists: of Humira or Cimzia 7) Juvenile Idiopathic Arthritis: a. Document previous use of one or more of the following tumor necrosis factor antagonists: Humira or Orencia 1) Dermatologist 2) Rheumatologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 32 of 148

33 EPO Procrit Exclusion Criteria: 1) Uncontrolled hypertension 1) Initial prescription: a. Hgb is less than 10 g/dl, b. CBC c. Total iron binding capacity d. Iron levels e. Ferritin levels f. Vitamin B12 level g. Folate level h. Serum creatinine i. BUN 2) HIV Patients: a. Concomitant use of Zidovudine at a maximum dose of 4200 mg/week 3) For reauthorizations: a. Patient who received erythropoietin in previous month: an increase in Hgb of at least 1 g/dl after at least 12 weeks of therapy b. Documentation of adequate iron stores c. Patient is receiving supplemental iron. Adequate iron stores: serum ferritin is at least 100 ng/ml or transferrin saturation is at least 20%. N/A Coverage Duration: 12 weeks Other Criteria: 1) Part D vs. Part B evaluation also applies (*) 2) For patients with chronic kidney disease not on dialysis, reduce or interrupt the dose if the hemoglobin level approaches or exceeds 10 g/dl 3) For all patients reduce the dose if the hemoglobin rises by 1g/dL in any 2 week period TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 33 of 148

34 ERIVEDGE Erivedge Exclusion Criteria: 1) Pregnancy 1) Diagnosis: a. Metastatic Basal Cell Carcinoma (BCC) OR b. Locally advanced BCC that has recurred following surgery or the patient is not a candidate for radiation or surgery. 2) Negative pregnancy affirmation 1) Hematologist 2) Oncologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 34 of 148

35 EXJADE Exjade Exclusion Criteria: 1) Creatinine Clearance (CRCL) less than 40 ml/min, 2) Severe hepatic impairment 3) Platelet count less than 50,000/mcL 4) Patient with poor performance status and high-risk myelodysplastic syndrome (MDS) or advanced malignancies 5) Exjade should not be used with Desferal (deferoxamine). 1) Provide the type of anemia or disease that leads to chronic iron overload 2) Provide serum ferritin concentration 3) Serum creatinine/creatinine clearance 4) Serum transaminases 5) Bilirubin 6) "Spot" urine test or 24-hour urine sample (urine protein). Age Restrictions: Two years of age and older 1) Hematologist 2) Oncologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 35 of 148

36 FABRAZYME Fabrazyme Exclusion Criteria: N/A 1) Provide alpha-galactosidase levels 1) Cardiologist 2) Nephrologist 3) Specialist in metabolic or genetic disorders Other Criteria: Part D vs. Part B evaluation also applies (*) TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 36 of 148

37 FARYDAK Farydak Exclusion Criteria: N/A 1) Documentation of patient has relapsed following treatment with at least 2 prior regimens, including Bortezomib and an immunomodulatory agent. 1) Oncologist 2) Hematologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 37 of 148

38 FENTANYL Fentora Lazanda Exclusion Criteria: 1) Patients who are not opioid tolerant. (Patients are considered opioid tolerant if they have been taking at least 60 mg of oral morphine per day, 25 mcg of transdermal fentanyl/hr, 30 mg of oral oxycodone daily, 8 mg of oral hydromorphone daily, 25 mg oral oxymorphone daily or an equianalgesic dose of another opioid for a week or longer). N/A Age Restrictions: Patients 18 years of age and older N/A Coverage Duration: 6 months Other Criteria: 1) Document of previous use of short acting or long acting opioid analgesics TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 38 of 148

39 FENTANYL PATCH FentaNYL Exclusion Criteria: 1) Patients who are not opioid tolerant. (Patients are considered opioid tolerant if they have been taking at least 60 mg of oral morphine per day, 25 mcg of transdermal fentanyl/hr, 30 mg of oral oxycodone daily, 8 mg of oral hydromorphone daily, 25 mg oral oxymorphone daily or an equianalgesic dose of another opioid for a week or longer) 2) Patients who do not require continuous opioid analgesia. 1) Document of previous use of short acting or long acting opioid analgesics N/A Coverage Duration: 6 months TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 39 of 148

40 FERRIPROX Ferriprox Exclusion Criteria: 1) Transfusional iron overload in patients with other chronic anemias. 1) Absolute neutrophil count (ANC) 2) Document current chelation therapy 3) CBC with differential Age Restrictions: 18 years of age or older 1) Hematologist 2) Oncologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 40 of 148

41 FIRAZYR Firazyr Exclusion Criteria: N/A N/A N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 41 of 148

42 FORTEO Forteo Exclusion Criteria: N/A 1) Document T-score = 2.5 2) Document previous osteoporosis therapy: a. Document if patient failed or had been intolerant to bisphosphonates. N/A Other Criteria: Therapy will be discontinued after a lifetime total of 24 months of treatment TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 42 of 148

43 FULYZAQ Fulyzaq Exclusion Criteria: N/A N/A N/A Other Criteria: Coverage will be provided if at least two (2) anti-diarrheal agents have been tried TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 43 of 148

44 GILOTRIF Gilotrif Exclusion Criteria: N/A N/A 1) Hematologist 2) Oncologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 44 of 148

45 GLEEVEC Gleevec Exclusion Criteria: N/A 1) Diagnosis 2) For ALL or lymphoblastic lymphoma: a. Newly diagnosed and Gleevec is used in combination with chemotherapy, disease is relapsed or refractory 3) For Gastrointestinal Stromal Tumor (GIST): a. Unresectable, recurrent, or metastatic GIST b. Use of Gleevec for adjuvant therapy following resection c. GIST is resectable and Gleevec will be used to improve surgical morbidity by reducing tumor size preoperatively 4) For pigmented villonodular synovitis/tenosynovial giant cell tumor (PVNS/TGCT): a. Gleevec will be used as a single agent. 1) Hematologist 2) Oncologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 45 of 148

46 GROWTH HORMONE Genotropin Genotropin MiniQuick Humatrope Norditropin FlexPro Norditropin NordiFlex Pen Nutropin AQ NuSpin 5 Nutropin AQ Pen Serostim Exclusion Criteria: 1) Active malignancy, active proliferative or severe non-proliferative diabetic retinopathy, acute critical illness 2) Closed epiphyses for pediatric patients 3) Prader-Willi syndrome, in patients who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment, sudden death has been reported 4) Underlying intracranial tumor, evidence of progression or recurrence 5) Post kidney transplant 6) Respiratory insufficiency 1) Total or partial deficiency of endogenous growth hormone evidenced by 1 or more of the following indicators: a. Minimum of 2 or more abnormal growth hormone provocative tests, secretion of the Growth Hormone is less than 10ng/ml b. Delayed bone age of 2 or more years (2 standard deviations below the mean for chronological age) c. Slowed growth rate demonstrated by deviation from normal growth curves (growth rate below 7cm per year for children 3 years old and younger and less than 4-5cm per year for children from 3 years old until puberty) 2) For HIV-wasting: a. Current antiretroviral therapy 3) For SBS: a. Dates of treatment with somatropin 4) Adult GHD (meets one of the following): a. Failed to stim tests with peak below 5 g/l TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 46 of 148

47 b. 3 or more PTH deficiency c. Child onset GHD with no mutations embriopathic lesions or irreversible structural lesions/damage, low pre-treatment IGF-1 and failed 1 stim test (peak below 5 g/l) prior to starting GH treatment. 1) Endocrinologist 2) Infectious Disease Specialist Coverage Duration: SBS: 8 weeks lifetime. HIV-wasting: 12 weeks. All other indications: One Year Other Criteria: Renewal for neonatal hypoglycemia: patient is euglycemic or treatment will be adjusted to optimize efficacy. Renewal for pediatric GHD, TS, NS, CRI, SGA, PWS, ISS, SHOXD: patient is growing more than 2 cm/year. For renewal of PWS only: body composition has improved. Renewal for adult GHD: IGF-1 levels will be evaluated to confirm appropriateness of continued tx. Renewal for HIV-wasting: BMI has improved or stabilized. TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 47 of 148

48 HARVONI Harvoni Exclusion Criteria: N/A 1) Documented diagnosis of chronic hepatitis C genotype 1 or 4 2) Documentation of hepatic fibrosis status by one of the following: a. Clinical evidence stating the cirrhosis status as attested by the prescribing physician b. Liver biopsy METAVIR score, or alternative scoring equivalent c. Radiological imaging of the liver d. Transient elastography (FibroScan) score e. FibroTest (FibroSure) score f. APRI score 3) Viral load 4) Prior use status of PEG-IFN, RBV, HCV protease or polymerase inhibitors Age Restrictions: 18 years of age or older 1) Hepatologist 2) Gastroenterologist 3) Infectious Disease Specialist Coverage Duration: 12 to 24 weeks based on HCV s and patient's characteristics see Other Criteria Other Criteria: 1) For Tx Naive: 12 weeks for GT1 and GT4 with or without cirrhosis. 8 weeks can be considered if pre-tx HCV RNA is below 6 million IU/mL without cirrhosis 2) For Tx Experienced (prior PEG-IFN, RBV): 12 weeks for GT1 without cirrhosis. 24 weeks can be considered if GT1 with cirrhosis. 12 weeks for GT4. TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 48 of 148

49 HEPSERA Adefovir Dipivoxil Hepsera Exclusion Criteria: N/A 1) Creatinine Clearance (CRCL) 2) For Hepatitis B: a. Hepatitis B surface antigen (HBsAg) 1) Gastroenterologist 2) Infectologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 49 of 148

50 HIGH RISK MEDICATIONS Benztropine Mesylate Butalbital-APAP-Caffeine Cyclobenzaprine HCl Cyproheptadine HCl Ergoloid Mesylates Estradiol GuanFACINE HCl Indomethacin Megestrol Acetate Oral Suspension Methocarbamol Premarin Exclusion Criteria: N/A 1) Provider acknowledgement that medication is a HRM in the elderly and that the patient has failed and/or tried at least one non-high risk alternative Age Restrictions: PA applies to patients 65 years of age or older N/A Other Criteria: Alternative medications available on formulary include but are not limited to: 1) For Cyproheptadine: a. Cetirizine, Desloratadine, Levocetirizine 2) For Estradiol, Premarin: a. Estrace (vaginal cream), Vagifem (vaginal tablet) 3) For Guanfacine: a. Clonidine, Doxazosin, Prazosin, Terazosin 4) For Indomethacin: a. Diclofenac, Etodolac, Ibuprofen, Meloxicam, Nabumetone, Naproxen, Piroxicam, Sulindac TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 50 of 148

51 HIGH RISK MEDICATIONS 2 Amitriptyline HCl ClomiPRAMINE HCl Doxepin HCl Imipramine HCl Imipramine Pamoate Megestrol Acetate Oral Tablet Surmontil Thioridazine HCl Exclusion Criteria: N/A 1) Provider acknowledgement that medication is a HRM in the elderly and that the patient has failed and/or tried at least one non-high risk alternative Age Restrictions: PA applies to patients 65 years of age or older N/A Other Criteria: Alternative medications available on formulary include but are not limited to: 1) For Amitriptyline, Clomipramine, Doxepin, Imipramine, Surmontil: a. Amoxapine, Desipramine, Nortriptyline, SSRIs, SNRIs, Bupropion 2) For Thioridazine: a. Chlorpromazine, Fluphenazine, Perphenazine, Prochlorperazine, Trifluoperazine 3) Megestrol Oral Tablets: a. Medroxyprogesterone Acetate, Dronabinol. TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 51 of 148

52 HUMAN PAPILLOMAVIRUS (HPV) VACCINE Cervarix Gardasil Exclusion Criteria: N/A N/A Age Restrictions: 1) For girls and women between the ages of 9 and 26 years (Gardasil) 2) For boys and men between the ages of 9 and 26 years (Gardasil) 3) For girls and women 9 through 25 years of age (Cervarix) N/A Coverage Duration: 1) According to the following schedule: 0, 1 and 6 months TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 52 of 148

53 HUMIRA Humira Humira Pen-Crohns Starter Exclusion Criteria: 1) Active infection (including TB) 2) Combination therapy with other biologic agent(s). 1) Latent tuberculosis test result. If positive must be on treatment 2) Negative Hep B test or currently on treatment 3) Rheumatoid arthritis 4) Chron s Disease: a. Inadequate response to at least 2 of the following: Corticosteroids, Sulfasalazine, Azathioprine, Mesalamine 5) Plaque Psoriasis: a. 5% BSA or crucial body areas 6) Ankylosing Spondylitis: a. Inadequate response to at least 2 NSAIDs. 1) Rheumatologist 2) Gastroenterologist 3) Dermatologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 53 of 148

54 ICLUSIG Iclusig Exclusion Criteria: N/A 1) Diagnosis 2) For treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) - no more information is required 3) For the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL - document resistance or intolerance to prior tyrosine kinase inhibitor therapy 1) Oncologist 2) Hematologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 54 of 148

55 ILARIS Ilaris Exclusion Criteria: 1) Active or chronic infection 2) Concurrent therapy live vaccines or TNF. 1) Patient has a diagnosis of cryopyrin-associated periodic syndromes (CAPS), including familial cold auto-inflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS) and Systemic onset juvenile chronic arthritis 2) For positive latent TB, patient must have completed or receiving treatment for LTBI prior to initiating Ilaris. 1) Rheumatologist 2) Immunologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 55 of 148

56 IMBRUVICA Imbruvica Exclusion Criteria: N/A 1) Diagnosis 2) For MCL or CLL, documentation of previous treatment 3) For Waldenstrom s macroglobulinemia, no medical information required. 1) Oncologist 2) Hematology TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 56 of 148

57 INCRELEX Increlex Exclusion Criteria: 1) Epiphyseal closure, active malignancy, or concurrent use with GH therapy. 2) Patient has secondary causes of IGF-1 deficiency (e.g. hypothyroidism, malignancy, chronic systemic disease, skeletal disorders, malnutrition, celiac disease). 1) Height standard deviation score 2) Growth hormone levels 1) Endocrinologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 57 of 148

58 INJECTABLE MULTIPLE SCLEROSIS Avonex Betaseron Copaxone Extavia Glatopa Rebif Rebif Rebidose Rebif Rebidose Titration Pack Rebif Titration Pack Exclusion Criteria: N/A 1) Diagnosis: Patient have a relapsing form of MS (e.g. relapsing-remitting MS, progressiverelapsing MS, or secondary progressive MS with relapses). Neurologist Other Criteria: 1) For Betaseron: Document previous used of Avonex and/or Copaxone. TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 58 of 148

59 INJECTABLE TESTOSTERONE Depo-Testosterone Testosterone Cypionate Testosterone Enanthate Exclusion Criteria: Carcinoma of the breast or known or suspected prostate cancer N/A N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 59 of 148

60 INLYTA Inlyta Exclusion Criteria: N/A 1) Patient has a diagnosis of advanced renal cell carcinoma (RCC) that has progressed after at least 1 prior systemic therapy for RCC. Examples of prior systemic therapies for RCC include regimens containing bevacizumab, pazopanib, sorafenib, sunitinib, temsirolimus, and cytokines (interferon alpha or interleukin-2). Age Restrictions: 18 years of age or older 1) Hematologist 2) Oncologist 3) Urologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 60 of 148

61 IVIG Carimune NF Gammagard Gammaplex Gamunex-C Exclusion Criteria: IgA deficiency with antibodies to IgA and a history of hypersensitivity, history of anaphylaxis or severe systemic reaction to human immune globulin or product components. For Carimune, history of anaphylaxis or severe systemic reaction to human immune globulin or product components. 1) Document at least one prior systemic therapy 2) CBC with diff 3) BMP N/A Other Criteria: Part D vs. Part B evaluation also applies (*) TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 61 of 148

62 JAKAFI Jakafi Exclusion Criteria: N/A 1) Document if the patient has intermediate or high-risk myelofibrosis: a. Intermediate and high-risk MF patients include anyone over the age of 65 or who have or have had any of the following: anemia, constitutional symptoms, elevated white blood cell or blast counts or platelet counts less than 100 X 109/L b. To continue therapy beyond 6 months, document spleen size reduction or symptom improvement since initiation of therapy with Jakafi (50% reduction from pretreatment baseline in palpable spleen length, or a 35% reduction in spleen volume on MRI or CT) 2) Document if the patient has polycythemia vera: a. If patient had an inadequate response to or are intolerant to hydroxyurea. N/A Coverage Duration: For polycythemia vera: 12 months. For myelofibrosis: Initial: 6 months, renewals: up to 12 months. TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 62 of 148

63 KINERET Kineret Exclusion Criteria: N/A 1) Latent tuberculosis test result (if is positive must be on treatment) 2) Negative Hep B test or currently on treatment 3) Rheumatoid arthritis: a. Document previous use/intolerance of Cimzia, Humira, Orencia or Xeljanz 4) For Chronic infantile neurological, cutaneous and articular syndrome: no medical information is required N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 63 of 148

64 KUVAN Kuvan Exclusion Criteria: N/A 1) For renewal: doctor must document a decrease in phenylalanine levels 1) Geneticist 2) Physician specialized in metabolic or genetic disorders Coverage Duration: Initial: 3 months, renewals: 12 months TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 64 of 148

65 LABA/ICS COMBINATIONS Breo Ellipta Exclusion Criteria: N/A N/A N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 65 of 148

66 LENVIMA Lenvima Exclusion Criteria: N/A N/A 1) Oncologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 66 of 148

67 LETAIRIS Letairis Exclusion Criteria: 1) Pregnancy 2) Idiopathic Pulmonary Fibrosis 1) Diagnosis of Pulmonary Arterial Hypertension, (WHO Group 1) 2) Cardiac catheterization results: a. Mean pulmonary artery pressure (mmhg) AND b. Pulmonary capillary wedge pressure (mmhg) 3) Acute vasodilator testing result (required for patients with Idiopathic Pulmonary Arterial Hypertension ONLY) 4) Document previous use of: Adcirca, Sildenafil or Ventavis Age Restrictions: 18 years of age or older 1) Pulmonologist 2) Cardiologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 67 of 148

68 LEUKINE Leukine Exclusion Criteria: 1) Hypersensitivity to yeast-derived products. 2) Use of Leukine within 24 hours preceding or following chemotherapy or radiotherapy. 3) Use of Leukine for prophylaxis of FN. 4) When Leukine is used for treatment of acute FN: patient received prophylactic Neulasta during the current chemotherapy cycle. 5) When Leukine is used for acute myelogenous leukemia (AML): excessive leukemic myeloid blasts (greater than or equal to 10%) in the bone marrow or peripheral blood. 1) Diagnosis 2) CBC with differential 3) Complete Metabolic Panel (CMP) 4) Body weight N/A Other Criteria: Part D vs. Part B evaluation also applies (*) TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 68 of 148

69 LIDOCAINE PATCH Lidocaine External Patch Exclusion Criteria: N/A 1) Diagnosis N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 69 of 148

70 LINZESS Linzess Exclusion Criteria: N/A N/A N/A Other Criteria: 1) Chronic Idiopathic Constipation: 145 mcg capsules 2) Irritable bowel syndrome: predominant constipation: 290mcg capsules TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 70 of 148

71 LYNPARZA Lynparza Exclusion Criteria: N/A 1) Document diagnosis for gbrca mutation 2) Document if patient has not responded to or has relapsed following treatment with at least three chemotherapy regimens. 1) Oncologist 2) Hematologist Coverage Duration: 6 months TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 71 of 148

72 MEKINIST Mekinist Exclusion Criteria: N/A N/A 1) Oncologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 72 of 148

73 MOVANTIK Movantik Exclusion Criteria: 1) Patients with known or suspected gastrointestinal obstruction and at increased risk of recurrent obstruction 2) Concomitant use with strong CYP3A4 inhibitors 1) Documented diagnosis of opioid induced constipation (OIC): for use in the treatment of OIC in adult patients with chronic non-cancer pain 2) Opioid use for at least 4 weeks 3) Current failure or clinically significant adverse effects to at least two constipation agents Age Restrictions: 18 years of age and older N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 73 of 148

74 NEUMEGA Neumega Exclusion Criteria: 1) Myeloablative chemotherapy 1) CBC with differential 2) Platelet counts Oncologist Other Criteria: Part D vs. Part B evaluation also applies (*) TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 74 of 148

75 NEUPOGEN / NEULASTA Neulasta Neupogen Exclusion Criteria: 1) For Neupogen: Hypersensitivity to E. coli-derived proteins. 1) CBC with differential 2) Platelet counts N/A Coverage Duration: 3 months Other Criteria: Part D vs. Part B evaluation also applies (*) TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 75 of 148

76 NEUPRO Neupro Exclusion Criteria: N/A 1) Diagnosis 2) For Parkinson's Disease: a. Document previous use of Mirapex and/or Requip or b. Patient is unable to take oral formulations 3) For restless leg syndrome: previous use of oral alternatives. N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 76 of 148

77 NEXAVAR Nexavar Exclusion Criteria: 1) Combination with carboplatin and paclitaxel in patients with squamous cell lung cancer 1) Renal cell carcinoma (RCC) - document one of the following: a. Disease relapse, b. Stage IV and medically or surgically unresectable disease, c. Progression despite cytokine therapy. 2) Unresectable hepatocellular carcinoma (HCC): a. Document diagnosis of unresectable hepatocellular carcinoma (Child-Pugh A and B). 3) Metastatic, locally recurrent thyroid cancer- Document failure /unresponsive to radioactive iodine treatment 1) Oncologist, 2) Nephrologist, 3) Gastroenterologist, 4) Hepatologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 77 of 148

78 NOXAFIL Noxafil Exclusion Criteria: 1) Concomitant use with ergot alkaloids (ergotamine and dihydroergotamine), HMG-CoA reductase inhibitors primarily metabolized by CYP3A4 (e.g. atorvastatin, lovastatin, and simvastatin), sirolimus, or CYP3A4 substrates that prolong the QT interval (pimozide and quinidine). 1) Liver Function test N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 78 of 148

79 NUEDEXTA Nuedexta Exclusion Criteria: 1) Concomitantly taking other drugs containing quinidine, quinine, mefloquine, monoamine oxidase inhibitors (MAOIs), or drugs that both prolong QT interval and are metabolized by CYP2D6. 2) Patient has a prolonged QT interval, congenital long QT syndrome or a history suggestive of torsades de pointes, or heart failure. 3) Patient has complete atrioventricular (AV) block without implanted pacemaker or is at high risk of complete AV block. 1) Patient has amyotrophic lateral sclerosis (ALS) OR multiple sclerosis (MS). N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 79 of 148

80 OCTREOTIDE Octreotide Acetate SandoSTATIN SandoSTATIN LAR Depot Exclusion Criteria: N/A 1) Diagnosis N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 80 of 148

81 OLYSIO Olysio Exclusion Criteria: N/A 1) Diagnosis: Chronic Hepatitis C (CHC) genoptype-1 infected subjects with compensated liver disease in combination with peginterferon alfa and ribavirin, 2) Detectable viral load (VL) prior to starting treatment (tx). 1) Gastroenterologist 2) Infectious Disease Specialist, 3) Hepatologist Coverage Duration: 24 weeks TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 81 of 148

82 OPSUMIT Opsumit Exclusion Criteria: Pregnancy 1) Diagnosis of Pulmonary Arterial Hypertension, WHO Group 1 2) Cardiac catheterization results: a. Mean pulmonary artery pressure (mmhg) AND b. Pulmonary capillary wedge pressure (mmhg) 3) Acute vasodilator testing result (required for patients with Idiopathic Pulmonary Arterial Hypertension ONLY) 4) Document previous use of: Adcirca, Sildenafil or Ventavis Age Restrictions: 18 years of age or older 1) Pulmonologist 2) Cardiologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 82 of 148

83 ORAL MULTIPLE SCLEROSIS Gilenya Tecfidera Exclusion Criteria: For Gilenya only: 1) Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization or Class III/IV heart failure, 2) History or presence of Mobitz Type II second-degree or third-degree atrioventricular (AV) block or sick sinus syndrome, unless patient has a functioning pacemaker, 3) Baseline QTc interval greater or equal to 500 ms, 4) Treatment with Class Ia or Class III anti-arrhythmic drugs. N/A 1) Neurologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 83 of 148

84 ORAL TESTOSTERONES Striant Exclusion Criteria: 1) Male patients who have carcinoma of the breast or known or suspected prostate cancer 1) Diagnosis: a. Breast cancer (Palliative treatment) b. Delayed puberty c. Hypogonadotropic hypogonadism d. Primary hypogonadism 2) Testosterone Levels (for men) 3) Striant is only indicated for hypogonadism. N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 84 of 148

85 ORENCIA Orencia Exclusion Criteria: 1) Concomitant use of biologic rheumatoid arthritis therapy (e.g. anakinra). 2) Tumor necrosis factor (TNF) antagonists, live vaccines, or use of live vaccines within 3 months of discontinuation of abatacept is not recommended. 1) Document previous use/intolerance of at least 2 of the following: a. DMARDs b. Methotrexate 2) Latent tuberculosis test result. If positive must be on treatment 3) Negative Hep B test or currently on treatment 1) Rheumatologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 85 of 148

86 ORFADIN Orfadin Exclusion Criteria: N/A N/A 1) Physician specializing in metabolic or genetic disorders 2) Geneticist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 86 of 148

87 PEGASYS Pegasys Pegasys ProClick Exclusion Criteria: 1) Hepatic decompensation (Child-Pugh score greater than 6 [class B or C]) in cirrhotic patients before treatment. 2) Autoimmune hepatitis. 1) Creatinine Clearance (CRCL) 2) For Chronic HCV: a. HCV genotype (G) b. Detectable viral load (VL) prior to starting treatment (tx) 3) For Hepatitis B: a. Hepatitis B surface antigen (HBsAg) 1) Gastroenterologist 2) Infectologist Coverage Duration: 1) Pegasys Monotx: 48 wks. 2) Pegasys/Copegus Comb. if genotype 1, 4: 48 wks., if genotype 2, 3: 24 wks. TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 87 of 148

88 PEGINTRON Peg-Intron Peg-Intron Redipen Exclusion Criteria: 1) Hepatic decompensation (Child-Pugh score greater than 6 [class B or C]) in patients with cirrhotic chronic hepatitis C before or during therapy. 2) Autoimmune hepatitis. 1) Creatinine Clearance (CRCL) 2) For Chronic HCV: a. HCV genotype (G) b. Detectable viral load (VL) prior to starting treatment (Tx). 1) Gastroenterologist 2) Infectologist Coverage Duration: 1) Pegintron Monotx: 12 months 2) Pegintron/Rebetol: a. Genotype 1: 48 wks. b. Genotype 2, 3: 24 wks. TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 88 of 148

89 POMALYST Pomalyst Exclusion Criteria: 1) Pregnancy 1) Diagnosis 2) Patient must have received at least 2 therapies including lenalomide and bortezomib 3) CBC with differential 1) Oncologist 2) Hematologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 89 of 148

90 PRADAXA Pradaxa Exclusion Criteria: 1) Patients with active pathological bleeding 2) Prosthetic heart valve, mechanical 1) Creatinine Clearance (CrCl) N/A Other Criteria: 1) For patients with CrCl greater than 30 ml/min: 150 mg orally, twice daily 2) For patients with CrCl ml/min: 75 mg orally, twice daily. TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 90 of 148

91 PROMACTA Promacta Exclusion Criteria: N/A 1) Document any of the following, if apply: a. Previous Corticosteroids use b. Previous Immunoglobulin use c. Splenectomy 2) Platelet count 3) CBC with differential 4) Liver Function Tests. N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 91 of 148

92 PROVIGIL Modafinil Provigil Exclusion Criteria: N/A 1) Diagnosis 2) Current therapies for sleep apnea 3) Provide CPAP history or status. Age Restrictions: Patients 16 years of age and older N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 92 of 148

93 RANEXA Ranexa Exclusion Criteria: 1) Concurrent use of CYP3A inducers (e.g. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort). 2) Concurrent use of strong CYP3A inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir) 3) Hepatic cirrhosis N/A 1) Cardiologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 93 of 148

94 RELISTOR Relistor Exclusion Criteria: 1) Known or suspected mechanical gastrointestinal obstruction 1) Diagnosis 2) Patient demonstrated an inadequate treatment response or intolerance or contraindication to a drug regimen of polyethylene glycol 3350 (PEG 3350) 3) Document patient s opioid regimen for chronic pain management 4) Creatinine Clearance N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 94 of 148

95 RESTASIS Restasis Exclusion Criteria: 1) For patients with active ocular infection 2) Herpes zoster oftalmicus 1) Failure to conventional Lubricant or corticosteroids agent. 1) Ophthalmologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 95 of 148

96 REVATIO Sildenafil Citrate Exclusion Criteria: 1) Patient requires nitrate therapy on a regular or intermittent basis. 1) Diagnosis of Pulmonary Arterial Hypertension, WHO Group 1 2) Cardiac catheterization results: a. Mean pulmonary artery pressure (mmhg) AND b. Pulmonary capillary wedge pressure (mmhg) 3) Acute vasodilator testing result (required for patients with Idiopathic Pulmonary Arterial Hypertension ONLY). Age Restrictions: 18 years of age or older 1) Pulmonologist 2) Cardiologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 96 of 148

97 REVLIMID Revlimid Exclusion Criteria: 1) Pregnancy N/A 1) Hematologist/oncologist 2) Prescribers, pharmacists, and patients must be registered and meet all the conditions of the RevAssist program. TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 97 of 148

98 RIBAVIRIN Rebetol Ribasphere Ribavirin Exclusion Criteria: 1) Women who are pregnant or men whose female are pregnant. 2) Hemoglobinopathy, hemoglobin less that 8.5 g/dl. 3) Coadministration with didanosine in HIV coinfected patients. 4) Renal impairment (CRCL less than 50 ml/min) for Rebetol only. N/A 1) Gastroenterologist 2) Infectious Disease specialist 3) Hepatologist Coverage Duration: Initial 12 weeks, for renewal up to 72 weeks TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 98 of 148

99 RILUZOLE Riluzole Exclusion Criteria: N/A N/A N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 99 of 148

100 SIMPONI Simponi Simponi Aria Exclusion Criteria: N/A 1) Latent tuberculosis test result. If positive must be on treatment 2) Negative Hep B test or currently on treatment 3) Rheumatoid arthritis: a. Document previous use of at least one of the following tumor necrosis factor antagonists Humira, Cimzia or Orencia 4) Ankylosing Spondylitis: a. Document previous use of one or more of the following tumor necrosis factor antagonists: Humira or Cimzia 5) Psoriatic Arthritis: a. Document previous use of one or more of the following tumor necrosis factor antagonists: of Humira or Cimzia 6) Moderate to severe Ulcerative colitis with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy. 1) Rheumatologist 2) Gastroenterologist 3) Dermatologist Other Criteria: Part D vs. Part B evaluation also applies to intravenous administration (*) TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 100 of 148

101 SIMVASTATIN Simvastatin Vytorin Exclusion Criteria: N/A N/A N/A Other Criteria: 1) Prior use of simvastatin 80mg and/or Vytorin 10/80 consecutively in the last 12 months. TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 101 of 148

102 SIRTURO Sirturo Exclusion Criteria: N/A N/A 1) Infectious Disease specialist 2) Pulmonologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 102 of 148

103 SIVEXTRO Sivextro Oral Tablet Exclusion Criteria: N/A Diagnosis N/A Coverage Duration: 31 days TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 103 of 148

104 SOMATULINE DEPOT Somatuline Depot Exclusion Criteria: N/A 1) For acromegaly: Patient meets the following criteria for initiation of therapy: a. Clinical evidence of acromegaly b. Pre-treatment high IGF-1 level for age/gender, and c. Patient has had an inadequate or partial response to surgery and/or radiotherapy OR there is a clinical reason for why the patient has not had surgery or radiotherapy 2) For continuation of therapy for acromegaly: a. IGF-1 level decreased or normalized 3) For unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs): No medical information required. N/A TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 104 of 148

105 SOMAVERT Somavert Exclusion Criteria: N/A 1) Patient meets the following criteria for initiation of therapy: a. Clinical evidence of acromegaly b. Pre-treatment high IGF-1 level for age/gender c. Patient has had an inadequate or partial response to octreotide or lanreotide OR patient is intolerant to or has a contraindication to octreotide or lanreotide, and d. Patient has had an inadequate or partial response to surgery and/or radiotherapy OR there is a clinical reason for why the patient has not had surgery or radiotherapy e. Liver Function Tests. 2) For continuation of therapy: a. IGF-1 level decreased or normalized. 1) Endocrinologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 105 of 148

106 SOVALDI Sovaldi Exclusion Criteria: N/A 1) Diagnosis: Chronic Hepatitis C (CHC) as a component of a combination antiviral treatment regimen, 2) HCV Genotype (G) 1) Gastroenterologist 2) Infectious Disease Specialist 3) Hepatologist 4) Oncologist Coverage Duration: Genotype 1, 2 and 4: 12 weeks. Genotype 3: 24 weeks. Waiting liver transplant: 48 weeks Other Criteria: 1) Must be given in combination with a pegylated interferon (i.e. Pegasys or PegIntron) and/or ribavirin: a. Sovaldi + peginterferon + ribavirin, genotype 1 or 4: 12 weeks b. Sovaldi + ribavirin: i. Genotype 1 (patients who are interferon ineligible): 24 weeks ii. Genotype 2: 12 weeks iii. Genotype 3: 24 weeks iv. Hepatocellular Carcinoma awaiting liver transplantation: 48 weeks. c. Sovaldi +Olysio: i. Genotype 1: 12 weeks TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 106 of 148

107 SPRYCEL Sprycel Exclusion Criteria: N/A 1) For newly diagnosed adults with Ph+ CML in chronic phase a. No additional medical information required 2) Adults with chronic accelerated, or myeloid or lymphoid blast phase Ph+ CML a. No additional medical information required 3) Adults with Ph+ ALL a. Resistance or intolerance to prior therapy. Age Restrictions: 18 years of age or older 1) Hematologist, 2) Oncologist TSA 2015 Royal, Classic, Vital and Vital Plus Formulary Page 107 of 148

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