WELLCARE/ OHANA HEALTH PLAN

Transcription

1 WELLCARE/ OHANA HEALTH PLAN 2014 PRIOR AUTHORIZATION CRITERIA No Changes Made Since: 08/2014 **To get updated information about the drugs covered by WellCare, please visit our website ( or call Customer Service. Our phone number is available on our Contact Us page.

2 PART B vs PART D DRUGS This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. Acetylcysteine Solution 10 % Inhalation Acetylcysteine Solution 20 % Inhalation Adagen Solution 250 UNIT/ML Intramuscular Albuterol Sulfate Nebulization Solution (2.5 MG/3ML) 0.083% Inhalation Albuterol Sulfate Nebulization Solution (5 MG/ML) 0.5% Inhalation Albuterol Sulfate Nebulization Solution 0.63 MG/3ML Inhalation Albuterol Sulfate Nebulization Solution 1.25 MG/3ML Inhalation Aldurazyme Solution 2.9 MG/5ML Intravenous Alimta Solution Reconstituted 100 MG Intravenous Alimta Solution Reconstituted 500 MG Intravenous Amifostine Solution Reconstituted 500 MG Intravenous Avastin Solution 100 MG/4ML Intravenous Avastin Solution 400 MG/16ML Intravenous Azacitidine Suspension Reconstituted 100 MG Injection Azathioprine Sodium Solution Reconstituted 100 MG Injection Azathioprine Tablet 50 MG ORAL Bleomycin Sulfate Solution Reconstituted 15 UNIT Injection Bleomycin Sulfate Solution Reconstituted 30 UNIT Injection Buprenorphine HCl Solution 0.3 MG/ML Injection CellCept Suspension Reconstituted 200 MG/ML Oral Chorionic Gonadotropin Solution Reconstituted UNIT Intramuscular Cromolyn Sodium Nebulization Solution 20 MG/2ML Inhalation Cyclophosphamide Solution Reconstituted 1 GM Injection Cyclophosphamide Solution Reconstituted 2 GM Injection Cyclophosphamide Solution Reconstituted 500 MG Injection Cyclophosphamide Tablet 25 MG Oral Cyclophosphamide Tablet 50 MG Oral Cyclosporine Capsule 100 MG Oral Cyclosporine Capsule 25 MG Oral Cyclosporine Modified Capsule 100 MG Oral Cyclosporine Modified Capsule 25 MG Oral Cyclosporine Modified Capsule 50 MG Oral Cyclosporine Modified Solution 100 MG/ML Oral Cyclosporine Solution 50 MG/ML Intravenous Elaprase Solution 6 MG/3ML Intravenous Elitek Solution Reconstituted 1.5 MG Intravenous Elitek Solution Reconstituted 7.5 MG Intravenous Emend Capsule 125 MG Oral Emend Capsule 40 MG Oral Emend Capsule 80 & 125 MG Oral Emend Capsule 80 MG Oral Engerix-B Suspension 10 MCG/0.5ML Injection Engerix-B Suspension 20 MCG/ML Injection Fabrazyme Solution Reconstituted 35 MG Intravenous Fabrazyme Solution Reconstituted 5 MG Intravenous Faslodex Solution 250 MG/5ML Intramuscular Gengraf Capsule 100 MG Oral Gengraf Capsule 25 MG Oral Updated 05/2014

3 Gengraf Solution 100 MG/ML Oral Hecoria Capsule 0.5 MG Oral Hecoria Capsule 1 MG Oral Hecoria Capsule 5 MG Oral Humulin R U-500 (Concentrated) Solution 500 UNIT/ML Subcutaneous Ipratropium Bromide Solution 0.02 % Inhalation Ipratropium-Albuterol Solution (3) MG/3ML Inhalation Ixempra Kit Solution Reconstituted 15 MG Intravenous Ixempra Kit Solution Reconstituted 45 MG Intravenous Lumizyme Solution Reconstituted 50 MG Intravenous Methotrexate Sodium (PF) Solution 25 MG/ML Injection Methotrexate Sodium Solution Reconstituted 1 GM Injection Mitoxantrone HCl Concentrate 25 MG/12.5ML Intravenous Mycophenolate Mofetil Capsule 250 MG Oral Mycophenolate Mofetil Tablet 500 MG Oral Mycophenolic Acid Tablet Delayed Release 180 MG Oral Mycophenolic Acid Tablet Delayed Release 360 MG Oral Myfortic Tablet Delayed Release 180 MG Oral Myfortic Tablet Delayed Release 360 MG Oral Myozyme Solution Reconstituted 50 MG Intravenous Naglazyme Solution 1 MG/ML Intravenous Nebupent Solution Reconstituted 300 MG Inhalation Nulojix Solution Reconstituted 250 MG Intravenous Ontak Solution 150 MCG/ML Intravenous Pediarix Suspension Intramuscular Prograf Solution 5 MG/ML Intravenous Prolastin-C Solution Reconstituted 1000 MG Intravenous Proleukin Solution Reconstituted UNIT Intravenous Pulmozyme Solution 1 MG/ML Inhalation Rapamune Solution 1 MG/ML Oral Rapamune Tablet 0.5 MG Oral Rapamune Tablet 1 MG Oral Rapamune Tablet 2 MG Oral Recombivax HB Suspension 10 MCG/ML Injection Recombivax HB Suspension 40 MCG/ML Injection Sandimmune Solution 100 MG/ML Oral Sandimmune Solution 50 MG/ML Intravenous Sirolimus Tablet 0.5 MG Oral Tacrolimus Capsule 0.5 MG Oral Tacrolimus Capsule 1 MG Oral Tacrolimus Capsule 5 MG Oral Treanda Solution Reconstituted 100 MG Intravenous Treanda Solution Reconstituted 25 MG Intravenous Trelstar Depot Mixject Suspension Reconstituted 3.75 MG Intramuscular Trelstar Depot Suspension Reconstituted 3.75 MG Intramuscular Trelstar LA Mixject Suspension Reconstituted MG Intramuscular Trelstar LA Suspension Reconstituted MG Intramuscular Trelstar Mixject Suspension Reconstituted 22.5 MG Intramuscular Trisenox Solution 10 MG/10ML Intravenous Twinrix Suspension Intramuscular Velcade Solution Reconstituted 3.5 MG Injection Vidaza Suspension Reconstituted 100 MG Injection Zoledronic Acid Solution 5 MG/100ML Intravenous Zortress Tablet 0.25 MG Oral Zortress Tablet 0.5 MG Oral Zortress Tablet 0.75 MG Oral Updated 05/2014

4 ABILIFY Abilify Solution 9.75 MG/1.3ML Intramuscular Medical documentation indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder (inj) and documented failure or intolerable side effects with first generation short acting injectable, haloperidol AND atypical antipsychotic, olanzapine or ziprasidone. 18 years and older Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

5 ABILIFY DISCMELT Abilify Discmelt Tablet Dispersible 10 MG Oral Abilify Discmelt Tablet Dispersible 15 MG Oral Medication documentation of FDA approved indication AND statement of swallowing difficulty or intolerance to two preferred alternatives. Preferred alternatives include: risperidone ODT, risperidone oral solution, and Abilify oral solution. 18 years or greater (Major Depressive Disorder, adjunctive treatment); 13 years or greater (Schizophrenia); 10 years or greater (Bipolar Disorder); 6-17 years (Autism) Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

6 ABILIFY MAINTENA Abilify Maintena Suspension Reconstituted 300 MG Intramuscular Abilify Maintena Suspension Reconstituted 400 MG Intramuscular Statement of FDA approved diagnosis of schizophrenia and patient must have documented treatment failure or intolerable side effects from treatment with Invega Sustenna and Risperdal Consta is required. If approved, requires concurrent treatment with a 14-day course of oral Abilify or another oral antipsychotic. 18 years and older Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

7 ACTIMMUNE Actimmune Solution UNIT/0.5ML Subcutaneous Statement indicating FDA approved diagnosis of chronic granulomatous disease or severe malignant osteoporosis. Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

8 ADCIRCA Adcirca Tablet 20 MG Oral Statement of FDA approved diagnosis of pulmonary arterial hypertension WHO group I with NYHA class II - III symptoms. 18 years and older Cardiologist or Pulmonologist Adcirca should not be used in combination with organic nitrates.

9 AFINITOR Afinitor Tablet 10 MG Oral Afinitor Tablet 2.5 MG Oral Afinitor Tablet 5 MG Oral Afinitor Tablet 7.5 MG Oral All medically accepted indications not otherwise excluded from Part D. Medical statement of FDA approved diagnosis for: 1. Treatment of patients with advanced renal cell cancer (RCC): a) First line, Member must have tried and failed or have a contraindication to preferred agent Sutent. b) Second line, Member must have tried and failed or have a contraindication to preferred agent Inlyta. 2. Treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous, sclerosis (TS) who require therapeutic intervention but are not candidates for curative surgical resection. 3. Treatment of patients with progressive neuroendocrine tumors of pancreatic origin (PNET) that is unresectable, locally advanced, or metastatic. 4. Postmenopausal women with advanced hormone receptor positive HER2 - Negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. 5. Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. 6. Liver transplant rejection, combination therapy prophylaxis. 7. Low to moderate risk renal transplant rejection combination therapy prophylaxis. Oncologist Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

10 AFINITOR DISPERZ Afinitor Disperz Tablet Soluble 2 MG Oral Afinitor Disperz Tablet Soluble 3 MG Oral Afinitor Disperz Tablet Soluble 5 MG Oral All medically accepted indications not otherwise excluded from Part D. Statement of FDA approved indication and for use of Afinitor Disperz, a statement that member has swallowing difficulties or cannot tolerate Afinitor tablets must be included. 1. Treatment of patients with advanced renal cell cancer (RCC) after failure of treatment with sunitinib or sorafenib. 2. Treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require therapeutic intervention but are not candidates for curative surgical resection. 3. Treatment of patients with progressive neuroendocrine tumors of pancreatic origin (PNET) that is unresectable, locally advanced, or metastatic. Oncologist Through the benefit year Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization. Updated 03/2014

11 ALINIA Alinia Suspension Reconstituted 100 MG/5ML Oral Alinia Tablet 500 MG Oral Approve after receiving medical documentation indicating treatment needed for diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Age 1 year or older (Suspension); Age 12 years or older (Tablets) 60 days

12 AMBISOME AmBisome Suspension Reconstituted 50 MG Intravenous Statement indicating FDA approved diagnosis of: - Empirical therapy for presumed fungal infection in febrile, neutropenic patients. - Treatment of Cryptococcal Meningitis in HIV infected patients - Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate. -Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with AmBisome, relapse rates were high following initial clearance of parasites 30 days This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. Updated 06/2013

13 AMITRIPTYLINE Amitriptyline HCl Tablet 10 MG Oral Amitriptyline HCl Tablet 100 MG Oral Amitriptyline HCl Tablet 150 MG Oral Amitriptyline HCl Tablet 25 MG Oral Amitriptyline HCl Tablet 50 MG Oral Amitriptyline HCl Tablet 75 MG Oral All medically accepted indications not otherwise excluded from Part D. Medical documentation of medically accepted indication including physician indication for the continued use of the HRM (high risk medication) with an explanation of the specific benefit established with the medication, and how that benefit outweighs the potential risk. AND The physician must document the ongoing monitoring plan for the agent. AND The physician must document that patient counseling has and will continue to take place outlining the risks and potential side effects of the medication. AND Trial and failure or contraindication to two preferred alternatives for established indication. Preferred alternatives include: For depression: paroxetine, sertraline, venlafaxine, duloxetine, citalopram, escitalopram, fluoxetine, and trazodone. For migraine: prophylaxis, propranolol, timolol, topiramate, valproic acid and divalproex. For anxiety: paroxetine, venlafaxine, duloxetine, and buspirone. For postherpetic neuralgia: gabapentin Prior authorization required for members 64 years or older. Automatic approval for members less than 64 years of age. Updated 04/2014

14 AMPHETAMINE/DEXTROAMPHETAMINE Amphetamine-Dextroamphetamine Tablet 10 MG Oral Amphetamine-Dextroamphetamine Tablet 12.5 MG Oral Amphetamine-Dextroamphetamine Tablet 15 MG Oral Amphetamine-Dextroamphetamine Tablet 20 MG Oral Amphetamine-Dextroamphetamine Tablet 30 MG Oral Amphetamine-Dextroamphetamine Tablet 5 MG Oral Amphetamine-Dextroamphetamine Tablet 7.5 MG Oral Statement of FDA approved diagnosis of narcolepsy or attention-deficit hyperactivity disorder (ADHD)

15 ANADROL-50 Anadrol-50 Tablet 50 MG Oral PA Criteria: PENDING CMS APPROVAL

16 APOKYN Apokyn Solution 10 MG/ML Subcutaneous Patient that has not been previously treated with standard dopaminergic therapy. Advanced Parkinson s disease: 1. Confirmed diagnosis of advanced Parkinson s disease AND 2. Unable to control "off" symptoms with adequate combinations of conventional oral therapy (eg, entacapone, pramipexole, ropinirole, carbidopa/levodopa, amantadine, tasmar, exelon patch, rivastigmine) AND 3. Used in combination with a non-5-ht3 antagonist antiemetic for initial therapy AND 4. Not used in combination with 5-HT3 antagonists as this is contraindicated. Apokyn will only be approved for intermittent subcutaneous injection. 18 years and older

17 APTIOM Aptiom Tablet 200 MG Oral Aptiom Tablet 400 MG Oral Aptiom Tablet 600 MG Oral Aptiom Tablet 800 MG Oral Statement of FDA approved indication for treatment as adjunctive therapy for partial-onset seizures. This medication should not be taken as an adjunctive therapy with oxcarbazepine. 18 years and older Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization. Updated 06/2014

18 ARCALYST Arcalyst Solution Reconstituted 220 MG Subcutaneous Medical statement indicating diagnosis is required. Approve for diagnosis cryopyrin-associated periodic syndromes (CAPS) including familial cold autoinflammatory syndrome (FCAS) and Muckle- Wells syndrome (MWS). 12 years and older

19 ASTAGRAF Astagraf XL Capsule Extended Release 24 Hour 0.5 MG Oral Astagraf XL Capsule Extended Release 24 Hour 1 MG Oral Astagraf XL Capsule Extended Release 24 Hour 5 MG Oral Statement of FDA approved diagnosis the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil and corticosteroids, with or without basiliximab induction AND trial and failure of immediate-release tacrolimus capsules. 16 years and older This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization. Updated 03/2014

20 AUBAGIO Aubagio Tablet 14 MG Oral Aubagio Tablet 7 MG Oral Statement of FDA approved diagnosis for the treatment of patients with relapsing forms of multiple sclerosis and trial and failure or contraindication to platform therapies. Preferred platform therapies include Rebif, Betaseron, and Copaxone. Statement must also include a first MS attack with document MRI scan abnormalities characteristic of MS, OR evaluation documenting EITHER, history of at least two focal neurological deficits (e.g. loss of vision, double vision, localized numbness or weakness), in which the first resolved and the second followed after a period of at least 6 months, OR history of one focal neurological deficit which has resolved, and an MRI suggestive of MS. Statement must also include a first MS attack with document MRI scan abnormalities characteristic of MS, OR evaluation documenting EITHER, history of at least two focal neurological deficits (e.g. loss of vision, double vision, localized numbness or weakness), in which the first resolved and the second followed after a period of at least 6 months, OR history of one focal neurological deficit which has resolved, and an MRI suggestive of MS. 18 years and older Neurologist Updated 03/2014

21 BANZEL Banzel Suspension 40 MG/ML Oral Banzel Tablet 200 MG Oral Banzel Tablet 400 MG Oral Dosages over 3200mg/day Statement indicating FDA approved diagnosis. Documentation for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome and that member's current medication regimen is inadequate to control member s disease. 4 years and older Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

22 BENZTROPINE Benztropine Mesylate Tablet 0.5 MG Oral Benztropine Mesylate Tablet 1 MG Oral Benztropine Mesylate Tablet 2 MG Oral Medical documentation of FDA-approved indication including physician indication for the continued use of the HRM (high risk medication) with an explanation of the specific benefit established with the medication, and how that benefit outweighs the potential risk. AND The physician must document the ongoing monitoring plan for the agent. AND The physician must document that patient counseling has and will continue to take place outlining the risks and potential side effects of the medication. Prior authorization required for members 64 years or older. Automatic approval for members less than 64 years of age.

23 BETASERON Betaseron Solution Reconstituted 0.3 MG Subcutaneous Stated diagnosis from neurologist of definite or probable relapsing-remitting MS, secondary progressive MS with relapses, or progressive relapsing MS. Statement may include a first MS attack with document MRI scan abnormalities characteristic of MS, OR evaluation documenting EITHER, history of at least two focal neurological deficits (e.g. loss of vision, double vision, localized numbness or weakness), in which the first resolved and the second followed after a period of at least 6 months, OR history of one focal neurological deficit which has resolved, and an MRI suggestive of MS. 18 years and older Neurologist

24 BONIVA Boniva Solution 3 MG/3ML Intravenous Ibandronate Sodium Solution 3 MG/3ML Intravenous Statement of contraindication or gastrointestinal intolerance of oral bisphosphonate therapy. Preferred oral bisphosphonates: alendronate, ibandronate (oral). 18 years and older This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. Updated 06/2014

25 BOSULIF Bosulif Tablet 100 MG Oral Bosulif Tablet 500 MG Oral Medical documentation indicating use for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) and trial and failure or contraindication to preferred agent Sprycel. 18 years and older Oncologist Members currently taking this medication at the time of enrollment will not be required to meet prerequisites for authorization

26 BRINTELLIX Brintellix Tablet 10 MG Oral Brintellix Tablet 20 MG Oral Brintellix Tablet 5 MG Oral Medical documentation of major depressive disorder (MDD) and documented trial and failure or intolerable side effects from treatment of two (2) preferred antidepressants from two different antidepressant classes. Preferred agents include: fluoxetine, paroxetine, citalopram, escitalopram, sertraline, bupropion, mirtazapine/mirtazapine ODT, trazodone, venlafaxine or venlafaxine er. 18 years and older Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization. Updated 03/2014

27 BUPHENYL Buphenyl Tablet 500 MG Oral Acute Hyperammonemia. Dosages over 20 grams per day Urea Cycle disorders: As adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamoyl phosphate synthetase (CPS), ornithine transcarbamoylase (OTC) or argininosuccinic acid synthetase (AAS). In patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). In patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

28 BUPRENORPHINE Buprenorphine HCl Tablet Sublingual 2 MG Sublingual Buprenorphine HCl Tablet Sublingual 8 MG Sublingual Doses above 24mg/day. Concurrent use of a short acting or long acting narcotic. Diagnosis of pain 1. Diagnosis of opioid dependence 2. Dose 3. Current urine drug screen 4. Documentation of ongoing psychosocial counseling with demonstration of compliance along with submission of medical notes regarding treatment plan, time frames for tapering, and psychosocial counseling 5. Taper schedule (if dose exceeds 16mg/day buprenorphine) 16 years and older Licensed physician who qualifies for a waiver under the Drug Addiction Treatment Act (DATA) and who has been assigned a DEA (X) number

29 BUTALBITAL CONTAINING PRODUCTS Butalbital-Acetaminophen Tablet MG Oral Butalbital-APAP-Caff-Cod Capsule MG Oral Butalbital-APAP-Caffeine Capsule MG Oral Butalbital-APAP-Caffeine Tablet MG Oral Butalbital-APAP-Caffeine Tablet MG Oral Butalbital-ASA-Caffeine Capsule MG Oral Butalbital-Aspirin-Caffeine Tablet MG Oral Zebutal Capsule MG Oral Medical documentation of FDA-approved indication including physician indication for the continued use of the HRM (high risk medication) with an explanation of the specific benefit established with the medication, and how that benefit outweighs the potential risk. AND The physician must document the ongoing monitoring plan for the agent. AND The physician must document that patient counseling has and will continue to take place outlining the risks and potential side effects of the medication. AND trial and failure or contraindication to two preferred alternatives. Preferred alternatives include: NSAIDs such as ibuprofen and sumatriptan or naratriptan. Prior authorization required for members 64 years or older. Automatic approval for members less than 64 years of age.

30 CANCIDAS Cancidas Solution Reconstituted 50 MG Intravenous Cancidas Solution Reconstituted 70 MG Intravenous Statement of FDA approved diagnosis: Empirical therapy for presumed fungal infections in febrile, neutropenic patients Treatment of candidemia and the following Candida infections, intra-abdominal abscesses, peritonitis and pleural space infections Treatment of esophageal candidiasis Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies (amphotericin B, itraconazole) Infectious Disease 6 months

31 CARIMUNE NANOFILTERED Carimune NF Solution Reconstituted 12 GM Intravenous Carimune NF Solution Reconstituted 3 GM Intravenous Carimune NF Solution Reconstituted 6 GM Intravenous Statement indicating FDA approved diagnosis. Documented hypogammaglobulinemia (IgG less than 400 mg/dl). Idiopathic Thrombocytopenic Purpura (ITP): 1. When there is an immediate need to increase the plt count (e.g., serious bleeding episodes) AND plt count less than 30, In preparation for splenectomy or other invasive procedures AND platelet count less than 20, In pregnant women at risk of bleeding AND a. Plt count less than 10,000 at any time during the pregnancy OR b. Plt count 10,000 to 30,000 in the second or third trimester OR c. Clinically significant bleeding. 4. In chronic ITP not responding to steroids. Other applicable and relevant supporting medical information, such as failure or contraindication to immunosuppression or alternative therapy. ITP, 5 days, Primary Immune Deficiency Disorder, through benefit year Part B coverage is available for IVIG administered in the home for individuals whose diagnosis is primary immune deficiency disease. For Primary immunodeficiency diseases (e.g. agammaglobulinemia or hypogammaglobinemia), Carimune is covered under Medicare Part B.

32 CARISOPRODOL Carisoprodol Tablet 350 MG Oral Medical documentation of FDA-approved indication including physician indication for the continued use of the HRM (high risk medication) with an explanation of the specific benefit established with the medication, and how that benefit outweighs the potential risk. AND The physician must document the ongoing monitoring plan for the agent. AND The physician must document that patient counseling has and will continue to take place outlining the risks and potential side effects of the medication. AND trial and failure or contraindication to two preferred alternatives. Preferred alternatives include: baclofen tablets, tizanidine tablets and capsules Prior authorization required for members 64 years or older. Automatic approval for members less than 64 years of age.

33 CEREZYME Cerezyme Solution Reconstituted 200 UNIT Intravenous Cerezyme Solution Reconstituted 400 UNIT Intravenous Statement of FDA approved diagnosis and trial and failure to preferred agent Vpriv. AND A confirmed diagnosis of Type 1 Gaucher disease that results in one or more of the following conditions: anemia, thrombocytopenia, bone disease, hepatomegaly or splenomegaly This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination.

34 CHLORDIAZEPOXIDE/AMITRIPTYLINE Chlordiazepoxide-Amitriptyline Tablet MG Oral Chlordiazepoxide-Amitriptyline Tablet MG Oral All medically accepted indications not otherwise excluded from Part D. Medical documentation of medically accepted indication including physician indication for the continued use of the HRM (high risk medication) with an explanation of the specific benefit established with the medication, and how that benefit outweighs the potential risk. AND The physician must document the ongoing monitoring plan for the agent. AND The physician must document that patient counseling has and will continue to take place outlining the risks and potential side effects of the medication. AND trial and failure or contraindication to two preferred alternatives. Preferred alternatives include: paroxetine, sertraline, venlafaxine, duloxetine, citalopram, escitalopram, fluoxetine, and trazodone Prior authorization required for members 64 years or older. Automatic approval for members less than 64 years of age.

35 CIALIS Cialis Tablet 2.5 MG Oral Cialis Tablet 5 MG Oral Females Statement of FDA approved indication for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 18 years and older Updated 10/2013

36 CLOZAPINE ODT CloZAPine Tablet Dispersible 100 MG Oral CloZAPine Tablet Dispersible 12.5 MG Oral CloZAPine Tablet Dispersible 25 MG Oral PA Criteria: PENDING CMS APPROVAL

37 COMETRIQ Cometriq (100 mg Daily Dose) Kit 1 X 80 & 1 X 20 MG Oral Cometriq (140 mg Daily Dose) Kit 1 X 80 & 3 X 20 MG Oral Cometriq (60 mg Daily Dose) Kit 20 MG Oral Stated diagnosis from oncologist for treatment of patients with progressive, metastatic medullary thyroid cancer (MTC) 18 years and older Oncologist Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

38 COPAXONE Copaxone 40 MG/ML Subcutaneous Copaxone Kit 20 MG/ML Subcutaneous Stated diagnosis from neurologist of definite or probable relapsing-remitting MS, secondary progressive MS with relapses, or progressive relapsing MS. Statement may include a first MS attack with document MRI scan abnormalities characteristic of MS, OR evaluation documenting EITHER, history of at least two focal neurological deficits (e.g. loss of vision, double vision, localized numbness or weakness), in which the first resolved and the second followed after a period of at least 6 months, OR history of one focal neurological deficit which has resolved, and an MRI suggestive of MS. 18 years and older Neurologist Updated 05/2014

39 CUBICIN Cubicin Solution Reconstituted 500 MG Intravenous All medically accepted indications not otherwise excluded from Part D. Diagnosis of pneumonia Osteomyelitis: Trial and failure of vancomycin. History of failure with vancomycin or documented resistance to vancomycin. Cellulitis/Skin infections: Trial and failure of sulfamethoxazole/trimethoprim (Bactrim, Septra, SMX/TMP) or doxycyline and vancomycin. Also, a diagnosis of possible MRSA or confirmed MRSA infection Sepsis/Bacteremia: Culture and sensitivity with documented resistance to vancomycin dated within the past 30 days and/or trial and failure of vancomycin. Endocarditis: Trial and failure of vancomycin. History of failure with vancomycin or documented resistance to vancomycin. Septic Arthritis: Trial and failure of vancomycin. History of failure with vancomycin or documented resistance to vancomycin. Osteomyelitis: 56dy; Cellulitis/Skin inf: 14dy; Sepsis/Bacteremia/Endocarditis: 42dy; Septic arth: 28dy

40 CYCLOBENZAPRINE HCL Cyclobenzaprine HCl Tablet 10 MG Oral Cyclobenzaprine HCl Tablet 5 MG Oral Medical documentation of FDA-approved indication including physician indication for the continued use of the HRM (high risk medication) with an explanation of the specific benefit established with the medication, and how that benefit outweighs the potential risk. AND The physician must document the ongoing monitoring plan for the agent. AND The physician must document that patient counseling has and will continue to take place outlining the risks and potential side effects of the medication. AND trial and failure or contraindication to two preferred alternatives. Preferred alternatives include: baclofen tablets, tizanidine tablets and capsules Prior authorization required for members 64 years or older. Automatic approval for members less than 64 years of age.

41 CYCLOSET Cycloset Tablet 0.8 MG Oral Type 1 diabetes Statement of FDA approved diagnosis and trial and failure or contraindication to two preferred agents for type 2 diabetes mellitus. Preferred blood glucose regulators include: acarbose, Byetta, Bydureon, glimepride, glipizide, Levemir, Lantus, Humulin, Humalog, nateglinide, pioglitazone, Prandin, Januvia, tolazamide, and tolbutamide. 18 years or older Updated 06/2013

42 CYPROHEPTADINE Cyproheptadine HCl Syrup 2 MG/5ML Oral Cyproheptadine HCl Tablet 4 MG Oral Medical documentation of FDA-approved indication including physician indication for the continued use of the HRM (high risk medication) with an explanation of the specific benefit established with the medication, and how that benefit outweighs the potential risk. AND The physician must document the ongoing monitoring plan for the agent. AND The physician must document that patient counseling has and will continue to take place outlining the risks and potential side effects of the medication. AND trial and failure or contraindication to preferred alternatives. The preferred alternative for pruritis, urticaria, seasonal or perennial allergy is levocetirizine Prior authorization required for members 64 years or older. Automatic approval for members less than 64 years of age.

43 CYSTAGON Cystagon Capsule 150 MG Oral Cystagon Capsule 50 MG Oral Cysteamine is contraindicated in patients who have demonstrated hypersensitivity to cysteamine or penicillamine hypersensitivity. Statement of FDA approved diagnosis: Management of nephropathic cystinosis in children and adults.

44 DEXTROAMPHETAMINE SULFATE Dextroamphetamine Sulfate Tablet 10 MG Oral Dextroamphetamine Sulfate Tablet 5 MG Oral Statement of FDA approved diagnosis of narcolepsy or attention-deficit hyperactivity disorder (ADHD) AND For the treatment of ADHD must have documented failure or adverse effect to our preferred alternatives including amphetamine salt combo, methylphenidate, or dexmethylphenidate.

45 DEXTROAMPHETAMINE SULFATE ER Dextroamphetamine Sulfate ER Capsule Extended Release 24 HOUR 10 MG Oral Dextroamphetamine Sulfate ER Capsule Extended Release 24 HOUR 15 MG Oral Dextroamphetamine Sulfate ER Capsule Extended Release 24 HOUR 5 MG Oral Statement of FDA approved diagnosis of narcolepsy or attention-deficit hyperactivity disorder (ADHD) AND For the treatment of ADHD must have documented failure or adverse effect to our preferred alternatives including amphetamine salt combo, metadate er, and methylphenidate sr.

46 DIFICID Dificid Tablet 200 MG Oral Treatment of systemic infections Documented diagnosis of Clostridium difficile associated diarrhea AND contraindication to preferred agents metronidazole (oral or systemic) or oral vancomycin hydrochloride or failure of an adequate trial of 5-7 days of metronidazole (oral or systemic) or oral vancomycin hydrochloride. Contraindications to or failure of an adequate trial of metronidazole (oral or systemic) or oral vancomycin is excluded in patients receiving myelosuppressive chemotherapy, hematopoietic stem cell transplant recipients, or patients receiving concomitant systemic antibiotics 18 years and older Gastroenterologist, Infectious disease specialist, or Oncologist 10 days

47 DIGOXIN Digoxin Tablet 0.25 MG Oral Medical documentation of FDA-approved indication including physician indication for the continued use of the HRM (high risk medication) with an explanation of the specific benefit established with the medication, and how that benefit outweighs the potential risk. AND The physician must document the ongoing monitoring plan for the agent. AND The physician must document that patient counseling has and will continue to take place outlining the risks and potential side effects of the medication. AND lab work including digoxin levels. Prior authorization required for members 64 years or older. Automatic approval for members less than 64 years of age.

48 DIPYRIDAMOLE Dipyridamole Tablet 25 MG Oral Dipyridamole Tablet 50 MG Oral Dipyridamole Tablet 75 MG Oral Medical documentation of FDA-approved indication including physician indication for the continued use of the HRM (high risk medication) with an explanation of the specific benefit established with the medication, and how that benefit outweighs the potential risk. AND The physician must document the ongoing monitoring plan for the agent. AND The physician must document that patient counseling has and will continue to take place outlining the risks and potential side effects of the medication. AND trial and failure or contraindication to preferred alternatives. Preferred alternative includes: clopidogrel. Prior authorization required for members 64 years or older. Automatic approval for members less than 64 years of age.

49 DOXEPIN Doxepin HCl Capsule 10 MG Oral Doxepin HCl Capsule 100 MG Oral Doxepin HCl Capsule 150 MG Oral Doxepin HCl Capsule 25 MG Oral Doxepin HCl Capsule 50 MG Oral Doxepin HCl Capsule 75 MG Oral Doxepin HCl Concentrate 10 MG/ML Oral All medically accepted indications not otherwise excluded from Part D. Medical documentation of medically accepted indication including physician indication for the continued use of the HRM (high risk medication) with an explanation of the specific benefit established with the medication, and how that benefit outweighs the potential risk. AND The physician must document the ongoing monitoring plan for the agent. AND The physician must document that patient counseling has and will continue to take place outlining the risks and potential side effects of the medication. AND trial and failure or contraindication to two preferred alternatives. Preferred alternatives include: paroxetine, sertraline, venlafaxine, duloxetine, citalopram, escitalopram, fluoxetine, and trazodone. Prior authorization required for members 64 years or older. Automatic approval for members less than 64 years of age.

50 DRONABINOL Dronabinol Capsule 10 MG Oral Dronabinol Capsule 2.5 MG Oral Dronabinol Capsule 5 MG Oral For treatment of chemotherapy-induced nausea or vomiting refractory to conventional antiemetic agents: 1. Patient is receiving cancer chemotherapy AND 2. Failure to preferred 5HT-3 receptor antagonist. Preferred agents include: ondansetron or granisetron AND 3. Failure to one of the following agents: a. Antihistamine b. Corticosteroid c. Prokinetic agent d. Antipsychotic For treatment of anorexia associated with weight loss in patients with HIV: 1. Patient is receiving AIDS anti-retroviral therapy AND 2. Experienced as least a. 7.5% unintentional weight loss over 6 months b. 10% unintentional weight loss over 12 months c. 5% body cell mass (BCM) loss within 6 months d. BMI less than20 kg/m2 e. BCM less than35% male (less than23% female) and a BMI less than27 kg/m2 AND 3. Documentation of trial and failure, contraindication, or intolerance to megestrol at doses up to 800mg daily. 18 years old and greater for the treatment of anorexia associated with weight loss in patients with HIV For N/V - 6 months; For anorexia in HIV positive patients - 3 months

51 EGRIFTA Egrifta Solution Reconstituted 1 MG Subcutaneous Egrifta Solution Reconstituted 2 MG Subcutaneous Statement of FDA approved indication: Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Patient must be receiving AIDS anti-retroviral therapy at time of request AND documentation of a waist to hip ratio greater than 0.94 for men or greater than 0.88 for women. 6 months Updated 03/2014

52 ELIDEL Elidel Cream 1 % External Medical statement for treatment as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in nonimmunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable and trial and failure of an adequate treatment course of at least two preferred topical corticosteroids. Preferred corticosteroids include: alclometasone dipropionate, betamethasone, clobetasol, dexamethasone, diflorasone diacetate, fluocinolone acetonide, fluocinonide, mometasone furoate, and triamcinolone acetonide.

53 ELIGARD Eligard Kit 22.5 MG Subcutaneous Eligard Kit 30 MG Subcutaneous Eligard Kit 45 MG Subcutaneous Eligard Kit 7.5 MG Subcutaneous All medically accepted indications not otherwise excluded from Part D. Pregnancy Category X For the treatment of advanced prostate cancer, anemia due to uterine leiomyoma, preoperatively, with iron therapy, central precocious puberty, and endometriosis. Patients must have stated failure or intolerance to Trelstar. 18 years and older This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

54 EMCYT Emcyt Capsule 140 MG Oral All medically accepted indications not otherwise excluded from Part D. Prescriber statement that medication is being requested for palliative treatment of metastatic and/or progressive prostate cancer. 18 years and older Oncologist Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

55 EMSAM Emsam Patch 24 HR 12 MG/24HR Transdermal Emsam Patch 24 HR 6 MG/24HR Transdermal Emsam Patch 24 HR 9 MG/24HR Transdermal Major depressive disorder: Failure of two (2) preferred antidepressants from two different antidepressant classes. For patients with swallowing difficulty mirtazapine orally disintegrating tablets and citalopram solution should be tried. Preferred agents include: Fluoxetine capsules, Paroxetine, Citalopram, Bupropion, Mirtazapine/ Mirtazapine ODT, Trazodone, escitalopram, Venlafaxine or, phenelzine sulfate, or tranylcypromine sulfate. 12 years and older Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

56 ENBREL Enbrel Kit 25 MG Subcutaneous Enbrel Solution 25 MG/0.5ML Subcutaneous Enbrel Solution 50 MG/ML Subcutaneous Enbrel SureClick Solution 50 MG/ML Subcutaneous Rheumatoid Arthritis: Monotherapy or as adjunct therapy for the treatment of moderately to severely active RA when the patient has failed an adequate trial (defined by the ACR) to 2 preferred disease modifying anthrheumatic drugs (DMARDs). Preferred agents include: methotrexate, sulfasalazine, hydroxychloroquine, cuprimine, azathioprine, leflunomide. Psoriatic Arthritis: Monotherapy or as adjunct therapy for the treatment of active arthritis in patients with moderate to severe psoriatic arthritis with documented intolerance, contraindication, or allergy to at least 2 different drugs of our preferred products: methotrexate, sulfasalazine, hydroxychloroquine, cuprimine, azathioprine, leflunomide. Plaque Psoriasis: Failure of two oral agents including methotrexate and a steroid, OR PUVA treatment. Juvenile Rheumatoid Arthritis(Juvenile Idiopathic Arthritis (JIA)): For the treatment of moderately to severely active polyarticular juvenile idiopathic arthritis when patient had inadequate response to methotrexate alone for the appropriate treatment period OR methotrexate is contraindicated AND one NSAID. Preferred NSAIDs include: ibuprofen, naproxen, and meloxicam. Ankylosing Spondylitis: Monotherapy for reducing signs and symptoms of active ankylosing spondylitis when patient hasn't responded to at least two NSAIDS. Preferred NSAIDs include: ibuprofen, naproxen, and meloxicam. 18 years old and greater for uses other than juvenile idiopathic arthritis. 2 years and older for juvenile idiopathic arthritis Rheumatologist- for RA, JRA/JIA, Psoriatic Arthritis, Anklyosing spondylitis; Dermatologist for Plaque Psoriasis

57 ERIVEDGE Erivedge Capsule 150 MG Oral Doses above 150mg/day Medical documentation of metastatic basal cell carcinoma or locally advanced basal cell carcinoma that has occurred following surgery. 18 years and older Oncologist Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

58 ESTROGENS Estradiol Patch Weekly MG/24HR Transdermal Estradiol Patch Weekly MG/24HR Transdermal Estradiol Patch Weekly 0.05 MG/24HR Transdermal Estradiol Patch Weekly 0.06 MG/24HR Transdermal Estradiol Patch Weekly MG/24HR Transdermal Estradiol Patch Weekly 0.1 MG/24HR Transdermal Estradiol Tablet 0.5 MG Oral Estradiol Tablet 1 MG Oral Estradiol Tablet 2 MG Oral Estropipate Tablet 0.75 MG Oral Estropipate Tablet 1.5 MG Oral Estropipate Tablet 3 MG Oral Menest Tablet 0.3 MG Oral Menest Tablet MG Oral Menest Tablet 1.25 MG Oral Menest Tablet 2.5 MG Oral Medical documentation of FDA-approved indication including physician indication for the continued use of the HRM (high risk medication) with an explanation of the specific benefit established with the medication, and how that benefit outweighs the potential risk. AND The physician must document the ongoing monitoring plan for the agent. AND The physician must document that patient counseling has and will continue to take place outlining the risks and potential side effects of the medication. AND trial and failure or contraindication to two preferred alternatives for established indication. Preferred alternatives include: Vasomotor systems of menopause, requires provider acknowledgement of HRM status. Vulvar or vaginal atrophy, Estrace cream, Premarin cream - Osteoporosis, alendronate, ibandronate, raloxifene Prior authorization required for members 64 years or older. Automatic approval for members less than 64 years of age. Updated 03/2014

59 EXJADE Exjade Tablet Soluble 125 MG Oral Exjade Tablet Soluble 250 MG Oral Exjade Tablet Soluble 500 MG Oral Doses above 40mg/kg Medical documentation of FDA approved diagnosis, serum ferritin and serum creatinine every 6 months. Exjade (deferasirox) is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older such as when the patient is receiving transfusions and has a serum ferritin consistently above 1000 mcg/l. In patients not adequately controlled with doses of 30 mg/kg (e.g. serum ferritin levels persistently above 2500 mcg/l and not showing a decreasing trend over time), doses of up to 40 mg/kg may be considered. After commencing therapy, it is recommended that serum ferritin be monitored every month and the dose adjusted if necessary every 3 to 6 months based on serum ferritin trends. If the serum ferritin falls consistently below 500 mcg/l, consideration should be given to temporarily interrupt therapy. Exjade is also indicated for the treatment of patients 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia. Covered for those 2 years of age and older with chronic iron overload due to blood transfusions. 10 years and older for chronic iron overload resulting from a genetic blood disorder called non-transfusion dependent thalassemia. Six months

60 FANAPT Fanapt Tablet 1 MG Oral Fanapt Tablet 10 MG Oral Fanapt Tablet 12 MG Oral Fanapt Tablet 2 MG Oral Fanapt Tablet 4 MG Oral Fanapt Tablet 6 MG Oral Fanapt Tablet 8 MG Oral Fanapt Titration Pack Tablet 1 & 2 & 4 & 6 MG Oral Schizophrenia: Documented treatment failure or intolerable side effects from treatment with two formulary medications within the same class. Formulary atypical antipsychotics include: risperidone, quetiapine, olanzapine, Latuda, and Abilify. 18 years and older Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

61 FAZACLO FazaClo Tablet Dispersible 12.5 MG Oral Refractory Schizophrenia/Schizoaffective Disorder: Fazaclo 12.5mg orally disintegrating tablet will be approved upon receipt of physician statement that member requires the use of an atypical antipsychotic for the treatment of refractory schizophrenia that has failed to respond adequately to appropriate courses of standard formulary antipsychotic agents or to reduce the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder AND is intolerant to oral solutions or unable to swallow other oral formulations. Formulary generic antipsychotics: clozapine (tablet), risperidone (orally disintegrating tablet, tablet, solution), quetiapine (tablet), olanzapine (tablet), and ziprasidone (tablet). 18 years and older Part of a clozapine registry Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

62 FENTANYL CITRATE FentaNYL Citrate Lollipop 1200 MCG Buccal FentaNYL Citrate Lollipop 1600 MCG Buccal FentaNYL Citrate Lollipop 200 MCG Buccal FentaNYL Citrate Lollipop 400 MCG Buccal FentaNYL Citrate Lollipop 600 MCG Buccal FentaNYL Citrate Lollipop 800 MCG Buccal Only approved for management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy for underlying persistent cancer pain. Patients considered opioid-tolerant are those who are taking at least 60 mg morphine/day or an equianalgesic dose of another opioid for a week or longer. Patient must have documented trial and failure of at least two preferred agents. Preferred agents include: morphine oral solution, oxycodone immediate release, and methadone. 16 years and older Oncologist or Pain specialist 6 months Available only to those enrolled in the Transmucosal Immediate Release Fentanyl (TIRF) REMS Program. Not approved if patient is on Suboxone or Subutex. Contraindicated for the management of acute or postoperative pain including headache/migraines.

63 FETZIMA Fetzima Capsule Extended Release 24 Hour 120 MG Oral Fetzima Capsule Extended Release 24 Hour 20 MG Oral Fetzima Capsule Extended Release 24 Hour 40 MG Oral Fetzima Capsule Extended Release 24 Hour 80 MG Oral Fetzima Titration 20 & 40 MG Oral Medical documentation of major depressive disorder (MDD) and documented trial and failure or intolerable side effects from treatment of two (2) preferred antidepressants from two different antidepressant classes. Preferred agents include: fluoxetine, paroxetine, citalopram, escitalopram, sertraline, bupropion, mirtazapine/mirtazapine ODT, trazodone, venlafaxine or venlafaxine er. 18 years and older Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization. Updated 03/2014

64 FORTEO Forteo Solution 600 MCG/2.4ML Subcutaneous Approve for the following indications: 1. Treatment of postmenopausal women with osteoporosis at high risk for fracture OR 2. Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, and, meet any of the following criteria: a. member had had at least one fracture OR b. member had BMD screening results of -2.5 or below OR c. member had previously used any of the following, Miacalcin Inj or NS, alendronate, Actonel, ibandronate, or Reclast 3. Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture, and meet any of the following criteria: a. member has had at least one fracture, OR b. member has multiple risk factors for fracture, OR c. member had previously used any of the following, Evista, Miacalcin Inj or NS, alendronate, Premarin, Prempro, Estradiol, Actonel, Jinteli 1/5, Boniva, or Reclast. Preferred bisphosphonate agents include, alendronate or ibandronate (PO or Inj) but not more than 2 years total Treatment failure is defined as documented continued bone loss after at least three months despite treatment with a bisphosphonate or SERM (Evista). Note: Since the effects of long-term treatment with teriparatide are not known at this time, therapy for more than 2 years duration is considered experimental and investigational. Because of an increased incidence of osteosarcoma, Forteo should not be prescribed for patients who are at increased baseline risk for osteosarcoma (including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, or prior radiation therapy involving the skeleton).