2014 Medicare Step Therapy Criteria

Last Modified: 09.30.2014 Last Submitted to CMS: 09.02.2014

Table of Contents

AMITIZA, LINZESS ...... 3 ANTIDEPRESSANTS - Viibryd / Pexeva / Pristiq / Desvenlafaxine ...... 4 ANTIDEPRESSANTS - Aplenzin ...... 5 APTIOM ...... 6 AROMATASE INHIBITORS ...... 7 ATYPICAL ANTIPSYCHOTICS ...... 8 BENIGN PROSTATIC HYPERPLASIA (BPH) THERAPY ...... 9 BISPHOSPHONATES ORAL ...... 10 BRAND ACE-I/ARB ...... 11 BRAND NSAIDS ...... 12 BUTRANS ...... 13 DIFICID ...... 14 DIRECT RENIN INHIBITORS ...... 15 FENOFIBRATE ...... 16 HMG STEP ...... 17 LONG ACTING OPIOIDS ...... 18 LYRICA / HORIZANT ...... 19 MIRAPEX ...... 20 NASAL STEROIDS ...... 21 NAMENDA XR ...... 22 OVERACTIVE BLADDER ...... 23 PPI ENHANCED ...... 24 STRATTERA ...... 25 TOPICAL CORTICOSTEROIDS ...... 26 TOPICAL IMMUNOMODULATORS ...... 27 VALPROID ACID ...... 29 ZETIA ...... 30

POLICY NAME: AMITIZA, LINZESS Effective Date: 01/01/2014 Last Review Date: 10/21/2012

If the patient has tried a Step 1 drug(at least a 30-day supply in the prior 180 days), then authorization may be given.

Step 1 Drug(s): enulose, lactulose, polyethylene glycol 3350 (PEG 3350)

Step 2 Drug(s): Amitiza, Linzess

 Coverage will be provided if polyethylene glycol 3350 (PEG 3350) or lactulose have been tried (at least a 30-day supply in the prior 180 days)

POLICY NAME: ANTIDEPRESSANTS - Viibryd / Pexeva / Pristiq / Desvenlafaxine Effective Date: 01/01/2014 Last Review Date: 10/21/2012

If the patient has tried two Step 1 drugs, then authorization for a drug in Step 2 drug may be given.

Step 1 Drug(s): Citalopram HBr, Escitalopram Oxalate, Fluoxetine Hcl, Fluvoxamine Maleate, Paroxetine HCL, Paroxetine HCL ER, Sertraline HCL, Venlafaxine HCL, Venlafaxine ER.

Step 2 Drug(s): Brintellix, Desvenlafaxine ER, Fetzima, Khedezla, Latuda, Paxil Susp, Pexeva, Pristiq, Viibryd

 If the patient has tried two Step 1 drugs, then authorization may be given.

 Patients who have taken Viibryd, Pexeva, Pristiq or desvenlafaxine at any time in the past and discontinued its use may receive authorization to restart Viibryd, Pexeva, Pristiq or desvenlafaxine(whichever they used in the past).

 Authorization may be given for Viibryd if the patient is a child or adolescent aged 18 years or less, or has suicidal ideation.

 Symptoms of suicidal ideation: approve Pexeva, Pristiq or desvenlafaxine without a trial of a step 1 agent.

 This step therapy program applies to new utilizers only.

POLICY NAME: ANTIDEPRESSANTS - Aplenzin Effective Date: 01/01/2014 Last Review Date: 10/21/2012

If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given.

Step 1 Drug(s): Budeprion SR ER, Bupropion HCl, Bupropion HCl ER

Step 2 Drug(s): Aplenzin

 Authorization may be given for step 2 if the patient is currently taking the requested agent.

 This step therapy program applies to new utilizers only.

POLICY NAME: APTIOM Effective Date: 03/12/2014 Last Review Date: 6/01/2014

If the patient has tried a Step 1 drug(at least a 30-day supply in the prior 180 days), then authorization may be given.

Step 1 Drug(s): carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, valproate, clobazam, gabapentin, oxcarbazepine, topiramate

Step 2 Drug(s): Aptiom

POLICY NAME: AROMATASE INHIBITORS Effective Date: 01/01/2014 Last Review Date: 10/21/2012

If the patient has tried a Step 1 drug(at least a 30-day supply in the prior 365 days), then authorization for a Step 2 drug may be given.

Step 1 Drug(s): anastrozole, Arimidex

Step 2 Drugs(s): Aromasin, Exemestane, Femara, Letrozole

POLICY NAME: ATYPICAL ANTIPSYCHOTICS Effective Date: 01/01/2014 Last Review Date: 10/21/2012

If the patient has tried a Step 1 drug (generic or brand form), then authorization may be given.

Step 1 Drug(s): Geodon, olanzapine, risperidone, quetiapine , Seroquel XR, ziprasidone, Zyprexa, Zyprexa Zydis

Step 2 Drug(s): Abilify, Fanapt, Latuda, Saphris

 Authorization will be granted for Abilify, without a trial of a step 1 agent, for treatment of major depressive disorder requiring adjunctive treatment.

POLICY NAME: BENIGN PROSTATIC HYPERPLASIA (BPH) THERAPY Effective Date: 01/01/2014 Last Review Date: 10/02/2012

If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given.

Step 1 Drug(s): finasteride

Step 2 Drug(s): Avodart, Jalyn

POLICY NAME: BISPHOSPHONATES ORAL Effective Date: 01/01/2014 Last Review Date: 10/21/2012

If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given. If the patient has tried a Step 2 drug, then authorization for a Step 3 drug may be given.

Step 1 Drug(s): Alendronate Sodium Tab

Step 2 Drug(s): Actonel, Atelvia

 Authorization may be given for Actonel for use in the management of Paget's disease if the patient has already started therapy with Actonel. .

POLICY NAME: BRAND ACE-I/ARB Effective Date: 01/01/2014 Last Review Date: 09/23/2012

If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given. If the patient has tried a Step 2 drug, then authorization for a Step 3 drug may be given.

Step 1 Drug(s): Amlodipine Besylate-benazepril, Benazepril Hcl, Benazepril-hydrochlorothiazide, Captopril, Captopril-hydrochlorothiazide, Candesartan, Candesartan-hydrochlorothiazide, Enalapril Maleate, Enalapril-hydrochlorothiazide, eprosartan, Fosinopril Sodium, Fosinopril-hydrochlorothiazide, Lisinopril, Lisinopril-hydrochlorothiazide, Losartan Potassium, Losartan-Hydrochlorothiazide, Moexipril Hcl, Moexipril-hydrochlorothiazide, Perinodpril erbumine, Quinapril Hcl, Quinapril-hydrochlorothiazide, Ramipril, Trandolapril.

Step 2 Drug(s): Azor, Benicar, Benicar Hct, Tribenzor, Telmisartan, Telmisartan-amlodipine, Telmisartan – hydrochlorothiazide, Valsartan.

Step 3 Drug(s): Atacand, Diovan, Edarbi, Exforge, Exforge Hct, Micardis, Micardis Hct, Tarka, Teveten, Teveten Hct, Twynsta

 Authorization may be given for a step 2 or step 3 angiotensin receptor blocker (ARB) or ARB- containing combination product, without a trial of a step 1 or 2 agent, if the patient was recently hospitalized and discharged within the previous 30 days for a cardiovascular event (eg, myocardial infarction, hypertensive emergency, decompensated heart failure) and has already been started and stabilized on the requested agent.

 Authorization may be given for Atacand in children aged less than 6 years.

POLICY NAME: BRAND NSAIDS Effective Date: 01/01/2014 Last Review Date: 10/02/2012

If the patient has tried TWO Step 1 drug, then authorization for a Step 2 drug may be given.

Step 1 Drug(s): Diclofenac Potassium, Diclofenac Sodium, Diflusinal, Etodolac, Fenoprofen Calcium, Flurbiprofen, Ibuprofen, Ketoprofen, Meloxicam, Mefenamic Acid, Nabumetone, Naproxen, Naproxen Sodium, Oxaprozin, Piroxicam, Sulindac, Tolmetin Sodium

Step 2 Drug(s): Flector Patch, Mobic Susp, Nalfon cap, Naprelan ER tab, Pennsaid Sol, Vimovo tab, Zipsor.

 Authorization for Vimovo may be given if the patient has claims history for both omeprazole or lansoprazole or pantoprazole sodium and a prescription naproxen or naproxen sodium product.

 Authorization for a step 2 drug, other than Vimovo, may be given if the patient has tried two unique generic prescription strength non-steroidal anti-inflammatory drugs (NSAIDs) for the current condition.

 Authorization may be given for Flector or Pennsaid for patients with difficulty swallowing or cannot swallow.

 Authorization may be given for Pennsaid for patients with a chronic musculoskeletal pain condition (eg, osteoarthritis) in 3 or fewer joints/sites (ie, hand, wrist, elbow, knee, ankle, or foot each count as 1 joint/site) who are at risk of NSAID-associated toxicity (eg, previous gastrointestinal [GI] bleed, history of peptic ulcer disease, impaired renal function, cardiovascular disease, hypertension, heart failure, elderly patients with impaired hepatic function, or those taking concomitant anticoagulants)..

POLICY NAME: BUTRANS Effective Date: 01/01/2014 Last Review Date: 10/21/2012

If the patient has tried TWO Step 1 drugs, then authorization for a Step 2 drug may be given.

Step 1 Drug(s): Acetaminophen w/ Codeine, Co-Gesic, Endocet, Endodan, Hydrocodone- Acetaminophen, Oxycodone w/ Acetaminophen, Reprexain, Roxicet sol, Stagesic Tramadol HCl, Tramadol HCl ER, Tramadol-Acetaminophen

Step 2 Drug(s): Butrans patch

 Coverage will be provided if TWO of the following agents have been tried or there is documented rationale for avoidance: hydrocodone-acetaminophen products, hydrocodone- ibuprofen products, oxycodone-acetaminophen products, oxycodone-ibuprofen products, codeine-acetaminophen products, tramadol products.

POLICY NAME: DIFICID Effective Date: 01/01/2014 Last Review Date: 10/21/2012

If the patient has tried a Step 1 drug, then authorization may be given.

Step 1 Drug(s): Vancomycin Hcl

POLICY NAME: DIRECT RENIN INHIBITORS Effective Date: 01/01/2014 Last Review Date: 10/21/2012

If the patient has tried a Step 1 drug, then authorization may be given.

Step 1 Drug(s): Amlodipine Besylate-benazepril, Atacand, Azor, Benazepril Hcl, Benazepril- hydrochlorothiazide, Benicar, Candesartan-hydrochlorothiazide, Captopril, Captopril- hydrochlorothiazide, Diovan, Edarbi, Enalapril Maleate, Enalapril-hydrochlorothiazide, Eprosartan, Exforge, Exforge Hct, Fosinopril Sodium, Fosinopril-hydrochlorothiazide, Irbesartan, Irbesartan- hydrochlorothiazide, Lisinopril, Lisinopril-hydrochlorothiazide, Losartan Potassium, Losartan- hydrochlorothiazide, Micardis, Micardis Hct, Moexipril Hcl, Moexipril-hydrochlorothiazide, Perinodpril Erbumine, Quinapril Hcl, Quinapril-hydrochlorothiazide, Ramipril, Tarka, Teveten Hct, Trandolapril, Tribenzor, Twynsta

Step 2 Drug(s): Amturnide, Tekamlo, Tekturna, Tekturna HCT, Valturna

 Coverage will be provided if one of the following has been tried: Accupril, Accuretic, Aceon, Altace, Amlodipine Besylate-benazepril, Atacand, Atacand Hct, Avalide, Avapro, Azor, Benazepril Hcl, Benazepril-hydrochlorothiazide, Benicar, Benicar Hct, Captopril, Captopril- hydrochlorothiazide, Candesartan-hydrochlorothiazide, Cozaar, Diovan, Diovan Hct, Edarbi, Edarbyclor, Enalapril Maleate, Enalapril-hydrochlorothiazide, eprosartan, Exforge, Exforge, Hct, Fosinopril Sodium, Fosinopril-hydrochlorothiazide, Hyzaar, Lisinopril, Lisinopril- hydrochlorothiazide, Losartan Potassium, Losartan-Hydrochlorothiazide, Lotensin, Lotensin Hct, Lotrel, Mavik, Micardis, Micardis Hct, Moexipril Hcl, Moexipril-hydrochlorothiazide, Perinopril erbumine, Prinivil, Prinzide, Quinapril Hcl, Quinapril-hydrochlorothiazide, Ramipril, Tarka, Teveten, Teveten Hct, Trandolapril,Tribenzor, Twynsta, Uniretic, Univasc, Vaseretic, Vasotec, Zestoretic, Zestril.

POLICY NAME: FENOFIBRATE Effective Date: 01/01/2014 Last Review Date: 10/02/2012

If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given.

Step 1 Drug(s): Fenofibrate Micronized Cap, Fenofibrate Tab, Fenofibric Acid Cap

Step 2 Drug(s): Fenoglide, Fibricor, Lipofen

 Coverage will be provided for Fenoglide, Lipofen, Fibricor, Fenofibrate 150mg and 50mg capsule if other strength fenofibrate capsules or tablets have been tried.

POLICY NAME: HMG STEP Effective Date: 01/01/2014 Last Review Date: 10/02/2012

If the patient has tried a Step 1 and a Step 2 drug, then authorization for a Step 3 drug may be given.

Step 1 Drug(s): Atorvastatin, Fluvastatin, Lovastatin, Pravastatin Sodium, Simvastatin.

Step 2 Drug(s): Crestor, Vytorin.

Step 3 Drug(s): Altoprev, Livalo

POLICY NAME: LONG ACTING OPIOIDS Effective Date: 01/01/2014 Last Review Date: 10/21/2012

If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given.

Step 1 Drug(s): Morphine sulfate IR / ER, oxymorphone/ ER.

Step 2 Drug(s): Exalgo, Nucynta ER, Opana ER, Oxycontin.

 Coverage will be provided if morphine sulfate IR, morphine sulfate ER (capsule or tablet), oxymorphone ER has been tried.

 Authorization may be given for Exalgo, OxyContin, or Nucynta ER if the patient is unable to tolerate or has a drug allergy noted with morphine sulfate.

 Authorization may be given for Exalgo, OxyContin, or Nucynta ER if the patient has renal insufficiency.

 Authorization may be given for OxyContin if the patient is pregnant.

POLICY NAME: LYRICA / HORIZANT Effective Date: 01/01/2014 Last Review Date: 10/30/2012

If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given.

Step 1 Drug(s): Gabapentin, Neurontin.

Step 2 Drug(s): Gralise, Horizant, Lyrica

 Members with a history of the following drugs within the 130 day look back period are excluded from step therapy for Lyrica: Seizure Medications - Diazepam, Felbamate, Ethotoin, Phenytoin, Succinimides, Primidone, Phenobarbital.

 Authorization for Lyrica, without a trial of a step 1 agent, may be given for patients with symptoms of seizure disorder.

 Authorization may be given for Lyrica if the patient has tried Horizant.

 Authorization for Lyrica may be given if the patient cannot tolerate gabapentin due to adverse events.

 Authorization for Lyrica may be given, without a trial of a step 1 agent, if the patient has symptoms of fibromyalgia.

 Authorization may be given for Lyrica if the patient has symptoms of generalized anxiety disorder (GAD) and has been previously treated with two drugs from the following drug classes - tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), or buspirone.

 This step therapy program applies to new utilizers only.

POLICY NAME: MIRAPEX Effective Date: 01/01/2014 Last Review Date: 10/30/2012

If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given.

Step 1 Drug(s): Pramipexole Dihydrochloride, Ropinirole Hcl.

Step 2 Drug(s): Mirapex ER, Neupro patch

 Coverage will be provided if Pramipexole Dihydrochloride, Ropinirole Hcl, Ropinirole ER has been tried.

 Authorization may be given for Mirapex ER if the patient has symptoms of Parkinson's disease and is currently taking (or has taken in the past) the requested agent.

POLICY NAME: NASAL STEROIDS Effective Date: 01/01/2014 Last Review Date: 10/21/2012

If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given.

Step 1 Drug(s): Flunisolide, Fluticasone Propionate, Triamcinolone acetonide.

Step 2 Drug(s): Beconase Aq, Budesonide, Nasonex, Omnaris, Qnasl, Rhinocort Aqua, Veramyst.

 Authorization for Rhinocort Aqua or Budesonide Suspension may be given if the patient is pregnant.

 Authorization for Nasonex or Veramyst may be given if the patient is less than 4 years of age.

POLICY NAME: NAMENDA XR Effective Date: 07/01/2014 Last Review Date: 06/03/2014

If the patient has tried a Step 1 drug (at least a 30-day supply in the prior 180 days), then authorization may be given.

Step 1 Drug(s): donepezil, rivastigmine, galantamine, memantine

Step 2 Drug(s): Namenda XR

POLICY NAME: OVERACTIVE BLADDER Effective Date: 01/01/2014 Last Review Date: 10/21/2012

If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given.

Step 1 Drug(s): Oxybutynin Chloride, Oxybutynin Chloride ER, Tolterodine, Trospium Chloride.

Step 2 Drug(s): Detrol LA, Enablex, Gelnique, Myrbetriq, Oxytrol, Toviaz, Vesicare.

 Authorization for Oxytrol or Gelnique may be given for patients who cannot swallow or who have difficulty swallowing.

POLICY NAME: PPI ENHANCED Effective Date: 01/01/2014 Last Review Date: 10/21/2012

If the patient has tried TWO Step 1 drugs, then authorization for a Step 2 drug may be given.

Step 1 Drug(s): Lansoprazole capsules, Omeprazole, Pantoprazole Sodium.

Step 2 Drug(s): Aciphex, Dexilant, Esomeprazole, Nexium, Omeprazole-Sodium Bicarbonate, Prevacid Solutabs, Protonix Granules, Rabeprazole Sodium, Zegerid pkt.

 Authorization may be given for Prevacid ODT for patients with a feeding tube (eg, nasogastric tube, gastric tube) and patients post-bariatric surgery.

 Authorization may be given for a Step 2 agent for children less than 2 years old.

 Authorization for Nexium may be given in patients less than 1 year of age.

 Authorization may be given for a step 2 agent concomitantly receiving clopidogrel who have tried a step 1 agent (not required to try a second step 1 agent).

POLICY NAME: STRATTERA Effective Date: 01/01/2014 Last Review Date: 10/02/2012

If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given.

Step 1 Drug(s): Amphetamine Salt Combo, Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin, ER, Methylphenidate Hcl, Methylphenidate ER, Methylphenidate SR, Ritalin, Ritalin LA, Vyvanse.

Step 2 Drug(s): Strattera.

 Coverage will be provided if one of the following have been tried: Adderall Xr, Amphetamine Salt Combo, Concerta, Daytrana, Desoxyn, Dexedrine, Dexmethylphenidate Hcl, Dextroamphetamine Sulfate, Focalin, Focalin Xr, Metadate Cd, Metadate Er, Methamphetamine Hcl, Methylin, Methylin Er, Methylphenidate Hcl, Methylphenidate Er, Methylphenidate Sr, Ritalin, Ritalin La, Ritalin-sr, Vyvanse.

 Authorization for Strattera may be given for symptoms of of attention deficit hyperactivity disorder (ADHD)/attention deficit disorder (ADD) if the patient has a documented history of addiction to controlled substances.

 Authorization for Strattera may be given for symptoms of ADHD/ADD if the patient has a history of seizures.

 Authorization for Strattera may be given for symptoms of ADHD/ADD if the patient has co- morbid anxiety.

 Authorization for Strattera may be given for symptoms of ADHD/ADD if the patient has a history of motor tics or a family history or diagnosis of Tourette's syndrome.

 Authorization for Strattera may be given for symptms of ADHD/ADD if the patient has hypertension, heart failure, recent myocardial infarction, hyperthyroidism or for other medical conditions as documented.

POLICY NAME: TOPICAL CORTICOSTEROIDS Effective Date: 01/01/2014 Last Review Date: 10/30/2012

If the patient has tried TWO Step 1 drugs, then authorization for a Step 2 drug may be given.

Step 1 Drug(s): Alclometasone Dipropionate, Amcinonide, Betamethasone Dipropionate, Betamethasone Valerate, Clobetasol Emollient, Clobetasol Propionate, Desonide, Desoximetasone, Diflorasone Diacetate, Fluocinolone Acetonide, Fluocinonide, Fluocinonide Emollient, Fluticasone Propionate, Halobetasol Propionate, Hydrocortisone, Hydrocortisone Butyrate, Hydrocortisone Valerate, Mometasone Furoate, Prednicarbate, Triamcinolone Acetonide.

Step 2 Drug(s):, Alacort, Amcinonide, Clobex, Cloderm, Cordran, Desonate, Halog, Kenalog, Lokara, Topicort, Triderm, Vanos, Verdeso.

POLICY NAME: TOPICAL IMMUNOMODULATORS Effective Date: 01/01/2014 Last Review Date: 10/21/2012

If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given.

Step 1 Drug(s): Ala-cort, Alclometasone Dipropionate, Amcinonide, Betamethasone Dipropionate, Betamethasone Valerate, Clobetasol Propionate, Clobex, Cloderm, Cordran tape, Desonate, Desonide, Desowen, Desoximetasone, Diflorasone Diacetate, Fluocinolone Acetonide, Fluocinonide, Halobetasol Propionate, Halog, Hydrocortisone, Kenalog, Lokara, Mometasone Furoate, Topicort, Triamcinolone Acetonide, Triderm, Vanos, Verdeso,

Step 2 Drug(s): Elidel, Protopic.

 If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given. Step 1 Drug(s): Aclovate, Ala-cort, Ala-scalp Hp, Alclometasone Dipropionate, Amcinonide, Betamethasone Dipropionate, Betamethasone Valerate, Carmol Hc, Clobetasol Emollient, Clobetasol Propionate, Clobex, Cloderm, Cordran, Cordran Sp, Cutivate, Derma-smoothe-fs, Dermatop, Desonate, Desonide, Desowen, Desoximetasone, Diflorasone Diacetate, Diprolene, Diprolene Af, Elocon, Fluocinolone Acetonide, Fluocinonide, Fluocinonide Emollient, Fluticasone Propionate, Halobetasol Propionate, Halog, Hydrocortisone, Hydrocortisone Butyrate, Hydrocortisone Valerate, Kenalog, Locoid, Locoid Lipocream, Lokara, Luxiq, Mometasone Furoate, Olux-e, Pandel, Prednicarbate, Temovate, Topicort, Topicort Lp, Triamcinolone Acetonide, Triderm, U-cort, Ultravate, Vanos, Verdeso, Westcort. Step 2 Drug(s): Elidel, Protopic.

 Authorization may be given for Elidel or Protopic, if the patient has tried one prescription strength topical corticosteroid for atopic dermatitis or eczema in the previous 60 days.

 Authorization for Protopic or Elidel may be given for patients with a dermatologic condition on or around the eyes, eyelids or genitalia.

 Authorization for Protopic or Elidel may be given for patients with the following conditions after a trial of a prescription strength topical corticosteroid: lichen planus, seborrheic dermatitis, chronic hand dermatitis, cutaneous lupus erythematosus or dermatomyositis or discoid lupus erythematosus, psoriasis, and vitiligo.

 Authorization for Protopic may be given for patients with the following conditions after a trial of a prescription strength topical corticosteroid: dyshidrotic palmar eczema, pyoderma gangrenosum, orofacial or perineal Crohn's disease, erosive pustular dermatosis, chronic cutaneous graft-vs-host disease (GVHD), chronic actinic dermatitis, allergic contact dermatitis, and bullous pemphigoid.

 Authorization may be given for Elidel or Protopic, for steroid-induced rosacea if the patient has tried two therapies for rosacea (e.g., azelaic acid, topical metronidazole, topical tretinoin products, oral antibiotics [e.g., tetracycline, metronidazole, doxycycline, minocycline, clarithromycin], or oral isotretinoin).

 Authorization may be given for Protopic, for severe uremic pruritus if the patient has tried two other therapies for this condition (e.g., emollients, capsaicin, topical corticosteroids, ultraviolet B irradiation).

POLICY NAME: VALPROID ACID Effective Date: 01/01/2014 Last Review Date: 10/21/2012

If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given.

Step 1 Drug(s): Amphetamine-Dextroamphetamine, Divalproex Sodium, Divalproex Sodium ER, Valproic Acid.

Step 2 Drug(s): Depakene, Depakote, Depakote ER, Depakote Sprinkle, Stavzor.

 Authorization may be given for a Step 2 drug if the patient is currently taking the requested agent.

 Authorization may be given for Stavzor if the patient has taken it at any time in the past.

 This step therapy program applies to new utilizers only.

POLICY NAME: ZETIA Effective Date: 01/01/2014 Last Review Date: 10/21/2012

If the patient has tried TWO Step 1 drugs, then authorization for a Step 2 drug may be given.

Step 1 Drug(s): Altoprev, Atorvastatin, Crestor, Fluvastatin. Juvisync, Livalo, Lovastatin, Pravastatin Sodium, Simvastatin

Step 2 Drug(s): Zetia.

 Coverage will be provided if TWO of the following medications have been tried: atorvastatin, Advicor, Altoprev, Caduet, Crestor, Juvisync, Lescol, Lescol Xl, Lipitor, Livalo, Lovastatin, Mevacor, Pravachol, Pravastatin Sodium, Simcor, Simvastatin, Vytorin, Zocor.

 Authorization of Zetia may be given if the patient has tried one HMG-CoA reductase inhibitor (statin) or HMG-CoA reductase inhibitor (statin) combination product or if Zetia is being initiated in combination with an HMG-CoA reductase inhibitor (statin).

 Authorization for Zetia may be given if the patient is taking or will be taking a medication that has a significant drug interaction with any of the HMG-CoA reductase inhibitors [statins] (eg, cyclosporine, fibrates, niacin more than 1 g/day, itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, amiodarone, and verapamil).

 Authorization of Zetia may be given if the patient has severe renal impairment (creatinine clearance of 30 mL/minute or less).

 Authorization of Zetia may be given if for management of homozygous familial sitosterolemia.

 Authorization of Zetia may be given for use in pregnant woman.

 Authorization of Zetia may be given if the patient has active liver disease or unexplained persistent elevations of serum transaminases.

 Exceptions are NOT recommended for Zetia for use in patients with moderate or severe hepatic insufficiency.

 As reviewed by a pharmacist, authorization for Zetia may be given for use in patients who have been previously diagnosed with myopathy or rhabdomyolysis (either medication-related or not medication related) OR the patient has an underlying muscle/muscle-metabolism-related disorder (eg, myositis, McArdle disease).