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2015 Medicare Step Therapy Criteria

Last Modified: 12/31/2014

Last Submitted to CMS: 10/29/2014

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Table of Contents

AMITIZA, LINZESS ................................................................................................................................. 3

ANTIDEPRESSANTS - Viibryd / Pexeva / Pristiq / Desvenlafaxine ..................................... 4

ANTIDEPRESSANTS - Aplenzin ......................................................................................................... 5

ANTI-CONVULSANTS ............................................................................................................................ 6

ATYPICAL ANTIPSYCHOTICS .............................................................................................................. 7

BENIGN PROSTATIC HYPERPLASIA (BPH) THERAPY ................................................................ 8

BISPHOSPHONATES ORAL .................................................................................................................. 9

BRAND ARB............................................................................................................................................. 10

BRAND NSAIDS ..................................................................................................................................... 11

BUTRANS ................................................................................................................................................. 12

DIFICID .................................................................................................................................................... 13

DIRECT RENIN INHIBITORS ............................................................................................................. 14

FENOFIBRATE ........................................................................................................................................ 15

HMG STEP ............................................................................................................................................... 16

LONG ACTING OPIOIDS ..................................................................................................................... 17

LYRICA / HORIZANT ............................................................................................................................ 18

MIRAPEX, NEUPRO PATCH ................................................................................................................ 19

NASAL STEROIDS ................................................................................................................................. 20

NAMENDA XR ......................................................................................................................................... 21

OVERACTIVE BLADDER ...................................................................................................................... 22

PPI ENHANCED ...................................................................................................................................... 23

STRATTERA ............................................................................................................................................. 24

TOPICAL CORTICOSTEROIDS .......................................................................................................... 25

TOPICAL IMMUNOMODULATORS .................................................................................................... 26

ZETIA ........................................................................................................................................................ 27

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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): polyethylene glycol 3350 (PEG 3350), lactulose Step 2 Drug(s): Amitiza, Linzess

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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 may be given for Step 2 agent. Step 1 Drug(s): Citalopram, Citalopram Hbr, Duloxetine, Escitalopram, Fluoxetine Dr, Fluoxetine Hcl, Fluvoxamine Maleate, Paroxetine Hcl, Paroxetine ER, Venlafaxine Hcl, Venlafaxine ER Step 2 Drug(s): Fetzima, Brintellix, Latuda, Viibryd ,Pexeva, desvenlafaxine

Authorization may be given for Viibryd if the patient has suicidal ideation. .

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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): Bupropion Hcl SR, Bupropion IR 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.

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POLICY NAME: ANTI-CONVULSANTS Effective Date: 03/12/2014 Last Review Date: 6/01/2014

If the patient has tried TWO Step 1 drug(at least a 30-day supply in the prior 180 days), then authorization may be given. Step 1 Drug(s): carbamazepine,divalproex, lamotrigine, levetiracetam, oxcarbazepine, valproate, clobazam, gabapentin, oxcarbazepine, topiramate, valproic acid, Lamictal, Onfi, Gralise, Horizant Step 2 Drug(s): Aptiom

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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): olanzapine, risperidone, quetiapine (brand or generic), ziprasidone Step 2 Drug(s): Abilify, Fanapt, Latuda, Seroquel, Saphris, Orap

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

uthorization will be gratned for Abilify injection, without a trial of a step 1 agent, for the treatment of agitation in schizophrenia.

Authorization will be grated for Orap, without a trial of a step 1 agent, for the treatment of Tourette's syndrome.

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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

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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, Ibandronate 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. .

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POLICY NAME: BRAND 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. . Step 1 Drug(s): Eprosartan, Irbesartan-HCTZ, Candesartan-HCTZ, Candesartan, Telmisartan-amlodipine, Telmisartan-HCTZ Telmisartan, Losartan, Losartan-HCTZ, Irbesartan, Valsartan-HCTZ Step 2 Drug(s): Diovan, Edarbi, Exforge, Exforge Hct, Teveten, Teveten HCT, Azor, Benicar, Benicar HCT, Tribenzor

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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, Nabumetone, Naproxen, Naproxen Sodium, Oxaprozin, Piroxicam, Sulindac, Tolmetin Sodium Step 2 Drug(s): Flector, Mefenamic Acid, Naprelan, Pennsaid, diclofenac sodium topical solution,Vimovo

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).

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

If the patient has tried TWO Step 1 drugs, or there is documented rationale for avoidance, then authorization for a Step 2 drug may be given. Step 1 Drug(s): hydrocodone / acetaminophen products, hydrocodone / ibuprofen products, oxycodone / acetaminophen products, oxycodone / aspirin products, codeine / acetaminophen products, and tramadol products Step 2 Drug(s): Butrans patch

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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 Capsules

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

If the patient has tried two Step 1 drug, then authorization for a Step 2 drug may be given. Step 1 Drug(s): Amlodipine Besylate-benazepril, Azor, Benazepril Hcl, Benazepril-hydrochlorothiazide, Benicar, Benicar Hct, Captopril, Captopril-hydrochlorothiazide, Candesartan, Candesartan-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, Moexipril Hcl, Perinopril erbumine, Quinapril Hcl, Quinapril-hydrochlorothiazide, Ramipril, Telmisartan, Telmisartan-Amlodipine, Teveten Hct, Trandolapril,Tribenzor Step 2 Drug(s): Amturnide, Tekamlo, Tekturna, Tekturna HCT, Valturna.

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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 capsules (130mg, 134mg, 200mg, 43mg, 67mg) Fenofibrate tablet (48mg, 54mg, 145mg, 160mg), Fenofibric Acid capsule delayed release (135mg) Step 2 Drug(s): Fenofibrate capsule (50mg, 150mg), Fenoglide, Lipofen, Fibricor

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

Coverage will be provided if the patient has tried two Step 1 drugs, then authorization for a Step 2 drug will be given. If patient has tried a Step 1 and 2 drug, then authorization for a Step 3 drug will be given Step 1 Drug(s): Atorvastatin, Fluvastatin, Lovastatin, Pravastatin Sodium, Simvastatin. Step 2 Drug(s): Crestor Step 3 Drug(s): Livalo, Vytorin 10/40mg OR Vytorin 10/80mg

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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): hydromorphone ER, morphine sulfate ER (capsule or tablet), oxymorphone ER, fentanyl patches Step 2 Drug(s): Exalgo, Nucynta ER, Opana, Oxycontin

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.

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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 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, without a trial of a step 1 agent, if the patient has symptoms of Fibromyalgia or neuropathic pain associated with spinal cord injury.

This step therapy program applies to new utilizers only.

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POLICY NAME: MIRAPEX, NEUPRO PATCH 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, Ropinirole ER Step 2 Drug(s): Mirapex ER, Neupro patch

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.

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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, Nasonex, Veramyst, Omnaris, Rhinocort, Qnasl

Authorization for Rhinocort Aqua may be given if the patient is pregnant.

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

Authorization for Nasonex or Beconase may be given for diagnosis of nasal polyps.

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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 Step 2 Drug(s): Namenda XR

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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 (RR OR ER), Trospium Chloride. Step 2 Drug(s): Enablex, Toviaz, Myrbetriq, Oxytrol, Gelnique, Vesicare

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

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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, Rabeprazole Step 2 Drug(s): Dexilant, Esomeprazole, Nexium, Prevacid Solutabs, Protonix Granules, Zegerid, omeprazole/sodium bicarbonate

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).

Authorization for Nexium may be given for patients with continuous oral NSAID therapy at risk for developing gastric ulcers.

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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, Ritalin-sr, Vyvanse Step 2 Drug(s): Strattera.

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.

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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, 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): Amcinonide, Clobex, Cloderm, Cordran, Desonate, Halog, Kenalog, Lokara, Topicort, Triderm, Vanos

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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): clovate, 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 year.

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).

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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): atorvastatin, Crestor, fluvastatin, Livalo, Lovastatin, Pravastatin Sodium, Simvastatin, Vytorin Step 2 Drug(s): Zetia

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

Authorization for Zetia may be given for use in patients who have been previously diagnosed with rhabdomyolysis OR the patient has an underlying muscle/muscle-metabolism-related disorder (eg, myositis, McArdle disease)