Pharmacy Management Drug Policy

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1 PAGE: Page 1 of 9 DESCRIPTION: Step Therapy encourages use of safe, cost-effective medications within different therapeutic drug categories. The entry of new generics and cost-effective therapeutic alternatives has provided an opportunity to promote these therapies as First Line. This policy applies to members that have an open formulary prescription drug benefit. POLICY: Step Therapy requires members try certain First Line options before other medications will be considered medically necessary for treatment of a specific condition. Step therapy requirements may apply to both brand and generics. Typically First Line medications are classified as generics, but there are instances where brand name medications may be preferred. Based upon our review and assessment of the peer-reviewed literature, these medications have been medically proven to be effective and therefore medically necessary for medical treatment if the request meets the following criteria: Hypertension medications: a. Branded Amturnide, Tekturna/HCT, and Tekamlo must have documentation of severe intolerance or therapeutic failure to the following First Line alternative medications: an ACE inhibitor or ARB AND at least one other antihypertensive medication from a different class (i.e., diuretic, beta-blocker, calcium channel blocker). b. Branded Coreg CR must have documentation of severe intolerance or therapeutic failure to at least one of the following First Line alternative medications: carvedilol. c. Branded Atacand, Teveten, Cozaar, Benicar and Micardis must have documentation of severe intolerance or therapeutic failure to at least one of the following First Line alternative medications: losartan, irbesartan, valsartan (Diovan) d. Branded Atacand HCT, Teveten HCT, Hyzaar, Benicar HCT and Micardis HCT must have documentation of severe intolerance or therapeutic failure to at least one of the following First Line alternative medications: losartan/hctz, irbesartan/hctz or valsartan/hctz e. Branded Edarbi must have documentation of severe intolerance or therapeutic failure to at least 2 first line medications: losartan, irbesartan, valsartan (Diovan) f. Branded Edarbyclor must have documentation of severe intolerance or therapeutic failure to at least 2 first line medications: losartan/hctz, irbesartan/hctz or valsartan/hctz

2 PAGE: Page 2 of 9 Insomnia medications a. Branded Ambien, Ambien CR, Edluar, Intermezzo, Lunesta, Rozerem, Silenor, Sonata and Zolpimist must have documentation of severe intolerance or therapeutic failure to at least one of the following First Line alternative medications before consideration for coverage: zolpidem. b. Belsomra must have documentation of severe intolerance or therapeutic failure to TWO first line medications ( zolpidem, eszopiclone, zaleplon). Brand Antidepressants a. Branded Aplenzin, Celexa, Desvenlafaxine ER, Effexor XR, Emsam, Forfivo XL, Khedezla, Lexapro, Paxil, Paxil CR, Pexeva, Pristiq, Prozac, Prozac Weekly, Oleptro, Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Zoloft must have documentation of severe intolerance or therapeutic failure to at least one of the following First Line alternative medication when prescribed by a psychiatrist, and at least two of the following First Line alternative medication when prescribed by someone other than a psychiatrist before consideration for coverage: escitalopram, fluoxetine, citalopram, sertraline, paroxetine, mirtazapine, bupropion, venlafaxine or venlafaxine ER capsules. b. Venlafaxine ER tablets (all strengths) will not be authorized unless there is valid rationale as to why venlafaxine ER capsules are not clinically appropriate. Equal doses of venlafaxine HCL extended-release tablets are bioequivalent to Effexor XR capsules but are not substitutable at the pharmacy A daily dose of 225mg venlafaxine ER can be obtained by ordering venlafaxine ER 75mg capsules, taken as 3 capsules once daily The claims processing system will not read history for this edit therefore claims will not automatically pay Antipsychotics: a. Abilify 1. Step therapy does not apply to prescriptions written by a psychiatrist 2. Step therapy does not apply for a psychosis diagnosis (bipolar, schizophrenia) 3. Diagnosis of depression requires documentation of severe intolerance or therapeutic failure to TWO different antidepressants AND trial of one proven augmentation therapy (lithium, buspirone, thyroid, bupropion) in combination with an antidepressant. 4. Diagnosis of autism requires documentation of severe intolerance or therapeutic failure to risperidone 5. All other diagnosis will be denied as off-label based on not being compendium listed as safe and effective for the condition being treated.

3 PAGE: Page 3 of 9 b. Fanapt, Latuda and Saphris- 1. A request for Fanapt, Latuda, or Saphris, for a diagnosis of schizophrenia, requires documentation of severe intolerance or therapeutic failure to TWO atypical Antipsychotics (risperidone, olanzapine, ziprasidone, quetiapine). 2. Requests for Saphris for a diagnosis of bipolar disorder require documentation of severe intolerance or therapeutic failure of at least TWO generic atypical Antipsychotics (risperidone, olanzapine, ziprasidone,quetiapine). 3. Requests for Latuda for a diagnosis of bipolar depression require documentation of severe intolerance or therapeutic failure to at least TWO alternative therapies for bipolar depression ( lamotrigine, lithium, quetiapine, olanzapine, valproate). PPI medications - Documentation of severe intolerance or therapeutic failure to the following First Line alternative medication before consideration for coverage: a. Brand Zegerid must have documentation of severe intolerance or therapeutic failure to omeprazole at a total daily dose of at least 40mg. b. Brand Dexilant must have documentation of severe intolerance or therapeutic failure to lansoprazole or omeprazole. c. Brand Protonix, Prevacid, Prilosec (Rx), and Aciphex must have documentation of severe intolerance or therapeutic failure to both omeprazole at a total daily dose of at least 40mg AND lansoprazole. d. Brand Nexium and generic Esomeprazole must have documentation of severe intolerance or therapeutic failure to any three of the following: Omeprazole, Pantoprazole, Lansoprazole or Rabeprazole. HMG medications a. Advicor, Altoprev, Lipitor, Lescol/XL, Mevacor, Pravachol, Zocor and Simcor must have documentation of severe intolerance or therapeutic failure to at least one of the following First Line alternative medications before consideration for coverage: atorvastatin, lovastatin, simvastatin or pravastatin. b. Vytorin must have documentation of severe intolerance or therapeutic failure to the following first line medications before consideration for coverage: Simvastatin AND Crestor.

4 PAGE: Page 4 of 9 c. Livalo must have documentation of severe intolerance or therapeutic failure of one generic statin (atorvastatin, lovastatin, pravastatin or simvastatin) AND Crestor d. Liptruzet must have documentation of therapeutic failure of atorvastatin 80mg AND severe intolerance or therapeutic failure of Crestor. Overactive Bladder: a. Branded Detrol, Detrol LA, Enablex, Ditropan XL, Toviaz, Myrbetriq, Sanctura, Sanctura XR, Oxytrol, and Gelnique must have documentation of a severe intolerance or therapeutic failure to TWO of the following first line medications before consideration for coverage: Oxybutynin/Oxybutynin ER, Tolterodine and Trospium/Trospium XR b. Enablex may be used first line in those patients where prolongation of the QT interval may be clinically significant. c. Gelnique will be allowed in individuals 65 years of age or older without step therapy requirements Osteoporosis New starts on oral bisphosphonate therapy with branded medications: a. Branded Actonel, Atelvia, Binosto, Boniva and Fosamax (all forms) must have documentation of a severe intolerance or therapeutic failure to alendronate before consideration for coverage Anti-emetics Branded anti emetics must have documentation of a severe intolerance or therapeutic failure to the following first line agents: a. Branded Anzemet, Zofran, Zuplenz must have documentation of severe intolerance or therapeutic failure to ondansetron b. Branded Sancuso must have documentation of a severe intolerance or therapeutic failure to ondansetron AND granisetron Topical Steroids Branded Cloderm, Clocortolone pivalate, Cordran, Desonate, Halog, Kenalog spray, Locoid, Lipocream, Luxiq, Olux, Olux E, Pandel, Trianex, Vanos, and Verdeso requires documentation of a severe intolerance or therapeutic failure to TWO of the following generic topical steroids: aclometasone, amcinonide, betamethasone, clobetasol, desonide, desoximetasone, diflorasone, fluocinolone, fluocinonide E, fluticasone, halobetasol, hydrocortisone 2.5%, hydrocortisone valerate, hydrocortisone butyrate, mometasone, prednicarbate, triamcinolone. a. Kenalog spray will be allowed as first line therapy for the treatment of seborrheic dermatitis

5 PAGE: Page 5 of 9 Taclonex Ointment - Requires documentation of ONE high potency generic topical steroid (amcinonide, augmented betamethasone, betamethasone, clobetasol, desoximetasone, diflorasone, fluocinonide, or halobetasol) if written by a dermatologist OR TWO high potency steroids if written by another specialty. Topical Antifungals Branded Ecoza, Ertaczo, Extina, Loprox, Luzu, Mentax, Naftin, Nizoral Shampoo, Oxistat, and Xolegel require documentation of a severe intolerance or therapeutic failure to TWO of the following generic topical antifungals: ciclopirox, econazole, ketoconazole and nystatin. a. Coverage of Loprox for the diagnosis of seborrheic dermatitis requires a trial and failure of ketoconazole and ciclopirox shampoo. Topical Acne/Rosacea Products - a. Branded Zaclir and Pacnex require documentation of a severe intolerance or therapeutic failure to benzoyl peroxide AND tretinoin. b. Branded Clindagel, Cleocin T and Evoclin require documentation of a severe intolerance or therapeutic failure to clindamycin AND tretinoin. c. Aczone requires documentation of a severe intolerance or therapeutic failure of generic benzoyl peroxide AND topical retinoid d. Differin Lotion requires documentation of a severe intolerance or therapeutic failure of adapalene Cream or Gel AND a topical tretinoin cream or gel e. Metrogel, Noritate and Soolantra require documentation of a severe intolerance or therapeutic failure of generic metronidazole cream, gel or lotion. Topical Antibiotics - Altabax and Bactroban cream must have documentation of a severe intolerance or therapeutic failure to generic mupirocin Oral Acne Branded Doryx, Oracea and Doxycycline ER 40mg require documentation of a severe intolerance or therapeutic failure to doxycycline IR AND minocycline IR. Skelaxin Coverage of Skelaxin requires documentation of a severe intolerance or clinical failure of two different generic muscle relaxants (carisoprodol, baclofen, tizanidine, methocarbamol, orphenadrine, or cyclobenzaprine) Uloric Coverage of Uloric for new starts requires documentation of a previous trial and failure or significant intolerance to allopurinol. An exception to this step therapy will be made if the patient has documented renal insufficiency.

6 PAGE: Page 6 of 9 Triptan Medications a. Coverage of oral or nasal Maxalt, Maxalt MLT, Amerge, Treximet, Axert, Frova, Imitrex, Relpax, or Zomig for new starts will require documentation of a trial and failure or significant intolerance to two generic triptans (sumtriptan, zolmitriptan, naratriptan or rizatriptan). Frova will be allowed first line for the diagnosis of menstrual migraines b. Coverage of Imitrex injection, Sumavel or Alsuma requires documentation of a severe intolerance or clinical failure to injectable sumatriptain Metozolv Coverage of Metozolv will require documentation of trial and failure or significant intolerance to metoclopramide. Seizure medications: a. Coverage of Lamictal ODT or Lamictal XR requires documentation of a trial and failure of generic lamotrigine. Parkinson medications: a. Coverage of Zelapar requires documentation of severe intolerance or therapeutic failure of any other anti-parkinson s medication. b. Coverage of Mirapex ER requires documentation of severe intolerance or therapeutic failure of immediate release pramipexole. c. Coverage of Requip XL requires documentation of a severe intolerance or therapeutic failure to generic ropinirole. Benign Prostatic Hyperplasia: a. Coverage of brand Flomax, Uroxatral or Rapaflo requires documentation of severe intolerance or therapeutic failure of tamsulosin. b. Coverage of Avodart requires documentation of a trial and failure of finasteride Alzheimer s a. Coverage of Aricept 23mg requires documentation of trial and failure to an adequate trial of donepezil 10mg. Nasal sprays

7 PAGE: Page 7 of 9 a. Coverage of brand Astepro and Patanase requires documentation of severe intolerance or therapeutic failure of generic azelastine nasal spray. b. Coverage of brand Beconase AQ, Flonase, Nasacort AQ, QNASL, Rhinocort AQ, and Veramyst requires documentation of severe intolerance or therapeutic failure of a generic prescription nasal steroid such as fluticasone, flunisolide, or budesonide AND Nasonex AND Omnaris nasal sprays. c. Coverage of brand Omnaris and Zetonna requires documentation of severe intolerance or therapeutic failure of a generic prescription nasal steroid such as fluticasone, flunisolide, or budesonide AND Nasonex nasal sprays. Azasan - Coverage of Azasan requires documentation of severe intolerance or therapeutic failure to generic azathioprine. Daliresp - Coverage of Daliresp requires documentation of severe intolerance or therapeutic failure to either an inhaled steroid or long acting beta agonist. Pulmicort/Budesonide Nebulizers- Coverage of Pulmicort or Budesonide Nebulizers requires documentation of severe intolerance or therapeutic failure to a steroid inhaler (Flovent, Asmanex, QVAR) for children age 4-8 years old. For children 9 years or older, documentation of a physical inability to use an inhaler is required. Dificid - Coverage of Dificid requires documentation of severe intolerance or therapeutic failure to oral vancomycin. Prescriptions written by infectious disease specialists are exempt from step therapy requirements. Myfortic - Coverage of Myfortic requires documentation of severe intolerance or therapeutic failure to generic mycophenolate. Eye Drops: a. Coverage of Lumigan and bimatoprost requires documentation of severe intolerance or therapeutic failure to latanoprost b. Coverage of Travatan Z, Travoprost, Zioptan and Xalatan requires documentation of severe intolerance or therapeutic failure to both latanoprost and Lumigan ADHD: a. Coverage of Adderall XR, Aptensio XR, Daytrana, Focalin XR, Metadate CD, and Ritalin LA will require documentation of a severe intolerance or therapeutic failure to two generic long acting stimulants such as amphetamine/dextroamphetamine ER, dexmethylphenidate ER or methylphenidate LA.

8 PAGE: Page 8 of 9 b. Coverage of Kapvay will require documentation of trial and failure of at least one long acting stimulant (amphetamine/dextroamphetamine ER, dexmethylphenidate ER, methylphenidate LA) and Intuniv (guanfacine ER) c. Coverage of Strattera will require documentation of trial and failure of at least one long acting stimulant (amphetamine/dextroamphetamine ER, dexmethylphenidate ER, methylphenidate LA) AND Intuniv (guanfacine ER) for individuals under the age of 18 OR just one generic long acting stimulant for individuals 18 years of age and older. Osphena Requires documentation of severe intolerance or therapeutic failure to at least one of the following vaginal estrogen product: Estrace cream, Premarin cream, Femring or Vagifem. Multiple Sclerosis a. Coverage of Betaseron will require documentation of trial and failure of TWO of the following preferred products: Avonex, Copaxone, Rebif, Tecfidera, and Plegridy. b. Coverage of Aubagio or Gilenya will require documentation of trial and failure of ONE of the following preferred products: Avonex, Copaxone, Rebif, Tecfidera, and Plegridy. c. Coverage of Glatopa will require documentation of trial and failure of Copaxone 40 mg. Savella Coverage of Savella will require documentation of severe intolerance or therapeutic failure of duloxetine Amitiza Coverage of Amitiza will require documentation of severe intolerance or therapeutic failure of Linzess for a diagnosis of chronic idiopathic constipation or irritable bowel syndrome with constipation. A trial of Linzess will not be required for a diagnosis of opioid-induced constipation Diabetes Medications (SELECT BENEFITS ONLY) Coverage of Onglyza, Kombiglyze, Nesina, Kazano, and Oseni will require documentation of severe intolerance or therapeutic failure of Januvia, Janumet, Tradjenta or Jentadueto Diabetic Strips and Meters (SELECT BENEFITS ONLY) Coverage of a non-preferred meter or strips require a previous trial and failure of any Abbott or One Touch product. Oral anticoagulantsa. Savaysa Must have therapeutic failure or severe intolerance to one of the First Line alternatives ( Xarelto, Eliquis, Pradaxa).

9 PAGE: Page 9 of 9 POLICY GUIDELINES: 1. Prior-authorization is contract dependent. 2. Look back in history for a first line medication. If in history, then pay branded drug at the appropriate tier. If no history, then deny PA required. 3. Supportive documentation of previous drug use must be submitted for any criteria that requires trial of a preferred agent, if the preferred drug is not found in claims history. 4. Approval for step therapy requirements does not bypass MAC penalty. Please see MAC penalty policy for detail of this benefit.

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