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Prior Authorization Protocol
ANTIDEPRESSANT STEP THERAPY

APLENZINR (bupropion ER), DESVENLAFAXINE FUMARATE EXTENDED-RELEASE TABLETS, FORFIVO XL (bupropion hydrochloride extended-release tablets), PRISTIQR (desvenlafaxine succinate), KHEDEZLAR (desvenlafaxine succinate), VIIBRYDTM (vilazodone)

NATL
Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Treatment of major depressive disorder (MDD)
    • (For Aplenzin only) Treatment of seasonal affective disorder (SAD)
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of depression
    AND
      • Failure or clinically significant adverse effects to one of the following generic antidepressants: Budeprion SR, bupropion, bupropion SR, bupropion XL, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, mirtazapine, paroxetine, sertraline, venlafaxine, venlafaxine XR
    OR
      • The patient or a first degree relative of the patient has been successfully treated in the past with the requested agent
    OR
    • (For Aplenzin only) Diagnosis of seasonal affective disorder (SAD)
    AND
    • Failure or clinically significant adverse effects to generic bupropion extended release (generic Wellbutrin-XL)
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature
    • Use of monamine oxidase inhibitor
  4. General Information:
    • Desvenlafaxine fumarate extended release tablets is not a generic equivalent of Pristiq. (desvenlafaxine succinate extended release) or Khedezla (desvenlafaxine extended release) but is a new dosage form of existing agents for the same indication
    • Failure of antidepressant therapy for major depressive disorder is defined as the inability to achieve minimal or partial response after 4 weeks of therapy at maximum tolerated doses.
    • Nefazodone requires prior authorization and is not included as a required agent; however, a prior trial of nefazodone will be sufficient for approval of a step therapy agent.
    • A first-degree relative is defined as a parent, sibling, or offspring.
    • In clinical trials, doses of Pristiq 50-400 mg/day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg/day and adverse events and discontinuations were more frequent at higher doses
    • Aplenzin and Forfivo are not FDA-approved for smoking cessation treatment.
    • Black box warning for Aplenzin, Forfivo, Pristiq, Desvenlafaxine and Viibryd includes that these agents are not approved for use in pediatric patients. Pooled analyses of short-term placebo-controlled studies of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with MDD and other psychiatric disorders.
    • Use of monoamine oxidase inhibitors (MAOI) with Aplenzin, Pristiq, Forfivo, Desvenlafaxine or Viibryd concomitantly is contraindicated due to the risk of serious, sometimes, fatal, drug interactions with serotonergic drugs. These interactions have been associated with symptoms that include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant syndrome, seizures, rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. Allow at least 14 days after stopping Aplenzin, Forfivo, Pristiq, Desvenlafaxine or Viibryd before starting an MAOI.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Selective Serotonin Reuptake Inhibitors

    citalopram (CelexaR)



    20 mg PO QD



    40 mg/day

    fluvoxamine (Luvox CRR)

    50-300 mg PO QD

    300 mg/day

    escitalopram (LexaproR)

    10-20 mg PO QD

    20 mg/day

    fluoxetine (ProzacR)

    20 mg PO QD

    80 mg/day

    paroxetine (PaxilR)

    20 mg PO QD

    50 mg/day

    paroxetine controlled release (Paxil CRR)

    25 mg PO QD

    62.5 mg/day

    sertraline (ZoloftR)

    50 mg PO QD

    200 mg/day

    Dual-acting Antidepressants

    venlafaxine (EffexorR)



    75 mg/day PO in divided BID-TID



    375 mg/day

    venlafaxine extended release (Effexor XRR)

    37.5-75 mg PO QD

    225 mg/day

    mirtazapine (RemeronR or RemeronR SolTab)

    15 mg PO QD

    45 mg/day

    duloxetine (Cymbalta)

    40-60 mg PO QD

    60 mg/day

    Dopaminergic Agents

    bupropion sustained release (Wellbutrin SRR, Budeprion SRR)

    150 mg PO BID

    400 mg/day

    bupropion sustained release 24 hour (Wellbutrin XLR)

    150-450 mg PO QD

    450 mg/day

    bupropion (WellbutrinR, BudeprionR)

    100 mg PO TID

    450 mg/day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Aplenzin

    Major Depressive Disorder:
    Starting dose: 174mg PO QD. After 4 days, may increase to 348 mg PO QD
    Seasonal Affective Disorder:
    Initiate treatment in the autumn prior to onset of seasonal depressive symptoms.
    Starting dose: 174 mg PO QD (equivalent to 150 mg bupropion HCl). Usual target dose: 348 mg PO QD (equivalent to 300 mg bupropion HCl).
    After one week, may increase the dose to 348 mg PO QD. Continue treatment through the winter season.

    Length of Benefit

    Pristiq

    50 mg PO QD

    Length of Benefit

    Khedezla

    50 mg PO QD

    Length of benefit

    Desvenlafaxine Fumarate Extended-Release Tablets

    50 mg PO QD

    Length of Benefit

    Viibryd

    20 - 40 mg PO QD

    Length of Benefit

    Forfivo XL

    450 mg PO QD

    Do not initiate treatment with Forfivo XL, use another bupropion formulation for initial dose titration. Patients currently treated with other bupropion products at 450 mg/day can be switched to equivalent dose of Forfivo XL.

    Length of Benefit

  7. Product Availability:
    Aplenzin extended-release tablets: 174 mg, 348 mg, 522 mg
    Forfivo extended-release tablets: 450 mg
    Pristiq extended release tablets: 25, 50 mg, 100 mg
    Viibryd tablets: 10 mg, 20 mg, 40 mg
    Khedezla extended release tablets: 50 mg, 100 mg
    Desvenlafaxine Fumarate Extended-Release Tablets: 50 mg, 100 mg
  8. References:
    1. Khedezla [Prescribing Information] Par Pharmaceutical Cos., Inc. Spring Valley, NY; September 2013
    2. Aplenzin [Prescribing Information] Bridgewater, NJ: Sanofi-aventis; August 2012.
    3. Pristiq [Prescribing Information] Philadelphia, PA: Wyeth Pharmaceuticals; December 2013.
    4. Viibryd [Prescribing Information] St. Louis, MO: Forest Laboratories; April 2014.
    5. Forfivo [Prescribing Information] Austin, TX: Edgemont Pharmaceuticals; November 2011.
    6. Desvenlafaxine Fumarate Extended-Release Tablets [Prescribing Information] Teva Pharmaceuticals USA, Sellersville, PA, October 2013.
    7. American Psychiatric Association: Practice guideline for the treatment of patients with major depressive disorder 3rd edition. Am J Psychiatry 2010;167(suppl):1-152.
    8. Nemeroff CB, et al. Comprehensive analysis of remission (COMPARE) with venlafaxine versus SSRIs. Biol Psychiatry 2008;63:424-34.
    9. Papakostas GI, et al. Are antidepressant drugs that combine serotonergic and noradrenergic mechanisms of action more effective than the selective serotonin reuptake inhibitors in treating major depressive disorder? A meta-analysis of studies of newer agents. Biol Psychiatry 2007;62:1217-27.
    10. Kennedy SH, et al. Efficacy of escitalopram in the treatment of major depressive disorder compared with conventional selective serotonin reuptake inhibitors and venlafaxine XR: a meta-analysis. J Psychiatry Neurosci 2006;31(2):122-31.
    11. Clayton AH, et al. Bupropion extended release compared with escitalopram: effects on sexual functioning and antidepressant efficacy in 2 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry 2006;67:736-46.
    12. Dunn JD, et al. Utilization and drug cost outcomes of a step-therapy edit for generic antidepressants in an integrated health system. JMCP 2006;12(4):294-302.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.