HN Logo
Prior Authorization Protocol
SAVELLAR (milnacipran)

NATL
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Management of fibromyalgia
  2. Health Net Approved Indications and Usage Guidelines:
    Fibromyalgia
    • Diagnosis of fibromyalgia
    AND
    • Failure or clinically significant adverse effects to duloxetine
    Depression
    • Failure or clinically significant adverse effects to TWO generic antidepressants: bupropion, bupropion SR, bupropion XL, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, mirtazapine, paroxetine, paroxetine SR, sertraline, venlafaxine, venlafaxine XR
  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.
    • Pediatric patients
    • Use of monoamine oxidase inhibitors (MAOI) concomitantly or in close temporal proximity
  4. General Information:
    • Class IIb recommendation in Micromedex for depression.
    • Black box warning for Savella includes that these agents are not approved for use in pediatric patients. Pooled analyses of short-term placebo-controlled studies of antidepressant drugs (selective serotonin reuptake inhibitors (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 MAOI with Savella 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 an MAOI before starting Savella. Allow at least 5 days after stopping Savella before starting an MAOI.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    duloxetine (CymbaltaR)

    Fibromyalgia:
    60 mg PO QD
    Depression:
    20 mg PO BID

    60 mg/day
    120 mg/day

    bupropion (WellbutrinR)

    Depression:
    100 mg PO TID

    450 mg/day

    bupropion SR (Wellbutrin SRR)

    Depression:
    150 mg PO BID

    400 mg/day

    bupropion XL (Wellbutrin XLR)

    Depression:
    150 -300 mg PO QD

    450 mg/day

    citalopram (CelexaR)

    Depression:
    20-40 mg PO QD

    40 mg/day

    escitalopram (LexaproR)

    Depression:
    10 mg PO QD

    20 mg/day

    fluoxetine (ProzacR)

    Depression:
    20 mg PO QD

    80 mg/day

    fluvoxamine (LuvoxR)

    Depression (off-label):
    50 mg PO QD

    300 mg/day

    mirtazapine (RemeronR)

    Depression:
    15 mg PO QD

    45 mg/day

    paroxetine (PaxilR)

    Depression:
    10 mg PO QD

    50 mg/day

    paroxetine SR (Paxil CRR)

    Depression:
    12.5 mg PO QD

    62.5 mg/day

    sertraline (ZoloftR)

    Depression:
    50 mg PO QD

    200 mg/day

    venlafaxine( EffexorR)

    Depression:
    75 mg PO QD

    375 mg/day

    venlafaxine SR (Effexor XRR)

    Depression:
    37.5 mg PO QD

    225 mg/day

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

    Savella

    The recommended dose of Savella is 100 mg/day (50 mg PO BID).
    Dosing should be titrated to 100 mg/day over a 1-week period:
    Day 1: 12.5 mg once PO
    Days 2-3: 25 mg/day (12.5 mg PO BID)
    Days 4-7: 50 mg/day (25 mg PO BID)
    After Day 7: 100 mg/day (50 mg PO BID)
    May be increased to 200 mg/day (100 mg PO BID) based on individual response.
    Doses above 200 mg/day have not been studied.

    Length of benefit

  7. Product Availability:

    Tablets: 12.5 mg, 25 mg, 50 mg, 100 mg

  8. References:
    1. Savella [Prescribing Information]. St. Louis, MO: Forest Laboratories; January 2015.
    2. American Psychiatric Association: Practice guideline for the treatment of patients with major depressive disorder 3rd edition. Am J Psychiatry 2010;167(suppl):1-152.
    3. Savella. ClinicalTrials.gov available at http://clinicaltrials.gov/ct2/show/study/NCT00797797. Accessed June 1, 2012.
    4. American College of Rheumatology. Diagnostic Criteria for Fibromyalgia 2010. Available at: http://www.rheumatology.org/practice/clinical/classification/fibromyalgia/2010_preliminary_diagnostic_criteria.pdf. Accessed June 1, 2012.
    5. Clauw DJ, Mease P, Plamer RH. Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial. Clin Ther. 2008;30(11):1988-2004.
    6. Savella. In: DRUGDEXR System (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/ Accessed June 5, 2015.
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.