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Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
DESCRIPTIONSavella® (milnacipran) is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of fibromyalgia in adult patients. Although not approved for the treatment of depression, Savella® carries the same black box warning as other antidepressants concerning increased risk of suicidal ideation, thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders.
The most recent guidelines from the American Pain Society (APS) and the European League against Rheumatism (EULAR) recommend a combination of education, nonpharmacologic, and pharmacologic therapies for management of fibromyalgia symptoms. Recommended first-line medications include antidepressants (i.e. tricyclics, serotonin reuptake inhibitors, dual serotonin-norepinephrine inhibitors), anticonvulsants(gabapentin, pregabalin), cyclobenzaprine, and tramadol. Comparative efficacy among these medication options has not been established. Choice of pharmacologic treatment of fibromyalgia should be based on patient-specific factors, comorbidities, and concurrent medications.
POLICYSavella is considered medically necessary for fibromyalgia. Documentation of failure with at least three of the following drug classes are required: gabapentin, pramipexole, tricyclic antidepressants (amitriptyline, nortriptyline, desipramine, imipramine), muscle relaxants (baclofen, cyclobenzaprine, tizanidine), SSRI/SNRI (fluoxetine, venlafaxine ER, Cymbalta®), and tramadol.
POLICY EXCEPTIONSSavella prior authorization is not required for Federal Employee Program (FEP) and State Health Plan members.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY01/01/2014: New policy added.
SOURCE(S)Savella® Prescribing Information
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.