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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.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
07/23/2015: Code Reference section updated for ICD-10.
02/02/2016: Approved by Pharmacy & Therapeutics (P&T) Committee. Policy guidelines updated to add medically necessary and investigative definitions.
05/31/2016: Policy number 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.