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L.5.01.471
Savella (milnacipran)
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.
Savella (milnacipran) is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia in adult patients. Although not approved for the treatment of depression, Savella (milnacipran) 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.
Per the American College of Rheumatology, fibromyalgia is a neurologic problem that causes widespread pain, tenderness, and fatigue. It is more common in women and often starts in middle adulthood. There is no cure for fibromyalgia. However, symptoms can be treated with both non-drug (i.e., cognitive behavioral therapy, acupuncture, massage therapy, etc.) and medication based treatments. Often the best outcomes are achieved by using multiple types of treatments. Research shows that the most effective treatment for fibromyalgia is physical exercise and should be used in addition to any drug treatment. The FDA has approved three medications for fibromyalgia: Cymbalta (duloxetine), Lyrica (pregabalin), and Savella (milnacipran). Other agents commonly used to treat the symptoms of fibromyalgia include antidepressants, muscle relaxers, tramdol, and OTC pain relievers. Choice of pharmacologic treatment of fibromyalgia should be based on patient-specific factors, comorbidities, and concurrent medications.
Prior authorization is required.
The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.
Savella (milnacipran) may be considered medically necessary when ALL of the following criteria are met:
The individual is 18 years of age or older;
The individual has a documented diagnosis of fibromyalgia;
BOTH of the following:
The individual has failed (see definition of Medication Failure in the Policy Guidelines section) at least three of the following:
Gabapentin
Pramipexole
Tricyclic antidepressant (i.e., amitriptyline, nortriptyline, desipramine, imipramine)
Muscle relaxants (i.e., baclofen, cyclobenzaprine, tizanidine); OR
SSRI/SNRI (i.e., duloxetine, fluoxetine, venlafaxine ER); AND
The individual has failed maximally tolerated dose of pregabalin (up to 450 mg/day in two divided doses);
The individual does not have any contraindication(s) to therapy with the requested agent; AND
The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.
State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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 Mental Health Disorders, 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 medical necessity, “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.
BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.
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.
Medication Failure
Medication failure is defined as disease progression at generally accepted doses (for >3 months use) as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.
BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.
01/01/2014: 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 L.5.01.471 added.
02/07/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
02/06/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
02/05/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added drug name to the top of the policy. Policy section updated to add that prior authorization is required and that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Policy statement revised to state that savella is considered medically necessary for fibromyalgia in adult patients. Policy statement updated to remove tramadol from list of drugs. Sources section updated. Effective 04/01/2019.
02/10/2020: Policy statement revised to state that savella (milnacipran) is considered medically necessary for fibromyalgia in adult patients when documentation of BOTH of the requirements are met. Policy statement criteria updated to add "trial and failure (>3 months use) with maximally tolerated dose of pregabalin."
05/18/2020: Policy statement updated to reference the Policy Guidelines for the definition of failure. Policy statement regarding trial and failure with maximally tolerated dose of pregabalin updated to add "up to 450 mg/day in two divided doses." Policy Guidelines updated regarding medication failure. Sources updated.
05/06/2021: Policy description updated regarding fibromyalgia. Revised medically necessary criteria. Policy Exceptions updated. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders," to add information regarding BCBSMS request for medical records, and to define medication failure. Sources updated.
02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
06/03/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Medically necessary criteria updated to change "member" to "individual." Sources updated.
American College of Rheumatology. Fibromyalgia. Last updated February 2025. https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Fibromyalgia
Lyrica prescribing information. Parke-Davis Div of Pfizer Inc. June 2020. Last accessed April 2025.
Savella prescribing information. Allergen, Inc. May 2024. Last accessed April 2025.
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