Pharmacy Prior Authorization Criteria

Savella (milnacipran)

For diagnosis of Fibromyalgia
Indicated for the management of fibromyalgia. Savella is not approved for use in pediatric patients.

*Amitriptyline and cyclobenzaprine are considered to be potentially inappropriate medications for use in patients 65 years of age and older. [2, A]

Step Therapy

Length of Approval: 12 Month(s)

Requested drug is being used for a Food and Drug Administration (FDA)-approved indication

AND

Trial and failure (of a minimum 30 day supply), contraindication, or intolerance to one of the following generics: [A]

2025-03-05, 2024-03-04, 2023-02-01, 2022-01-10, 2021-10-06, 2021-09-27, 2021-05-20, 2021-03-26, 2021-03-03, 2020-02-19, 2019-12-05

Savella Prescribing Information. Allergan USA, Inc. Irvine, CA. May 2024.
American Geriatrics Society. American Geriatrics Society 2019 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2019 Jan 29.
Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55.

The 2019 Beers Criteria recommends avoiding the use of amitriptyline (independent of diagnosis or condition) and cyclobenzaprine in older adults due to their highly anticholinergic and sedating properties. [2] However, amitriptyline and cyclobenzaprine have strong evidence for efficacy in treating fibromyalgia. [3]

2025-03-05: Annual review: Updated T/F trial duration verbiage to align with standard language. Background updates.
2024-03-04: Annual Review - No criteria changes
2023-02-01: Annual Review - no criteria changes
2022-01-10: Annual Review - addition of diagnosis verification
2021-10-06: EHB specific guideline, removed Gralise as a target.
2021-09-27: EHB specific guideline, added to EHB formulary, removed from ORx standard formulary. no changes to criteria
2021-05-20: EHB specific guideline, added to EHB formulary, removed from ORx standard formulary. no changes to criteria
2021-03-26: Added new Gralise Starter Pack GPI
2021-03-03: 2021 Annual Review. Removed Gralise Starter Pack as target (obsolete). No changes to clinical criteria.
2020-02-19: 2020 Annual review, no changes to criteria.
2019-12-05: Updated criteria for Savella: removed brand Lyrica and added pregabalin as a prerequisite option.