Pharmacy Prior Authorization Criteria

Neurologic Agents

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

For diagnosis of Neuropathic pain associated with diabetic peripheral neuropathy
Indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy.
Efficacy of Lyrica CR has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures.
For diagnosis of Postherpetic neuralgia
Indicated for the management of postherpetic neuralgia.
Efficacy of Lyrica CR has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures.

For diagnosis of Postherpetic Neuralgia (PHN)
Indicated for the management of PHN.
Gralise is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.

Amitriptyline and cyclobenzaprine are considered to be potentially inappropriate medications for use in patients 65 years of age and older. [3, A]

Step Therapy

Length of Approval: 12 Month(s)

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

AND

Step Therapy

Length of Approval: 12 Month(s)

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

AND

2024-03-06, 2023-10-13, 2023-02-01, 2022-01-10, 2021-06-02, 2021-03-26, 2021-03-03, 2020-02-19, 2019-12-05, 2019-09-12

Savella Prescribing Information. Allergan USA, Inc. Irvine, CA. September 2021.
Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA. 2004;292(19):2388-95.
Fick DM, Semla TP, Steinman M, et al. American Geriatrics Society 2019 Updated AGS Beers Criteria® for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2019; 67:674-694. doi: 10.1111/jgs.15767.
Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014;311(15):1547-1555.
Lyrica CR Prescribing Information. Pfizer, Inc. New York, NY. June 2020.
Gralise Prescribing Information. Almatica Pharma LLC. Morristown, NJ. February 2021.
Pregabalin Extended-Release Prescribing Information. Alvogen, Inc. Morristown, NJ. December 2020.

Amitriptyline is part of the Beer’s Criteria for potentially inappropriate medication use in older adults (independent of diagnoses or condition) because of its strong anticholinergic and sedation properties while cyclobenzaprine is listed as most muscle relaxants and antispasmodic drugs are poorly tolerated by elderly patients, since these cause anticholinergic adverse effects, sedation, and weakness. [3] However, amitriptyline and cyclobenzaprine have the strongest evidence for efficacy in fibromyalgia amongst the tricyclic antidepressants. [2,4]

2024-03-06: Annual Review
2023-10-13: Addition of Gralise 450mg, 750mg and 900mg to guideline
2023-02-01: Annual Review - no criteria changes
2022-01-10: Annual Review - addition of diagnosis verification
2021-06-02: Added generic pregabalin extended release as target to mirror brand Lyrica CR.
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: Added Gralise to guideline (removed from anticonvulsants guideline).
2019-12-05: Combined Savella and Lyrica CR into one guideline; removed brand Lyrica and added generic pregabalin as a prerequisite agent.
2019-09-12: Annual review. No updates to clinical criteria. Background updates only.