WHA

Neurologic Agents

Indications for Prior Authorization

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

Lyrica CR (pregabalin extended-release)
  • 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.

Gralise (gabapentin)
  • 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.

Gabarone (gabapentin)
  • For diagnosis of Postherpetic Neuralgia (PHN)
    Indicated for the management of postherpetic neuralgia in adults

  • For diagnosis of Partial Onset Seizures
    Indicated as adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy

Criteria

Savella, Brand Lyrica CR, generic pregabalin extended-release

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
  • Trial and failure, contraindication, or intolerance to one of the following:
    • amitriptyline*
    • cyclobenzaprine*
    • duloxetine
    • gabapentin (generic Neurontin)
    • pregabalin immediate-release
Brand Gralise, Brand Gralise Starter Pack, generic gabapentin (generic Gralise), Brand Gabarone

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 or intolerance to generic gabapentin (generic Neurontin)

  • Guideline ID
    GL-164658

  • Formulary
    premium

  • Effective date
    Mar 1, 2025

  • P&T approval date

P & T Revisions

2025-02-05, 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

  1. Savella Prescribing Information. Allergan USA, Inc. Irvine, CA. May 2024.
  2. Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA. 2004;292(19):2388-95.
  3. 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.
  4. Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014;311(15):1547-1555.
  5. Lyrica CR Prescribing Information. Pfizer, Inc. New York, NY. June 2020.
  6. Gralise Prescribing Information. Almatica Pharma LLC. Morristown, NJ. March 2023.
  7. Pregabalin Extended-Release Prescribing Information. Alvogen, Inc. Morristown, NJ. August 2021.
  1. 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]
  • 2025-02-05: Annual review: Added Brand Gabarone as a ST target with t/f requirement through generic gabapentin (Neurontin). Background updates.
  • 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.