Prior Auth Protocol

Prior Authorization Protocol

GRALISE^TM (gabapentin tablets)

NATL

Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.

FDA Approved Indications:
- Management of postherpetic neuralgia (PHN)
Health Net Approved Indications and Usage Guidelines:
- Diagnosis of postherpetic neuralgia (shingles or herpes zoster)
AND
- Failure or clinically significant adverse effects to a gabapentin dose greater than or equal to 1,200 mg/day
Coverage is Not Authorized For:
- Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
General Information:
- Gabapentin has been shown to provide pain relief for post-herpetic neuralgia at dosage of 1200 to 3600 mg/day.
Therapeutic Alternatives:

Drug Dosing Regimen Dose Limit/ Maximum Dose
gabapentin (Neurontin^R)
300 to 3600 mg PO in divided TID doses
3600 mg/day
* Requires Prior Authorization
Recommended Dosing Regimen and Authorization Limit:

Drug Dosing Regimen Authorization Limit
Gralise
Initial dose of 300 mg PO QD and titrate to 1800 mg PO QD over two weeks
Length of benefit
Product Availability:

Tablets: 300 mg, 600 mg
30-day starter pack: 9x300 mg tablets & 69x600 mg tablets
References:
1. Gralise [Prescribing Information] Depomed, Inc. Menlo Park, CA. December 2012.
2. Rowbotham M, Harden N, Stacey B, Bernstein P, Magnus-Miller L. Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial. JAMA 1998;280:1837-42.
3. Rice ACS, Maton S. Gabapentin in postherpetic neuralgia: a randomised, double blind, placebo controlled study. Pain 2001;94:215-224.

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
gabapentin (Neurontin^R)	300 to 3600 mg PO in divided TID doses	3600 mg/day

Drug	Dosing Regimen	Authorization Limit
Gralise	Initial dose of 300 mg PO QD and titrate to 1800 mg PO QD over two weeks	Length of benefit

The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.