Gabapentin ER – NC Standard

Restricted Product(s):

Restriction applies to brand and generic products

• Gralise (gabapentin)
• Horizant (gabapentin enacarbil ER)

FDA Approved Use:

Gralise

• For the management of Postherpetic Neuralgia (PHN)

Horizant

• For the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults
• For the management of postherpetic neuralgia (PHN) in adults

Criteria for Approval of Restricted Product(s):

Initial Coverage Criteria:

1. The patient has a diagnosis of Postherpetic Neuralgia (PHN); AND
   1. The patient has experienced a therapeutic failure or inadequate response to generic immediate release gabapentin; OR
      1. The patient had a documented intolerance, hypersensitivity, or FDA labeled contraindication to generic immediate release gabapentin; OR
2. The patient has a diagnosis of moderate-to-severe primary Restless Legs Syndrome (RLS); AND
   1. The request is for Horizant; AND
   2. The patient has experienced a therapeutic failure or inadequate response to generic ropinirole or generic pramipexole; OR
      1. The patient had a documented intolerance, hypersensitivity, or FDA labeled contraindication to generic ropinirole and/or generic pramipexole; AND
3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of approval: 365 days (1 year)

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period);
   AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of approval: 365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

November 2024: Criteria update: Clarified that the patient must try generic immediate release gabapentin for PHN.

February 2024: Criteria update: Added note that restriction applies to brand and generic products.

May 2023: Criteria change: Added Gralise 450mg, 750mg, 900mg tablets to policy. Gralise 600mg quantity limit reduced to 2 tabs per day.

Gralise starter pack removed from policy (obsolete).

May 2022: Criteria update: Duration of approval updated to 365 days.

April 2021: Criteria change: Require FDA approved diagnosis for all restricted products.

May 2019: Criteria update: Reformatted criteria; changed duration of approval to 1095 days (3 years)

Oct 2018: Annual review; No change

Oct 2017: Annual review; No change

January 2016: Original utilization management criteria issued.