ModifiedHealth NetPolicy CP PMN.240

Gabapentin ER (Gralise, Horizant) coverage

Defines medical necessity, prior authorization, and coverage criteria for Gralise and Horizant for postherpetic neuralgia (PHN) and restless legs syndrome (RLS) across Health Net lines of business.

Policy Summary

PayerHealth Net

PolicyGabapentin ER (Gralise, Horizant) coverage

Policy CodePolicy CP PMN.240

Change TypeCriteria revisions, step therapy updates, prior authorization clarifications

Effective Date09.01.20

Next Review Date

Key ActionSubmit documentation (office notes, labs, or other clinical information) demonstrating trials of required prior therapies and generic availability to support authorization.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for IL HIM per IL HB 5395.

For PHN, member must use generic Gralise if available.

Revised PHN criteria to require trial of pregabalin IR OR ER instead of both IR AND ER.

For all indications, added asterisk that authorization may be required for pregabalin and clarified failure of generic gabapentin is required.

2FDA indications

12 moApproval duration (Medicaid/HIM)

1800 mg/dayMax Gralise dose

1200 mg/dayMax Horizant dose (PHN)

600 mg/day

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Coverage Criteria

Initial Approval — Postherpetic Neuralgia (PHN)

Covered when ALL of the following are met:

PHN initial criteria: 1) Diagnosis of postherpetic neuralgia (PHN). 2) Age >= 18 years. 3) Failure of a >=30-day trial of immediate‑release generic gabapentin at up to maximally indicated doses (unless contraindicated or clinically significant adverse effects). 4) Failure of a >=30-day trial of generic pregabalin (immediate‑release OR controlled‑release) at up to maximally indicated doses (unless contraindicated or clinically significant adverse effects). 5) If member is < 64 years of age: failure of a >=30‑day trial of a tricyclic antidepressant unless contraindicated or intolerant. 6) For Gralise requests, member must use generic once‑daily gabapentin if available unless contraindicated or intolerant. 7) Requested dose does not exceed maximums: Gralise 1,800 mg/day (<= 2 tablets/day) or Horizant 1,200 mg/day (<= 2 tablets/day).see node text

Illinois HIM requests: step therapy requirements do not apply as of 1/1/2026 per IL HB 5395 (documented).

Initial Approval — Restless Legs Syndrome (RLS)

Covered when ALL of the following are met:

RLS initial criteria: 1) Diagnosis of restless legs syndrome (RLS). 2) Request is for Horizant. 3) Age >= 18 years. 4) Failure of a >=30‑day trial of immediate‑release generic gabapentin at up to maximally indicated doses (unless contraindicated or clinically significant adverse effects). 5) Failure of a >=30‑day trial of generic pregabalin (immediate‑release OR controlled‑release) at up to maximally indicated doses (unless contraindicated or clinically significant adverse effects). 6) Requested dose does not exceed Horizant 600 mg/day (1 tablet/day).see node text

Illinois HIM requests: step therapy requirements do not apply as of 1/1/2026 per IL HB 5395 (documented).

Continued Therapy

Covered when ALL of the following are met:

Continued therapy criteria: 1) Member is currently receiving medication via the plan benefit OR previously met initial approval criteria (continuity of care per state rules may apply). 2) Member is responding positively to therapy. 3) If request is for a dose increase, the new dose does not exceed maximums: Gralise 1,800 mg/day; Horizant for PHN 1,200 mg/day; Horizant for RLS 600 mg/day. 4) For Gralise requests, member must use generic once‑daily gabapentin if available unless contraindicated or clinically significant adverse effects are experienced.see node text

Approval durations: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Updated Prior Therapy Criteria (partial)

Policy updates and criteria highlights (partial):

PHN prior therapy requirement: PHN prior‑therapy requirement revised to require trial of pregabalin immediate‑release OR pregabalin extended/controlled‑release (not both).trial documented

Also requires use of generic Gralise if available for PHN.

RLS prior therapy update: RLS approval criteria updated to remove trials of ropinirole and pramipexole and to require trials of gabapentin IR and generic pregabalin to align with RLS Foundation guidelines.trial documented

Step therapy bypass added for Illinois HIM per IL HB 5395; see state‑specific applicability.

Non‑FDA approved indications that are not specifically addressed by this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (for commercial: CP CPA.09; for Health Insurance Marketplace: HIM.PA.154; for Medicaid: CP.PMN.53) or the applicable evidence of coverage documents.

For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with this clinical policy; providers should consult the applicable state Medicaid manual for any coverage provisions that apply to this policy.

Coverage decisions described in this clinical policy are subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract). This policy does not guarantee payment and does not constitute medical advice or a contract; providers must exercise professional judgment and remain responsible for treatment decisions.

Dosing and Coding Highlights

Maximum doses summary for Gralise and Horizant

Gralise (gabapentin ER)Maximum 1,800 mg per day (≤2 tablets/day)

Horizant (gabapentin enacarbil ER) — PHNMaximum 1,200 mg per day (≤2 tablets/day)

Horizant (gabapentin enacarbil ER) — RLSMaximum 600 mg per day (1 tablet/day)

Gralise maximum daily dose

Gralise maximum daily dose1,800 mg/day (≤2 tablets/day)

Source—policy dosing and continued therapy limitsSee dosage and administration and continued therapy criteria requiring requested dose does not exceed 1,800 mg/day

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Documentation

Prior authorization is required for requests for Gralise and Horizant. For pregabalin products, prior authorization may also be required — check benefit design. Step therapy requirements (trials of generic gabapentin IR and generic pregabalin) apply unless otherwise noted below. Documentation (office notes, labs, or other clinical information) must be submitted to support that the member has met all approval criteria; absence of documentation may result in denial or delay.

Affected products: Gralise (gabapentin ER), Horizant (gabapentin enacarbil), pregabalin (brand and generics).
Prior authorization may be required for pregabalin; verify member-specific benefit.
Submit office chart notes, lab results, and other clinical information to corroborate trials and failures.
Lack of supporting documentation may trigger denial or processing delays.

Step Therapy

Step Therapy Requirements and Generic Use

Step therapy requirements apply for PHN and RLS indications: trial and failure of immediate‑release generic gabapentin and trial and failure of generic pregabalin (IR or CR) at maximally indicated/tolerated doses for at least 30 days, unless contraindicated or clinically significant adverse effects occur. For PHN specifically, trials of TCAs may be required for members < 64 years per criteria. For Gralise requests, prescribers must use generic once‑daily gabapentin if available unless contraindicated.

Background

Gabapentin formulations covered by this policy include Gralise (gabapentin ER), an extended‑release formulation of gabapentin with GABA agonist activity, and Horizant (gabapentin enacarbil ER), a prodrug of gabapentin. Both products are FDA‑approved for management of postherpetic neuralgia (PHN); Horizant is also FDA‑approved for treatment of moderate‑to‑severe primary restless legs syndrome (RLS) in adults. Dosing, titration, and maximum daily limits differ between formulations and indications and are specified elsewhere in the policy.

Definitions and Dosing Details

PHN definition and FDA-approved indication listing

Definition — PHNPostherpetic neuralgia (PHN): neuropathic pain following herpes zoster; FDA‑approved indication for Gralise and Horizant

FDA‑approved agents for PHNGralise (gabapentin ER) and Horizant (gabapentin enacarbil ER)

Clinical notePolicy requires documentation of diagnosis and applicable prior therapy trials for approval

RLS definition and FDA-approved indication for Horizant

Definition — RLSRestless legs syndrome (RLS): moderate‑to‑severe primary RLS in adults; FDA‑approved indication for Horizant

Approved product for RLSHorizant (gabapentin enacarbil ER)