CurrentCignaPolicy N/A

Gabapentin Step Therapy Policy

Cigna step therapy policy that requires trial of a Step 1 gabapentin product (generic gabapentin capsules, tablets, or oral solution) before coverage of Step 2 products (Gabarone, Gralise brand/generic, Horizant, Neurontin). Approvals are for 1 year.

Policy Summary

PayerCigna

PolicyGabapentin Step Therapy Policy

Policy CodePolicy N/A

Change TypeAnnual Revision (no material criteria changes)

Effective DateN/A

Next Review Date02/05/2025

Key ActionIf the Step Therapy rule is not met for a Step 2 product at point of service, coverage will be determined by the Step Therapy criteria; approvals are provided for 1 year.

POLICY UPDATE CHANGES

Annual Revision - Review Date 02/05/2025; Summary of Changes = Gabarone tablets: Added to Step 2 products (noted in history).

4Step 2 Products Listed

1Required Step 1 Trial

Summary of changes and key points

This is a Cigna Step Therapy policy that requires a trial of a Step 1 gabapentin product (generic gabapentin capsules, tablets, or oral solution) before coverage of Step 2 products (Gabarone, Gralise brand/generic, Horizant, Neurontin). Note that ER products are not interchangeable with other gabapentin products due to different pharmacokinetic profiles. Annual Revision - Review Date 02/05/2025; Summary of Changes = Gabarone tablets: Added to Step 2 products (noted in history). This revision is not a material change (has_material_change = false) and the policy coverage stance is mixed.

Step Therapy / Medical Necessity Criteria

Step Therapy / Medical Necessity

Covered when ALL of the following are met:

ALL of the following

Patient has tried one Step 1 Product (brand [Neurontin] or generic gabapentin capsules, tablets, or oral solution).
Step 2 Products
- Gabarone (gabapentin tablets - INA Pharmaceuticals)
- Gralise (gabapentin extended-release tablets - Almatica, generic)
- Horizant (gabapentin enacarbil extended-release tablets - Arbor)
- Neurontin (gabapentin capsules, tablets, and solution - Pfizer, generic)

Approvals under this Step Therapy policy are provided for 1 year. If the Step Therapy rule is not met for a Step 2 product at the point of service, coverage will be determined by the Step Therapy criteria and enforcement is at point of service as described in the policy.

Step 1 and Step 2 product groups

Step 1 products (required first step)mixedCovered

	generic gabapentin capsules, tablets, and oral solution (any brand or generic of immediate-release gabapentin)
Neurontin	brand gabapentin (listed as Step 1 example in criteria)

Step 2 products (require prior Step 1 trial or meet exception)mixedCovered

Gabarone	gabapentin tablets - INA Pharmaceuticals
Gralise	gabapentin extended-release tablets - Almatica (brand and generic)
Horizant	gabapentin enacarbil extended-release tablets - Arbor
Neurontin	gabapentin capsules, tablets, and solution - Pfizer (also listed as Step 2 product)

Actions required at point of service

Step Therapy

Step therapy enforcement at point of service

If the Step Therapy rule is not met for a Step 2 product at point of service, coverage will be determined by the Step Therapy criteria; approvals are provided for 1 year.

Approvals are provided for 1 year
Coverage determined by Step Therapy criteria when rule not met at POS

Drug background, indications, and definitions

Gabapentin is available in multiple formulations: immediate-release (capsules, tablets, oral solution), extended-release (ER) tablets, and as a prodrug (gabapentin enacarbil). FDA indications include management of postherpetic neuralgia, gabapentin and Gabarone are approved as adjunctive therapy for partial-onset seizures in adults and children ≥ 3 years, and Horizant is indicated for moderate-to-severe restless leg syndrome (RLS). Product labeling notes that gabapentin ER and Horizant are not to be used interchangeably with other gabapentin products due to different pharmacokinetic profiles that affect dosing frequency or plasma concentrations.

Term	Definition
Step 1
generic gabapentin capsules, tablets, and oral solution
Step 2
Gabarone, Gralise (brand and generic), Horizant, Neurontin

Prescribing information referencesNeurontin PI Jul 2022; Gralise Apr 2023; Horizant Aug 2022; Gabarone Dec 2024

Policy updates and history

02/07/2024revised

Early Annual Revision - Gabapentin ER tablets (generic for Gralise) added to Step 2 products.

02/05/2025revisedLatest