Subject: vigabatrin products SGM 1770-A P2025

Drug

vigabatrin products

SABRIL  (vigabatrin)

VIGADRONE  (vigabatrin)

VIGAFYDE  (vigabatrin)

VIGPODER  (vigabatrin)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications

Sabril, vigabatrin, Vigadrone, Vigpoder^1-4,6

• Monotherapy for the treatment of infantile spasms in pediatric patients 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.
• Adjunctive therapy in patients two years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Vigabatrin products are not indicated as a first line agent for complex partial seizures.

Vigafyde⁵

Monotherapy for the treatment of infantile spasms in pediatric patients 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.

All other indications are considered experimental/investigational and not medically necessary.

Coverage Criteria

Infantile Spasms^1-7,10

Authorization of 4 weeks may be granted for treatment of infantile spasms (infantile epileptic spasms syndrome [IESS]) in members less than 2 years of age.

Complex Partial Seizures (Sabril, vigabatrin, Vigadrone, Vigpoder only)^1-4,6,8-9

Authorization of 3 months may be granted for treatment of refractory complex partial seizures when member has had an inadequate response to at least two alternative treatments for complex partial seizures.

Continuation of Therapy

Infantile Spasms

Authorization of 6 months may be granted for members requesting vigabatrin for continuation of therapy when member has shown substantial clinical benefit from vigabatrin therapy.

Complex Partial Seizures (Sabril, vigabatrin, Vigadrone, Vigpoder only)

Authorization of 12 months may be granted for members requesting vigabatrin for continuation of therapy when member has shown substantial clinical benefit from vigabatrin therapy.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Sabril [package insert]. Deerfield, IL: Lundbeck Inc.; October 2021.
2. Vigabatrin for oral solution [package insert]. Malvern, PA: Endo USA; August 2023.
3. Vigabatrin tablet [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; November 2022.
4. Vigadrone [package insert]. Maple grove, MN: Upsher-Smith Laboratories, LLC; March 2023.
5. Vigafyde [package insert]. Parsippany, NJ: Pyros Pharmaceuticals. Inc.; June 2024.
6. Vigpoder [package insert]. Parsippany, NJ: Pyros Pharmaceuticals, Inc; July 2023.
7. Go CY, Mackay MT, Weiss SK, et al. Evidence-based guideline update: Medical treatment of infantile spasms: Report of the Guideline Development Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2012;78(24):1974-1980.
8. Faught E. Vigabatrin therapy for refractory complex partial seizures: review of clinical trial experience in the United States. Acta Neurol Scand. 2011;124(192):29-35.
9. Kanner AM, Ashman E, Gloss D, et al. Practice guideline update summary: Efficacy and tolerability of the new antiepileptic drugs II: Treatment-resistant epilepsy. Neurology. 2018;91:82-90.
10. Carmant L. Vigabatrin therapy for infantile spasms: review of major trials in Europe, Canada, and the United States; and recommendations for dosing. Acta Neurol Scand. 2011;124(192):36-47.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 12, 2025