Subject: Vigabatrin products 1770-A SGM P2024

Drug

SABRIL  (vigabatrin )

VIGADRONE  (vigabatrin )

VIGAFYDE  (vigabatrin )

VIGPODER®  (vigabatrin )

vigabatrin

Policy:

      I.  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

          A.  Sabril, vigabatrin, Vigadrone, Vigpoder
               1.  Infantile spasms: Monotherapy in pediatric patients one month to two years of age for
                    whom the potential benefits outweigh the potential risk of vision loss.
               2.  Refractory Complex Partial Seizures: Adjunctive therapy in patients two years of age
                    and older who have responded inadequately to several alternative treatments. Vigabatrin
                    products are not indicated as a first line agent for complex partial seizures.

          B.  Vigafyde
               Infantile spasms: Monotherapy in pediatric patients one month to two 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.


    II.  CRITERIA FOR INITIAL APPROVAL

          A.  Infantile Spasms
               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.

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


   III.  CONTINUATION OF THERAPY

          A.  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.

         B.  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. Vigadrone [package insert]. Maple grove, MN: Upsher-Smith Laboratories, LLC; February 2020.
4. Vigafyde [package insert]. Parsippany, NJ: Pyros Pharmaceuticals. Inc.; June 2024.
5. Vigpoder [package insert]. Parsippany, NJ: Pyros Pharmaceuticals, Inc; July 2023.
6. 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. 2012;78(24):1974-1980.
7. Willmore LJ, Abelson MB, Ben-Menachem E, et al. Vigabatrin: 2008 Update. 2009; 50(2):163-173.
8. Xu Z, Gong P, Jiao X, et al. Efficacy of vigabatrin in the treatment of infantile epileptic spasms syndrome: A systemic review and meta-analysis. Epilepsia Open. 2023;8(2):268-277.
9. ILAE classification and definition of epilepsy syndromes with onset in neonates and infants: Position statement by the ILAE Task Force on Nosology and Definitions. 2022;63(6):1349-1397.
10. Faught E. Vigabatrin therapy for refractory complex partial seizures: review of clinical trial experience in the United States. Acta Neurol Scand Suppl. 2011;(192):29-35.
11. Gatson TN, Freemont OA, Coleman RL, et al. Vigabatrin (Sabril) for the treatment of refractory complex focal seizures in adults: Pharmacology and clinical considerations. 2023;15(10):e46414.

 

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 30, 2024