Subject: vigabatrin-Sabril-Vigadrone 1770-A SGM P2023

Drug

SABRIL  (vigabatrin tablets and powder for oral solution)

VIGADRONE  (vigabatrin powder for oral solution)

vigabatrin tablets and powder for oral solution

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.  Infantile spasms: Monotherapy for pediatric patients with
               infantile spasms one month to two years of age for whom the
               potential benefits outweigh the potential risk of vision loss.
          B.  Complex Partial Seizures: Adjunctive therapy for adults and
               pediatric 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.

          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 in members less than 2 years of age.

           B.  Complex Partial Seizures
                Authorization of 3 months may be granted for treatment of
                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
               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]. Chestnut Ridge, NY: Par Pharmaceutical; October 2021.
3. Vigadrone [package insert]. Maple grove, MN: Upsher-Smith Laboratories, LLC; February 2020.
4. Livingston JH, Beaumont D, Arzimanoglou A, et al: Vigabatrin in the treatment of epilepsy in children. Br J Clin Pharmacol. 1989; 27:109S-112S.
5. Luna D, Dulac O, Pajot N, et al: Vigabatrin in the treatment of childhood epilepsies: a single-blind placebo-controlled study. 1989; 30:430-437.
6. Pellock JM, Hrachovy R, Shinnar S, et al. Infantile spasms: A U.S. consensus report. Epilepsia. 2010:51:2175-2189.
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. 2012; 78:1974-1980.
8. Hancock EC, Osborne JP, Edwards SW. Treatment of infantile spasms. Cochrane Database Syst Rev. 2013;6:CD001770.
9. Riikonen R. Recent advances in the pharmacotherapy of infantile spasms. CNS Drugs 2014; 28:279-290.
10. Pavone P, Striano P, Falsaperla R, et al. Infantile spasms syndrome, West Syndrome and related phenotypes: what we know in 2013. Brain & Development. 2014; 739-751.
11. Willmore LJ, Abelson MB, Ben-Menachem E, Pellock JM, Shields WD. Vigabatrin: 2008 Update. 2009; 50(2):163-173.
12. Faught E. Vigabatrin therapy for refractory complex partial seizures: review of clinical trial experience in the United States. Acta Neurol Scand. 2011; 124(Suppl.192):29-35.

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 14, 2023