Vigabatrin agents (SABRIL; VIGADRONE)

Vigabatrin agents (SABRIL; VIGADRONE)

Self-Administration – oral tablet, powder for oral solution packets.

Diagnosis considered for coverage:

• Refractory Complex Partial Seizures (CPS): Indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Sabril/Vigadrone is not indicated as a first line agent for complex partial seizures.
• Infantile Spasms (IS) (1 Month to 2 Years of Age): Indicated as monotherapy for pediatric patients with infantile spasms (IS) 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.

Coverage Criteria:

For diagnosis of seizures:

• One of the following:
  • Both of the following:
    • Diagnosis of infantile spasms (IS)
    • Patient is 1 month to 2 years of age; OR
  • All of the following:
    • Diagnosis of complex partial seizures (CPS)
    • Patient is 2 years of age or older
    • Used as adjunctive therapy
    • One of the following:
      • Trial and failure, contraindication, or intolerance to two preferred anticonvulsants [e.g., Lamictal (lamotrigine), Depakene (valproic acid), Dilantin (phenytoin)]
      • For continuation of prior therapy; AND
• For brand Sabril only: One of the following:
  • Trial and failure or intolerance to generic vigabatrin tablets or oral suspension
  • For continuation of prior therapy if the patient is established on brand Sabril

Reauthorization Criteria:

For diagnosis of seizures:

• Documentation of positive clinical response to therapy.

Dosing:

Refractory Complex Partial Seizures (CPS):

• Adults (17 years of age and older): Initiate at 1,000 mg/day (500 mg twice daily); increase total daily dose weekly in 500 mg/day increments, to the recommended dose of 3,000 mg/day (1,500 mg twice daily)
• Pediatric (2 to 16 years of age): The recommended dosage is based on body weight and administered as two divided doses
• Dose patients weighing more than 60 kg according to adult recommendations

Infantile Spasms (IS):

• Pediatric (1 Month to 2 Years of Age): Initiate at a daily dose of 50 mg/kg (25 mg/kg twice daily); increase total daily dose every 3 days, in increments of 25 mg/kg/day to 50 mg/kg/day, up to a maximum daily dose of 150 mg/kg (75 mg/kg twice daily)

Coverage Duration:

• 1 year

Authorization is not covered for the following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• VIGADRONE is pure vigabatrin powder with no additional inactive ingredient. Compared to SABRIL (vigabatrin) for Oral Solution, VIGADRONE contains the same active ingredient in the same strength and uses the same dosage form (powder that is mixed with water) and administration method.
• Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) program overview: Vigabatrin Sponsors have created Vigabatrin REMS program to administer the REMS process, which facilitates access to vigabatrin only through select specialty and inpatient pharmacies.

Policy Updates:

• 11/14/2023 – New policy approved by WHA P&T Committee for drug with existing utilization management. (P&T 11/14/2023)

References:

1. Sabril Prescribing Information. Lundbeck. Deerfield, IL. May 2020.
2. Vigadrone Prescribing Information. Upsher-Smith Laboritories, LLC. Maple Grove, MN. February 2020.
3. REMS@FDA: Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. U.S. Food and Drug Administration; Available at: https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=364. Accessed February 15, 2021.
4. Kwan P, Arzimanoglou A, Berg AT, et al. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77.