Pharmacy Prior Authorization Criteria

Sabril, Vigadrone, Vigafyde (vigabatrin)

Indications for Prior Authorization

Sabril (vigabatrin), Vigadrone (vigabatrin)

• For diagnosis of Refractory Complex Partial Seizures
  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.

• For diagnosis of Infantile Spasms (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.

Vigafyde (vigabatrin)

• For diagnosis of Infantile Spasms (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.

Criteria

Generic vigabatrin, Vigadrone

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Both of the following:
• Diagnosis of infantile spasms [A]
• Patient is 1 month to 2 years of age
OR
• All of the following:
• Diagnosis of complex partial seizures
AND
• Patient is 2 years of age or older
AND
• Used as adjunctive therapy
AND
• One of the following:
• Trial and failure, contraindication, or intolerance to two formulary anticonvulsants [e.g., Lamictal (lamotrigine), Depakene (valproic acid), Dilantin (phenytoin)] [B]
• For continuation of prior therapy

Brand Sabril

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

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

Brand Vigafyde

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Both of the following:
• Diagnosis of infantile spasms [A]
• Patient is 1 month to 2 years of age
AND
• One of the following:
• Trial and failure, or intolerance to generic vigabatrin oral suspension
OR
• For continuation of prior therapy

Generic vigabatrin, Vigadrone, Brand Sabril, Brand Vigafyde

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy

P & T Revisions

2024-09-16, 2024-03-04, 2023-12-20, 2023-10-12, 2023-03-01, 2022-02-16, 2021-09-27, 2021-05-26, 2021-05-25, 2021-03-03, 2020-09-01, 2020-02-27, 2019-10-29

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.
5. Vigafyde Prescribing Information. Pyros Pharmaceuticals, Inc. Parsippany, NJ. June 2024.

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End Notes

1. 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. The REMS includes the following elements: 1) Patient Guide: outlines the vision loss that can occur with vigabatrin treatment; 2) Elements to Assure Safe Use (ETASU): Vigabatrin Sponsors will maintain a database of certified prescribers (e.g., must counsel regarding the risks associated with vigabatrin, including vission loss; ensure periodic visual monitoring is performed on an ongoing basis, report any adverse event suggestive of vision loss; enrolling patients taking vigabatrin in the REMS program) and will ensure that prescribers comply with the requirements of the REMS and may de-certify noncompliant prescribers. [3] Assessing the effectiveness of vigabatrin should be done within 12 weeks for CPS patients and within 2-4 weeks for IS. Vision monitoring is mandatory in adults and it is required to the extent possible in infants at baseline (no later than 4 weeks after starting vigabatrin) and at least 3 months while on therapy. Vision testing is also required about 3-6 months after the discontinuation of vigabatrin therapy. [1, 2] Under REMS requirement, pharmacies that dispense vigabatrin will be specially certified. Vigabatrin Sponsors will ensure that each patient treated with vigabatrin is enrolled in the Vigabatrin REMS before vigabatrin is dispensed and that vigabatrin will be dispensed to patients with documentation of safe-use conditions. 3) Implementation system: Vigabatrin Sponsors will ensure that vigabatrin is only distributed to certified pharmacies by ensuring that the wholesale/distributors comply with the program requirements, which includes submission of distribution records of all vigabatrin shipments to the REMS program. Vigabatrin Sponsors will maintain a secure database of all certified pharmacies and patients enrolled in the REMS program. A REMS program call center and website will be maintained by Vigabatrin Sponsors in order to provide resources and support for all aspects of the REMS program. [3]
2. To improve patient care and facilitate clinical research, the International League Against Epilepsy (ILAE) appointed a Task Force to formulate a consensus definition of drug resistant epilepsy. The following definition was formulated: Drug resistant epilepsy may be defined as failure of adequate trials of two tolerated and appropriately chosen and used antiepileptic drug (AED) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom. [4]

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Revision History

• 2024-09-16: update guideline
• 2024-03-04: Annual Review - no changes to clinical intent
• 2023-12-20: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-10-12: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-03-01: Annual Review - No criteria changes
• 2022-02-16: Annual Review - addition of age criteria to align with FDA labeled indication
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2021-03-03: 2021 Annual Review, no changes to criteria.
• 2020-09-01: Update criteria to allow for either t/f requirements or continuation of therapy
• 2020-02-27: Updated indication/age range/annual review.
• 2019-10-29: Added step through generic for brand

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