CurrentCignaPolicy DQM023

Antiseizure Medications - Vigabatrin Drug Quantity Management Policy - Per Days for Individual and Family Plans - (DQM023)

Drug Quantity Management policy governing maximum dispensed quantities per time period for vigabatrin products (Sabril, Vigadrone, Vigpoder, Vigafyde) for individual and family plans administered by Cigna; includes allowed overrides when specific criteria are met. Approvals provided for 1 year; DQM criteria do not replace other PA/medical necessity requirements.

Policy Summary

PayerCigna

PolicyAntiseizure Medications - Vigabatrin Drug Quantity Management Policy - Per Days for Individual and Family Plans - (DQM023)

Policy CodePolicy DQM023

Change TypeNew policy

Effective Date05/01/2026

Next Review Date

Key ActionSubmit request for quantity override when patient requires >3,000 mg/day for 500 mg tablets/packets (or >2,500 mg/day for Vigafyde); approvals are granted per listed maximums and are valid for 1 year.

SourceLink

POLICY UPDATE CHANGES

New policy created for Vigabatrin Drug Quantity Management.

4Products listed (Sabril, Vigadrone, Vigpoder, Vigafyde)

180Tablet retail 30-day limit (tablets)

200Powder packet retail 30-day limit (packets)

5Vigafyde retail 30-day limit (bottles)

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Coverage Summary

Payer: Cigna. Policy short title: Vigabatrin Drug Quantity Management (DQM023), effective 2026-05-01 (Policy Number DQM023). Products covered: Sabril, Vigadrone, Vigpoder, Vigafyde (vigabatrin tablets, powder for oral solution, and oral solution formulations). Purpose: this Drug Quantity Management (DQM) program limits dispensing quantities per time period with defined overrides when higher-dose therapy is medically necessary to promote safe, effective, and economical use. Approvals are provided for 1 year. The DQM criteria do not replace or satisfy other prior authorization or medical necessity requirements.

Key thresholds and quick facts

Retail Maximum Quantity Per 30 Days (tablets)180 tablets

Retail Maximum Quantity Per 30 Days (powder packets)200 packets

Retail Maximum Quantity Per 30 Days (Vigafyde bottles)5 bottles (750 mL)

Home Delivery Maximum Quantity Per 90 Days (tablets)540 tablets

Home Delivery Maximum Quantity Per 90 Days (powder packets)550 packets

Home Delivery Maximum Quantity Per 90 Days (Vigafyde bottles)15 bottles (2,250 mL)

Override thresholds>3,000 mg/day for tablets/packets; >2,500 mg/day for Vigafyde

Override maximums (per dispensing)Tablets: up to 360 retail / 1,080 home delivery; Packets: up to 400 retail / 1,100 home delivery; Vigafyde: up to 15 retail / 45 home delivery

Approval duration1 year

Products listed (count)4

Drug Quantity Limits & Overrides (what prescribers/dispensers must know)

Drug Quantity Limits - Standard Limits

Standard maximum quantity allowed per dispensing unless an exception below is met:

ALL of the following

Sabril 500 mg tablets - Standard Limits: Sabril (vigabatrin) 500 mg tablets: Retail Maximum Quantity Per 30 Days = 180 tablets; Home Delivery Maximum Quantity Per 90 Days = 540 tablets.
Sabril 500 mg powder packets - Standard Limits: Sabril (vigabatrin) 500 mg powder packets: Retail Maximum Quantity Per 30 Days = 200 packets; Home Delivery Maximum Quantity Per 90 Days = 550 packets.
Vigadrone 500 mg tablets - Standard Limits: Vigadrone 500 mg tablets: Retail Maximum Quantity Per 30 Days = 180 tablets; Home Delivery Maximum Quantity Per 90 Days = 540 tablets.

Applicable Products / Codes

Products covered by the quantity management policy (by brand/generic and form)mixedCovered

Sabril	vigabatrin tablets and powder for oral solution (500 mg tablets; 500 mg powder packets)
Vigadrone	vigabatrin tablets and powder for oral solution (500 mg tablets; 500 mg powder packets)
Vigpoder	vigabatrin powder for oral solution (500 mg powder packets)
Vigafyde	vigabatrin oral solution 100 mg/mL (150 mL bottle)

Background & Definitions

Background: Vigabatrin is indicated for refractory complex partial seizures as adjunctive therapy in patients ≥2 years and for infantile spasms as monotherapy in patients 1 month to 2 years. Dosing varies by indication, age, weight, and formulation (tablets, powder packets, or oral solution), and renal impairment requires dose adjustment. The Drug Quantity Management program is intended to ensure safe, effective, and economical use by limiting standard dispensing quantities while providing defined overrides when patients require higher doses.

Term	Definition
Retail Maximum Quantity Per 30 Days
Maximum quantity allowed to be dispensed at retail for a 30-day supply as specified per product/formulation.
Home Delivery Maximum Quantity Per 90 Days
Maximum quantity allowed to be dispensed via home delivery for a 90-day supply as specified per product/formulation.

Clinical Evidence & References

Evidence: References include prescribing information for Sabril, Vigadrone, Vigafyde, and Vigpoder, and the AAN/AES practice guideline update (2018). The BRIEF cites these references but does not present specific trial metrics in this summary.

Revision History

2026-05-01policy effectiveLatest

Policy published effective 05/01/2026 as new coverage rule DQM023.

Exceptions to Quantity Limits (Medically Necessary Overrides)

Exceptions are covered as medically necessary when ONE of the following criteria is met; any other exception is not medically necessary:

ANY of the following

Tablets override - Sabril and Vigadrone 500 mg tablets: For Sabril and Vigadrone 500 mg tablets: If a patient requires a dose of more than 3,000 mg per day, approve requested quantity not to exceed 360 tablets per dispensing at retail or 1,080 tablets per dispensing at home delivery.> 3,000 mg/day
Allows dosing up to 6,000 mg/day.
Powder packets override - Sabril, Vigadrone, Vigpoder 500 mg packets: For Sabril, Vigadrone, and Vigpoder 500 mg powder packets: If a patient requires a dose of more than 3,000 mg per day, approve requested quantity not to exceed 400 packets per dispensing at retail or 1,100 packets per dispensing at home delivery.> 3,000 mg/day
Allows dosing up to approximately 6,000 mg/day, rounded to nearest 50-packet carton.
Vigafyde solution override - 100 mg/mL: For Vigafyde 100 mg/mL solution: If a patient requires a dose of more than 2,500 mg per day, approve requested quantity not to exceed 15 bottles (2,250 mL) per dispensing at retail or 45 bottles (6,750 mL) per dispensing at home delivery.> 2,500 mg/day
Allows dosing up to approximately 6,000 mg/day, rounded to nearest 150 mL bottle.

Prior Authorization

Drug Quantity Management override request

Submit a Drug Quantity Management override request when a patient requires more than 3,000 mg/day for 500 mg tablets or packets (or more than 2,500 mg/day for Vigafyde); if approved, authorize quantities up to the listed maximums per product (tablets: up to 360 tablets retail / 1,080 home delivery; powder packets: up to 400 packets retail / 1,100 home delivery; Vigafyde solution: up to 15 bottles (2,250 mL) retail / 45 bottles (6,750 mL) home delivery) and approvals are valid for 1 year; note that meeting Drug Quantity Management criteria does not replace any other prior authorization or medical necessity requirements.

Sabril (500 mg tablets; 500 mg powder packets)
Vigadrone (500 mg tablets; 500 mg powder packets)
Vigpoder (500 mg powder packets)
Vigafyde (100 mg/mL oral solution, 150 mL bottle)

Documentation Required

Clinical justification for higher dosing

Document and provide clinical rationale that the patient requires dosing greater than 3,000 mg/day for 500 mg tablets/packets (or greater than 2,500 mg/day for Vigafyde) to support approval of a quantity override; include relevant dosing calculation (weight-based dosing for pediatric or infantile spasms), indication (e.g., refractory complex partial seizures or infantile spasms), and any clinical data showing inadequate response to alternatives, and note that other medical necessity criteria may still apply.

Weight-based dosing calculations and patient weight (to justify dose >3,000 mg/day or >2,500 mg/day for Vigafyde)
Specific diagnosis (refractory complex partial seizures or infantile spasms) and age
Prior treatment history showing inadequate response to alternatives
Renal function or other factors affecting dosing and safety monitoring