Subject: Libervant, Valtoco Limit 3518-H P06-2025

Drug

LIBERVANT  (diazepam )

VALTOCO  (diazepam )

Policy:

Indications

FDA-approved Indications

Libervant

Libervant is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 to 5 years of age.

Valtoco

Valtoco is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 years of age and older.

Initial Limit Quantity

Limits should accumulate across all drugs and strengths up to highest quantity listed depending on the order the claims are processed.

The duration of 25 days is used for a 30-day fill period and 75 days is used for a 90-day fill period to allow time for refill processing.

Drug	1 Month Limit	3 Month Limit
Libervant (diazepam buccal film)	10 individual pouches / 25 days	30 individual pouches / 75 days
Valtoco (diazepam nasal spray)	10 blister packs / 25 days	30 blister packs / 75 days

Place of Service:

Outpatient

The above policy is based on the following references:

References

1. Libervant [package insert]. Warren, NJ: Aquestive Therapeutics; April 2024.
2. Valtoco [package insert]. San Diego, CA: Neurelis, Inc.; April 2025.
3. Lexicomp Online, Pediatric and Neonatal Lexi-Drugs. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com. Accessed May 2, 2025.
4. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 05/02/2025).

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 11, 2025