Subject: Nayzilam PA with Limit 3102-C P06-2025

Drug

NAYZILAM  (midazolam )

Policy:

Indications

FDA-approved Indications

Nayzilam 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 12 years of age and older.

Coverage Criteria

Intermittent, Stereotypic Episodes of Frequent Seizure Activity

Authorization may be granted when the requested drug is being prescribed for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from the patient’s usual seizure pattern in a patient with epilepsy when the following criteria is met:

• The patient is 12 years of age or older.

Quantity Limits Apply

10 nasal spray units per 25 days or 30 nasal spray units per 75 days

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.

Duration of Approval (DOA)

• 3102-C: DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Nayzilam [package insert]. Smyrna, GA: UCB, Inc.; January 2023.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com. Accessed May 2, 2025.
3. 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