Subject: Lagevrio Limit 5078-H P09-2024_R

Drug

LAGEVRIO  (molnupiravir)

Policy:

Uses

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product Lagevrio for treatment of adults with mild-to-moderate coronavirus disease 2019 (COVID-19):

• who are at high risk for progression to severe COVID-19, including hospitalization or death.
• for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.

Limitations of Use

• Lagevrio is not authorized for use in patients who are less than 18 years of age.
• Lagevrio is not authorized for initiation of treatment in patients hospitalized due to COVID-19. Benefit of treatment with Lagevrio has not been observed in subjects when treatment was initiated after hospitalization due to COVID-19.
• Lagevrio is not authorized for use for longer than 5 consecutive days.
• Lagevrio is not authorized for pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

Initial Limit Quantity

This drug is for short-term acute use.

Drug	Limit
Lagevrio (molnupiravir) 200 mg capsule	40 capsules / 30 days

Place of Service:

Outpatient

The above policy is based on the following references:

1. Lagevrio [Emergency Use Authorization Fact Sheet for Healthcare Providers]. Rahway, NJ: Merck Sharp & Dhome LLC; June 2024.
2. Lexicomp Online, Lexi-Drugs Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed August 5, 2024.
3. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 08/05/2024).

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.

February 16, 2025