Subject: Paxlovid Limit 5099-H P09-2024_R

Drug

Antiviral for the Treatment of Covid-19

PAXLOVID for Emergency use Authorization  (nirmatrelvir tablets and ritonavir tablets)

PAXLOVID  (nirmatrelvir tablets and ritonavir tablets)

Policy:

Indications

FDA-Approved Indications

Paxlovid is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

Limitations of Use

• Paxlovid is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

Emergency Use Authorization

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of PAXLOVID for the treatment of adults and pediatric patients 12 years of age and older weighing at least 40 kg with mild-to-moderate coronavirus disease 2019 (COVID-19) and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Limitations of Use

• Paxlovid is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

Initial Limit Quantity

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

These drugs are for short-term acute use.

Drug	Limit
Paxlovid For Emergency Use Authorization   (300 mg nirmatrelvir; 100 mg ritonavir)	60 tablets (2 cartons containing 30 tablets (10 doses) each of 2 tablets of   nirmatrelvir 150 mg and 1 tablet of ritonavir 100 mg) / 30 days
Paxlovid (300 mg nirmatrelvir; 100 mg ritonavir)	60 tablets (2 cartons containing 30 tablets (10 doses) each of 2 tablets of   nirmatrelvir 150 mg and 1 tablet of ritonavir 100 mg) / 30 days
Paxlovid For Emergency Use Authorization   (150 mg nirmatrelvir; 100 mg ritonavir)	40 tablets (2 cartons containing 20 tablets (10 doses) each of 1 tablet of   nirmatrelvir 150 mg and 1 tablet of ritonavir 100 mg) / 30 days
Paxlovid (150 mg nirmatrelvir; 100 mg ritonavir)	40 tablets (2 cartons containing 20 tablets (10 doses) each of 1 tablets of   nirmatrelvir 150 mg and 1 tablet of ritonavir 100 mg) / 30 days

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Paxlovid [package insert]. New York, NY: Pfizer Inc.; May 2023.
2. Paxlovid [Emergency Use Authorization Fact Sheet for Health Care Providers]. New York, NY: Pfizer Inc.; November 2023.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed August 8, 2024.
4. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/https://online.lexi.com. (cited: 08/08/2024).

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.

March 23, 2025