Oral antiviral treatment works by targeting specific proteins on the SARS-CoV-2 virus to prevent efficient virus replication within the host cell.
Paxlovid and molnupiravir reduce the risk of hospitalization and death by 88% and 30% respectively, in patients at high-risk for severe COVID-19 when started early after symptom onset.
As of November 1st, 2023, COVID-19 antivirals, Paxlovid and Lagevrio (molnupiravir), will begin their transition from United State Government distribution to traditional commercial channels. Please refer to the Commercialization section for more information regarding this transition.
The FDA authorized two oral antivirals, Pfizer's Paxlovid and Merck's molnupiravir, for the treatment of COVID-19 in certain patients who:
The FDA also expanded approval of Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing who are:
Health care providers should discuss the risks and benefits of treatment with their patients.
As of November 1st, 2023, both Lagevrio and Paxlovid will begin their transition from United State Government distribution to traditional commercial channels. Wholesale distributors anticipate having commercial orders filled within one to two weeks.
Any supply of U.S. government-issued therapeutics, including Paxlovid, must remain available to patients at no cost. Paxlovid should be dispensed to patients until the provider has commercial supply stocked. Moreover, Lagevrio should be dispensed to patients until depletion or expiration, whichever comes first. Once commercialized, programs will be established to ensure that Paxlovid is available to uninsured and underinsured individuals. Please refer to the Programs for Underinsured and Uninsured Individuals section for more information regarding these programs.
Paxlovid Disposal Management
Any expired product should be disposed of through the manufacturers return process or on site in accordance with federal, state, and local regulations.
Lagevrio Disposal Management
Product cannot be returned or disposed of unless expired (first expiry is in 2024). Once expired, product should be disposed of through the manufacturers return process or on site in accordance with federal, state, and local regulations.
USG Inventory Reporting
In accordance with the COVID-19 Therapeutics Provider Agreement, providers are expected to continue to provide reporting of all USG courses that they received and should report inventory, administration/dispensing, and disposal data until the provider’s USG product inventory is fully reconciled. Please do not record inventory or dispensing of commercially acquired inventory into HPOP, only USG product should be entered into current HPOP reporting fields.
Paxlovid and Lagevrio Expiry
The USG-procured supply has a distinct National Drug Code from the commercial EUA-labeled supply. The first lot expiry of government purchased Paxlovid began on July 31st, 2023, and most in field is later. The first lots of government purchased Lagevrio will begin expiring in February 2024 and the last in February 2025. Please continue to check the ASPR searchable expiration database for specific expiration dates.
Resources
For more information regarding the commercialization of Paxlovid, please refer to the COVID-19 Therapeutics Commercialization Transition Guide.
Programs for Uninsured and Underinsured Individuals
Paxlovid Patient Assistance Program (PAP)
Through December 31, 2024, anyone uninsured or covered by federal programs, such as Medicare or Medicaid, can receive USG procured, NDA-labeled Paxlovid at no cost through the USG PAP operated by Pfizer until 2028. Participating PAP dispensing sites will be sent replacement product for any dispensed product within this program.
Starting January 1, 2025, eligible uninsured and underinsured patients can receive USG procured, NDA-labeled Paxlovid at no cost. Participating PAP dispensing sites will be sent replacement product for any dispensed product within this program.
For retail pharmacies that would like to participate in the Patient Assistance Program, please contact the program vendor at [emailprotected] or call 1-877-219-7225.
Paxlovid Co-pay Savings Program
A co-pay savings program will be available for eligible commercially insured patients. More information will be provided shortly.
Lagverio Patient Assistance Program
This private and confidential program provides medicine, free of charge, for up to one year to eligible individuals, mostly the uninsured, who, without our assistance, could not afford needed Merck medicines. This program is expected to begin mid-November, 2023. For more information, please refer to the Merck Patient Assistance Program brochure or call 1-800-727-5400.
Lagevrio Bulk Replacement Program
For more information on the bulk replacement program, please call 1-888-727-8180.
Availability
HHS has created two resources to assist providers:
- A COVID-19 Therapeutics Locator which can be used to find locations with available Paxlovid or Molnupiravir.
- A Medication Locator which can be used to find Test to Treat locations and pharmacies to fill COVID-19 prescriptions.
- If you are within New York City, please refer to: COVID-19: Outpatient Therapeutic Information for Providers - NYC Health
Patients will require a prescription for Paxlovid and molnupiravir (Lagevrio).
Contact
Please contact the COVID-19 Therapeutics team at [emailprotected] if you have any questions and/or concerns.
