The U.S. Department of Health and Human Services (HHS), announced that HHS and Pfizer have reached an agreement that extends patient access to Paxlovid, maximizes taxpayer investment, and begins Paxlovid’s transition to the commercial market in November 2023. This agreement builds on HHS and Pfizer’s strong partnership over the last three years that enabled the development, manufacture, and distribution of COVID-19 vaccines and therapeutics at a record pace.

HHS has consistently expressed a shared interest in jointly transitioning Paxlovid to the commercial market while ensuring that the United States taxpayer continues to receive fair and reasonable benefit from the HHS procurement of this product, with a focus on ensuring affordable access for beneficiaries in public programs like Medicare and Medicaid as well as for those who are uninsured. Per the agreement announced today, HHS and Pfizer will begin preparations for Pfizer to transition Paxlovid to the commercial market in November 2023.

Key features of today’s agreement are:

• Protecting individuals in public programs, particularly Medicare. Individuals on Medicare, Medicaid, and those who are uninsured will continue to be able to access HHS-procured Paxlovid for free through the end of 2024 via a patient assistance program. From 2025-2028, Pfizer will continue to run a patient assistance program for individuals who are uninsured or underinsured with HHS-procured Paxlovid. In parallel, Pfizer will operate a copay assistance program for individuals with commercial insurance through 2028.
• Ensuring no HHS-procured product is lost to expiry. Up-to-date product will be refreshed from Pfizer through 2028, ensuring that the HHS inventory of Paxlovid will not expire and will include all new formulations of Paxlovid authorized or approved for use in the U.S.
• Creating a stockpile for future emergencies. In addition to ensuring that HHS maintains every course of Paxlovid that it has purchased, Pfizer will provide HHS with a stockpile of an additional one million treatment courses to ensure preparedness for future COVID-19 surges. 
• Providing a smooth transition to the commercial market. HHS will ensure a smooth and predictable transition to the commercial market over the next few months while prioritizing and reserving our HHS-procured treatment courses for people with Medicare and Medicaid, and for those who are uninsured. During this transition to commercial distribution, Paxlovid will remain available for ordering from HHS through December 15, 2023.

You can learn more about HHS’ COVID-19 response and preparedness at HHS.gov.