Leaders from both HHS and Pfizer highlighted the importance of continued affordable and
equitable access to Paxlovid as it transitions to the commercial market

On Monday, January 22, HHS and Pfizer leadership met virtually with health care provider groups, including the American Medical Association, American Academy of Family Physicians, and others – highlighting the pathways for a smooth transition of oral antivirals for COVID-19, including Paxlovid, to the commercial market and the importance of provider education and clear communication to consumers.

During the call, HHS leadership reminded providers that no patient should be forced to pay the full out-of-pocket cost to access Paxlovid, regardless of their insurance status. Providers should take steps to ensure patients understand the full range of options when it comes to accessing these life-saving treatments and anyone who is facing difficulties at the pharmacy counter should be directed to the PAXCESS patient assistance program (PAP).

Per the agreement with Pfizer announced on October 13, 2023, all individuals on Medicare, Medicaid, and those who are uninsured will continue to be able to access Paxlovid for free through the end of 2024. Additionally, on January 4, 2024, the Centers for Medicare & Medicaid Services (CMS) issued guidance that describes how Medicare Part D plans can operationalize agreements with Pfizer that will allow their enrollees to access Paxlovid for free through the plan without needing to enroll in the PAP.

Pfizer leadership also provided a demonstration of the PAXCESS PAP and detailed the resources available for both providers and patients on Paxlovid’s website – including prescriber information, drug interactions, PAP details, locations where people can find Paxlovid, and a hotline for patients.

The call included participants from the groups below:

• American Medical Association (AMA)
• American Osteopathic Association (AOA)
• American Nurses Association (ANA)
• American Association of Nurse Practitioners (AANP)
• American Association of Physician Assistants (AAPA)
• American College of Physicians (ACP)
• American Academy of Family Physicians (AAFP)
• American Geriatrics Society (AGS)
• AMDA – The Society for Post-Acute and Long-Term Care Medicine

The Biden-Harris Administration has made historic progress in our nation’s ability to manage COVID-19 so that it no longer meaningfully disrupts the way we live our lives. For the first time, vaccines are available to protect older adults in the United States against all three winter respiratory illnesses – COVID-19, flu, and RSV – and there are millions of courses of free USG Paxlovid at provider sites across the country available by the federal government. Free COVID-19 tests are also available at COVIDTests.gov.

Today’s call is part of a series of recent actions HHS has taken to maintain broad access to oral antivirals for COVID-19 as part of the transition to the commercial market:

• Since last fall, HHS, the Administration for Strategic Preparedness & Response (ASPR), CMS, and Pfizer have regularly met with stakeholder groups to discuss continued Paxlovid access and address other stakeholder questions around oral antivirals commercialization.
• As of October 13, 2023, HHS and Pfizer reached an agreement extending patient access to Paxlovid, maximizing taxpayer investment, and beginning Paxlovid’s transition to the commercial market. Under the October, 2023 agreement, individuals - including those on Medicare and Medicaid - maintain access to Paxlovid through the end of 2024. The agreement also enables access for the uninsured through 2028 and ensures that no HHS-procured product will be lost to expiry.
• On October 27, 2023, at the outset of Paxlovid’s transition to the commercial market, Secretary Becerra wrote to therapeutics manufacturers, distributors, pharmacies, and the health care payer community requesting their partnership as therapeutics transitioned to the commercial market and asking that they inform HHS immediately if they encounter any operational problems that could impede patient access to these treatments.
• On January 4, 2024, CMS released guidance for Medicare Part D plans that describes coverage and processing claims for COVID-19 therapeutics. As a reminder, Medicare Part D plans must cover commercially available oral antivirals for COVID-19, either as a formulary product or through the formulary exception process. We expect that many Part D plans will take advantage of an agreement with Pfizer that will allow their enrollees to access Paxlovid for free through the plan without needing to enroll in Pfizer’s patient assistance program.
• On January 9, 2024, Secretary Becerra met virtually with pharmacies, pharmacy benefit managers, and insurers to discuss HHS’ continued commitment and partnership to increase equitable access to COVID-19 therapeutics.