HHS and Pfizer Reach Paxlovid Agreement to Improve Access

Last week, the United States Department of Health and Human Services (HHS) announced that it had negotiated an agreement with Pfizer Inc. to bolster access to Paxlovid as it enters the commercial market next month.

Paxlovid, nirmatrelvir packaged with ritonavir, is an antiviral drug used to manage COVID-19 in patients with mild to moderate infections. The US Food and Drug Administration granted the drug an Emergency Use Authorization (EUA) on December 22, 2021. Earlier this year, the drug received full approval from the FDA for patients aged 12 and older with mild-to-moderate COVID-19.

The agreement between the HHS and Pfizer has four major components: protecting patients in public programs, managing HHS-procured products, creating a stockpile for emergencies, and smoothly transitioning into the commercial market.

One of the primary goals was to ensure that patients enrolled in public insurance programs, particularly Medicare, are protected and can access Paxlovid even after it is commercialized. Under the new agreement, the HHS will continue to provide Paxlovid to uninsured individuals and Medicare and Medicaid beneficiaries until the end of 2024.

The HHS will discontinue its patient assistance program at the close of the next year. For 2025–2028, Pfizer has agreed to run a patient assistance program for uninsured or underinsured patients using HHS-procured Paxlovid. Additionally, the company will offer copay assistance programs for patients with private insurance.

Beyond securing patient access, the agreement is intended to bolster the supply of Paxlovid. By managing HHS-procured products and refreshing the available pool, the HHS and Pfizer will collaboratively ensure that the product is not lost to expiry. In addition, both entities are working together to develop a national stockpile of one million treatment courses to prepare for potential outbreaks.

Finally, the HHS plans to maintain the availability of Paxlovid throughout its transition to commercial distribution.

“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,” the HHS press release noted.