HHS pledges to keep Paxlovid available as it transitions to commercial market

The Department of Health and Human Services (HHS) announced on Friday it had reached an agreement with Pfizer to ensure continued access to the antiviral Paxlovid for the next few years as it prepares to transition the drug into the commercial market.

HHS said the agreement “maximizes taxpayer investment.”

“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 department said in a statement.

Since it was authorized by the Food and Drug Administration (FDA) in December 2021 to treat the coronavirus, Paxlovid has been distributed for free by the government. HHS said the transition to commercialization will begin in November.

The federal government has purchased tens of millions of doses of the medicine at a discounted price from Pfizer, which has agreed to provide an additional 1 million treatment courses for the Strategic National Stockpile.

Pfizer will also refresh HHS’s inventory of Paxlovid with up-to-date products through 2028 to make sure none of its supply is expired and that the agency has the latest formulation.

As part of the transition, HHS said it will be “prioritizing and reserving” the doses it has acquired for the uninsured and people on Medicare and Medicaid.

Paxlovid will remain available for order through HHS until Dec. 15.

Unlike vaccines, Paxlovid works by targeting a protein that COVID-19 viruses need to continue replicating. This protein mutates less than the spike proteins targeted by vaccines, allowing Paxlovid to retain its efficacy as new strains crop up.

As part of the agreement, people on Medicare and Medicaid as well those who are uninsured will still be able to receive doses of Paxlovid that were acquired by HHS through the end of 2024.

Between 2025 and 2028, Pfizer will continue operating a “patient assistance program” for uninsured individuals and the copmany will also maintain copay assistance program for those on commercial insurance plans.

The U.S. government paid about $530 per course of Paxlovid, a discounted price that will almost certainly be higher once the transition to commercialization commences. Pfizer did not disclose the expected list price in its press release on the agreement Friday, saying a price was to be negotiated with health care payers.

The company said courses labelled under the Emergency Use Authorization will remain free to patients through the end of the year, during which time it will also begin distributing courses designated for the commercial market.