HHS commits to keeping Paxlovid available as it transitions to the commercial market

The Department of Health and Human Services (HHS) announced Friday that it has reached an agreement with Pfizer to ensure continued access to the antiviral Paxlovid over the next several years as it prepares to transition the drug to the commercial market.

HHS said the deal “maximizes taxpayers’ investment.”

“This agreement builds on the strong partnership between HHS and Pfizer over the past three years, which has enabled the development, manufacturing 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 free by the government. HHS said the transition to commercialization would begin in November.

The federal government purchased tens of millions of doses of the drug at a discounted price from Pfizer, which agreed to provide an additional million treatments for the strategic national stockpile.

Pfizer will also refresh HHS’s Paxlovid inventory with current products through 2028 to ensure none of its supplies are expired and that the agency has the latest formulation.

As part of the transition, HHS said it would “prioritize and reserve” the doses it has acquired for the uninsured and those on Medicare and Medicaid.

Paxlovid will remain available for order through HHS until December 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 maintain its effectiveness as new strains emerge.

Under the agreement, people with Medicare and Medicaid as well as those who are uninsured will still be able to receive HHS-acquired doses of Paxlovid through the end of 2024.

Between 2025 and 2028, Pfizer will continue to operate a “patient assistance program” for the uninsured and the company will also maintain a copayment assistance program for those with 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 begins. Pfizer did not disclose the expected list price in its news release on the deal Friday, saying a price needed to be negotiated with health care payers.

The company said courses labeled under the emergency use authorization will remain free to patients until the end of the year, during which time it will also begin distributing courses aimed at the commercial market .