HHS Patient Assistance Program Aims To Boost Access to COVID-19 Drug

The Department of Health and Human Services (HHS) will ensure access to a coronavirus therapy from Pfizer for Medicare and Medicaid beneficiaries and the uninsured through a patient assistance program, the department announced.

“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 press release stated.

According to the agreement, the drug known as Paxlovid will be available to public payer beneficiaries in Medicare and Medicaid as well as the uninsured through the end of 2024. Beneficiaries will not have to pay for access.

The process of transitioning Paxlovid to the commercial market will start in November 2023.

According to the Pfizer announcement, Paxlovid will be commercialized starting January 1, 2024.

The US government will return 7.9 million treatment courses of the drug to Pfizer. These treatment courses were labeled for use under the emergency use authorization, the Pfizer press release explained.

In return, the federal government will have credit for future Pfizer treatment courses with an NDA label. Pfizer will give 1.0 million Paxlovid treatment courses to the national stockpile.

Additionally, Pfizer will participate in a patient assistance program for federally insured and uninsured or underinsured individuals. The program will serve both federal beneficiaries and uninsured and underinsured individuals through the end of 2024. Then, from 2024 through 2028, the program will continue to serve uninsured and underinsured patients only.

Pfizer will work with payers to negotiate prices for the commercialized Paxlovid treatment.

The pharmaceutical company expected to see lower revenues as a result of this deal, bringing the expected revenue range of $67.0 to $70.0 billion down to $58.0 to $61.0 billion.

“Over the past several years, we have continued to ensure supply readiness for our COVID products, and as we gain additional clarity around vaccination and treatment rates for COVID, we will be better able to estimate the appropriate level of supply to meet demand and continue to address any ongoing public health needs,” Albert Bourla, chairman and chief executive officer of Pfizer Inc., shared in the pharmaceutical company’s press release.

“As a result, we continue to expect our COVID-related revenues to contribute to our business in future periods, helping us to further invest in activities that drive Pfizer’s long-term growth potential.”

The announcement comes as the country transitions from federal coverage for COVID-19 vaccines and treatments to private payer coverage.

Commercialization involves opening up a treatment purchased by the federal government to adoption by private payers in addition to public payers.  

Some experts anticipate that the commercialization of the coronavirus vaccine in particular will offset payers’ savings from coronavirus testing cost-sharing.

This announcement represents only one of the steps HHS is taking to ensure affordable access to coronavirus vaccines and treatments for Americans. Earlier in 2023, the department announced a public-private partnership with pharmaceutical companies to continue access to treatment for uninsured individuals. Paxlovid was one of the drugs involved in this effort.