Letter to COVID-19 therapeutics manufacturers, distributors, pharmacies and the health care payer community.

To COVID-19 therapeutics manufacturers, distributors, pharmacies and the health care payer community:

We appreciate your strong partnership over the past three years in providing broad access to COVID-19 therapeutics. Together, we have distributed more than 28 million treatment courses of therapeutics. Your collaboration and dedication to this mission have enabled the Department of Health and Human Services (HHS) to deliver safe and effective medical countermeasures to the American public efficiently and equitably.

As we work together to transition the COVID-19 oral antiviral treatments from government distribution to traditional health care distribution channels, I am writing today to ask for ongoing partnership during and after this transition.

The COVID-19 response remains a significant public health priority for the Biden-Harris Administration. People are still at risk of infection and re-infection, and millions are experiencing the longer-term effects of the virus.

Recent studies suggest that oral antiviral treatments can reduce deaths and hospitalizations from COVID-19 by as much as 10-fold for people at high risk for progression to severe disease.¹ These treatments include Paxlovid (nirmatrelvir co-packaged with ritonavir), a product that is FDA approved for the treatment of mild-to-moderate COVID-19 in adults who are at high-risk for progression to severe COVID-19, and Lagevrio (molnupiravir), a product that is available under Emergency Use Authorization.  Lagevrio is authorized for the treatment of adults with mild-to-moderate COVID-19 in patients who are at high risk for progression to severe disease and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.   It is of paramount importance that these medications remain widely accessible to high-risk patients after commercial distribution begins in order to minimize hospitalizations and deaths from COVID-19.

This transition process will begin on November 1, 2023, when two manufacturers of oral antivirals, Pfizer and Merck, will begin to distribute product into traditional channels.  As the federal government transitions away from distributing these products, access will primarily depend on the arrangements in the private commercial market among each of the particular drug manufacturers and private insurers. We urge the drug manufacturers and private insurers to work together to ensure access to these lifesaving medications—including those under Emergency Use Authorization—and share here our best understanding to date.² 

For Paxlovid, during this transition and through the end of 2024, people who are uninsured and those who have Medicare or Medicaid coverage will continue to access Paxlovid with no out-of-pocket costs through Pfizer’s new patient assistance program. Federal entities such as the Indian Health Service, the Department of Veterans Affairs, and the Department of Defense will retain access to Federally-acquired Paxlovid, as they have accessed the product for the last two years. We expect that individuals with private insurance will continue to be able to access Paxlovid as coverage is established over the next few months.  Pfizer has also stated that it is setting up a co-pay savings program for those with private insurance, which will be independent of the patient assistance program.

Lagevrio will also begin transition on November 1, 2023, as an option for eligible individuals who are unable to take Paxlovid or Veklury.³   Again, we expect there to be commercial coverage for Lagevrio as well, but for those who cannot afford the product, the Merck patient assistance program will be available to assist certain patients.

Over the coming weeks and months, manufacturers should work with the Centers for Medicare & Medicaid Services (CMS) and other payors to make sure that such payors have the required information from the manufacturers to make payments for these therapeutics after commercial distribution begins.

The U.S. government (USG) remains committed to maximizing access to COVID-19 treatments through this transition.  At this time, as products enter commercial distribution, we are encouraging all partners managing USG product to continue to use Federally-acquired product until it is depleted or until it expires, at no cost to patients.⁴  Distributors and health care providers may continue to order from the USG until November 10 for Lagevrio and December 15 for Paxlovid.  Beyond these dates, all providers should ensure that they order sufficient commercial product after November 1 ahead of that transition.  Based on lessons learned during the transition to commercial distribution for vaccines, we want to underscore the public health importance of reducing barriers to coverage however possible and urge you to consider any and all ways to reduce these barriers. It is critical to help members navigate insurance networks. If you encounter any operational problems that impede patient access to these treatments, we expect you to inform HHS immediately so the Department can facilitate collaboration across the health care landscape, as it has done before.

We also encourage individuals to work with their health care provider, pharmacy, and insurer to verify supply and coverage eligibility. This will be a complex task at a time when individuals are struggling with illness, and we ask all of these private sector entities to help people navigate as much as possible by sharing data.

Accurate and timely data will continue to be vital as we uphold our shared goal of facilitating equitable access to COVID-19 products. Throughout the pandemic response, HHS has used distribution and administration data to spotlight communities that have been left behind and enhance distribution efforts to maximize access to therapeutics. As ordering and distribution transitions to more traditional pathways, HHS asks our partners to find sustainable ways to enable continued visibility of the availability of therapeutics. Sharing of information with government partners is fundamental to maintaining our mutual commitment to equity.

HHS looks forward to continuing to build our relationship and working closely with you throughout and after the transition in the fourth quarter of 2023.  Thank you for your support.

Sincerely,

Xavier Becerra

Endnotes

¹  Nirmatrelvir or Molnupiravir Use and Severe Outcomes From Omicron Infections | Infectious Diseases | JAMA Network Open | JAMA Network

² Paxlovid is FDA-approved for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. The FDA-approved labeling for Paxlovid may be found at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217188s000lbl.pdf

Paxlovid remains authorized for emergency use under EUA for the treatment of mild-to-moderate COVID-19 in certain pediatric patients. Information on the EUA for Paxlovid may be found at: https://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products

³   https://www.fda.gov/media/155054/download

⁴   COVID-19 Therapeutics Commercialization Transition Guide | October 20, 2023 (hhs.gov)