According to a letter addressed to COVID-19 therapeutics manufacturers, distributors, pharmacies and the healthcare payer community, starting Nov. 1, 2023, Pfizer and Merck will begin distributing their products through traditional healthcare channels. "Access will primarily depend on the arrangements in the private commercial market among each of the particular drug manufacturers and private insurers," the HHS letter states.

HHS urges manufacturers and private insurers to work together to reduce barriers to access. "We want to underscore the public health importance of reducing barriers to coverage however possible," the Department noted in the letter.

According to the facts cited in the HHS letter, oral antivirals like Paxlovid and Lagevrio have shown to reduce COVID-19 hospitalizations and deaths by up to 10-fold for high-risk individuals. "It is of paramount importance that these medications remain widely accessible to high-risk patients after commercial distribution begins," HHS emphasized.

However, the HHS also recognizes the need to ensure access for those who may not have private insurance coverage. As per the official HHS letter, those who are uninsured or have Medicare or Medicaid will continue to access Paxlovid at no cost through Pfizer's new patient assistance program. Lagevrio will similarly be accessible through a Merck program. Federal entities such as the Department of Veterans Affairs will retain access to federally-acquired Paxlovid.

In the letter, HHS also emphasized the need for timely data sharing for equitable access. "Sharing of information with government partners is fundamental to maintaining our mutual commitment to equity," stated the HHS.

The transition in the distribution of COVID-19 therapeutics marks a significant change in how these treatments will be accessed by individuals. While the government will no longer provide them for free, the HHS is urging manufacturers and private insurers to work together to ensure that barriers to access are minimized. The goal is to maintain widespread availability of these oral antiviral treatments, especially for high-risk individuals, even after commercial distribution begins.