HHS, Pfizer reach agreement to increase Paxlovid access
HHS wants to ensure affordable access for beneficiaries in public programs such as Medicare and Medicaid, and for the uninsured.
Photo: Malorny/Getty Images
The Department of Health and Human Services has reached an agreement with Pfizer to extend patient access to Paxlovid, which is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients.
The drug is targeted at patients 12 years old and older who are at high risk for progression to severe COVID-19, including hospitalization or death.
The agreement also "maximizes taxpayer investment," according to HHS, and begins Paxlovid's transition to the commercial market in November 2023.
A partnership between HHS and Pfizer over the last three years enabled the development, manufacture, and distribution of COVID-19 vaccines and therapeutics at a record pace, HHS said.
The agency added it wants to ensure affordable access for beneficiaries in public programs such as Medicare and Medicaid, as well as for those who are uninsured.
WHAT'S THE IMPACT?
Individuals on Medicare, Medicaid, and those who are uninsured will continue to be able to access HHS-procured Paxlovid for free through the end of 2024 via a patient-assistance program.
From 2025-2028, Pfizer will continue to run a patient-assistance program for individuals who are uninsured or underinsured with HHS-procured Paxlovid. In parallel, Pfizer will operate a co-pay assistance program for individuals with commercial insurance through 2028.
An up-to-date product will be refreshed from Pfizer through 2028, ensuring that the HHS inventory of Paxlovid will not expire – and will include all new formulations of Paxlovid authorized or approved for use in the United States.
In addition to ensuring that HHS maintains every course of Paxlovid it has purchased, Pfizer will provide HHS with a stockpile of an additional one million treatment courses to ensure preparedness for future COVID-19 surges, HHS said.
The agency also said it would ensure a "smooth and predictable" transition to the commercial market over the next few months, while prioritizing and reserving HHS-procured treatment courses for people with Medicare and Medicaid, and for those who are uninsured. During this transition to commercial distribution, Paxlovid will remain available for ordering from HHS through December 15.
THE LARGER TREND
When released, Paxlovid was hailed as a lifesaving drug, but fears of COVID-19 rebound associated with the medication have reportedly decreased demand. Doctors who treat people for active COVID-19 infections say they aren't widely prescribing Paxlovid, since the medication interacts with several common drugs and is only approved for people vulnerable to severe illness -- older adults and people with underlying medical conditions, according to NBC News.
Medications such as Paxlovid have been developed to not only mitigate COVID-19 among patients, but to ease the burden on healthcare systems and facilities that have buckled under the weight of rising case counts at times during the pandemic.
The FDA originally issued an EUA for Paxlovid just before Christmas 2021. Importantly, the drug is not authorized for the prevention of COVID-19, or for treating those already requiring hospitalization due to severe or critical COVID-19. It's also not a substitute for vaccination in those for whom the shot and a booster dose are recommended.
According to the FDA, Paxlovid must be taken within five days of symptom onset in order for it to be effective. Because of that small window, the agency said authorizing state-licensed pharmacists to prescribe the drug could expand access to more people in the eligible population.
Data published by Pfizer in May of last year found Paxlovid proved ineffective at preventing coronavirus infection among people living in the same house as an infected person. While there were risk reductions of 32% and 37% in adults who had received Paxlovid for five and 10 days, respectively, the results were not statistically significant. It's a disappointing finding for a drug that sought to prevent infection from household contact.
While the finding is not what Pfizer had hoped, the company said the results don't impact the strong efficacy and safety data observed in an earlier trial that tested the drug's effect in preventing severe illness, and pointed out that use of Paxlovid is on the rise globally.
Twitter: @JELagasse
Email the writer: Jeff.Lagasse@himssmedia.com
