On May 12, 2022 CHAI announced agreements with leading generic manufacturers to make generic Paxlovid (nirmatrelvir/ritonavir – NIR/r) available to low- and middle income countries for under US$25 per treatment course. The announcement can be found here.
How will these agreements help save lives?
These agreements provide low- and middle-income country (LMIC) governments, donors, procurers, and implementing partners assurances that they will have access to affordable, quality-assured generic products in the future and greater visibility on timing and pricing, which allows them to prepare accordingly and accelerate plans and build capacity for decentralized testing and treatment of high-risk patients.
Are low- and middle-income countries equipped to introduce and roll out NIR/r to high-risk COVID-19 patients?
Partner countries have extensive experience in introducing new treatments, most recently with successful introductions of HIV treatments such as dolutegravir which has been introduced, rolled out, and scaled up to millions of patients in just a couple of years. To ensure and accelerate broad-based access to the lifesaving oral antivirals, catalytic efforts by global partners are still necessary.
These include development of a clear, decentralized COVID-19 care delivery paradigm for high-risk patients using rapid antigen tests and treatment with nirmatrelvir/ritonavir (NIR/r) or molnupiravir; operational research funding from donors and suppliers to provide data needed to scale LMIC test and treat programs; limited donation programs from Pfizer (Paxlovid) and Merck (Lagevrio) for early adopting countries; and procurement funding for both rapid COVID-19 diagnostic tests and drugs by Global Fund, UNICEF, and USG to accelerate the entry of affordable and quality-assured generic products.
CHAI is committed to supporting its partner governments to rapidly introduce, integrate, and scale SARS-CoV-2 oral antivirals into national COVID-19 response efforts to reduce hospitalizations and deaths from future waves of COVID-19.
Who are the leading generic manufacturers?
The generic manufacturers are well–established generic suppliers with products approved by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO) and experience working with international agencies and procurers including the United States President’s Emergency Plan for AIDS Relief (PEPFAR). The manufacturers have signed agreements with the Medicines Patent Pool (MPP) to manufacture and supply the generic version of Pfizer’s oral COVID-19 treatment NIR/r to 95 LMICs. As these manufacturers are in early stage of product development and have not received regulatory approval, their names cannot be shared publicly.
Are there any volume requirements associated with the agreements?
For each manufacturer, the ceiling price of US$25 per treatment course will apply if the aggregate of all orders for public sector use in the 95 LMICs during the year is anticipated to meet or exceed one million treatment courses and any single order is for a quantity of least 50,000-treatment courses.
Which purchasers are eligible to access the terms of the agreements?
Any organization or entity that is purchasing NIR/r on behalf of public sector patients in the 95 LMICs, including procurement agents, government agencies, non-governmental organizations (NGOs), and similar organizations.
If you are not able to get required donor funding, will the agreements move forward?
The agreements have been executed and are not contingent on donor funding to be valid. However, given the minimum volume requirements, mobilizing funding will be needed to use the agreements and get access to the generic treatments at no more than US$25 per treatment course.
When can patients realistically expect to begin receiving NIR/r for treatment?
In the near–term, before more affordable generic drugs become available, LMIC countries will need to procure the innovator product (Paxlovid) from Pfizer through UNICEF or Global Fund at Pfizer’s not-for-profit price. For generics, their availability will be dependent on the speed of product development and regulatory review, and the manufacturers in these agreements have committed to file for WHO prequalification (PQ) or Stringent Regulatory Authority (SRA) approval by the first quarter of 2023.