Medicare drug price negotiations: impact on healthcare development and patient access to medicines

Category: Meeting Report
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Author byline as per print journal: Michael S Reilly, Esq; Thomas R Barker, Esq, JD; Charles M Clapton, Steven J Potts, PhD, MBA; Andrew Spiegel, Esq

In the US, a Medicare price negotiation provision has been introduced in the form of the 2022 Inflation Reduction Act (IRA). An online webinar on the introduction of IRA was held to discuss its implications on medicines innovation and impact on patient access to medicines.
The webinar was held by the Alliance for Safe Biologic Medicines (ASBM) in collaboration with the Generics and Biosimilars Initiative (GaBI) on 26 July 2023. A number of expert speaker presentations were followed by a Q&A with the panel and the audience also had the opportunity to ask questions online throughout the webinar.
Presentations examined how the Medicare price negotiation provision (IRA) can be considered a type of price-setting policy, similar to the European-style price control policies applied to medicines. In addition, the threat that government price setting poses regarding innovation and access to medicines for patients was discussed. Experiences with cost containment efforts in different countries and their impact on patient care and innovation were a key focus. Further details of the presentations were discussed during the Q&A and clarifications made via the concurrent online Q&A.
The webinar enabled in-depth discussion of IRA and its possible impact on patient care and innovation. The concept of negotiation versus price-setting was explored and the US situation compared to that in Europe.


In 2022, the Inflation Reduction Act (IRA) (Public Law 117-169) was signed into law in the US. This is designed to empower the US Secretary of Health and Human Services (HHS) and enable them to develop and implement methods and a process to negotiate a limited number of maximum fair prices (MFPs) for prescription drugs in the Medicare programme, directly with manufacturers. At present, under the negotiation programme, the US government will select 10 Part D drugs for negotiation for initial price applicability in year 2026; and scale up to 20 Part B and Part D drugs by 2028 [1].

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. 

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