ISSUE: The US pharmaceutical market is the largest in the world, resulting in high biopharmaceutical investment in research and development (R&D). As an attractive market with prices determined by private market negotiations, the US benefits from early-launches, ensuring patients currently obtain the fastest and widest access to therapies in the world. The new Inflation Reduction Act (IRA) contains measures to curb Federal spending on medicines. The impact of these measures is uncertain, but this session provides some early perspectives on their possible impact on incentives for developers, launch timings for new medicines and indications, and patient access.

OVERVIEW: We present and debate the potential implications of the IRA on drug development incentives and patient access, drawing on examples from relevant disease areas and lessons from Europe where price negotiations have been standard for many years. Steuten will moderate, setting the scene by briefly introducing the IRA and specifically its price negotiation provisions, and outlining transferable evidence from Europe, providing early evidence on the link between price/expenditure limits and access delays. Mehrotra will provide an investor’s perspective, outlining the potential impact on incentives for drug development and concomitantly the impact on innovation across therapeutic areas. Ward will provide a patient’s perspective on access to emerging therapeutics for Alzheimer’s disease and other treatments focused on older adult populations. Spangler will outline the challenges and benefits of using value assessment elements in price negotiations, balancing equitable patient access and financial sustainability. Each speaker will talk for 8 minutes, before the panel together look forward and discuss (13 minutes): How can we work together to optimise the negotiation process and the implementation of the IRA? What lessons can be leveraged from elsewhere? Steuten will encourage an open debate, seeking additional questions and perspectives from the audience (15 minutes).