International Fallout: How the Inflation Reduction Act (IRA) in the US and Joint Clinical Assessment (JCA) and Revision of the EU Pharmaceutical Strategy in Europe Will Have Global Consequences

PURPOSE:

The session will seek to highlight the consequences of the Inflation Reduction Act (IRA) and Joint Clinical Assessment (JCA) and revision of the EU Pharmaceutical Legislation and the intra- and inter- impact on healthcare systems and R&D.

DESCRIPTION:

IRA (15 minutes, Brixner) Whilst the primary aim of the IRA is to reduce spending for Medicare – its impact will be broader. There will be spillovers to other US markets via the Best Price for the Medicaid Rebate Program, the 340B ceiling price, and the calculation of Average Sales Price. It is likely to affect competitive dynamics in Medicare Part D, with competing products in impacted therapeutic classes facing pressure to match the government-set price, further reducing industry revenue.

Will this impact global drug pipelines and thereby influence access across the rest of the world?

JCA and EU legislation (15 minutes, Teale) Is there the potential in Europe for a "perfect storm": JCA with "challenging" PICOs, Value judgements lying outside the scope of JCA, JCA “insufficient” for National HTA, and price driven by affordability and reference pricing "disconnected" from JCA and National HTA.

How will JCA impact access to medicines in US and Europe?

What is a pharmaceutical company’s view? (15 minutes, Mettam) Recent substantial landscape changes on both sides of the Atlantic with JCA and the IRA have increased uncertainty for manufacturers. These changes, when brought together with increasing payer pressure in general have made designing evidence generation both more difficult and more important.

What are the impacts for manufacturers, and how does it change evidence planning for full lifecycle global access success?

Moderated discussion (15 minutes, Alderson) What will the major areas of global impact of all the above be? What should be done today and tomorrow to ensure these developments lead to a win-win for all stakeholders?