Contributed by:
Anne Heyes, MBA
Vice President, Head of Value & Access, Europe
RTI Health Solutions
With the EU developing guidelines designed to standardise and bring more equity to health technology assessments, drug and medical device developers are looking to understand the potential implications of what will emerge when the guidelines have been finalised.
Anne Heyes, Vice President and Head of Value and Access at RTI Health Solutions, has more than 30 years of industry and consultancy experience in market access strategies and evidence generation. Below, she shares how she is seeing product developers respond to Joint Clinical Assessments regulation and Medicare price negotiations.
Interview with Anne:
I see companies responding on several levels.
Portfolio Level Response
Because small molecules or multiple-indication orphan drugs are disincentivised by the Inflation Reduction Act (IRA), companies might consider rebalancing their investments to include more large-molecule drugs or biologicals instead.
Disease Level Response
Companies might be thinking of prioritising the larger indication therapies, because the IRA clock starts with the first approval. They might also do so because of the additional workload and the uncertainties around the initial EU JCAs. Companies could find choosing to pursue research for the larger rather than the smaller and rarer populations more tenable.
Individual Drugs in Development
We will see changes in strategy, particularly for phase 2b or 3 trials, where pivotal trials are being designed or have already started. Manufacturers are equipping themselves to address potential challenges they may face in drug development as they move toward regulatory approval and market access in the US and EU.
Overall, developers will need to rethink or even more closely align their strategies for clinical development, regulatory processes, market access, and pricing. Integrated evidence planning and evidence generation will be extremely important. Early preparation to address the specific perspectives and priorities of all the various healthcare stakeholders, particularly those of the payer and HTA bodies, will be crucial.