Preparing For Change: How To Navigate The EU HTA Regulation For Better Market Access

As the European Union prepares to implement the new Health Technology Assessment (HTA) Regulation, significant changes loom for the biopharma industry. Recent interviews with Cencora experts Herbert Altmann and Ruairi O’Donnell have highlighted the complexities that manufacturers will face with the forthcoming Joint Clinical Assessment (JCA). Central to this regulation is the PICOs framework—specific queries concerning population, intervention, comparator, and outcomes—which introduces a level of unpredictability as companies must engage in scenario planning to anticipate diverse needs across 27 member states.

This unpredictability presents both challenges and opportunities for effective product positioning. To navigate the evolving landscape, manufacturers are advised to conduct simulations to identify impactful PICOs, especially given the tight 100-day window to respond to finalized queries. A key concern is that smaller EU nations may have their needs overlooked during the JCA process, raising questions about equitable access to therapies. While the JCA aims for standardization, it does not eliminate the relevance of national HTAs, necessitating that manufacturers address local requirements as unselected PICOs may still inform pricing and reimbursement discussions. The transition to JCAs will be a learning experience for all stakeholders, with adaptability and vigilance essential as the industry refines strategies in response to these new regulatory demands.

The insights shared by Altmann and O’Donnell provide a strategic roadmap for manufacturers, emphasizing the importance of foresight and understanding the intricate nature of European healthcare systems in the face of regulatory evolution.