Managing the impact of EU HTA regulations on asset launch planning

This case study highlights our ability to deliver actionable regulatory intelligence that translates into commercial advantage.

Background

The EU Health Technology Assessment Regulations (HTAR), designed to streamline processes and provide a permanent framework for joint HTAs across EU Member States, mandates that all new centrally authorised medicines undergo a JCA at the EU level by 2030.

Our client was developing an asset targeting a 2029/2030 launch, which could be affected by the JCA in terms of launch timelines, indication sequencing, and positioning.

Therefore, we aimed to understand the JCA methodology, explore its integration into the client’s product development process, and assess its impact on the asset’s launch planning. 

What we did

We conducted desk research using available guidelines, and EU HTA case studies to summarise the key implications of the EU HTAR, focusing on timelines, dossier requirements and procedural steps.

To illustrate how nuanced elements of the regulation could impact the asset’s launch at both EU and Member State levels, we analysed several scenarios. These included missing PICO evidence, unfavourable JCA outcomes, second-line treatment launch, and the impact of only launching in private insurance markets.

The results

The project deliverable package comprised an executive summary that outlined the key elements of the EU HTAR and their implications at both the EU and Member State levels. It highlighted tailored recommendations for each critical aspect of the regulation, identifying potential opportunities and risks for the client’s asset. In addition, market-level insights and assumptions, based on existing national HTA processes, were summarised to provide context for how the JCA could influence local launch strategies. To support practical decision-making, a timeline of recommended actions was also included, offering a clear framework to help optimise the asset’s launch strategy under the evolving EU HTA landscape.

What next?

Our full analysis, including scenario implications and tailored recommendations for our client’s asset, will be integrated into internal launch planning and may be shared in future industry forums. Please get in touch if you would like to discuss these insights in more detail.

More broadly, our findings and similar approaches could be used to:

• anticipate how JCA outcomes may influence EU and national launch timelines, indication sequencing, and market access strategies;
• support early integration of JCA evidence requirements into product development planning;
• inform cross-functional alignment on EU vs. Member State launch pathways and help mitigate associated risks;
• develop frameworks to stress-test launch strategies under multiple regulatory and HTA scenarios; and
• guide investment decisions by highlighting opportunities and risks linked to the evolving EU HTA landscape.