One HTA to assess them all

An EU-wide harmonization of the Health Technology Assessment (HTA) process similar to the central market authorization represents a consequent step in the evolution of European healthcare systems. However, throughout the different milestones in development, the initial criticism of several stakeholders, especially from the industry, regarding unrealistic timelines and substantially increased uncertainty, did not decline. Now, this European HTA paradigm shift is just around the corner.

The European HTA regulation entered into force in January 2022 and regulates a Joint Clinical Assessment (JCA) of new medicinal products at the European level. The respective national systems will remain responsible for the assessment of all non-clinical parameters, in particular price negotiations and reimbursement. Starting point is the 12^th of January 2025 for Advanced Therapy Medicinal Products (ATMPs) and oncological products.

The EU HTA brings several impactful aspects that need to be thoroughly considered, such as

• diverse member state-specific evidence requests,
• a strict overarching methodology based on German standards, and
• a tight timeline, carrying the realistic risk of a delay for authorities, industry – and eventually for patients.

In addition, national systems have to work on capacities and processes to guarantee a seamless link between EU and national processes.

As of today, the EU HTA timelines, the changes to the current system, and the remaining uncertainties have been descriptively mentioned by various stakeholders numerous times – a strategic, in-depth assessment leading to actual actions is still missing. Therefore, we have analyzed the implications of the EU HTA framework and derived operative, strategic, and structural success factors to optimally prepare and handle the new process.

1. Introduction
2. EU HTA – History and intended purpose
3. The EU HTA process
4. Challenges and success factors: Strategic, operative and structural
5. Key learnings & outlook