One HTA to assess them all 2.0

EU HTA is coming: From the 12^th of January 2025 as the first wave, Advanced Therapy Medicinal Products (ATMPs) and oncological products will be subject to the new centralized Joint Clinical Assessment (JCA), followed by pricing and reimbursement assessments on the individual national member state level. 

In May 2024, the European Commission (EC) adopted the Implementing Act on the JCA for medicinal products, providing a supposedly reliable and transparent framework for the upcoming process. Some individual aspects have been adapted/improved - potentially as a sign of goodwill towards the industry. While most of our previous working hypotheses have proven to be true, the publication of this key piece of the puzzle has now led us to update our whitepaper as well. 

Especially during the publication phase of the Implementing Act, the description of the upcoming process, its timelines, and remaining uncertainties have been described several times by consultancies, manufacturers, and other stakeholders – a strategic, in-depth assessment leading to actual actions is still missing. Therefore, we have (re-)analyzed the implications of the newly defined EU HTA framework and updated our operative, strategic, and structural success factors to optimally prepare for and handle the new process. In just a few pages, our whitepaper portrays the relevant factors of EU HTA and explains its strategic importance with concrete steps and food for thought.  

1. Significance statement
2. Introduction
3. EU HTA – History and intended purpose
4. The EU HTA process
5. Challenges and success factors
6. Key learnings & outlook 
7. SKC - the market access special forces
8. Appendix