Bringing Your Innovations to European Patients

EU-HTA

Navigating the harmonized European HTA framework that will be applied in stages starting in 2025 will be a significant challenge for all stakeholders. While there will be a centralized clinical assessment, member States remain responsible for defining Populations, Comparators, and Outcomes (PICOs) as well as all decisions on Pricing & Reimbursement. The resulting process is a hybrid system requiring perfectly aligned national and central activities.

Pivotal evidence generated by clinical trials is the basis for both, marketing authorization by EMA and the EU-HTA process. Thorough scientific advice is needed for both to plan and execute successful clinical programes.

2.1 EMA - Central Marketing Authorization
Marketability across entire EU
The EMA authorization automatically triggers the EU-HTA procedure.

2.2 EU-HTA - Central Clinical Evidence Assessment
Central dossier submission for assessment of clinical data with joint methodology.
Starts after the submission of the marketing authorization application to EMA and ends max. of
30 days after approval.

Timelines EU-HTA
2025 – All newly authorized oncology drugs and ATMP
2028 – Expansion to all newly authorized orphan drugs
2030 – Full implementation: All centrally authorized drugs with new active pharmaceutical ingredients

National decision on therapeutic value, price and reimbursement – further evaluation of clinical data feasible.