The first joint clinical assessments under the new EU Health Technology Assessment (HTA) Regulation (EU 2021/2282) have officially begun.
The initial assessments cover two innovative medicines:
- Medicinal paediatric cancer treatment (for low-grade glioma). This is assumed to be tovorafenib by Day One Biopharmaceuticals. This product is being assessed by the National Centre for Pharmacoeconomics, Ireland, and the Institute for Quality and Efficiency in Health Care (IQWiG), Germany
- An advanced therapy medicinal product (ATMP) for melanoma. This is believed to be lifileucel by Lovance Biotherapeutics. The assessors are the National Authority for Health (HAS), France, and the Agency for Health Technology Assessment and Tariff System (AOTMiT), Poland.
The assessors are the National Authority for Health (HAS), France, and the Agency for Health Technology Assessment and Tariff System (AOTMiT), Poland.
The recently launched coordinated EU HTA process, designed to run in parallel with the EMA’s marketing authorisation, is expected to streamline HTA in Europe and accelerate patient access to medicines. It will also provide consistency in HTA evaluation across Member States. The joint EU assessment reports will inform national health technology assessments. While this is aimed at offering a more unified approach to pharmaceutical market access in the EU, how the outcomes will impact local pricing and reimbursement decisions remains to be seen.
Manufacturers should act now to update their internal processes and prepare for the new joint EU HTA requirements. The Joint Clinical Assessment (JCA) timeline will be tight, as it runs alongside the EMA regulatory submission. Companies need to evaluate their readiness for the JCA process and make the necessary adjustments to handle upcoming challenges. Early thinking around potential PICOs (Population, Intervention, Comparator, Outcome) will be key, while still giving proper attention to national HTA submissions, which may be needed to address gaps in the joint dossier.
Now is the time to act. Being proactive is essential to optimise your path to EU market access and stay ahead in this critical new phase of joint EU HTA assessment.
Don’t wait for challenges to arise — connect with one of our experts at Remap Consulting today. We have the tools and experience to help you navigate the complexities, avoid costly missteps, and ensure you’re strategically prepared from the outset.