HTA processes will change in the EU, but the importance of patient relevant outcomes stays the same!
While there has been a centralized European marketing authorization procedure for years, Health Technology Assessments (HTA) remained decentralized at state level – this will change with the EU regulation (2021/2282) on HTA.
For the first time, it regulates benefit assessment at European level and provides the framework for binding cooperation among national HTA authorities. The regulation is now coming into force, but the first few years will be used to define standards and methodological principles for the European benefit assessment. The joint evaluation will start in 2025.
Why is the regulation relevant for patients?
The outcome of the HTA of a novel and innovative health technology indicates its added value compared to existing technologies and thus informs resource allocation decisions by affecting reimbursement prices.
This impacts patients’ access considerably!
Moreover, the HTA outcome provides a holistic and evidence-based view on a technology and its application which can inform clinical decision-making. Favorable outcomes will promote the use of effective new therapies or diagnostics for state-of-the-art patient healthcare.
This positively influences patients’ care!
What is the value of the regulation to patients?
A harmonization of HTA procedures and related methodologies could accelerate availability of innovative health technologies to patients. It could lower costs for the member states but also for technology developers and may be favorable for an equal access across the EU.
However, as stated in the EU HTA regulation, cooperation plays an important role to ensure joint work of the highest scientific quality, inclusiveness, transparency and reflecting the latest state-of-the-art research. This involves the cooperation with patient organizations as well as individual patients affected by the disease.
Therefore, it is extremely important to complement the framework set out by the EU HTA regulation with meaningful methodology to facilitate patient engagement. Cooperations with patient communities need to be transparent, trustworthy, and respectful to truly ensure patient relevance. However, it is necessary to provide good guidance on the requirements considering patient perspectives such as patient preference information (PPI) and patient reported outcomes (PRO) in the HTA benefit assessment.