Presentation (CTI)

OBJECTIVES: The EU Health Technology Assessment Regulation (HTAR) introduces new mandatory requirements for medical devices, notably Joint Clinical Assessments (JCAs) to harmonize clinical evaluations across Member States. While the value of conducting JCAs centrally is widely recognized, the absence of a direct link between JCA reports and national reimbursement decisions may raise costs for health technology developers (HTDs). This study examines cost implications of increased access requirements and advocates for a best practice framework integrating JCA reports into national reimbursement processes.
METHODS: A targeted literature review was conducted to evaluate the increased costs incurred by the pharmaceutical industry under the implementation of the EU HTAR, as well as the potential benefits gained. In addition, stakeholder interviews were carried out to explore the applicability of these findings to the MedTech sector, considering the structural and regulatory differences between medicinal products and medical devices.
RESULTS: Preliminary findings indicate that while the implementation of the EU HTAR introduces additional demands on HTDs, particularly related to data generation, documentation, and stakeholder engagement, it also offers the opportunity to strengthen the overall evidence base and streamline market access processes in the long term.Experts acknowledge the distinctive nature of the MedTech industry, including limited patent protection, steep learning curves, and the frequent rollout of updated technologies. Furthermore, concerns are raised about the lack of alignment between JCA reports and national reimbursement procedures, which may create uncertainty for HTDs and impact investment decisions. Ultimately, this may delay or limit patient access to technologies addressing unmet medical needs. Experts call for clearer guidance and alignment mechanisms tailored to the MedTech context.
CONCLUSIONS: To preserve the benefits of the EU HTAR while limiting its cost burden, Member States should align JCA reports with national reimbursement decisions. This would improve predictability and accelerate patient access.