The European Union is set to implement its new Health Technology Assessment Regulation (HTAR, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2282) on January 12, 2025, marking a significant shift in the evaluation and market access processes for medicinal products.
The HTAR introduces a streamlined, EU-wide framework for assessing the clinical value of these health technologies, replacing the patchwork of national processes with a single, harmonized approach. Coordinated by the European Network for Health Technology Assessment (EUnetHTA 21), the regulation aims to reduce duplication of efforts, ensure equitable access to innovative treatments across member states, and enhance the efficiency of healthcare systems.
Key features of the HTAR include:
- Joint Clinical Assessments (JCAs): Developers of oncology drugs, ATMPs, and specific high-risk medical devices will now undergo a centralized clinical evaluation, with findings intended to inform national reimbursement decisions.
- Transparency and Collaboration: The regulation mandates close collaboration among EU countries to improve data sharing and ensure consistency in evaluating health technologies.
- Transitional Period: The HTAR will be phased in gradually, initially focusing on oncology drugs and ATMPs, with broader implementation for other therapeutic areas and devices in subsequent years.
Proponents of the HTAR anticipate faster access to innovative treatments for patients, reduced administrative burdens for manufacturers, and greater alignment of health technology assessments across the EU. The HTAR is part of the EU’s broader agenda to strengthen its healthcare systems and foster innovation in line with its Pharmaceutical Strategy for Europe. As the January 2025 deadline approaches, stakeholders are urged to prepare for the new requirements to ensure compliance and capitalize on the opportunities it presents.
While clinical assessments will be centralized, the economic evaluation of health technologies will remain under the jurisdiction of individual EU member states. We at Billev Pharma East can offer you support in economic evaluation of health technologies in Slovenian market. Our team of experts have long time experiences with reimbursement submissions at Slovenian competent authorities.
