Preparing for the EU HTA Regulation: Insights from the Dutch Perspective

Area of Science:

• Health Policy
• Regulatory Science
• Pharmaceutical Assessment

Background:

• The European Health Technology Assessment (HTA) regulation (HTAR) commenced in January 2025, mandating consideration of joint clinical assessment (JCA) reports by EU Member States.
• This necessitates national adaptations to existing HTA frameworks and processes.

Purpose of the Study:

• To describe anticipated changes to the Dutch national HTA process under the new HTAR.
• To outline the preparation and implementation strategy of the Dutch National Health Care Institute (Zorginstituut Nederland, ZIN) for the HTAR.
• To share experiences relevant for the EU HTAR's future expansion.

Main Methods:

• A project-governance structure and continuous gap analysis of ZIN's current national assessment and appraisal processes for medicinal products.
• Development of a concrete action plan based on identified gaps and challenges.
• Analysis of implications for ZIN's HTA process, including earlier scoping and JCA report utilization.

Main Results:

• Two major implications for ZIN's HTA process: earlier scoping phase and the JCA report serving as the national assessment's starting point.
• Identified gaps, challenges, and issues across categories: information/knowledge, IT/templates, communication/stakeholder engagement, capacity/resources, and financial aspects.
• ZIN has developed a thorough implementation plan and is prepared for the HTAR.

Conclusions:

• ZIN is ready to implement the HTAR into its national HTA processes.
• ZIN is prepared to assume (co-)assessor roles for JCA of medicinal products starting in 2025.
• Sharing ZIN's implementation experience can benefit other Member States and the EU HTAR's future development.