Paving the road for a successful EU HTA Reform implementation

Area of Science:

• Health policy
• Regulatory science
• Health economics

Background:

• The EU Health Technology Assessment Regulation (EU HTAR) aims to harmonize HTA processes across Member States.
• Implementation presents challenges including diverse national preparedness levels and concerns over sovereignty.

Purpose of the Study:

• To analyze the challenges and opportunities associated with the EU HTAR implementation.
• To identify key factors for successful adoption and optimization of HTA processes.

Main Methods:

• Qualitative analysis of regulatory frameworks and stakeholder feedback.
• Review of national HTA readiness and perceived barriers.

Main Results:

• Member States exhibit varying levels of readiness for EU HTAR.
• Concerns exist regarding national sovereignty and bureaucratic inefficiencies.
• Joint Scientific Consultation (JSC) is vital but requires expansion of slots and criteria.

Conclusions:

• National preparedness, reduced bureaucracy, and transparent communication are essential.
• Expanding JSC and increasing clinician/patient involvement will foster trust and effective implementation.
• Strengthening collaboration and optimizing regulatory pathways are key to maximizing EU HTAR benefits for patient access to innovative medicines.