EU Joint Clinical Assessment: A Framework for Optimising Use with Cost-Effectiveness Decision-Making.

Area of Science:

• Health Economics
• Pharmaceutical Policy
• Regulatory Science

Background:

• The European Union (EU) Joint Clinical Assessment (JCA) regulation (EU) 2021/2282 aims to standardize health technology assessments (HTAs) across member states.
• Oncology is a key area impacted by these changes, affecting both national appraisals and health technology developers (HTDs).

Purpose of the Study:

• To explore the implications of the EU JCA framework on cost-effectiveness (CE) analysis and HTDs, particularly in oncology.
• To identify challenges and opportunities in aligning JCA and CE modeling outcomes.

Main Methods:

• Analysis of the JCA framework's requirements and its exclusion of economic evaluations.
• Contrast of evidence requirements between JCA and CE frameworks.
• Discussion of PICO parameter diversity and the need for indirect comparison methodologies.

Main Results:

• The JCA standardizes clinical effectiveness and safety assessments but necessitates separate CE modeling by HTDs.
• Diverse comparators in PICO surveys increase complexity, potentially requiring indirect comparison methods.
• Early communication between HTDs and HTA bodies is crucial for effective decision-making.

Conclusions:

• Aligning JCA and CE modeling presents challenges but offers opportunities for improved decision-making.
• Proactive sharing of national PICO parameters can enhance evidence generation and maximize the JCA framework's potential.
• Successful implementation can lead to better patient access to innovative medicines.