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

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The EU Joint Clinical Assessment (JCA) harmonizes health technology assessments but excludes economic evaluations. Health technology developers must align cost-effectiveness models with JCA PICO parameters for optimal drug access.

Keywords:
comparative effectivenesscost effectiveness analysisdecision-makinghealth technology assessmentjoint clinical assessment

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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.