Technology Assessment vs. Technology Appraisal-How to Strengthen the Science/Value Dichotomy with EU HTA?

Area of Science:

• Health Policy
• Health Economics
• Medical Decision Making

Background:

• Health Technology Assessment (HTA) is vital for global reimbursement and pricing decisions.
• HTA involves distinct steps: assessment and appraisal, with inconsistent stakeholder terminology.
• Ambiguity in 'assessment' and 'appraisal' definitions hinders clear understanding of technology evaluation activities.

Purpose of the Study:

• To address the heterogeneity in HTA terminology, specifically the distinction between assessment and appraisal.
• To highlight the urgency of clarifying these terms due to the new EU HTA Regulation.
• To propose a framework for distinguishing assessment and appraisal to support the regulation's goals.

Main Methods:

• Conceptual analysis of HTA terminology.
• Discussion of the science/value dichotomy for differentiating assessment and appraisal.
• Examination of the transition from centralized assessment to decentralized appraisal.

Main Results:

• The distinction between assessment and appraisal should be framed as a science/value dichotomy.
• Centralized assessment activities should transition to country-level appraisal for local context.
• Categorization of overall added benefit should occur at the local level.

Conclusions:

• Clarifying the terms 'assessment' and 'appraisal' is essential for the success of the EU HTA Regulation.
• Adopting a science/value dichotomy can enhance efficiency and reduce duplication in HTA processes.
• Acknowledging uncertainty in medical decision-making remains a critical component.