Relative Added Value: What are the Tools to Evalue it?

Area of Science:

• Health Economics and Outcomes Research
• Pharmacoeconomics
• Drug Evaluation and Regulation

Background:

• France's Transparency Commission (TC) evaluates drug added value using Improvement in Actual Benefit (IAB).
• IAB assessment relies on efficacy and safety within a defined population and therapeutic strategy.
• Previous evaluations (2004-2007) highlighted limitations in direct comparative data and evaluation criteria.

Purpose of the Study:

• To review and rationalize the criteria used for assessing the relative added value of drugs.
• To explore the incorporation of Public Health Impact (PHI) into drug benefit assessments.
• To consider additional parameters like compliance and impact on professional practice.

Main Methods:

• Analysis of TC opinions issued between 2004 and 2007 across various therapeutic areas.
• Review of evaluation items including clinical effect, comparator relevance, and methodology (e.g., indirect comparisons).
• Discussion and consideration of broadening evaluation criteria to include Public Health Impact.

Main Results:

• Direct comparative data for drug evaluations were found to be rare.
• Public Health Impact (PHI) was deemed more relevant to relative added value (IAB) than Actual Benefit (AB).
• PHI criteria (population health, unmet needs, healthcare system impact) are not systematically considered in current assessments.

Conclusions:

• Relative added value assessments should incorporate Public Health Impact.
• Future drug evaluations could be based on expected improvement in medical service, requiring real-world data.
• Post-registration studies are crucial for confirming improvements in actual benefit upon re-registration.