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Updated: May 7, 2026
13:04
Measuring the Subjective Value of Risky and Ambiguous Options using Experimental Economics and Functional MRI Methods
Published on: September 19, 2012
[Risk-sharing agreements: choice of study design and assessment criteria]
1Réseau d'évaluation en économie de la santé (REES), 28, rue d'Assas, 75006 Paris, France.
Annales Pharmaceutiques Francaises
|October 1, 2013
Summary
A novel taxonomy for market entry agreements (MEAs), or risk-sharing agreements, distinguishes between monitoring and evaluation studies. This framework aims to reduce clinical, economic, and budgetary uncertainty in healthcare programs.
Area of Science:
- Health Economics
- Pharmaceutical Policy
- Clinical Trial Design
Context:
- Market entry agreements (MEAs), also known as risk-sharing agreements, are crucial in pharmaceutical policy.
- Conventional MEA taxonomies often rely on outcome performance and financial contract distinctions.
- There is a need for a more robust framework to manage uncertainty associated with new treatments.
Purpose:
- To develop a new taxonomy for market entry agreements (MEAs).
- To differentiate MEAs based on the type of study design employed: monitoring versus evaluation.
- To provide a framework for reducing clinical, economic, and budgetary uncertainty in healthcare.
Summary:
- The proposed taxonomy moves beyond traditional outcome-based classifications.
- It establishes a clear distinction between monitoring studies (continuous performance tracking) and evaluation studies (assessing specific treatment effects).
- This framework facilitates the proposal of tailored study designs, indicators, and financial clauses.
Impact:
- Enhances the precision of assessing treatment effectiveness and program performance.
- Provides a structured approach to mitigate risks for payers and manufacturers.
- Supports evidence-based decision-making in healthcare procurement and policy development.
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