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Methods for determining cost-benefit ratios for pharmaceuticals in Germany
J- Matthias Graf von der Schulenburg1, Christoph Vauth, Thomas Mittendorf
1School of Economics and Management, Centre for Health Economics and Health System Research, Leibniz University Hanover, Hannover, Germany.
Summary
This paper outlines methods for cost-benefit assessment under Germany's new Competition Enhancement Act. It proposes a catalogue of criteria and a process for regulatory decision-making in German healthcare.
Area of Science:
- Health Economics
- Health Policy
- Regulatory Science
Background:
- Implementing cost-benefit assessment in healthcare is complex due to varying international frameworks.
- Germany's new Competition Enhancement Act requires specific adaptations for health economic evaluations.
- A clear international consensus on specific health economic methods for assessment is lacking.
Purpose of the Study:
- To summarize evidence on implementing cost-benefit assessment within the German legislative framework.
- To provide a minimum catalogue of methods and criteria meeting German legal and local requirements.
- To recommend a detailed assessment process for regulatory decision-making in Germany.
Main Methods:
- Literature review and synthesis of international standards in health economic methodology.
- Identification of common consensus points and debated areas in German health economics (e.g., QALY, modeling, perspective).
- Development of a catalogue of methods and criteria tailored to the German healthcare system.
Main Results:
- A consensus exists on the internal properties of health economic methods, despite varying regulatory schemes.
- A catalogue of minimum methods and criteria is proposed, aligning with German legal and healthcare system specifics.
- Key debated areas in German cost-benefit assessment are identified and addressed.
Conclusions:
- The paper provides a foundation for implementing cost-benefit assessment in Germany.
- A structured approach and recommended methods facilitate regulatory decision-making.
- This work contributes to adapting international health economic standards to the German context.
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