A Framework for Integrating the Fourth Hurdle into Translational Medicine
Author Information
Author(s): Wolf H Rogowski, Susanne C Hartz, Jürgen H John
Primary Institution: Helmholtz Zentrum München, German Research Center for Environmental Health
Hypothesis
How can a process-oriented framework be developed to monitor fourth hurdle procedures in the context of product development from bench to bedside?
Conclusion
Coverage determination decisions for new procedures tend to be less formalized than for novel drugs, with proof of patient benefit being essential.
Supporting Evidence
- The framework identifies eight key steps for monitoring coverage procedures.
- Coverage decisions vary significantly between countries and types of technologies.
- Cost-effectiveness is becoming increasingly important in coverage decisions.
Takeaway
This study created a simple guide to help companies understand how new medical technologies get approved for use and paid for by insurance.
Methodology
The study used expert interviews, literature searches, and analysis of 47 websites of coverage decision-makers in England, Germany, and the USA.
Potential Biases
The study may not account for informal influences on decision-making processes.
Limitations
The analysis is a snapshot and may not capture the dynamic nature of coverage decision processes, which are subject to frequent changes.
Digital Object Identifier (DOI)
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