Episode 306
The 15% Threshold in Germany and Why You Should Care
Interview with Michael Hennig
The Effective Statistician - in association with PSI
September 5, 202339m 55s
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Show Notes
Interview with Michael Hennig
- What is Health Technology Assessment and how is it used to assess the added benefit of a drug on a patient level?
- What are the Minimal Important Difference (MID) and Minimal Clinical Important Difference (MCID) and how are they assessed through patient surveys to ensure drug efficacy?
- Why is the 15% threshold important and why can it be difficult to reach due to statistical issues arising from continuous outcomes?
- Why should statisticians working in development consult with HTA statisticians early on in study design to create evidence that will meet the threshold?
- How does the scale of the endpoint impact drug reimbursement and can a drug be reimbursed if patients show 14% improvement in one area but a 17% improvement in another?
The 15% threshold is an essential element of the HTA system in Germany, and it's crucial for statisticians beyond market access experts to understand how it affects the HTA process in Germany and beyond.
By following best practices and involving HTA statisticians from the beginning stages of a study, you can create reliable evidence that meets the 15% threshold. By doing so, you can help ensure that essential drugs reach patients, improving their quality of life.
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