The 15% Threshold in Germany and Why You Should Care

• 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?

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