© Copyright 2016 - AMNOG: Germany Pharmaceuticals Pricing Legislation Overview - MediPaper Medical Writer Hong Kong
AMNOG Product Classification System
When a new prescription drug/indication is introduced, the manufacturer can set price for the 1st year. During this year, the Federal Joint Committee (G-BA) in collaboration with the Institute for Quality and Efficiency in Health Care (IQWiG) review the manufacturer’s value dossier.
During this review, two variables are considered, leading to a classification for both variables.
Value compared to G-BA appointed “Appropriate Comparative Therapy” (ACT), e.g.
- Effect size at outcome level
- Confidence interval associated with effect
- Non- Quantifiable
- No Added Benefit
- Reduced Benefit
Certainty of evidence presented by manufacturer, e.g.
- Number of appropriate clinical studies available
- Use of valid measurement instruments
- The risk of bias (e.g. non-blinding)
- Endpoint-type (e.g. hard, surrogate)
- No Proof