AMNOG analysis surrogate endpoints
Customer Situation
Surrogate endpoints are usually rejected by IQWiG and G-BA in the early benefit assessment on the grounds that they are not validated. A typical example is the endpoint “progression-free survival” (PFS) in oncology, which is not accepted as a surrogate for overall survival. A large research-based pharmaceutical company from Germany was preparing for the early benefit assessment and wanted to include findings on surrogate endpoints from previous procedures in the strategic planning.
Our Solution
We carried out a comprehensive evaluation of the surrogate endpoints used in all previous benefit assessments. We prepared an interactive overview of all surrogate endpoints as well as the validation trials carried out and their recognition by IQWiG and G-BA. We identified the surrogate endpoints already recognised in the early benefit assessment and analysed the underlying reasoning. The results of the analysis were submitted as an abstract to ISPOR.
Customer Benefit
Based on our analysis, our client had a much better understanding of the role of surrogate endpoints in the early benefit assessment and could incorporate this knowledge into the strategic considerations. In addition, the data helped to raise awareness of the importance of surrogate endpoints among the relevant stakeholders.