Benefit assessment oncology

Client Situation

Our client was shortly expecting the approval of an oncological drug and required a complete benefit dossier including data evaluation in order to be able to launch the drug on the German market as quickly as possible after market authorisation.

Our Solution

Within five months, we were able to prepare a complete benefit dossier for the client. A randomised controlled trial (RCT) provided the basis for the presentation of the benefits and additional benefits. The control arm of this RCT represented the appropriate comparator as determined by the G-BA only for one subpopulation. For the other subpopulation an adjusted indirect comparison according to Bucher had to be calculated. We performed all analyses and prepared the complete benefit dossier within the allocated timeframe, which we were able to ensure through time-efficient review cycles and absolute prioritisation of this project. We also supported our client in the subsequent written statement and hearings.

Client Benefit

With our support, our client was able to bring the drug to market in Germany as planned and to achieve the hoped-for extent of additional benefit. The final reimbursement price was in line with our client’s expectations.