Client Situation
Our client was awaiting approval of an oncological drug and needed a complete benefit dossier, including data evaluation, for a swift launch in the German market post-authorization.
Our Solution
The team prepared a complete benefit dossier. A randomised controlled trial (RCT) formed the basis for demonstrating the drug’s benefits and additional advantages. The control arm of this RCT was suitable as appropriate comparator for only one subpopulation, as per G-BA standards. . For the other subpopulation, an adjusted indirect comparison following Bucher’s method was required. All analyses were performed, and the complete benefit dossier was prepared within the set timeframe, achieved through efficient review cycles and high prioritization of the project. co.value also aided the client in the ensuing written statement and hearings.
Client Benefit
With the company's assistance, the client successfully launched the drug in the German market as intended and attained the anticipated level of additional benefit. The final reimbursement price met the client’s expectations.