White Paper: Orphan Drugs in Germany - lessons learned from AMNOG
For orphan drugs, there are specific challenges that the manufacturer has to meet. Due to the randomness of the disease, subpopulations are small and study data are scarce. This leads to a considerable uncertainty about the perceived value of the drug and, thus, to intense and sometimes tough negotiations with high rebates in the end. Pharmaceutical companies planning to introduce new orphan drugs into the German market should prepare well in advance a sound and stringent strategy to optimize the performance throughout the entire market access processes.
Tim Kirchmann, Heike Kielhorn-Schönermark and Prof. Matthias P. Schönermark M.D., Ph. D. wrote the white paper „Orphan Drugs in Germany – lessons learned from AMNOG, best and worst practices and strategic implications” that elaborates all relevant orphan drug issues and describes important recommendations for manufacturers facing these challenges.
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Through the support of numerous orphan drug procedures, we at SKC consulting have unrivaled expertise for the market access of drugs for rare diseases.