Abstract
In Germany, a negotiation-based pricing system for new drugs based on results of an early benefit assessment was implemented in 2011. A legal framework determines a price premium in the case of a proven additional benefit and a comparator-based price in the case of an unproven additional benefit. To discriminate drug prices among different indications with varying value, for every fourth new pharmaceutical (n=49) a mixed-price had to be negotiated, reflecting both, a price premium and a comparator-based price. However, it is still unclear to what extent the real prescription behavior reflects the volume weights within a mixed price. For 17 of 49 pharmaceuticals with mixed prices, subpopulation-specific prescription rates were calculated based on data from a large German health sickness fund. The results were compared with the volume weights (prevalence estimates made by the Federal Joint Committee, FJC) on which a mixed price is regularly based on. Based on prescription data for 2016, a high congruence of the prescription rates of subpopulations with additional benefit and their prevalence estimate made by the FJC can be determined for seven pharmaceuticals. For other drugs, only an average or low congruence of the mixed price to the prescription ratio was observed. Thus, the percentage of prescriptions realized in the indications or subpopulations without proven additional benefit was proportionately higher than the underlying prevalence estimate. Divergence in clinical value by indication may complicate assessments of appropriate pricing by payers. In Germany, a mixed-price in applied, to reflect mixed value indications within one price. However, this approach is currently being discussed both legally and politically. However, the available data show that a mixed price may be able to reflect indications with different values in one price adequately.
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