Reimbursement prices of new, innovative medicines in Germany: a comparison of negotiation and cost-effectiveness analysis.

This study aimed to compare reimbursement prices for new, innovative non-orphan drugs in Germany based on price negotiation and cost-effectiveness analysis, using the efficiency frontier (EF) approach and cost-utility analysis (CUA). For the EF, the next effective intervention and no intervention were used as comparators. Three pairwise comparisons were conducted: negotiation vs EF, CUA vs EF and negotiation vs CUA. For the comparison between negotiation and EF, relative risk reductions for a given added health benefit were assigned, and resulting price premiums were determined using an empirical estimate from the literature and a conceptual model. The difference between CUA vs EF was determined based on an aggregation rule and thresholds for CUA based on the average and marginal cost-effectiveness of the health care system. The difference between negotiation and CUA was determined through an indirect comparison. Price premiums based on negotiation are approximately 10-40 per cent higher than those based on EF using no intervention as a comparator. Furthermore, price premiums based on CUA (threshold at system-average cost-effectiveness) are approximately 25-50 per cent higher than those based on EF using no intervention as a comparator. The indirect comparison predicts that price premiums based on CUA (threshold at system-average cost-effectiveness) are approximately 10-15 per cent higher than those based on negotiation. For a threshold set at system-marginal cost-effectiveness, price premiums based on CUA are more than threefold higher than those based on negotiation. In the German health care system, CUA with a threshold set at system-average or system-marginal cost-effectiveness is predicted to yield higher reimbursement prices than price negotiations or the EF approach based on no intervention as a comparator.