Authors: Lara Schroeder, Florian Stieglitz, Matthias P. Schönermark
Tuesday 11th Nov 2025
Poster Presentation: 10:30 - 13:30
Discussion Period: 12:30 - 13:30
OBJECTIVES
This study examines the impact of the 2022 GKV-FinStG (SHI Financial Stabilization Act) guardrails on the outcomes of price negotiations in the German AMNOG process. These guardrails introduced mandatory discount thresholds based on the additional benefit granted relative to the cost of the appropriate comparative therapy (ACT), as determined by the G-BA.
METHODS
A comparative data analysis was conducted using Kintiga’s proprietary database. All non-orphan initial submissions that would be subjected to the guardrails and orphan drug procedures exceeding the new 30-million-euro threshold were analyzed. A comparable cohort of procedures completed prior to the implementation of the guardrails was used for comparison. Key variables included the negotiated discount and the percentage difference between the launch price and the ACT, stratified by whether the ACT fell under the scope of the guardrails.
RESULTS
Overall, the introduction of the guardrails had limited effect on the average negotiated discount (pre-guardrails: 28.80% vs. post-guardrails: 28.03%). For procedures where the ACT was subject to the new rules, discounts were comparable to those where the ACT was not (28.91% vs. 31.81%). However, a slightly smaller launch price markup over the ACT was observed for therapies under the guardrails (43.36%) compared to those not covered (52.48%). Furthermore, a stronger positive correlation emerged between the launch price’s deviation from the ACT and the final discount after the introduction of the guardrails, with R² increasing from 0.187 to 0.207, and up to 0.336 for ACTs falling under the guardrails.
CONCLUSIONS
While average discounts remained stable, the findings suggest that the GKV-FinStG guardrails have increased the relevance of ACT knowledge and pricing strategy. Manufacturers may face greater pressure to align launch prices with the cost of the comparator, thus with the standard of care, to optimize negotiation outcomes.
