Presentation (CTI)

OBJECTIVES: Evaluating the financial impact of regulatory instruments in the pharmaceutical market is essential for evidence-based policy refinement. In Germany, recent reforms - including obligatory price-volume agreements introduced with the GKV-FinStG - aim to balance innovation with financial sustainability. However, the timing and structure of pharmaceutical revenue development raise questions about the real-world efficacy of these tools, particularly in the context of early price negotiations under the AMNOG framework.
METHODS: This real-world data analysis is based on anonymized claims data from DAK-Gesundheit, Germany’s third-largest statutory health insurer (5.4 million insured), covering the years 2019 to 2024. We evaluated annual expenditures on patent-protected medicines, stratified by the number of years since market entry, to assess revenue growth trajectories and the temporal alignment with regulatory interventions.
RESULTS: Expenditures in the patent-protected segment are still largely concentrated on drugs launched several years ago. In 2024, 14.0% of revenues in the patent market stem from original products introduced before 2010. The largest spending shares now accrue to drugs launched between 2016 and 2020. Medicines approved since 2021 have already increased total expenditures in the patent-protected market by 16%, whereas spending on older products (pre-2021) has decreased by only 3.9%. Despite mandatory price-volume agreements, the data show limited short-term impact on expenditure growth especially for multi-indication drugs. Implementation delays and restricted applicability to existing rebate contracts further diminish their effectiveness.
CONCLUSIONS: Our findings suggest that new regulatory instruments are currently unable to significantly curb expenditure dynamics in the early post-launch phase. Instead, more substantial savings may be achieved through stricter enforcement of existing tools - particularly for high-volume, older patent-protected medicines. Policymakers should critically reassess whether regulatory innovations or better execution of established mechanisms yield more sustainable cost control.