With the SHI Financial Stabilisation Act (GKV-FinStG), the framework conditions for price negotiations for medicinal products in Germany have been made more complex and have been systematically tightened by the legislator to the disadvantage of the pharmaceutical industry. On the one hand the extend of the additional benefit and on the other hand the prices, patent protection, and previous benefit assessments of the comparative therapies have a major impact on negotiations of the reimbursement amount.
Try out our new guide, which will lead you through the various scenarios of the price negotiations following AMNOG benefit assessment. For further questions, we are happy to advise you!
The price-volume regulation shall no longer be subject to arbitration. The default mechanism kicks in if no agreement between the pharmaceutical company and the statutory health insurances is reached and adjusts the reimbursement amount annually (starting in the third calendar year after launch) usi…
The current draft bill on statutory health insurance contribution rate stabilization (BStabG) sets out the health policy objective of tighter expenditure control — with direct implications for pricing, market access, and reimbursement in the German market. An overview of the key changes for innovati…
Pediatric drug shortages: has the situation really improved? In recent years, Germany has faced shortages of essential medicines for children, including antipyretics and antibiotics. To encourage manufacturers to increase production and supply, the GKV-SV (GKV-Spitzenverband, German SHI association)…
Since the beginning of 2025, member states of the European Economic Area (EEA) have been working together on joint clinical assessments (JCA) of new medicines. Recently, the first 9 JCAs were announced, assessing 2 ATMPs with Orphan drug status and 7 oncologics. Germany, France, and Ireland are curr…
