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!
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…
Products with initial market entry after January 1st, 2025 are now benefiting from less strict pricing guidelines if the studies used for AMNOG benefit assessment included ≥ 5 % German patients. The benefit will last for 3 years and can be maintained even afterwards for companies with active R&D…
Changes to the German pricing system for innovative drugs are now in effect due to the Medical Research Act (Medizinforschungsgesetz, MFG). As of January 1st, 2025, European reference prices will no longer be included in the price negotiations according to § 130b SGB V following AMNOG benefit assess…
