With the German Health Insurance Contribution Rate Stability Act (BStabG) now in force, statutory health insurances can establish cross-molecule rebate contracts for clusters of innovative, patent-protected medicines under §130e SGB For manufacturers, the implications are significant: Intensi…
The draft bill for the health care reform in Germany not only extends the price moratorium until 2030 but also cuts free pricing for nex Gx products. In the future, Gx prices for new products will depend on the existing market prices. The decisive factor will be whether a drug with the same active i…
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…
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…
