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 innovative products:
The central instrument for cost-control in the pharmaceutical market will be the dynamic manufacturer discount limiting the drug expenditure to the income of the statutory health insurances. The implicit drug budget will have impact on the pricing for new innovative drugs and will create interdependencies between prices for new drugs and patent-protected drugs that are already in the market.
After the implementation of the BStabG with far-reaching consequences, a reform of the AMNOG process itself (AMNOG 2.0) is now being discussed. Beyond that the Finance Committee on Health recently proposed expanding the role of cost-benefit assessments for reimbursement price negotiations, effective…
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 dynamic manufacturer rebate is a regulatory misstep The planned introduction of a dynamic manufacturer rebate for patent-protected medicines (§ 130a para. 1b SGB V) as part of the BStabG (statutory health insurance contribution rate stabilization bill) raises significant regulatory questions — p…
