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:
What should manufacturers do now?
Germany’s reimbursement landscape is changing rapidly, and early preparation will be critical.
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…
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…
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…
