On Friday, 21 Oct 2022, the German House of Representatives has now finalized the law on the financial stabilization of statutory health insurance (GKV-FinStG).
The law covers important changes to the AMNOG legislation:
- The negotiated reimbursement prices will apply retroactively from month 7 onwards (instead of month 13).
- The price cap for products outside of reference price groups (German: “Preismoratorium”) will be extended for another 4 years until the end of 2026. This price moratorium has been in place since 2009 already.
- The mandatory manufacturer discount will be increased for one year from 7% to 12%.
- The annual sales threshold for orphan drugs triggering a full early benefit assessment will be lowered to €30 mn (instead of the current €50 mn threshold). The initial draft law had even foreseen reducing the threshold to €20mn, but this was raised to €30mn at the last minute.