In their 2nd and 3rd reading, the German Parliament has decided further specifications of the new law on the financial stabilisation of the statutory health insurances (GKV-FinStG).
As already outlined in the draft of the law, the outcome of the AMNOG benefit assessment will further gain importance for the subsequent price negotiations. In case the appropriate comparative therapy (ACT) is patent-protected, a premium price will only be possible for products with a considerable or major added benefit. If the patent-protected ACT has not been subjected to AMNOG benefit assessment itself, further rebates will be applied. For ACTs that are not patent-protected, there are no changes, and products with an added benefit of any extent can achieve premium prices. Furthermore, only products with considerable or major added benefit will be exempted from the mandatory 20 % discount if they are used in combination with other drugs.
Currently, the added benefit of orphan drugs is proven by their market authorization and submission of a full AMNOG dossier is not necessary as long as the annual sales do not exceed 50M €. The initial draft of the GKV-FinStG law proposed a reduction of this threshold to 20M €. However, this threshold has now been increased to 30M €. The German Parliament estimates that approximately 10 orphan drug products will need to undergo reassessment after implementation of the law.
The outcome of the AMNOG benefit assessment will gain importance for the subsequent price negotiations.
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…
