Germany: Changes to innovative drug pricing and AMNOG ahead
A new reform act to address the GKV (statutory health insurance) budget gap is in the making in Germany, and medicines funding does not remain untouched, most importantly, the price setting rules for innovative medicines through the AMNOG price negotiations.
The first draft of the GKV finance stabilization act (GKV FinStG) has just been presented and holds tough news for industry. An outline of the key pricing and AMNOG changes proposed:
- Extension of the “price freeze” for another 4 years (Companies are not allowed to raise medicine prices beyond general inflation level)
- For 2023 and 2024 a “solidarity levy” will be introduced – a payment that will be a function of the companies revenue with the GKV (to be defined in a separate article)
- The free pricing for 12 months for new medicines will be reduced to 6 months
- Price negotiations and price agreements will need to include price-volume agreements and/or budget caps
- The price rules in relation to the AMNOG outcome will change such as:
- “No additional benefit”: Lower price then patented SOC
- “Minor” or “non-quantifiable benefit”: Similar price to patented SOC
- The price premium will be only possible for “significant” or “major benefit” ratings
- Potential AMNOG or price negotiations for patented medicines that have not been through AMNOG
- The orphan drug ceiling will be reduced to €20 millions (instead of the current €50m)
- 20% discount on drug combination therapies
The schedule for the further consultations on the law is not yet clear. Industry has already heavily critised the draft, seeing innovation not sufficiently rewarded and contradictions with government initiatives to strengthen the attractiveness of Germany for pharmaceutical companies.
