On 6 December 2021, Prof. Dr. Karl Lauterbach was announced as the new German health minister. This might mean quite a lot of changes for the early benefit assessment and pricing of products.
While the exact reforms are currently unknown, we can get an idea of the plans of the new health minister from his commentary on the AMNOG report from September 2020. He addressed 5 key areas:
AMNOG process
Lauterbach proposed to speed up the whole AMNOG process from the current 12 months to 6–9 months. This could be achieved by reducing the bureaucracy and tightening the commenting and hearing procedures.
Orphan drugs
In addition, he wants to revoke the exemption for orphan drugs to not undergo an early benefit assessment. He argues that patients affected by orphan diseases would be put at risk since there is no data and therefore no transparency on the effect of these drugs.
Re-assessments
Currently, the G-BA can request a re-assessment of a drug when new scientific evidence has become available.
Since 15 May 2017, pharmaceutical companies can also apply for a re-assessment based on new scientific findings, even if no time restriction was applied by the G-BA to the original HTA. Lauterbach wants to introduce mandatory re-assessments after 3–5 years based on observational data from real-world clinical practice.
Negotiated reimbursement price
The final reimbursement price that is negotiated between the manufacturer and the GKV-SV should be applied retroactively from the day of launch.
Risk-sharing
Lastly, Lauterbach supports risk-sharing reimbursement models. For example, SHI funds would only cover the costs of a product if the claimed benefit is achieved such as the patients going into remission. If there is no effect, then the manufacturers have to cover the costs.