The German Ministry of Health released the “Referentenentwurf” or updated draft bill last week. This comes following an initial release in March which was rejected due to its immaturity. This updated bill contains some similar measures to those proposed in March as well as some additional measures which could negatively impact the pharmaceutical industry.
Proposed changes include:
- The EUR 50 million threshold for orphan drugs to not undergo full cost evaluation will be lowered to EUR 20 million. This will cause more orphan drugs to undergo assessment.
- The principle of free pricing shall be reduced from 12 months to 6 months so the AMNOG rebate will occur in the 7th month.
- Price negotiations on annual budgets and volumes between the pharmaceutical company and the National Association of Statutory Health Insurance Funds will also apply for follow-on indications.
- Combination products with new compounds will begin to incur an additional mandatory rebate of 20%.
There is also a proposal to add financial obligations for pharmaceutical companies:
- A EUR 1 billion “solidarity fund” which pharmaceutical companies will have to pay into to help to recover the deficit for the health insurance funds.
- The price freeze is extended for another four years after 31 December 2022.
- Medicines with no, minor, or non-quantifiable additional benefits will begin to have reimbursement caps of the following:
- Reimbursement amount should be lower than the comparator when there is no additional benefit.
- Comparable reimbursement amounts as the comparator when there is minor or non-quantifiable additional benefit.
- http://www.portal-sozialpolitik.de/uploads/sopo/pdf/2022/2022-06-30_RefE_GKV_FinStG.pdf “Referentenentwurf des Bundesministeriums für Gesundheit Entwurf eines Gesetzes zur finanziellen Stabilisierung der gesetzlichen Krankenversicherung”, 30th June