The Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) has proposed a new benefit-assessment pathway for selected medicines as part of its developing 'AMNOG 2.0' reforms. The concept was presented to the pharmaceutical and medical-technology dialogue on 3 September and has subsequently drawn objections from statutory health insurance and IQWiG.
The pathway would apply to medicines receiving specified forms of regulatory treatment, including conditional marketing authorisation, authorisation under exceptional circumstances, accelerated assessment, PRIME support and orphan designation. This would potentially bring a substantial proportion of new medicines within the new route rather than limiting it to rare exceptional cases.
An initial assessment would use the 'best available evidence'. The concept also proposes greater acceptance of endpoints used in pivotal regulatory trials. A second assessment would normally follow after three to four years using evidence generated after launch, with data from the Health Research Data Centre expected to contribute.
The Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) argues that AMNOG can already assess suitable non-standard evidence and that the proposed categories do not themselves identify medicines requiring different evidentiary standards. It also questions whether routine health data are sufficiently suited to confirm comparative benefit.
The National Association of Statutory Health Insurance Funds (GKV-Spitzenverband, GKV-SV) estimates that around 60% of new active substances could meet at least one proposed eligibility criterion and projects additional annual expenditure of €100–280 million if weaker initial evidence results in higher added-benefit ratings and reimbursement amounts.
If adopted, the model would make post-launch evidence generation more closely connected to both benefit assessment and price. An initially favourable assessment could support a higher reimbursement amount, while the three- to four-year reassessment would expose that position to revision if subsequent evidence does not confirm the expected benefit.
Source: Institute for Quality and Efficiency in Health Care
Link: Stellungnahme des IQWiG zu den in der 4. Sitzung der AG 3 des Pharma- und Medizintechnikdialogs vom 03.09.2026 aufgeworfenen Fragen, insbesondere zum Foliensatz des BMG zum Thema ‘AMNOG 2.0’ (IQWiG statement on questions raised at the fourth meeting of Working Group 3 of the Pharmaceutical and Medical Technology Dialogue, particularly the BMG presentation on ‘AMNOG 2.0’)
Date: 29 September 2026
Source: National Association of Statutory Health Insurance Funds
Link: Stellungnahme des GKV-Spitzenverbandes vom 18.09.2026 zum Regelungsentwurf des Bundesministeriums für Gesundheit für eine Änderung des AMNOG ‘AMNOG 2.0’ (GKV-SV statement of 18 September 2026 on the Federal Ministry of Health proposal to amend AMNOG)
Date: 18 September 2026
