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Identify decision-paths and trends in early benefit assessment. The AMNOG monitor is indispensable for managers and decision-makers in market access, pricing and reimbursement.

Dear readers of the AMNOG-Monitor,

The Federal Ministry of Health (BMG) is undergoing a reorganisation: it is becoming younger, leaner and more female. Fifty per cent of the management positions at the BMG are now held by women, which should be a matter of course, but is still rather the exception in Germany. While Department 1, ‘Medicines, Medical Devices, Biotechnology,’ continues to be headed by Thomas Müller, Department 2, ‘Health Care, Health Insurance’ is now headed by Barbara Geiger, a former Federal Social Court (BSG) judge. Department 6, ‘Health Security, Resilience, International Europe,’ is being reorganised and will be headed by Dr. Katja Pohlmann, who is moving from the Federal Chancellery to the Ministry of Health, replacing Dr. Ute Teichert. With the immediate measures that have been decided upon, the BMG aims to ensure price stability in the statutory health insurance system for 2026. https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/O/Organisationsplan/Organisationsplan_Entwurf_neue_Orga.pdf

On 12 November, the first pharmaceutical dialogue took place under the leadership of Health Minister Nina Warken (CDU) and Chancellery Chief Thorsten Frei (CDU). The meeting is intended to mark the start of a pharmaceutical and medical device technology strategy to define measures for improving the framework conditions. The pharmaceutical industry is one of the few sectors in Germany that is growing, but there are repeated shortages of low-cost medicines, for which Germany is strongly dependent on China and India. At the same time, health insurance companies are complaining about increased expenditure in the pharmaceutical segment (+6% in the first half of 2025). Proposals are now to be developed in working groups.

The G-BA has decided to restrict the prescribers for Lecanemab; therapy initiation and monitoring must be carried out by specialists in neurology or specialists in psychiatry and psychotherapy who have experience in the treatment of Alzheimer's disease and access to timely magnetic resonance imaging (MRI) diagnostics. The reason for this restriction is the requirement set out in the product information for diagnosis and therapy monitoring, as well as the severity of the possible side effects of Lecanemab. The decision to amend Annex III (10a) of the “Arzneimittel-Richtlinie” (AM-RL) will be submitted to the BMG for legal review. 

On 18 November 2025, new G-BA rules of procedure (Verfahrensordnung; VerfO) came into force, regulating how dossiers submitted at EU level (EU-HTA) can be incorporated into the national procedure (AMNOG). The new dossier modules are now available on the G-BA website. https://www.g-ba.de/presse/pressemitteilungen-meldungen/1273/

In November, there were 14 new decisions on early benefit assessment (cf. table below) and 6 new procedures were initiated.

A new EU-HTA procedure for Relacorilant – a noval antiglucocorticoid compound – was started for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. All current EU HTA procedures are shown in the following link: https://health.ec.europa.eu/document/download/d947533e-7e4e-4e82-a9c6-e06830d708f8_en?filename=hta_ongoing-jca_en.xlsx

New reimbursement prices of AMNOG products are available here.
EMA Positive Opinions for new drugs are shown here.

Kind regards,
Dr Johannes Hankowitz and Christian Rieke