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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 AMNOG Monitor readers,

The Federal Ministry of Health (BMG) has published the current financial figures for statutory health insurance: Revenue in 2023 amounted to €304.4 billion compared to expenditure of €306.2 billion. The deficit of around €1.9 billion was significantly lower than expected. Expenditure grew by 5.0%, which was mainly due to higher personnel and material costs. Expenditure on hospital treatment rose by 7.0%, on medicinal products by 2.9% and on outpatient medical services by 1.7%. The decline in corona-specific billing figures, in particular testing, had a dampening effect. www.bundesgesundheitsministerium.de (PDF, German)

On March 27, the German government passed the Medical Research Act (MFG), which is intended to strengthen Germany as a research location for medicinal products and medical devices. From the point of view of AMNOG procedures, the most important point is that pharmaceutical companies are to be given the opportunity to agree confidential reimbursement prices for new medicinal products. www.bundesgesundheitsministerium.de (PDF, German)

On April 4, the G-BA amended its rules of procedure with the necessary adjustments resulting from the GKV-FinStB and ALBVVG. www.g-ba.de (PDF, German)

The European Commission published the new methods paper for obtaining evidence from direct and indirect study comparisons for the planned EU HTA (start: 15.01.2025): health.ec.europa.eu (Methodological Guideline, PDF) and health.ec.europa.eu (Practical Guideline, PDF) as well as the drafts of the Implementation Acts and the feedback from the Public Consultation ec.europa.eu (Draft Implementing Regulation, PDF)..

In April, there was only one G-BA resolution on early benefit assessment (see table), five new procedures were started. We would be happy to inform you and any new employees about the AMNOG Monitor in a free training course. Please contact us with a suggested date.

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