Evaluation of a risk-adapted PSA and MRI-based screening for prostate cancer in Germany

On October 16, 2025, the Federal Joint Committee (G-BA) launched the consultation procedure on a risk-adapted prostate-specific antigen (PSA) and MRI-based screening for the early detection of prostate cancer, in line with §135 SGB V (G-BA Directive on Ambulatory Care Methods; conceptually new diagnostic and therapeutic methods). Public comments may be submitted electronically by November 23, 2025.

The evaluation was initiated following an application by the patient representative to the G-BA in July 2025. A final decision on the method is expected in October 2027.

In addition, on October 9, 2025, the G-BA commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to perform a systematic search, presentation, and assessment of the current scientific evidence regarding risk-adapted PSA and MRI screening for the early detection of prostate cancer. IQWiG’s final report is anticipated in October 2026.

Under German regulations, measuring PSA levels in blood is not currently recognized as a population-based screening examination.

The full details in German can be found here (G-BA) and here (IQWiG).

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.