IQWiG General Methods 8.0: new version in force

With the General Methods 8.0 of December 2025, the new IQWiG methods for setting minimum volume standards for medical service groups in hospitals also came into force. As of 1 July 2026, the English translation of the General Methods is now available.

Reports by the Institute for Quality and Efficiency in Health Care (IQWiG) form the scientific basis for key decisions in Germany’s statutory health insurance (SHI) system. These include the inclusion and exclusion of medical services from reimbursement, the setting of annual minimum volumes for complex procedures in hospitals, and the negotiation of reimbursement prices for new drugs. This makes it all the more important that IQWiG ensures its assessment methods always remain up to date, scientifically recognized and transparent.

In December 2025, the Institute completed the revision of its methods paper and published Version 8.0 of its General Methods on www.iqwig.de. “Compared with the draft version that we published for discussion at the end of February 2025, a number of adjustments were made following external comments. We clarified the wording and, in some cases, explained our approach in greater detail. However, no major changes were necessary,” explains Ralf Bender, Head of IQWiG’s Medical Biometry Department.

In General Methods 8.0, a separate chapter (Chapter 8) is devoted, for the first time, to the question of how IQWiG involves people affected by certain diseases or interventions in its work. Here, the Institute summarizes the methods it uses to obtain information and data from people affected or representatives of patient organizations. Previously, this information was scattered across several chapters of the methods paper.

In addition, the Institute has expanded its approach to meta-analyses involving very few studies (Section 10.3.7). To this end, an IQWiG team, in collaboration with researchers from Göttingen, developed a method that assesses the benefit of medical interventions more precisely when only a few studies are available. Existing information is incorporated into Bayesian random-effects meta-analyses: To estimate heterogeneity between studies more reliably, data from previous benefit assessments stored in an IQWiG database are utilized.

Separate commenting procedure for new methods on minimum volume standards