IQWiG’s methods: New version in force

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

Additions or amendments to IQWiG’s General Methods may also arise from new statutory regulations. This was the case with the German Hospital Reform, which came into force in 2024. Under this reform, the Federal Ministry of Health may in future commission IQWiG to draw up scientific recommendations for the first-time setting and regular further development of minimum volume standards for medical service groups in hospital care. IQWiG’s recommendations are followed by an analysis by the Institute for the Hospital Remuneration System (InEK), which examines the impact of the respective minimum volume standards on the number and geographical distribution of hospital sites. On the basis of these analyses, the Ministry sets the minimum volume standards for each medical service group by statutory order, which must then be approved by the Bundesrat.

In September 2025, IQWiG published its draft on the new methods and invited comments for discussion. To explain the calculation approach, the Institute organized its first-ever webinar, which attracted over 300 participants. “This broad scientific exchange was important to us because we were breaking new methodological ground,” says Tim Mathes, Head of IQWiG’s Health Economics Department. “I was therefore all the more pleased with the many comments and the generally positive feedback. However, this did not result in any fundamental changes to the methods.”

“The data basis for such analyses still needs improvement, however, and this was also the consensus among those who submitted comments,” adds IQWiG Director Thomas Kaiser. “Developing the data basis in a transparent and nationally consistent manner is a key task to which we are keen to contribute – to ensure appropriate minimum volume standards and adequate inpatient care.”

The methods for setting minimum volume standards are published in a separate document and will be incorporated into a subsequent version of IQWiG’s General Methods.

Methods for EU HTA are defined at the European level

The methods for the European health technology assessment (EU HTA) of new drugs, which were launched in 2025, are not covered by the IQWiG methods paper, as this falls within the remit of the European level. However, once the European process has been established, IQWiG will describe how the results of completed European HTA reports are incorporated into the national assessment process in a future version of the General Methods.