IQWiG presents new version of its General Methods

Today the Institute for Quality and Efficiency in Health Care (IQWiG) presented the draft of a supplemented and revised version of its General Methods. The General Methods summarize the scientific standards according to which the Institute assesses the benefit and harm of medical interventions. Interested persons and institutions may submit comments on this draft until 8 April 2011.

Among other things, the revision was required as a result of the Institute's new tasks following the "Law on the Reorganization of the Pharmaceutical Market" (AMNOG). It became the responsibility of the Federal Joint Committee (G-BA) to assess the benefit of newly approved drugs in January 2011. The assessment is performed on the basis of dossiers that the manufacturers are obliged to submit to the G-BA. It is expected that the G-BA will generally commission IQWiG with the assessment of the dossiers.

What is new?

The implementation of this task is described in two new sections of the General Methods 4.0: "Dossier assessment" and "Benefit assessment of drugs according to § 35(a) Social Code Book V." In addition, experience with unpublished study data is considered in a separate section specifying which effects non-published study results have on the conclusions of benefit assessments.

The section "Surrogates of the patient-relevant medical benefit" was fundamentally revised and supplemented. This revision is based on the results of the rapid report " Validity of surrogate endpoints in oncology", which IQWiG published at the end of February 2011.

In order to indicate the reliability of conclusions on benefit and harm that are based on surrogate endpoints, the Institute plans to introduce a new category ("hint" of a benefit or harm). So far IQWiG has classified conclusions on the benefit and harm of an intervention into two categories, depending on the certainty of results: "proof” (high reliability of the conclusion) or "indication" (medium reliability). The new category "hint" expresses that certain minimal requirements for the available studies have been fulfilled, but that conclusions on benefit and harm are only possible with low reliability. "This constellation may also occur in other projects," says IQWiG Director Jürgen Windeler.

Further supplementations and changes are described in the draft of General Methods 4.0 in the new overview "What is new?" Most sections of Version 3.0 were shortened and in part also restructured. "However, the principles regarding the content of IQWiG's work remain unchanged" says Jürgen Windeler.

Written comments possible

Version 3.0 of the General Methods for the benefit assessment of medical interventions was published by IQWiG in May 2008. In October 2009 the methods paper was supplemented by a separate document on health economic evaluation methods. These methods will be updated at a later date.

Written comments on the draft of General Methods 4.0 can be submitted to IQWiG for examination and evaluation until 6 April 2011. The General Methods will then be revised and published on the Institute's homepage.

Contact: Tel. ++49(0)221-35685-0, info@iqwig.de