The English translation of the new version of the methods paper (General Methods 4.2) by the German Institute for Quality and Efficiency in Health Care (IQWiG) is now available on iqwig.de. The German-language original was published on 22 April 2015. Since then, the new methods paper has been the basis for the scientific work of the Institute and its external experts as well as for the Institute's collaboration with its contracting agencies.
The new methods paper 4.2 comprises detailed sections on the assessment of the potential of new examination and treatment methods according to the Structure of Health Care Act (GKV-VStG). In addition, the revised methods on health economic evaluation have been re-integrated into the General Methods as new Chapter 4.
Since Version 4.0, the Institute has been revising the methods paper in a step-by-step process, instead of updating the complete document. Among other things, the first changes for Version 4.1 concerned the procedure for the (early) benefit assessment of drugs.
Assessments of potential according to the testing regulation
With the Structure of Health Care Act (GKV-VStG), in 2012 the legislator enabled further access to medical innovations by means of the amended §137c and the new §137e of the Social Code Book (SGB) V: If the benefit of a new examination or treatment method is not yet sufficiently proven, but the potential of such a method as a required treatment alternative can be recognized, then the Federal Joint Committee (G-BA) has the option of initiating clinical studies (testing). The G-BA generally commissions IQWiG to assess whether the potential of a method can be inferred from the documents submitted for an application for testing ("assessment of potential").
Stefan Lange, the Deputy Head of the Institute, notes: "With the assessment of potential, IQWiG has again entered a new methodological area. In order to determine any potential at all on the basis of a small amount of data, we have developed scientifically sustainable, but also flexible methods. The path to testing is thus open for innovations."
Methods on health economic evaluation integrated
In connection with a benefit assessment, the G-BA can also commission IQWiG with a health economic evaluation (according to §35b SGB V und §139a SGB V). The comparison of the relation of benefits to costs of medical technologies is to serve as the basis for decisions on the appropriateness and reasonableness of cost coverage by the statutory health insurance funds (GKV).
The previously separate methods paper on health economic evaluation has been completely revised and integrated as new Chapter 4 into the General Methods 4.2. This is connected to amendments in the section on the summarizing assessment of the patient-relevant benefit (Section 3.1.5). Furthermore, a new section (1.3) on health economic standards was added to Chapter 1.
With the relaunch of its health information website gesundheitsinformation.de (English version: informedhealthonline.org) in February 2014, IQWiG comprehensively revised the structure and many topics of the website and improved handling and visual impression. In the methods paper 4.2, the new text formats result in revisions to Section 2.1.7 and the whole Chapter 6.
The revised section on diagnostic tests (3.5) now also includes the previous section 3.8 on prognosis studies. In addition, the information on the handling of the unrequested submission of data in Chapter 7 and on the evidence hierarchy of non-randomized studies in Section 8.1.3 was supplemented. The section on patient-relevant outcomes (Section 8.3.3) was also revised.
Beyond these changes in content the Institute also made editorial changes and added current literature citations.
The draft for the second update step and the new sections were published by IQWiG on 18 June 2014 and interested parties were invited to submit comments in a commenting procedure. The comments were considered in the present Version 4.2.
Together with the methods paper, IQWiG published a "Documentation and evaluation of the hearing" (in German) in which it documented the written comments in full. In addition, the document contains the Institute's responses to all main arguments presented in the comments.
IQWiG will provide information on the next revision step in due course.