HTA reports are based on suggestions submitted on the website “ThemenCheck Medizin” (Topic check medicine) by statutory health insurance members and other interested people. The legislator has initiated this tool to provide a possibility for people to get involved in the promotion of evidence-based medicine.
These reports always assess benefit and harm of a medical procedure. In line with international HTA standards and depending on the topic, the HTA reports can also additionally investigate its economic, ethical, legal, social and organizational aspects regarding patient care. §139b (5) SGB V is the legal basis of the report production.
IQWiG forwards the HTA reports to institutions in Germany, which, for example, decide on the services and structure of the healthcare system. In this way the results of HTA reports are supposed to have a direct impact on the health care of patients in the German healthcare system, for example, in treatment decisions made in conversations between doctors and patients or in system decisions made by the self-government of the healthcare system or by policy makers.
In 2016 it is planned to start the first selection procedure after a shortened proposal phase of 3 months. The work on the first HTA reports is supposed to start in mid-2017. The first HTA reports are to be completed in 2018.
Each HTA report covers 2 parts: a basic report prepared by external experts according to IQWiG’s General Methods, as well as a publisher’s comment by IQWiG classifying the results.
Preparation of HTA reports (simplified description):
- Topic selection: From proposals made by members of the public, the Institute selects up to 5 topics per year that are especially important for patient care in Germany. These topics are selected in collaboration with patient representatives, members of the public, independent researchers as well as delegates of the Foundation Board. HTA reports on these topics are then prepared.
- Report protocol: According to IQWiG’s methods, the methodological approach for the work on the topic selected is specified by external experts in a report protocol and tested for conformity by IQWiG.
- Basic report: The external experts prepare a preliminary basic report. This also covers a conclusion and a generally understandable summary. After a conformity check and acceptance of the basic preliminary report by IQWiG, a written commenting procedure is conducted. An evaluation of the comments and, if necessary, changes to the report following the comments are made by the external experts.
- Publisher’s comment:IQWiG classifies the work results in a publisher’s comment.
- HTA report: the basic report of external experts is published as an HTA report together with a publisher’s comment by IQWiG.
- Gesundheitsinformation.de/ informedhealthonline.org: as stipulated by legislation, the results of the HTA reports are also published on IQWiG’s health information website.