Ways of commissioning
IQWiG does not conduct clinical trials or patient consultations. Rather, in its reports the Institute answers research questions using available, reliable evidence, i.e. scientific proof. We sometimes receive requests from the general public or other parties to investigate specific questions - for example, with the aim of protecting patients from harmful treatments. Is that possible? Who can actually award commissions to IQWiG? Moreover, under what circumstances can the Institute act on its own initiative?
The laws and directives regulating IQWiG's role and work result in four paths, each presented in a text and graph below:
- The Institute receives by far the most commissions from the Federal Joint Committee (G-BA), the supreme decision-making body in the statutory health insurance (SHI) system in Germany.
- The Federal Ministry of Health (BMG) can also award commissions to IQWiG.
- The topics of the health technology assessment (HTA) reports that IQWiG publishes under the label "ThemenCheck Medizin" are suggested by members of the general public, pre-selected by laypersons and experts, and finally selected by the Institute's Management. The reports are written by external authors.
- The so-called general commission enables IQWiG to act on its own initiative, either to produce comprehensible health information or to investigate further issues of fundamental importance that have arisen, for example, in other projects.
Regardless of the way the Institute operates: According to the will of the legislator, IQWiG must ensure that an assessment of the medical benefit of an intervention is performed following the internationally recognized standards of evidence-based medicine and a health economic evaluation is performed following the internationally recognized standards of health economics. IQWiG's methods are publicly available.
IQWiG never makes decisions on the market access or withdrawal of drugs, medical devices or health care services. Nor does it make decisions on the standard or supplementary services covered by SHI funds or on the services offered by physicians. The Institute’s task is limited to the review, analysis, presentation and assessment of the scientific evidence on health care issues.
Conjoint scientific projects (such as within the European Network for , EUnetHTA) are not mentioned here, as the Institute does not receive a commission in such cases, but actively seeks collaboration and further development in the field of evidence-based medicine, as specified in the German Social Code Book (SGB V §139a (3)).
Commissions from the Federal Joint Committee: What belongs in the catalogue of health care services covered by the SHI funds?
The Federal Joint Committee (G-BA), as the supreme decision-making body in the statutory health insurance (SHI) system, decides which health care services are covered by the SHI funds. The prerequisite for this is laid down in SGB V §12: "The services must be sufficient, appropriate and economical; they must not exceed what is necessary.”
The G-BA often assesses whether a treatment or a diagnostic procedure is appropriate (i.e. whether it has a positive benefit-harm ratio) by means of a report prepared by IQWiG. This type of commissioning is described in SGB V, §139b. The G-BA's rules of procedure (Section 4) state: Commissions to IQWiG are awarded for "questions of fundamental importance for the quality and efficiency" of the services provided within the SHI. In addition to the organizations represented in the G-BA, the Federal Ministry of Health (BMG), patient representatives or the Federal Patients' Representative can also apply to the G-BA for a commission to be awarded to the Institute.
After receipt of a G-BA commission, IQWiG has a specified period to prepare the report, send it to the G-BA and publish it. The deadline depends on the type of report required. An overview of report types can be found under About us > Methods > Results.
For example, our rapid reports aim to provide swiftly issued recommendations on current health care issues. Other reports are less urgent and take longer, because a preliminary report is published first and comments from the scientific community and other interested parties are requested. In addition, for comprehensive reports, the international literature is systematically searched for relevant evidence. In contrast, for other report types, IQWiG only uses the most important data sources or only assesses the documents that it receives from the G-BA or from the manufacturers or providers of a treatment when it is commissioned. This also influences the workload and thus the time to completion.
Due to changes in the law, the scope of IQWiG's report types has expanded over the years. Dossier assessments are used for the early benefit assessment of drugs with new active ingredients and are completed within three months. A commenting procedure only takes place afterwards during the G-BA deliberations. The G-BA can also request health economic evaluations from IQWiG, but this has not happened in recent years. Assessments of the potential of non-drug interventions commissioned by the G-BA aim to clarify whether an examination or treatment method (whose benefit has not yet been adequately proven) has at least the "potential to become a necessary treatment alternative." The G-BA can also commission the Institute to assess new examination and treatment methods with high-risk medical devices if hospitals have applied for additional coverage for the use of such methods.
The G-BA can also commission an addendum to an IQWiG report if further information is required during its deliberations.
The results of IQWiG's work have the character of recommendations that the G-BA must take into account in its decision-making, but from which it can also deviate - for example, if new findings arise after IQWiG has issued its recommendation.
Commissions from the Federal Ministry of Health: health policy makers ask, IQWiG answers
In addition to the G-BA, SGB V §139b names the Federal Ministry of Health (BMG) as IQWiG's second regular contracting agency. The Ministry not only initiates commissions via the G-BA, but also awards them directly to the Institute.
Such commissions serve, for example, to prepare evidence-based health policy decisions or to support medical societies. Previous BMG commissions include a report on the assessment of studies on rare diseases (2013), support in guideline development for natural childbirth (2016), a concept and a series of texts for the National Health Portal (2018 and 2020), and a rapid report on patient-specific blistering of drugs (2019).
However, BMG commissions to IQWiG are considerably less frequent than G-BA commissions.
HTA reports on questions submitted by the general public: IQWiG as a commissioning agency
In SGB V §139b, the legislator also transferred to IQWiG on a blanket basis the task of organizing the public proposal process for HTA reports and commissioning external experts to write the reports. This allows the Institute to regularly conduct this task without separate commissions for reports.
In this "ThemenCheck Medizin", all members of the public can suggest assessments of medical procedures and technologies whose benefits and relevance have not yet been sufficiently investigated. Once a year, the Institute selects up to five topics from the proposals received that are considered to be particularly important for patient care in Germany. Both the consumer and patient perspective, as well as the scientific perspective, are taken into account.
The IQWiG team first compiles the scientific information on the proposals and assesses this information: How many people are affected? How burdensome is the respective disease? Are any scientific studies on the topic available? How expensive is the medical procedure in question? Does anything indicate problems in the provision of health care? Do special ethical aspects need to be considered? Based on this information, a Selection Committee consisting of members of the general public and patient representatives first chooses up to 15 topics each year. In a second step, IQWiG's Management selects up to five topics per year after consultation with the Extended Advisory Board.
The HTA reports on these research questions are written on behalf of the Institute by external teams of researchers and supplemented by the publisher’s comments provided by IQWiG. In this case, the Institute does not act as a contractor, but rather as a commissioning agency. The reports are published on IQWiG's website and sent to the relevant health care organizations so that the findings can be used to improve health care. Each report is also accompanied by a document called "HTA compact", which summarizes the results in an easily understandable way.
The general commission: on IQWiG’s own initiative, but not arbitrarily
The Institute can also select and investigate issues of fundamental importance on its own initiative, without having to each time consult with the G-BA and the BMG. To this end, the G-BA awarded a so-called general commission to IQWiG in 2004, which was extended in 2006 and 2008.
The original general commission aims to provide the G-BA with information and suggestions on developments relevant to health care or to further develop the Institute's own methods by means of a continuous review of the scientific literature and the experience that the Institute gathers in the work on its commissions.
The results are mostly presented in working papers. These working papers are first sent to the G-BA, the Board of Directors and the Foundation Council, then to the Board of Trustees of the Foundation that supports IQWiG, and are finally published on the Institute's website.
Since its expansion, the general commission has also covered the Institute's task (specified in SGB V §139a) of providing consumers and patients with "comprehensible general information on the quality and efficiency of health care as well as on the diagnosis and treatment of diseases of considerable epidemiological relevance.” The health information website gesundheitsinformation.de (English version: informedhealth.org), which presents the most common diseases in Germany and the respective treatment options, serves this purpose. The G-BA is involved in the selection of topics, but thanks to the general commission, it does not have to initiate the production of information separately for each disease.
However, not all content on the health information website is created as part of the general commission: Part of the content is also the result of a topic-specific commission from the G-BA, usually following a commission for an assessment on the same topic. One example is the decision aid on biomarker tests in breast cancer, which the Institute produced after completion of the corresponding benefit assessment.