From commission to result: the products
The results of IQWiG's work differ in scope, objective and target group. For example, we develop recommendations to support policy decisions by the Federal Joint Committee (G-BA), as well as easily understandable health information for the general public.
IQWiG usually receives commissions from the G-BA and (less frequently) the Federal Ministry of Health (BMG).
We produce:
Addenda
Addenda are prepared for final reports, rapid reports, assessments of potential, §137h assessments, routine practice data collection (RPDC) concepts or dossier assessments if further work is required following the completion of an assessment. For instance, this might be the case if the evidence base changes during the consultations of the G-BA, e.g. if new studies are published. Addenda may be commissioned by the G-BA or the BMG.
Routine practice data collection (RPDC)
In the case of drugs for rare diseases (orphan drugs) and drugs with special marketing authorizations, the G-BA may require the pharmaceutical company to collect and analyse routine practice data. This is intended to improve the evidence base for assessing the added benefit of these drugs. As part of the decision as to whether RPDC is required, IQWiG may be commissioned to perform an assessment of the relevant patient numbers.
Working papers
Working papers are products published without a specific commission, particularly within the framework of the G-BA’s general commission. They are developed in accordance with the scientific standards set out in IQWiG’s General Methods. There are no deadlines for their publication. A discussion with the professional community takes place following publication.
Reports
A report is the term used for scientific documents produced by IQWiG (such as benefit assessments, health economic evaluations or guideline synopses) and developed on the basis of a commission from the G-BA or the BMG. They are drawn up in a defined process that provides for the opportunity for comments by interested persons or institutions, in particular through the publication of preliminary reports. All final reports are freely available on the website www.iqwig.de, with extracts of certain reports also translated into English www.iqwig.de/en/
- Topic selection: A report is always initiated by a commission from the Federal Joint Committee (G-BA) or the Federal Ministry of Health (BMG), either of which can specify the research question.
- Formation of a project group: The project group formulates the scientific research question and the outcomes for the project in agreement with the commissioning agency and possibly also with external experts.
- Production of the report plan: The report plan is a project outline that summarizes the key aspects of the assessment procedure.
- Commenting procedure on the report plan: The draft of the report plan is published, so that all interested parties have the opportunity to submit comments. These comments are then incorporated into the report plan, which forms the basis of the report production and is included in the preliminary report. (For assessments of examination and treatment methods there is no commenting procedure on the report plan.)
- Information retrieval and scientific evaluation: Based on the criteria laid out in the report plan, scientific publications and additional information are searched for worldwide, retrieved and screened. Researchers also evaluate the reliability of the results, i.e. the informative value of the data presented.
- Publication of the preliminary results: The preliminary results of the search and of the scientific evaluation are then published as a preliminary report initially.
- Commenting procedure on the preliminary report: Any interested party (individuals, institutions or companies) may submit comments on the preliminary results.
- Production of the final report: The comments are considered in the revision of the preliminary report. The resulting final report is published together with the documentation of the comments.
- Production of an addendum if needed: If a need for further work on the commission arises during the consultations on a final report (e.g. if new studies are published), the commissioning agency can commission IQWiG with a subsequent addendum.
Assessments of high-risk medical devices (assessments according to §137h SGB V)
Certain new examination and treatment methods involving high-risk class medical devices in hospital settings must be assessed by the G-BA in accordance with §137h of the German Social Code Book V (SGB V) with regard to the benefit, harm or ineffectiveness of the method. Documents submitted to the G-BA by hospitals and, where applicable, by the medical device manufacturers concerned form the basis of such an assessment. The G-BA usually commissions IQWiG to carry out this assessment. The results are published.
The Act to Strengthen the Provision of Health Care (GKV-VSG), which was introduced in 2015, mandates that certain examination and treatment methods with medical devices used in the hospital setting are subject to an assessment by the G-BA. The legal basis for this mandatory and deadline-bound benefit assessment is §137h of the German Social Code Book V (SGB V) as well as the Regulation on the Assessment of Methods for Medical Devices (MeMBV).
The assessment applies to those new examination and treatment methods (‘Neue Untersuchungs- und Behandlungsmethoden’, NUB) that meet the following preconditions:
- A hospital submits the first application according to §6 (2) Hospital Reimbursement Act (‘NUB application’) to the Institute for the Hospital Remuneration System (InEK).
- The technical application of the method is largely based on the use of a high-risk medical device. High-risk medical devices are those that are particularly invasive in nature ̶ either because the use of the medical device substantially interferes with essential functions, in particular of the heart, the circulatory system or the central nervous system, or because the medical device specifically affects essential organ functions by emitting energy or radioactivity.
- The method is based on a new theoretical-scientific concept. This means that the mode of action or the therapeutic indication differs substantially from other methods already introduced in inpatient care.
The hospital submitting the first NUB application for such a method at the same time also submits documents on the scientific state of knowledge to the G-BA. This is done in agreement with the medical device manufacturer. The G-BA publishes the submission form within two weeks, thus starting the procedure to supplement information. In this procedure, further hospitals and medical device manufacturers concerned can submit additional documents within four weeks. The G-BA decides within three months whether the benefit or the harmfulness or ineffectiveness of the method is to be regarded as sufficiently proven. The scientific assessment on the basis of the documents submitted is usually conducted by IQWiG on behalf of the G-BA. Because the §137 procedure is linked to the annual NUB procedure (with the submission deadline at the end of October), §137 assessments at IQWiG are usually only conducted during the winter.
Similar to other G-BA assessment procedures, the period to conduct the assessment is stipulated by law. The G-BA must decide on the benefit, harm or ineffectiveness within three months on the basis of the information submitted. Accordingly, the assessment at IQWiG must be completed within a few weeks. If neither benefit, harm nor ineffectiveness can be identified, the G-BA usually initiates a testing study to evaluate the benefit. For this purpose, IQWiG develops the key points of the study within the framework of its §137h assessment, if necessary.
If, on the basis of all documents submitted and the assessment conducted by IQWiG, the G-BA decides that neither the benefit nor the harmfulness or ineffectiveness of a method can be regarded as sufficiently proven, it can commission IQWiG to conduct a systematic literature search. This is done to ensure that all relevant studies are considered in the preparation of the testing directive. IQWiG conducts this search in the form of an addendum.
If the G-BA decides that the benefit of the method is to be regarded as sufficiently proven, it then examines whether directives on quality requirements are to be developed. If, on the other hand, the harmfulness or ineffectiveness of the method can be regarded as sufficiently proven, the G-BA decides on the rapid exclusion of the service from inpatient services.
- Transfer of all documents by the G-BA: With the commissioning of an assessment according to §137h SGB V, the documents are transferred to IQWiG. The documents include the ones provided by the applying hospital, the medical device manufacturer, and, if applicable, further hospitals and manufacturers.
- Scientific evaluation: On receipt of the documents at IQWiG, the Institute starts with the assessment of content. Medical experts may be consulted to consider current every-day health care. The process is completed with the preparation of the assessment according to §137h SGB V.
- Optional: The G-BA can commission IQWiG to conduct a systematic literature search to ensure that all relevant studies are considered. This search is conducted in the form of an addendum.
Dossier assessments
Dossier assessments are carried out as part of the early benefit assessment of drugs (in accordance with the Act on the Reform of the Market for Medicinal Products, AMNOG). Comprehensive dossiers submitted by pharmaceutical companies to the G-BA form the basis for the assessments. IQWiG examines whether the dossier proves an added benefit of the drug versus an appropriate comparator therapy. In contrast to other work results, the time period to conduct the assessment is stipulated by law: the dossier assessment must be completed within three months after receipt of the manufacturer's dossier.
- Submission of the dossier by the G-BA: A dossier assessment is always initiated by a commission from the G-BA and the submission of the dossier.
- Information retrieval and scientific evaluation: On receipt of the dossier at IQWiG, the Institute will start the assessment with regard to the contents of the dossier. The basis for the assessment is the manufacturer's dossier data. Optionally, the Institute may conduct its own additional search for information. Medical experts and patients are regularly consulted for the assessment.
- Production of the dossier assessment: The process ends with the production of a dossier assessment. In accordance with §35a Social Code Book V (SGB V), the assessment must be completed three months at the latest after the relevant date for submission of the dossier.
Estimation of patient numbers
In the case of a new drug that has entered the health care system via a special marketing authorization or as a treatment for a rare disease, the clinical trial data available at the time of authorization are generally of limited informative value for the early benefit assessment. In such cases, the G-BA may require the pharmaceutical company to collect and analyse routine practice data (routine practice data collection, RPDC), for the purpose of a benefit assessment.
When assessing whether RPDC is required for new drugs, the G-BA also examines the feasibility and appropriateness of data collection. In this context, IQWiG may be commissioned to conduct an assessment of the number of patients for the relevant therapeutic indication.
The assessment of the number of patients is completed within four weeks. Once completed, the document is sent to the G-BA. A notice is published on the Institute’s website when the G-BA initiates a procedure to request RPDC within the therapeutic indication area.
Decision-making criteria for minimum volume thresholds
For quality assurance reasons, minimum volume regulations have been established for particularly complex, scheduled inpatient procedures. For this purpose, principles for decision-making are developed. For medical procedures for which a minimum volume is to be introduced or adjusted, it is assessed whether a relationship can be demonstrated between the volume of services provided and the quality of treatment.
European health technology assessments (EU HTAs)
Starting in January 2025, benefit assessments called joint clinical assessments (JCAs) have been conducted in a coordinated manner across Europe for certain drugs. In addition, from 2026 onwards, coordinated JCAs are also being carried out across Europe for selected high-risk medical devices and in vitro diagnostics.
IQWiG is working on the production of these JCAs in collaboration with other European HTA agencies. The process is based on European legislation and a shared set of methods.
Health information
IQWiG’s health information is intended for the general public. It is easily understandable, free of charge and contains no advertising. It is designed to help people make informed decisions on individual health issues. The production of such health information is a further legal duty of IQWiG. The health information is produced on the basis of a commission from the G-BA or the BMG, or as accompanying information to a benefit assessment. IQWiG also addresses topics on its own initiative. You can find this information on the website www.informedhealth.org.
- Selection of topic: A health information product can be initiated by a commission from the G-BA or the BMG, by a scientific evaluation by IQWiG, or it can be a topic chosen by IQWiG itself.
- Formation of a project group: The project group formulates the scientific research question and the outcomes for the project.
- Information retrieval and scientific evaluation: Based on the criteria established, information is retrieved and its reliability evaluated.
- Text production and external review: The first text drafts on a topic are sent to at least one external reviewer.
- Second text draft: Based on the review, a second text draft is produced and undergoes an internal review.
- Submission of comments: The commissioning agency and the expert community - stakeholders, medical societies and patient representatives – then have the opportunity to submit comments on the texts within four weeks. The comments, and the results of a user test that is conducted simultaneously, are considered in the final editing of the texts before their publication.
- Publication: The finalized texts are published on the website www.informedhealth.org.
Health economic evaluations
Since 2007, the health economic evaluation of drugs has legally fallen under IQWiG’s responsibilities. The Institute can therefore be commissioned by the G-BA, in accordance with §35b of the German Social Code Book V (SGB V), to carry out health economic evaluations of drugs, and conduct hearings accordingly. Even though the health economic evaluation instrument is not currently being used, one of the tasks of the Institute’s Health Economics Department is to keep the methods of health economic evaluation up to date with international standards of evidence-based medicine and health economics, and to develop them further accordingly.
Guideline synopses for disease management programmes (DMPs)
Guideline synopses for disease management programmes (DMPs) outline the key elements of a clinically recommended health care standard, and form the basis for the G-BA’s specification of the requirements for structured treatment programmes for people with chronic conditions. Current recommendations from national and international evidence-based guidelines that are relevant to a DMP are summarized in guideline synopses, and the findings are compared with the current DMP.
Minimum resource requirements
Under the German 2024 Hospital Reform, the BMG may commission IQWiG to draw up scientific recommendations for establishing the minimum resource requirements for health services groups in hospital care, and for keeping these up to date. The BMG sets the minimum resource requirements for each health services group based on IQWiG’s recommendation and the impact analysis carried out by the Institute for the Hospital Remuneration System (InEK).
Assessments of potential
Under the ‘testing regulation’ provided for in §137e (7) of the German Social Code Book V (SGB V), manufacturers and providers may apply to the G-BA for the testing of a new examination or treatment method that does not rely solely on the use of drugs (non-drug intervention). This also includes what are known as medical devices. The assessment of the potential of a new method is part of this testing regulation. The assessment of the potential of examination and treatment methods is usually conducted by IQWiG after commissioning by the G-BA. The Institute does not hold hearings as part of the procedure. If an intervention is to be tested, the G-BA conducts a commenting procedure on the testing directive. Assessments of potential are part of an administrative procedure conducted by the G-BA. The topics and contents of this procedure are confidential. IQWiG submits the report on the assessment of potential to the G-BA. Whether the report is published depends on further decisions reached by the G-BA.
If the G-BA, on the basis of the documents submitted and of the assessment of potential conducted by IQWiG, decides that a method has potential, IQWiG is generally commissioned to conduct a further literature search. This is done to ensure that all relevant studies are considered. IQWiG conducts this search in the form of an addendum.
Similar to the early benefit assessment of drugs, the time period to conduct the assessment is stipulated by law: The G-BA has to decide about the potential of an examination or treatment method within three months after receipt of the application. The assessment of potential is carried out in this period, and hence has to be completed within a few weeks.
Rapid reports
Rapid reports are produced on commission from the G-BA or the BMG, primarily with the aim of providing timely information on relevant health care developments (including new technologies). This usually requires an accelerated procedure. The process of producing rapid reports differs from that of other reports in several key respects. As a rule, no hearings take place during the course of the project. In addition, internal IQWiG procedures, including the presentation of results, may be simplified or shortened versus other final reports. However, where there is a specific need, a public commenting procedure can be included in the commission (with a shortened deadline), including the subsequent production of a final rapid report.
Searches for disease registries
Searches for disease registries support the G-BA in deciding whether routine practice data collection (RPDC) is considered necessary for a new drug. The commission for this is issued by the G-BA, which specifies the therapeutic indication(s) for which a search for disease registries is to be carried out.
When searching for disease registries, a targeted information retrieval from various information sources is carried out within four weeks. Once completed, the document is sent to the G-BA. A notice is published on the Institute’s website when the G-BA initiates a procedure to request RPDC within the therapeutic indication area.
ThemenCheck reports
‘ThemenCheck Medizin’ (Topic check medicine) makes it possible for interested parties to submit proposals for the assessment of medical interventions and technologies. In a two-stage selection process, which also involves members of the public, several new topics of particular importance to patient care are selected from the proposals submitted each year. These reports always include an assessment of the benefit and harm of a medical intervention. In addition, economic, ethical, legal, social and organizational aspects are covered to varying degrees, depending on the specific topic. The ThemenCheck reports are not usually written by IQWiG itself, but by external experts. Their assessment is published together with a generally understandable executive summary and a publisher’s comment by IQWiG. However, since 2025, some of the ThemenCheck reports have also been produced in-house.