About us. An introduction to IQWiG. Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen

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Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Institute for Quality and Efficiency in Health Care About us An introduction to IQWiG

Photo: cbs/cora Berndt-Stühmer

Content Who we are... 4 What we produce... 5 Who commissions us... 6 How we work... 7 Events we offer... 9 Our main topics... 10 What s to be gained... 12 Where to find more information... 13 Where to find us... 14 Photo: cbs/cora Berndt-Stühmer 3

Who we are Quality and efficiency these are two crucial factors in a good and effective healthcare system. To achieve and maintain this goal, it is important to assess medical interventions using objective methods. This is precisely the task of the German Institute for Quality and Efficiency in Health Care (IQWiG). As an independent scientific institute, we examine the advantages and disadvantages of medical interventions, as well as their costs in some cases. In our reports we draw conclusions on what is beneficial from a diagnostic and therapeutic point of view and what is superfluous or even harmful. A typical question we ask is: What is the added benefit of a newly approved drug compared with conventional drugs? To provide an answer, we compare drugs with other drugs or non-drug interventions and determine what advantages and disadvantages they have for patients. We also highlight gaps in knowledge to initiate targeted research. We are funded through contributions from the members of all German statutory health insurance funds. This was specified by the law which, in the Healthcare Reform of 2004, not only initiated the establishment of IQWiG but also defined its tasks. 4

What we produce We produce reports on drugs medical devices surgical procedures diagnostic and screening tests clinical practice guidelines disease management programmes (DMPs) We also produce decision aids for the general public to inform them about the advantages and disadvantages of screening tests. Our topics include common diseases such as diabetes, hypertension, cancer, dementia and depression as well as rare diseases. We provide information on the advantages and disadvantages of diagnostic and therapeutic procedures by means of scientific reports and easily understandable health information. 5

Who commissions us According to the law, only two institutions can directly commission IQWiG: the Federal Joint Committee (G-BA) or the Federal Ministry of Health. The G-BA is the highest decision-making body of the self-governing system in health care. It is composed of representatives of doctors, dentists, hospitals and statutory health insurance funds. Patients have the right to submit applications, but do not have the right to participate in decisions. On the basis of our reports, the G-BA decides on the reimbursement of medical interventions by the statutory health insurance funds. IQWiG can also investigate open issues in health care on its own initiative. In addition, since 2016 members of the general public can propose diagnostic and therapeutic topics to be assessed within IQWiG s Themen- Check Medizin ( Topic check medicine, website available only in German). IQWiG collects these proposals, and in a two-step procedure determines up to five topics per year for assessment. Photo: Gemeinsamer Bundesausschuss (G-BA) Photo: Gemeinsamer Bundesausschuss (G-BA) Photo: BMG/Schinkel 6

How we work IQWiG itself does not conduct clinical studies. We systematically search the scientific literature to identify relevant studies. The focus is usually on the following question: When and how was a certain drug or diagnostic or therapeutic procedure tested or compared with other drugs/procedures? From the studies found we identify those that provide particularly reliable results. We then summarize these results in an overall conclusion. Our benchmark is what is important for patients. For instance, it is insufficient if a drug affects only a laboratory value. It must either increase life expectancy reduce the duration of disease reduce symptoms and complications, or improve quality of life We use methods of evidence-based medicine (EbM) to select studies and assess their results. EbM is characterized by the fact that it is primarily based on scientific evidence, not simply on opinions and consensus. Photo: IQWiG/Teichmann 7

We are independent in our work. This means that neither industry, political bodies, health insurance funds nor authorities can influence the content of our reports. Moreover, external experts and any other parties involved in IQWiG reports must disclose potential conflicts of interest. Patients, scientific associations or manufacturers of drugs or medical devices can contribute to IQWiG s assessments. We publish preliminary versions of our reports on our website (iqwig. de) interested parties can submit comments and indicate, for instance, if important studies or arguments have been missed. This is because transparency is important to us. We also publish easily understandable information on the results of our reports on our health information website, available in both German and English (gesundheitsinformation.de, informedhealth. org). We aim to reach healthcare professionals, patients and other stakeholders in the healthcare system. We don t perform research behind closed doors, but have lively exchanges with others. For instance, we commission external experts to work on our reports. In addition, we participate in international, primarily EU-wide, projects to further develop evidence-based medicine this is also our legal remit. Photo: IQWiG/Teichmann 8

Events we offer We believe that the debate about the assessment of the advantages and disadvantages of medical interventions and their impact on the German healthcare system is important. For this reason IQWiG has initiated two annual events where representatives from research, industry, and political bodies, as well as patients, can exchange views. These events are the IQWiG Autumn Symposium on more general scientific issues the IQWiG in Dialogue meeting on more specific scientific issues Photo: cbs/cora Berndt-Stühmer Photo: IQWiG/Teichmann 9

Our main topics Drugs: The Act on the Reform of the Market for Medicinal Products (AMNOG) became effective in 2011 and specified that it was IQWiG s task to assess almost all newly approved drugs. We ask the question: Do they have an added benefit over standard treatments or not? We prepare our assessments on the basis of so-called dossiers. Manufacturers of new drugs submit these dossiers at market entry; they must demonstrate that the new drug is superior to previous treatment options. In addition, we determine how many patients are eligible to receive the various treatments and what they cost. Non-drug interventions: We also assess the advantages and disadvantages of non-drug interventions. These are diagnostic or therapeutic procedures that do not involve drugs or where drugs are only used in combination with medical devices. They include treatments such as surgical procedures radiation therapy dental procedures psychotherapy 10

IQWiG also assesses diagnostic tests such as genomic testing of tumours or screening tests for the early detection of diseases. Health information: IQWiG publishes independent and easily understandable information on health topics for patients and the general public on its German and English-language health information websites (gesundheitsinformation.de, informedhealth.org). The articles, illustrations and short films cover a wide and growing range of topics, such as the common cold, arthritis, gout, erysipelas, and many more. In addition, IQWiG produces information and decision aids for members of the statutory health insurance funds on behalf of the G-BA. This includes a brochure on the German mammography screening programme, which women between the ages of 50 and 69 receive along with an invitation to screening. Clinical practice guidelines: Clinical practice guidelines provide recommendations on the best possible treatment options available. Together with external experts, IQWiG analyses national and international guidelines and prepares reports on their recommendations. These reports are used by the G-BA to update or establish disease management programmes (DMPs) for chronic diseases. Photo: cbs/cora Berndt-Stühmer 11

What s to be gained Which diagnostic procedure or treatment is the right one? Patients and their doctors are often faced with this decision. We provide the necessary information to help weigh the different options. We publish this information in scientific reports and easily understandable articles, which are available free of charge on the IQWiG website. Decisions on health care must be well founded. Whoever claims that an intervention is beneficial must prove it. Hope or personal experience in individual cases is not enough. Our assessments of diagnostic and therapeutic procedures provide a reliable basis for decisions on healthcare issues. As a matter of principle, IQWiG invites interested parties to comment on the results of its work. In the scientific community, this sometimes leads to controversial debates. IQWiG resolves scientific questions for patients and decision-makers in the healthcare system, so that the benefits of medical interventions can be determined and their costs remain affordable. In this way, we contribute to reducing gaps in knowledge and to creating the basis for better health care in Germany. 12

Where to find more information iqwig.de Here we publish all of our scientific reports as well as detailed information on the Institute and the options for submitting comments. informedhealth.org Here we publish easily understandable and descriptive articles, illustrations and short films on a wide range of healthcare topics, including the topics of our scientific reports. We do not consider ourselves to be an advisor recommending one thing and advising against another. We provide objective information on the mode of action and effects of medical interventions as well as on their advantages and disadvantages. We also highlight gaps in knowledge. This is because we would like to support autonomous decision-making on healthcare issues. themencheck-medizin.iqwig.de Here members of the general public can propose topics which, from their point of view, should be investigated in a scientific project. For instance: What is the real benefit of a certain diagnostic procedure? or What advantages or disadvantages does a certain treatment have?.* Twitter: @iqwig und @iqwig_ih Via Twitter (https://twitter.com/iqwig) IQWiG provides information on new press releases, publications and events (see @iqwig) as well as on new health information (see @iqwig_ih). * Please note: the website is available only in German. 13

Where to find us Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) Im Mediapark 8 D 50670 Köln Deutschland Tel. +49 221 35685-0 Fax +49 221 35685-1 E-mail: info@iqwig.de Publishing details Publisher Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) Im Mediapark 8 D 50670 Köln Deutschland Editor Dr. phil. Beatrice Wolter Photos IQWiG/Ralf Baumgarten (unless otherwise stated) Graphic design Désirée Gensrich, dbgw.de Printing purpur GmbH Photo: Dream Global/Christoph Pforr 14

Photo: IQWiG/Teichmann

www.iqwig.de