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IQWiG timeline

The Institute’s most important developments at a glance:

2016

November: The IQWiG Autumn Symposium is held in Cologne for the 12th time. The topic was “More light than shadow? Beneficial and hindering factors for successful clinical studies”.

November: IQWiG presents the final version of the decision aid for mammography screening. The 18-page brochure informs women between 50 and 69 years about the potential advantages and disadvantages of participating in the mammography screening programme. Among other things, the results of further user tests were incorporated in the final version.

October: IQWiG publishes the first 26 proposals on open issues in health care to be investigated in HTA reports. The proposals were submitted by members of the general public to IQWiG via its “ThemenCheck Medizin” website (Topic Check Medicine; available only in German). The proposals are then reviewed to identify 5 topics for which HTA reports will be produced. In future, up to 5 such reports will be published per year.

August: In a press release, IQWiG distances itself from the final report published by the European Medicines Agency (EMA) on the pilot project of adaptive pathways. The EMA report did not dispel the Institute’s concerns about adaptive pathways.
In this accelerated approval procedure, drugs are to be approved on the basis of less evidence for a highly restricted population. Further data on effectiveness, safety, and benefit for broader use of the drug are only to be generated after the approval – as so-called real-world data. The EMA report provided information on seven test runs selected. However, it failed to provide information as to how real-world data could be used after the approval to allow drawing reliable conclusions on benefit and harm.

July: The new website “ThemenCheck Medizin” (Topic check medicine) starts at IQWiG. IQWiG implements its new legal remit with this website, where members of the public can submit their proposals for assessments of medical examination and treatment methods online.

July: Controversial points of view presented at the IQWiG Autumn Symposium 2015 on the topic of “Real world data: a gain for benefit assessments?" are documented in a supplement of the German Journal for Evidence and Quality in Healthcare (ZEFQ). In this special issue, six of the nine speakers from Germany and abroad present their points of view in essays, accompanied by a foreword by Jürgen Windeler, Director of the Institute. Freely accessible full text versions of these essays are also available online.

June: The ninth event of the series “IQWiG in dialogue” takes place in Cologne. The topic is: “Do we need stricter criteria for assessing evidence?"

June: IQWiG publishes a parent information leaflet on newborn screening using pulse oximetry. The leaflet explains advantages and disadvantages of this screening method in a brief and easily understandable way.

April: IQWiG publishes a new version of its General Methods. The changes in the methods paper 4.2 mainly concern the sections on the assessment of the potential of non-drug interventions, on health economic evaluation and on health Information.

April: The planned closure of the German medical information centre ZB MED is in discussion. In an open letter, IQWiG supports maintaining the central provision of medical literature offered by the ZB MED, which is associated with the Leibniz Information Centre for Life Sciences.

March: The fourth Patient Information Day takes place during the EBM Conference in Cologne. The event entitled “Knowledge that helps me” offers patients ideas on how to obtain better information on health issues. The event is co-organized by the University Hospital Cologne, the Institute for Health Economics and Clinical Epidemiology (IGKE), and the German Network for Evidence-based Medicine (DNEbM).

2015

November: IQWiG’s Autumn Symposium is held in Cologne for the eleventh time. Topic: “Are real-world data an asset for benefit assessments?"

September: The Handelskrankenkasse is the fifth health insurance fund to use the evidence-based IQWiG texts published on informedhealth.org.

September: Members of the German Parliament and health policy experts from the Chancellery visit IQWiG to learn about the Institute’s mode of operation and the results of its work.

August: IQWiG’s evidence-based health information can now also be found on the website Arzt-Auskunft.de. Collaborations with other organizations are continuously expanded.

July: IQWiG publishes its Annual Report 2014.

July: The Act to Strengthen the Provision of Health Care (GKV-VSG) becomes effective. It supplements the Social Code Book V with §137h, which provides for an assessment of high-risk medical devices under certain circumstances. Furthermore, the VSG confirms IQWiG’s international commitment and assigns to IQWiG the task of supervising the production of HTA reports suggested by members of the public. This task was previously carried out by the German Institute of Medical Documentation and Information (DIMDI).

June: The eighth event of the series “IQWiG in dialogue” takes place in Cologne. Topic: “How confirmatory is HTA?"

June: The Foundation Council and the Foundation’s Board of Directors follow the proposal by the Institute’s Director Jürgen Windeler and confirm Stefan Lange as Deputy Director of the Institute.

April: IQWiG publishes a new version of its General Methods. The changes in the methods paper 4.2 mainly concern the sections on the assessment of the potential of non-drug interventions, on health economic evaluation and on health Information.

April: IQWiG’s health information is embedded into the website of the Independent Patient Counselling Service Germany (UPD).

March: IQWiG researchers describe a positive effect of the Act on the Reform of the Market for Medicinal Products (AMNOG) in the British Medical Journal. The key statement is: AMNOG has revealed a large amount of information from clinical studies.

February: IQWiG publicly comments on a proposal by the European Medicines Agency (EMA) in which EMA uses a broad definition of “commercially confidential information” for users of their study database under development, thus endangering the transparency of study data.

January: The Foundation Council and the Foundation’s Board of Directors confirm Jürgen Windeler as Director of the Institute and extend his contract until 2021.

2014

November: IQWiG’s Autumn Symposium is held in Cologne for the tenth time. Topic: “Evidence-based health care: Where should the journey go to? What can IQWiG contribute to the challenges and what can it do better?”

November: IQWiG welcomes the World Health Organization’s (WHO) Statement on Public Disclosure of Clinical Trial Results and participates in the consultation.

November: A special issue of the German Journal for Evidence and Quality in Health Care (ZEFQ) guest-edited by IQWiG investigates for seven countries what impact health economic evaluations have on decision-making processes and health care.

July: IQWiG presents the draft of version 4.2 of the General Methods for discussion.

July: The Institute tests a further method, the Conjoint Analysis (CA), which allows recording the preferences patients have regarding treatment goals. The result: The Conjoint Analysis is in principle suitable to find this out.

June: The seventh event of the series “IQWiG in dialogue” takes place in Cologne. Topic: “Benefit assessment in studies with allowed treatment switching”.

June: The supporting organization of IQWiG, the Foundation for Quality and Efficiency in Health Care, celebrates its 10th anniversary. IQWiG also celebrates its 10th anniversary.

May: The European Medicines Agency (EMA) publishes a draft of new rules on the publication of clinical study data. This draft includes severe limitations for researchers when using study data. In a comment, IQWiG protests against the so-called “screen only” rules.

April: IQWiG publishes a working paper on the reception of health information by socially disadvantaged people.

April: The 14th Amendment to Social Code Book V stipulates the discontinuation of the benefit assessment of drugs that entered the market before 2011 (established drug market).  Subsequently, IQWiG stops all ongoing assessments of the established drug market.

February: Relaunch of Informed Health Online: The website goes online with a new structure and a fresh look. Many topics have been thoroughly revised and usability has been improved.

February: The Federal Minister of Health Hermann Gröhe visits IQWiG.

2013

November: IQWiG’s General Methods are updated in steps: version 4.1 is published.

November: IQWiG’s Autumn Symposium is held in Cologne for the ninth time. Topic: “Quality of life in health care – do we know what we are doing?"

October: The Institute submits a comment on the draft of a guideline by the European Medicines Agency (EMA). This supports the aim to publish data from clinical studies, making them accessible for researchers outside the regulatory authority.

October: IQWiG publishes the first health economic evaluation, its topic is antidepressants. The report shows that the “efficiency frontier” method works and can provide informative results.

October: In a “PLOS Medicine” journal article, IQWiG researchers show that drugs can only be reliably assessed on the basis of clinical study reports, and that therefore these reports should be freely accessible.

September: The third IQWiG Patient Information Day takes place. The topic is again “Learning, weighing the evidence, and deciding: The path to making your own decision”.

July: IQWiG presents the first dossier assessments for the established drug market. These assessments deal with drugs from the group of gliptins.

June: The sixth event of the series “IQWiG in dialogue” takes place in Cologne. Topic: “Importance of approval status for the benefit assessment”.

June: IQWiG tests the analytic hierarchy process (AHP) in a pilot project. This method proves to be generally suitable for determining patients’ preferences with regard to treatment goals.

June: The Institute produces the first assessments of the potential of non-drug interventions according to the Structure of Health Care Act of the Statutory Health Insurance (GKV-VStG) and Social Code Book (SGB) V 137e (7): Manufacturers and providers can apply at the G-BA for the testing of a new examination or treatment method. Part of this testing regulation is the assessment of the “potential”, which the G-BA usually commissions IQWiG with.

April: The website IQWiG.de gets a new design: Improved navigation, better accessibility and responsive design for mobile devices were the main objectives.

April: The Institute presents the first changes to the methods paper 4.0 for discussion.

January: IQWiG signs the petition “alltrials.net”, which campaigns for all studies to be registered and all data of these studies to be made available.

January: The sixth workshop by the Health Research Council (GFR) and IQWiG takes place. Topic: “Therapeutic treatments with non-drug, non-technical approaches - evidence, evaluation and benefit assessment”.

2012

December: On 31 December the transitional regulation of the German Drug Law (AMG) expires, according to which manufacturers can immediately apply for a new benefit assessment if the added benefit is not regarded as proven due to incomplete submission of the necessary evidence. The companies Boehringer Ingelheim and Lilly have made use of this regulation for the drug linagliptin.

November: IQWiG’s Autumn Symposium is held in Cologne for the eighth time. Topics: "Cancer: Is everything different?” and "Can less be more?”.

November: The preliminary results of IQWiG's first cost-benefit assessment are published. "Venlafaxine, duloxetine, bupropion, and mirtazapine compared to further prescribable pharmaceutical treatments" were assessed.

October: The Federal Minister of Health, Daniel Bahr, visits IQWiG and is impressed by the Institute's work and expert networking.

September: The second IQWiG Patient Information Day takes place. Due to the great interest in the previous year the topic is again: “Knowledge that helps me – How I can find the medical information I need".

June: The fifth event of the series “IQWiG in dialogue” takes place in Cologne. The topic for 2012 is “Uncertainty in benefit assessments”.

February: At the end of February, IQWiG moves into larger premises. The seat of the Institute is now in Cologne Mediapark.

February: IQWiG publishes a joint statement from IQWiG, GMDS (German Society for Medical Informatics, Biometry and Epidemiology) and IBS-DR (German Region of the International Biometric Society) on the “Importance of results from indirect comparisons”.

February: Fifth workshop by the Health Research Council (GFR) and IQWiG with the main focus on "Studies on therapeutic treatment with medical devices".

January: The British Medical Journal (BMJ) dedicates a whole issue to the topic "unpublished data". This was triggered by an article by IQWiG researchers from August 2010, which dealt with the problem of biased reporting of study results of certain antidepressants.

January: The Structure of Health Care Act of the Statutory Health Insurance (GKV-VStG) becomes effective on 1 January 2012. In principle manufacturers and providers of new, non-drug examination or treatment methods, now have the opportunity to apply for testing them if there is a potential. The potential of an examination or treatment method will presumably be assessed by IQWiG. 

2011

December: The G-BA makes its first decision on the extent of added benefit of a new drug (ticagrelor).

November: IQWiG’s Autumn Symposium is held in Cologne for the seventh time. Topics: “Methodology: between regulations and arbitrariness” and "Personal responsibility”.

October: The first dossier assessment in accordance with §35a of Social Code Book (SGB) V (AMNOG) is published. The new drug ticagrelor was assessed, a platelet aggregation inhibitor.

September: IQWiG publishes the new version of its General Methods (Version 4.0), which has been supplemented by the procedure for the early benefit assessment of drugs according to AMNOG.

September: The first IQWiG Patients’ Day takes place in Cologne. More than 100 participants can find out about “Knowledge that helps me – how I can find the healthcare information I need.”

July: Selected and easily understandable health information from IQWiG’s website “informedhealthonline.org” is now also available on the website of the German health insurance fund “Techniker Krankenkasse”. See www.tk.de; keyword “Geprüfte Medizin” (“Tested medicine”).

June: The fourth event of the series “IQWiG in dialogue” takes place in Cologne. The topic for 2011 is “Heterogeneity in benefit assessments”.

February: Fourth Workshop by the Health Research Council and IQWiG with the main emphasis “Focus on diagnostic studies”.

January: IQWiG receives its first commission from the G-BA with regard to the early benefit assessment of new drugs according to AMNOG.

January: The G-BA decides on a new chapter for its code of procedure, which comprehensively regulates the early benefit assessment of medical interventions. The Federal Ministry of Health immediately approves the code of procedure.

2010

December: The German Parliament passes AMNOG; the Federal Ministry of Health issues a corresponding regulation (Regulation for Early Benefit Assessment of New Pharmaceuticals, AM-Nutzen-V). Both become effective on 1 January 2011.

November: IQWiG Autumn Symposium is held in Cologne for the sixth time. Topics: “Balancing of benefits and harms in health system decision-making” and “Data transparency as a precondition to the informed balancing of benefits and harms”.

September: Prof. Dr. Jürgen Windeler assumes his new position as Director of IQWiG.

June: The first draft of the Act on the Reform of the Market for Medicinal Products (AMNOG) is published by the Federal Ministry of Health (BMG).

June: The third event of the series “IQWiG in dialogue” takes place in Cologne. The topic for 2010 is: “The evaluation of clinical relevance in benefit assessments”.

May: The results of the evaluation of www.informedhealthonline.org by the World Health Organization (WHO) are presented in a press conference.

January: Third workshop of the Health Research Council and IQWiG on “Focus on outcomes of clinical trials”.

2009

December: The G-BA awarded the first two commissions to IQWiG for a health economic evaluation of drugs. The topics are “Clopidogrel in acute coronary syndrome and in peripheral occlusive arterial disease” and “Venlafaxine, duloxetine, bupropion, and mirtazapine in depression”.

November: Fifth IQWiG Autumn Symposium. Topics: „Medicine - belief and knowledge“ and „Health care system - experiencing and funding it“.

October: The “General Methods on assessing the relation between benefit and cost”, version 1.0, are published.

September: The commission package on Alzheimer’s disease is completed with the publication of the final report on memantine.

September: The G-BA decides that hyperbaric oxygen therapy (HBO) for the inpatient treatment of burns and idiopathic osteonecrosis of the femoral head will in future no longer be reimbursed by the Statutory Health Insurance Funds. This decision is based in part on a recommendation by IQWiG.

August: For the first time, the G-BA commissions the Institute to carry out an update search on a commission already completed (cholinesterase inhibitors).

July: The G-BA expands its code of procedure so that the relation between cost and benefit of drugs can also be assessed in future.

June: IQWiG approaches the media because a manufacturer of an antidepressant knowingly conceals large amounts of data that are necessary for working on a commission. As a result of public discussion in the media, the manufacturer submits the data.

June: The second event of the series “IQWiG in dialogue” takes place in Cologne. The topic for 2009 is “Assessing benefit without considering harm?”

June: The results of dry runs for the cost-benefit assessment of drugs are presented at an IQWiG event in Berlin. A heated debate ensues.

May: The G-BA decides that inpatient treatment for severe aplastic anaemia with allogeneic stem cell transplantation from non-related donors should continue to be covered by the Statutory Health Insurance Funds (GKV). This decision is based in part on a recommendation by IQWiG.

April: The Institute appoints the management consultancy firm, “prognos”, to carry out an evaluation of its structure and procedures.

March: The second draft (version 2.0) of the methods for cost-benefit assessment is published.

2008

November: In a verdict of first instance, the Social Court in Berlin confirms the G-BA’s decision on a directive referring to rapid-acting insulin analogues in diabetes type 2 and confirms that IQWiG has satisfied all requirements for scientific diligence and formal accuracy.

November: Fourth IQWiG Autumn Symposium. Topics: “Assessment of the Benefits and Harms of Medical Interventions” and “Science, Society, and the Individual”.

October: The Institute publishes a revised version (version 1.1) of the methods for cost-benefit assessment and supplements the draft with three technical appendices on modelling, cost estimation, and uncertainty.

October: Second workshop by the Health Research Council and IQWiG (“Transferability of study results in health care”).

September: The Institute’s website for consumer health information (informedhealthonline.org) is evaluated by the World Health Organization (WHO) in September and October.

August: The Federal Ministry of Health publishes a statement (comment) on the IQWiG methods draft for the cost-benefit assessment of drugs.

May: Version 3.0 of IQWiG general methods is published.

May: The first event of the new series “IQWiG in dialogue”, which addresses the benefit assessment and replication of study results, takes place on 30 May in Cologne.

February: IQWiG presents the methods draft to the scientific community at the IQWiG Symposium on Cost-Benefit Assessment on 26 February in Berlin.

January: The first draft on the methods for the cost-benefit assessment of drugs is published. The Institute accepts comments until 31 March.

2007

November: A revised draft of the methods version 3.0 is presented for discussion on the IQWiG website.

November: Third IQWiG Autumn Symposium. Topics: “Knowledge as the basis of physicians` and patients` decision-making” and “The financial significance of disease and health”.

November: The results of a survey are published on an international comparison of the quality of health care, conducted by the CWF and IQWiG.

October: For the first time, and in agreement with IQWiG, the G-BA revokes commissions. This affects the commissions on hyperbaric oxygen therapy for migraine/vascular headache, venous ulcers, and stroke.

September: The German Health Research Council (Gesundheitsforschungsrat, GFR) and IQWiG initiate a new discussion forum on benefit assessments in the health care system in the GFR workshop “Definition of terms and introduction” on 4 September in Berlin.

July: An international expert panel is established to develop methods for the assessment of the relation between the costs and benefits of drugs.

June: The British National Health Service (NHS) adopts IQWiG consumer health information.

April: Following the SHI Act to Promote Competition, IQWiG can not only assess the benefit of drugs, but also their cost-benefit relations.

2006

November: Second IQWiG Autumn Symposium. Topics: “Hopes and Errors in Medicine” and “Costs, Quality and Justice in the Health Care System”.

November: IQWiG publishes the revised methods version 2.0. New elements include in particular extended opportunities to comment on report plans.

October: IQWiG receives its first commission from the Federal Ministry of Health on the topic of endometriosis.

October: The Foundation’s Board of Directors decides that the seat of the Institute will remain in Cologne. This decision is confirmed by the plenum of the G-BA in December.

July: The G-BA makes its first decision on a directive on the basis of an IQWiG report (Rapid- acting insulin analogues in diabetes type 2).

April: IQWiG starts its regular exchange of experiences with the British National Institute for Health and Clinical Excellence (NICE) and the French Haute Autorité de Santé(HAS).

April: Gesundheitsinformation.de is now also available in English (www.informedhealth.org).

March: IQWiG Scientific Advisory Board comments on the current discussion on rapid-acting insulin analogues and calls for more objectivity in the debate.

February: The Institute goes online with its own website for consumer health information (www.gesundheitsinformation.de).

2005

December: IQWiG presents its first final reports to the G-BA. The topics of the reports are “Minimum volumes for total knee joint endoprosthesis” and “Rapid-acting insulin analogues in diabetes type 2”.

September: The Institute presents its first comprehensive benefit assessment in the form of a working paper (Statins [with particular consideration of atorvastatin]).

September: The first oral debate on a preliminary report (Rapid-acting insulin analogues in diabetes type 2) takes place on 8 September.

September: The results of a survey are published on an international comparison of the quality of health care, conducted by the Commonwealth Fund (CWF) and IQWiG.

September: IQWiG holds its first Autumn Symposium. Topics: “Diagnosis, Screening and Patient Oriented Research“ and “Knowledge and Decision-Making in Medicine”.

March: The final version of the methods version 1.0 is published.

March: IQWiG presents its first preliminary report (Rapid-acting insulin analogues in diabetes type 2).

March: The German Association of Research-based Pharmaceutical Companies and IQWiG regulate the confidential handling of manufacturer data.

February: Official opening ceremony of the Institute on 24 February 2005.

2004

December: The G-BA awards a “general commission” to the Institute. With this commission, IQWiG can also select and work on relevant topics on its own initiative.

November: IQWiG moves into its own premises in Cologne-Kalk.

November: The first draft of the IQWiG methods version 1.0 is presented for discussion.

November: IQWiG receives its first commissions from the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA).

November: At the request of the G-BA, the Institute prepares its first consumer health information on the cholesterol-lowering drug Sortis and the painkiller Vioxx.

October: The Institute starts work with a total of 11 employees.

June: On 18 June, the basis for the new Institute for Quality and Efficiency in Health Care is created by the establishment of the Foundation for Quality and Efficiency in Health Care. Professor Dr. med. Peter T. Sawicki is appointed as the Institute’s Director on 1 September.

January: On 1 January 2004, most sections of the SHI Modernization Act become effective.

2003

October: After the German Parliament (Bundestag), the Federal Council (Bundesrat) also passes the draft of the Statutory Health Insurance (SHI) Modernization Act, which, among other things, envisages the establishment of an Institute for Quality with the self-government as responsible body.

July: The self-government of the health care system proposes an alternative model: an Institute for Quality is to be affiliated to the self-government; the Ministry of Health is only to have legal supervision.

January: In the course of the Health Care Reform, the Federal Minister for Health, Ulla Schmidt, aims to establish a state-orientated Centre for Quality in Medicine.

Contact:

Phone+49 (0)221 - 35685-0

E-mailpresse@iqwig.de


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