Institute for Quality and Efficiency in Health Care

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Institute for Quality and Efficiency in Health Care (IQWiG)
Institute for Quality and Efficiency in Health Care (IQWiG)
Institute for Quality and Efficiency in Health Care
Carrier: Foundation for Quality and Efficiency in Healthcare
Consist: since 2004
Legal form of the carrier: legal foundation under private law
Seat of the wearer: Berlin
Facility location: Cologne
Branch office: Berlin
Type of research: Applied research
Subjects: Human medicine
Areas of expertise: HTA, health economics, biometrics, benefit assessment, cost-benefit assessment
Basic funding: System supplements from statutory health insurance (Section 139c SGB V)
Budget volume = approx. € 22 million
Management: Jürgen Windeler
Employee: approx. 230 (as of 2018)
Homepage: IQWiG.de , gesundheitsinformation.de

The Institute for Quality and Efficiency in Health Care (IQWiG) was founded in 2004 as part of the implementation of the Statutory Health Insurance Modernization Act as a special purpose operation of the Foundation for Quality and Efficiency in Health Care, in order to improve the quality and efficiency of patient care in Germany. The legal bases and tasks have since been adapted and expanded through several health reforms. The main tasks of the professionally independent scientific institute are

In accordance with the statutory mandate, the focus of the assessments is the benefit and harm of medical measures for patients. In particular, the improvement in the state of health, a shortening of the duration of the illness, an extension of the life span, a reduction in side effects and an improvement in the quality of life are taken into account. The evaluation results and further information on diseases and health issues are published in a form that is easy to understand.

organization

Sponsorship

The legal entity of the institute is the Foundation for Quality and Efficiency in Healthcare, based in Berlin . The Board of Trustees approved in particular the budget of the institute and ordered the board. The foundation's board of directors takes care of the day-to-day business and oversees the IQWiG while maintaining the institute's scientific and professional independence. The appointment of the institute management takes place in agreement with the Federal Ministry of Health (BMG).

financing

The IQWiG works in the system of the statutory health insurance (GKV) and is financed by so-called system surcharges according to Section 139c SGB ​​V. These are made up of a surcharge for each hospital case to be billed (also for self-payers) as well as an additional increase in the remuneration for outpatient medical and dental care. The Federal Joint Committee (G-BA) recalculates this surcharge every year. It includes the share for the G-BA, the IQWiG and the Institute for Quality Assurance and Transparency in Health Care (IQTIG).

The institute's budget for 2018 is a good 22 million euros.

Client, expert opinion and methods

The IQWiG receives orders exclusively (within the scope of its statutory tasks) from the BMG and the G-BA. The so-called general order of the Federal Joint Committee (G-BA) also enables the institute to independently take up topics and work on them scientifically. From 2016 onwards, the legislature transferred a public proposal process for the evaluation of examination and treatment procedures, so-called HTA reports ( Health Technology Assessment ), to the IQWiG in accordance with Section 139b (5) SGB V.

The IQWiG reports serve the G-BA as a basis for decisions on the reimbursement of benefits by the statutory health insurances (GKV). In order to fulfill its tasks, IQWiG also awards research contracts to external experts. The experts are bound to the methods developed by IQWiG when fulfilling these assignments.

Both the evaluation results and the regularly updated IQWiG method paper based on the internationally recognized standards of evidence-based medicine and health economics are published on the institute's website.

Personnel and management

The foundation was established on June 1, 2004. IQWiG started its work on October 1st, 2004 in Cologne under the direction of Peter Sawicki with eleven other employees. The diabetologist Peter Sawicki was previously the chief physician of the department for internal medicine at the St. Franziskus Hospital in Cologne and co-editor of the pharmacritical medicine telegram .

Since September 1, 2010, the institute has been headed by Jürgen Windeler , previously head of the Evidence-Based Medicine department of the Medical Service of the Central Association of Health Insurance Funds (MDS). Jürgen Windeler is a doctor and clinical epidemiologist and has been an adjunct professor for medical biometry and clinical epidemiology at the Ruhr University in Bochum since 2001 .

At the end of 2017, the institute had 230 employees, including student assistants. The strong growth reflects the expansion of statutory tasks.

history

In most European countries there were already before the founding of the IQWiG HTA institute for quality assurance in health care, e.g. B. since 1987 Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) in Sweden , since 1995 Finnish Office for Health Technology Assessment (FinOHTA) in Finland , since 1997 Danish Center for Health Technology Assessment (DACHET) in Denmark and since 1999 National Institute for Health and Care Excellence (NICE) in Great Britain . They are based on the methodology of evidence-based medicine.

Legal basis and tasks

In the course of the GKV Health Reform Act (GKV-RefG), Federal Minister of Health Ulla Schmidt initiated the establishment of one of the first HTA institutions in Germany in the BMG division in 2000: the German Agency for Health Technology Assessment (HTA) at the German Institute for Medical Documentation and Information (DAHTA @ DIMDI).

Statutory Health Insurance Modernization Act

In 2004 the IQWiG was founded as part of the GKV Modernization Act on the basis of § 139a , § 139b , § 139c SGB ​​V, as a professionally independent institute with the assessment of medical procedures as a central task. In the following years, various health reform laws expanded the range of tasks of the institute.

GKV Competition Strengthening Act

In 2007, the GKV Competition Strengthening Act (GKV-WSG) added the cost-benefit assessment (KNB) of pharmaceuticals ( Section 35b SGB ​​V). Originally, the results were intended to be the basis for decisions by the Central Association of Health Insurance Funds on maximum amounts of drugs. For this new task, IQWiG developed a methodology based on the so-called efficiency frontier in collaboration with external experts . The first KNB (on antidepressants ) was published in 2013. However, the legal situation had changed due to the Medicines Market Reform Act (AMNOG) in 2011: Since then, a KNB has primarily been provided for the case that price negotiations fail after the regular early benefit assessment and the arbitral award is also doubted. Then manufacturers or the National Association of Statutory Health Insurance Funds can apply for a KNB from the G-BA.

Pharmaceutical Market Reorganization Act

In 2011, the Medicines Market Reorganization Act brought the procedure for the early benefit assessment of medicines into the system under the responsibility of the G-BA ( Section 35a SGB ​​V). Since then, the G-BA has regularly commissioned IQWiG with the dossier assessment, the scientific assessment of the dossier that the manufacturer must submit for a new active ingredient when it enters the market. This must demonstrate an additional benefit of the new active ingredient or an active ingredient in a newly approved application area compared to the previous standard therapy. The subsequent price negotiations between the manufacturer and representatives of the statutory health insurance are based on the additional benefit. Until the AMNOG came into force, manufacturers were free to set the prices for their drugs in Germany. After the price negotiations, the amount that is reimbursed by the GKV often changes today.

Statutory health insurance supply structure law

The GKV Supply Structure Act (GKV-VStG) in 2012 contains the so-called test regulation ( Section 137e SGB ​​V): If the G-BA comes to the conclusion that an examination and treatment method offers the potential of a necessary treatment alternative, but its benefits do not yet If there is sufficient evidence, the G-BA can adopt a guideline for testing in order to gain the necessary knowledge for evaluating the benefits of the method through a scientific study. The G-BA regularly commissions IQWiG to evaluate the application documents from manufacturers or applicants (potential evaluation). The 2nd law amending drug law and other regulations expanded this regulation for services or measures for the treatment of sicknesses that are not drugs and that are not subject to the evaluation of examination and treatment methods according to § 135 or § 137c SGB ​​V, z. B. Remedies ( Section 139d SGB ​​V).

Statutory health insurance supply strengthening law

The assessment of medical devices was initiated in the Statutory Health Insurance Care Strengthening Act (GKV-VSG) in 2015 : New and particularly invasive examination and treatment methods (NUB) are therefore subject to a method evaluation if medical devices of high risk classes (IIb or III) are used and they are used are based on a new theoretical-scientific concept ( § 137h SGB ​​V).

The contract for a public proposal procedure for HTA reports was transferred with the GKV-VSG from DIMDI to IQWiG ( § 139b 5 SGB V); Since then, interested individuals have been able to submit proposals for scientific evaluations to IQWiG. The procedure started in 2016 under the name “Topic Check Medicine”. The law also confirms the institute's participation in international projects such as the European network for Health Technology Assessment (EUnetHTA) ( Section 139a (3) SGB V).

See also

Web links

Individual evidence

  1. ^ Gesundheitsinformation.de , accessed on September 10, 2018.
  2. ↑ a b Annual Report 2017 (PDF) .
  3. ↑ General Methods 5.0 (PDF) .
  4. ↑ Velasco-Garrido, M. and Busse, R .: Policy brief. European Observatory on Health Systems and Policies, WHO 2005 (PDF) .
  5. ↑ DIMDI: legal basis ( Memento of the original dated June 14, 2016 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. . @1@ 2Template: Webachiv / IABot / www.dimdi.de
  6. ↑ IQWiG press release on the first cost-benefit assessment .
  7. ↑ Topic Check Medicine