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1 year Institute for Quality & Efficiency in HC

Country: 
Germany
Partner Institute: 
Bertelsmann Stiftung, Gtersloh
Survey no: 
(7)2006
Author(s): 
Hesse, Sebastian
Health Policy Issues: 
Pharmaceutical Policy, Political Context, Quality Improvement, Benefit Basket, Remuneration / Payment, Responsiveness
Reform formerly reported in: 
Center for Quality in Medicine - Draft Bill
Current Process Stages
Idea Pilot Policy Paper Legislation Implementation Evaluation Change
Implemented in this survey? no no no no yes no no

Abstract

Founded in June 2004 as independent scientific institute, the "Institute for Quality & Efficiency in Health Care" (German abbreviation "IQWiG") started its work in February 2005. The IQWiG is responsible for the scientific evaluation of the effects, quality and efficiency of health care services. The work includes the evaluation of pharmaceuticals, surgical procedures, diagnostic tests, and clinical practice guidelines. The institute aims to foster quality and transparency in German health care.

Recent developments

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Characteristics of this policy

Degree of Innovation traditional rather innovative innovative
Degree of Controversy consensual highly controversial highly controversial
Structural or Systemic Impact marginal rather fundamental fundamental
Public Visibility very low high very high
Transferability strongly system-dependent system-neutral system-neutral
current current   previous previous

Compared to other countries the creation of an institute that evaluates quality and efficiency of medical procedures is not new (NICE/England, HAS/France). But in the context of the German health care system this is quite an innovation.

Purpose and process analysis

Current Process Stages

Idea Pilot Policy Paper Legislation Implementation Evaluation Change
Implemented in this survey? no no no no yes no no

Initiators of idea/main actors

  • Government
  • Payers
  • Patients, Consumers
  • Private Sector or Industry
  • Political Parties

Stakeholder positions

The creation of the IQWiG was discussed very controversially in Germany. Various stakeholder groups strongly opposed the idea suspecting that to establish an institute comparable to the English NICE would lead the German health care system towards a more state-run system or state-medicine ("Staatsmedizin"). The German system is governed by a self-governing body with physicians and sickness funds in the lead. They feared to lose influence and to be more under control of the state. (Detailed description see in earlier report: Center for Quality in Medicine - Draft bill 01/2003)

Sickness funds were by far more in favor of an institute in gerneral than the physician representatives who anticipated a loss of their therapeutic freedom.

The pharmaceutical industry strongly objected a fourth hurdle in the pharmaceutical evaluation process using cost-efficiency criteria. However, even though the IQWiG bears efficiency in its name, cost-efficiency analyses were in the end explicitly excluded from the purpose of the institute.

The idea of a "German NICE" was pushed forward by the Social Democrats. The at that time opposition party CDU/CSU (Christian Democrats), voicing concerns from the opposing stakeholders mentioned above, strongly opposed the idea.  Today, being in a grand coalition with the Social Democrats, the CDU is no longer publicly opposing the IQWiG any more.

Actors and positions

Description of actors and their positions
Government
MoHvery supportivevery supportive strongly opposed
testvery supportiveneutral strongly opposed
person 3very supportivevery supportive strongly opposed
person 4very supportiveneutral strongly opposed
person 5very supportivevery supportive strongly opposed
Payers
Sickness fundsvery supportivesupportive strongly opposed
Patients, Consumers
Patient representativesvery supportivesupportive strongly opposed
Private Sector or Industry
Pharmaceutical industryvery supportivestrongly opposed strongly opposed
Political Parties
CDUvery supportiveopposed strongly opposed
SPDvery supportivesupportive strongly opposed
current current   previous previous

Influences in policy making and legislation

When the idea for an institute first came up it was planned to make it a state-run institute. This idea was dropped in the all-party negotiations and the IQWiG was set up by the  Federal Joint Committee-FJC (Gemeinsamer Bundesausschuss) as a foundation under private law. In reality this means that the policy makers have decided to leave decisions about the benefit basket with the self-governing bodies of the German health care system, just as before.

Actors and influence

Description of actors and their influence

Government
MoHvery strongvery strong none
testvery strongstrong none
person 3very strongstrong none
person 4very strongneutral none
person 5very strongvery strong none
Payers
Sickness fundsvery strongstrong none
Patients, Consumers
Patient representativesvery strongneutral none
Private Sector or Industry
Pharmaceutical industryvery strongstrong none
Political Parties
CDUvery strongstrong none
SPDvery strongvery strong none
current current   previous previous
person 3MoH, person 5Patient representativesSickness fundsSPDperson 4testCDUPharmaceutical industry

Positions and Influences at a glance

Graphical actors vs. influence map representing the above actors vs. influences table.

Adoption and implementation

The Institute for Quality and Efficiency in Health Care (IQWiG) was set up by the Federal Joint Committee as a foundation under private law. The IQWiG takes action by order of the Federal Joint Committee (FJC) - the entity that defines the benefit basket in the German health care system - or when commissioned by the Ministry of Health. Besides working on assignment from the Ministry or the Federal Joint Committee, the IQWiG identifies and works on relevant health care topics on its own responsibility. The IQWiG is financed through means of the Statutory Health Insurance (sickness funds and health care providers under the regime of the Social Code Book V).

The IQWiG is organized in different departments:

  • Pharmaceutical benefit assessment
  • Medical biometrics
  • Health economics
  • Quality of care
  • Non-pharmaceutical procedures
  • Health information
  • Communication
  • Administration

 

The institute bundels scientific expertise, collects international available scientific data and evaluates this data.



The institute has a steering committee consisting of the institute's director, Professor Peter Sawicki, and the department heads. The steering committee decides about the methodology the IQWiG is using as basis for its work and advice and monitors the Institute's working procedures. The committee actually developed a new draft of the institute's methodology to be commented on by the various associations of the self-governing body and by the pharmaceutical industry end of April 2006.

The work of the IQWiG includes the evaluation of clinical practice  guidelines, the submission of recommendations on disease management programs, the evaluation of the effects of pharmaceuticals, and the publication of health information for patients and consumers (information from IQWiG Homepage).

The institute for example analyses drug therapies in comparison with one another as well as in comparison with non-drug therapies for several chronic diseases like diabetes mellitus types 1 and 2, hypertension, asthma, COPD, dementia, and depression.

The IQWiG regularly screens and evaluates literature for care related medical innovations and aims to distribute this information in an understandable form.

The institute was asked to carry out more than 70 evaluations since it started its work in the beginning of  2005 (numbers from: www.die-gesundheitsreform.de). Up to June 2006 nine evaluations had been finished.


Patient-centered independent health information

Under www.gesundheitsinformation.de (page available in English) the institute publishes independent health information for patients since 2006. Topics are chosen according to timeliness, evidence-base and patient-interest and the status of the scientific debate is described.


Cooperation with NICE and HAS

Modelled after the example of the National Institute for Health and Clinical Exellence (NICE) the IQWiG runs a cooperation with NICE and the French counterpart Haute Autorité de Santé (HAS). The three agencies meet twice a year to exchange information and experiences.


Federal Joint Committee and IQWiG

To understand the role of the IQWiG in the German health care system one has to look at the competencies of the Federal Joint Committee and the IQWiG.

The  Federal Joint Committee (FJC) sometimes is called the "little legislator" of the German health care system. The federal lawmaker creates the legal framework for this self-governing body. Comprised of the federal association of doctors and dentists, the German Hospital Federation, the sickness funds, and patient representatives (without vote), the FJC specifies the legal requirements in more detail and implements them. The FJC defines the benefit basket and decides whether a treatment or medical device will be reimbursed by the sickness funds and whether pharmaceuticals are subject to reference prices. It is the decision making body of the self-governing bodies. As described above the FJC can assign the IQWiG to carry out evaluations. The IQWiG supports the FJC in fulfilling its legislative duties by recommending decisions and providing scientific advice. IQWiG recommendations are, however, not binding for the FJC.

The FJC assessment of medical treatments and procedures follows a standardised procedure which is based on evidence-based medicine. The generally accepted current state of medical knowledge is ascertained for the purpose of assessing the effectiveness, quality and economic efficiency of the methods examined (information from FJC-Homepage). The IQWiG assesses the evidence-base under a medical perspective. It is the FJC that relates this to efficiency under an economic perspective.


Decision about reimbursement of insulin analogues
The case of the FJC and the IQWiG that receives the greatest attention in the health sector in Germany at the moment is the one about the reimbursement of insulin analogues. The final decision is expected on 18 July 2006. This decision not only creates visibility but also probably more massive criticism and opposition than any other decision of  FJC and IQWiG before.

The criticism went so far that the IQWiG decided for the first time to publish a statement regarding its recommendation and to ask its Scientific Advisory Board to publicly declare in a "Declaration of Honour" that the evaluation about the insulin analogues was carried out according to the current methodology the IQWiG uses. In the media and among scientists the expertise was critised as not being consistent with the methodology of the IQWiG. The declaration caused an even bigger outcry.


No reimbursement of insulin analogues if newly prescribed


The FJC will decide on 18 July 2006.
One possible decision under discussion at the moment is that insulin analogues will not be reimbursed if newly prescribed. It would then still be reimbursed for patients who already receive insulin analogues to treat their diabetes. This decision would be based on an evaluation of the IQWiG saying that insulin analogues have not proven to have any patient-relevant additional benefit compared to structurally unchanged  human insulin (Rapid-acting insulin analogues for the treatment of diabetes mellitus typ 2, Final reports 12 April 2006). Even if the FJC assums that insulin analogues have the same benefit as human insulin this does not justify - in the argumentation of the FJC - a higher price.

This possible decision led to a major outcry. It was especially criticized that a distinction was made between new prescriptions and patients who already use insulin analogues. The possible decision is seen as being not consequent.

It also refreshed a fierce debate about the methodology of the IQWiG. The institute based its decision on only seven studies even though more than 1.000 studies regarding the use of insulin analogues exist. This was strongly criticised reckonning that the patient's perspective (compliance) was not taken into account. The IQWiG on the other hand said that only these seven studies fulfilled the institute's standards regarding evidence-based medicine. Only these seven studies were randomized-controlled trials guaranteeing a full comparability of the insulin analogues with the human insulin. The critics reckon that this is only relevant in a scientific setting assuring the statistical verification but not taking into account day-to-day life, reality and patient needs. The decision is especially interesting because insulin analogues are one possible treatment option within the Disease Management Programs for diabetes.

Another possible way the FJC could decide is to include the insulin analogues in the reference price system. That actually would be a more reasonable decision causing not so many difficulties and debates.

The discussion about the insulin analogues leads to a basic discussion about the relevance of evidence-based medicine for the benefit basket of the German health care system.   

Expected outcome

The decision about the insulin analogues is very fundamental for the German health care system. It is the first very controversial evaluation of the IQWiG. The implication of the evaluation of the IQWiG is not to reimburse the insulin analogues. The decision about the insulin analogues regards not only the insulin analogues but basically it is about the quality and efficiency of the provision of pharmaceuticals in Germany on the whole. The FJC might decide to include the insulin analogues into the reference price system, not following the recommendation of the IQWiG in the end. The FJC is not obliged to follow the recommendations of the IQWiG. Nevertheless not following the IQWiG in such a prominent decision would maybe weaken the position of the institute.

For the moment it is too early to say what the systematic impact of the IQWiG will be. Experiences from the first year show that changes in the German health care system are difficult to apply because of the very heterogeneous structure of the system and the legions of lobbyists. The example of the insulin analogues has shown how the various stakeholder groups react.

It seems that the creation of an independent institute is easier to realize in a state health system like the NHS in England than in Germany with its self-governing body strongly defending its position.

The creation of the IQWiG in its current form is to a certain extent not consequent. It was planned as an independent, neutral player and "regulator" in the system but it was politically not realizable to make it a state-run institute. This causes some difficulties and it will need more time for the institute to find its position within the system.

Impact of this policy

Quality of Health Care Services marginal rather fundamental fundamental
Level of Equity system less equitable neutral system more equitable
Cost Efficiency very low low very high
current current   previous previous

At the moment cost-efficiency analyses are explicitly excluded from the responsibilities of the IQWiG. The judgement about cost-benefit relations is taken by the Federal Joint Committee - but based on the analysis carried out by the IQWiG.

References

Sources of Information

Institute for Quality and Efficiency in Health Care: www.iqwig.de; page in German, short description of the purpose of the institute in English.

Institute for Quality and Efficiency in Health Care, Methods, November 2005: www.iqwig.de/index.media.0ef4c90e08bc5567c96f12891f51b711.pdf 

Institute for Quality and Efficiency in Health Care, Rapid-acting insulin analogues for the treatment of diabetes mellitus type 2 - Final report, 12 April 2006:
www.iqwig.de/index.download.538df941a1d274bea0b8b1f9ae06921b.pdf

Patient-oriented health information provided by IQWiG: www.gesundheitsinformation.de/homepage.2.en.html

Federal Joint Committee (Gemeinsamer Bundesausschuss): www.g-ba.de/cms/front_content.php?idcatart=207&lang=1&client=1

Reform formerly reported in

Center for Quality in Medicine - Draft Bill
Process Stages: Policy Paper

Author/s and/or contributors to this survey

Hesse, Sebastian

Suggested citation for this online article

Hesse, Sebastian. "1 year Institute for Quality & Efficiency in HC". Health Policy Monitor, 01/06/2006. Available at http://www.hpm.org/survey/de/b7/2