Building a ship on the high seas
The maxim of IQWiG’s work was already described in the prototype of IQWiG’s methods from the year 2004: independent, patient-orientated, evidence-based, and transparent. To this day, these characteristics form the basis of the Institute’s work.
At the official starting point of IQWiG on 1 October 2004, Peter Sawicki called together the first employees and clearly stated that the first task was to develop and document the Institute’s working procedures – within 30 days! As a result, the first draft of the “Methods and rules of procedure” was put up for discussion on the new IQWiG website on 1 November 2004. This prototype was continuously developed by IQWiG and several follow-up versions of the further methodological steps have since been published.
Many amendments to the methods were required due to legal changes. For instance, in 2007 the Statutory Health Insurance (SHI) Act to Promote Competition (GKV-WSG) expanded the Institute’s range of responsibilities by introducing the health economic evaluation of drugs. IQWiG solved this challenge with the efficiency frontier method.
AMNOG brings a breath of fresh air
In the year 2011, a further task was given to the Institute through the Act on the Reform of the Market for Medicinal Products (AMNOG): the early benefit assessment of drugs. In addition, a revision of the methods paper followed. A new, third category regarding the reliability of conclusions on the benefit and harm from drugs was introduced: in addition to “indication” and “proof”, the category “hint” (of benefit or harm) was introduced as the lowest probability level of conclusions.
Assessment of the potential of medical devices
The Structure of Health Care Act of the Statutory Health Insurance (GKV-VStG) required the extension of the methods paper with new sections on the assessment of the potential of medical devices according to the testing Regulation.
In addition, in 2013 methods were added for determining patient preferences via the analytic hierarchy process and conjoint analysis.
Since the first version, the Institute’s methods have become more precise and thus more comprehensible. The key component is still the fair scientific comparison of different interventions as the basis of an assessment. In many areas, IQWiG has set methodological standards, and from the beginning was scrutinized critically by the scientific community, sometimes close to the limit.
Balancing act is manageable
The task was, and still is, to perform a methodological balancing act between sufficient specification on the one hand, and necessary flexibility on the other. The fact that terms first widely used in IQWiG documents are now almost common knowledge is something that IQWiG can be proud of. For example, “patient relevance of outcomes” is now commonly used in connection with benefit assessments and has even been introduced into the Social Code Book.