How IQWiG assesses – Version 7.0 of the method paper comes into force
28.09.2023 14:44
The Institute for Quality and Efficiency in Health Care (IQWiG) has completed the update of its methods paper to version 7.0 and published the immediately valid version of its “General Methods” on www.iqwig.de.
In its general methods, IQWiG describes in detail and transparently the criteria it uses to assess the benefits and harms of medical measures for patients. In order to reflect the further development of standards in the scientific disciplines and to comply with expanded legal obligations, this compendium is updated regularly - sometimes in smaller steps, sometimes through fundamental revision of entire chapters, which is then reflected in a new version number, as is now in version 7.0.
Revision of the cost-benefit assessment
The institute has completely revised the cost-benefit assessment of medical interventions anchored in Chapter 4 of the General Methods. As a result, the overarching section 1.4 on health economics was also completely rewritten.
Since 2011, the cost-benefit assessment can be used to guide the pricing of new drugs if the early benefit assessment according to the Medicines Market Reorganization Act (AMNOG) has been completed and the price negotiations between health insurance companies and manufacturers have failed. However, neither party has yet initiated such an assessment, which is probably due to the very complex process. Against this background, the institute has adapted its methodological basis for cost-benefit assessments and made them less complex overall. Among other things, the previous methodology required that all therapy options in the indication area be taken into account; now fewer comparative therapies can be used. In addition, IQWiG no longer derives a price recommendation. Instead, in the future, the incremental, i.e. gradually calculated, cost-benefit ratio will be stated in relation to the comparative therapy.
New order type: concepts for application-related data collection
IQWiG has now included a description of its approach in its method paper when it is commissioned by the Federal Joint Committee (G-BA) to create an AbD concept (AbD = application-accompanying data collection).
Since 2019, the G-BA has been able to demand an AbD including evaluation from the manufacturer of drugs for rare diseases (orphan drugs) in order to generate additional data for the quantification of the additional benefit. IQWiG then provides the necessary methodological work: it creates a concept in which the methodological requirements for carrying out the data collection are described. And it researches suitable registries in the indication area in order to be able to decide whether the planned AbD is fundamentally feasible and appropriate.
The new order types “AbD concept” and “Research according to indication registers” are, like the AMNOG dossier assessments, regulated in Section 35a of the Social Security Code V (SGB V) for the purpose of early benefit assessment of new drugs. The IQWiG now presents this expanded product range for assessments in accordance with Section 35a SGB V clearly in Chapter 2 of its General Methods Version 7.0.
Consequences from the opinion process
IQWiG presented the draft for method paper 7.0 in December 2022 and put it up for discussion. The institute then received 38 statements, some of them very detailed. After the comment period ended, a discussion with respondents took place in March 2023, during which open questions were clarified.
As a result of the opinion process, IQWiG has reworded and added explanations in several places. Among other things, the section on the “Consequences of incomplete data availability” was revised again: For the draft of version 7.0, the methodological approach to dealing with missing data was significantly streamlined, which sparked questions. In the current version, the procedure is now explained in more detail. As usual, IQWiG will provide early information about the next step in processing the method paper.
The method paper is ready here for download ready.