How IQWiG assesses medical interventions: Version 7.0 of the methods paper becomes effective – English translation now available

The German Institute for Quality and Efficiency in Health Care (IQWiG) completed the update of its methods paper to Version 7.0 and published the currently valid version of its "General Methods" on www.iqwig.de. An English translation is now available.

In its General Methods, IQWiG provides a detailed and transparent description of the criteria it uses to assess the benefits and harms of medical interventions for patients. In order to account for the further developments in standards in the scientific disciplines and to meet extended legal obligations, this compendium is regularly updated – sometimes in smaller steps, sometimes by a fundamental revision of entire chapters, which is then reflected in a new version number, as is now the case with Version 7.0.

Revision of the chapter on health economic evaluation

The Institute has completely revised Chapter 4 of the General Methods, which describes the health economic evaluation of medical interventions. As part of this revision, the superordinate Section 1.4 on health economics has also been completely revised.

Since 2011, the health economic evaluation of new drugs can be used to inform pricing if an early benefit assessment according to the German Act on the Reform of the Market for Medicinal Products (AMNOG) has been completed and price negotiations between health insurance funds and drug manufacturers have failed. So far, however, neither party has initiated such an evaluation, which is probably also due to the complexity of the procedure. Against this background, the Institute has adapted its methodological principles for health economic evaluations and made them less complex overall. For example, the previous methods required all treatment options in a given therapeutic indication to be considered; now fewer comparator therapies can be used. In addition, IQWiG no longer derives a price recommendation. Instead, it determines the incremental (i.e. calculated in steps) cost-benefit ratio in relation to the comparator therapy.

New type of commission: Concept for routine practice data collection

In its methods paper, IQWiG has newly included a description of its approach to develop an RPDC concept (RPDC = routine practice data collection) after commissioning by the Federal Joint Committee (G-BA).

Since 2019, the G-BA can require an RPDC, including an analysis, from the manufacturers of drugs for rare diseases (orphan drugs) to generate additional data for the quantification of the added benefit. IQWiG then provides the necessary methodological input: it develops a concept describing the methodological requirements for conducting the data collection. It also searches for suitable registries in the therapeutic indication (“disease registries”) to decide whether the planned RPDC is in principle feasible and appropriate.

Like the AMNOG dossier assessments for the early benefit assessment of new drugs, the new types of commission "RPDC concept" and "search for disease registries" are regulated in §35a of the German Social Code Book V (SGB V). IQWiG now clearly presents this extended range of products for assessments according to §35a SGB V in Chapter 2 of its General Methods Version 7.0.

Consequences of the commenting procedure

IQWiG presented the draft of its updated methods paper in December 2022 and invited comments. The Institute then received 38 comments, some of which were very detailed. After the end of the commenting period, a hearing was held in March 2023 with the commenters to resolve outstanding issues.

As a result of the commenting procedure, IQWiG has reworded several parts of the text and added explanations. For example, the section on "Consequences of incomplete data availability" has been revised again: In the draft of Version 7.0, the methodological approach to dealing with missing data had been greatly streamlined, which led to questions. In the current version, the approach is now explained in more detail again. The (German-language) General Methods 7.0 and the English translation were published on 22 September 2023 and 15 December 2023, respectively. As usual, IQWiG will provide information on the next stage of its work on the methods paper as soon as possible.