General methods for IQWiG's benefit assessment

In its general methods, the IQWiG describes in detail and transparently the criteria it uses to assess the benefits and harms of medical interventions for patients. In order to reflect the further development of standards in the scientific disciplines and to comply with extended legal obligations, this compendium is regularly updated. This update to version 7.0 includes a fundamental revision of the cost-benefit assessment and an addition of the concept of routine practice data collection.

A significant new feature relates to the cost-benefit assessment of medical interventions, which is embodied in chapter 4 of the general methods. In this context, section 1.4 on health economics has also been completely revised. Previously, the cost-benefit assessment could serve as a guide for the pricing of new drugs when the early benefit assessment of medicinal products in accordance with the Act on the Reform of the Market for Medicinal Products (AMNOG) had been completed and price negotiations had failed. However, such an assessment has not yet been initiated, presumably due to its complexity. To this end, the IQWiG has adapted and simplified its methodological basis for the cost-benefit assessment.

In order to quantify the added benefit of drugs for rare diseases, the Federal Joint Committee (G-BA) has been able to require manufacturers to conduct routine practice data collection (Anwendungsbegleitende Datenerhebungen AbD), including evaluation, since 2019. For this purpose, a new type of commission was defined in the updated methods paper, which reflects IQWiG's methodological work in this process.

We at SKC have analyzed these updates and implications in detail and are in contact with the G-BA and the IQWiG. Please feel free to contact us if you have any questions about the cost-benefit assessment or the routine practice data collection or if you are considering conducting one of those. We are the Market Access Special Forces.

Sources:

• Institut für Wirtschaftlichkeit und Qualität im Gesundheitswesen (IQWiG). Pressemitteilung vom 19.09.2023.
• Institut für Wirtschaftlichkeit und Qualität im Gesundheitswesen (IQWiG). Allgemeine Methoden, Version 7.0 vom 19.09.2023.
• SKC Beratungsgesellschaft mbH. Whitepaper: Routine practice data collection for benefit assessment: Lessons learned from 2 years, risk factors and strategic implications. 2023.