Introduction Evidence-based healthcare decisions rely on rigorous and transparent assessments of the benefits and harms of medical drugs and procedures. The Institute for Quality and Efficiency in Health Care (IQWiG) is a leading institution in Germany that conducts such assessments, which inform healthcare policy, reimbursement, and pricing. To ensure the validity and reliability of its assessments, IQWiG follows a set of General Methods that define its work procedures and principles. These General Methods are periodically revised to incorporate the latest developments in healthcare and science as well as IQWiG’s legal obligations. This blog discusses the recent updates in the General Methods version 7.0, released in September 2023, with a focus on the areas of cost-benefit assessment and Real-World Evidence (RWE) collection.
General Methods and Updates The General Methods provide a comprehensive and consistent framework for IQWiG’s work, covering various aspects of its assessments, such as early benefit and method assessments. The General Methods are not static, but rather dynamic and adaptable to the changing healthcare environment and scientific standards. IQWiG regularly updates its General Methods to reflect the current state of knowledge and practice in its field. The latest version, 7.0, incorporates several changes, additions, and improvements that are discussed in this article.
Revisions based on Stakeholder Input IQWiG values transparency and continuous improvement in its work. Therefore, before finalizing the General Methods version 7.0, IQWiG invited feedback from stakeholders on the draft document, which was presented in December 2022. IQWiG received 38 statements from various parties, such as health insurance companies, pharmaceutical manufacturers, patient organizations, and scientific societies. In March 2023, IQWiG held a discussion with the respondents to address and clarify the open questions and issues raised by the statements. As a result of this opinion process, IQWiG made several modifications and clarifications in the document, enhancing its clarity and comprehensibility.
Revision of the Cost-Benefit Assessment One of the most significant updates in the General Methods version 7.0 is the complete revision of Chapter 4, which deals with the cost-benefit assessment of medical interventions. This revision also affected the overarching section 1.4 on health economics. The cost-benefit assessment is a method that can be used to guide the pricing of new drugs, especially when the early benefit assessments under the “Act on the Reform of the Market for Medicinal Products” (AMNOG) have been completed, but the subsequent negotiations between health insurance companies and manufacturers have failed. However, due to the complexity of the previous methodology, such an assessment has never been requested. In response to this, IQWiG simplified its methodological approach to make cost-benefit assessments more feasible and less complicated. The main changes concern the selection of therapy options and the presentation of price recommendations. Previously, all therapy options within the indication area had to be considered, but now only a subset of relevant comparators can be included. Moreover, IQWiG no longer provides a specific price recommendation, but rather an incremental cost-benefit ratio over the comparative therapy.
Integration of RWE framework into the General Methods Another important update in the General Methods version 7.0 is the integration of a new methodological framework for generating RWE. RWE refers to data that are collected outside of controlled clinical trials, such as in routine clinical practice or registries. RWE can complement the evidence from clinical trials, especially for drugs that received regulatory approval under special conditions, such as drugs for rare diseases (orphan drugs). Since 2020, the German Federal Joint Committee (G-BA), which is the highest decision-making body in the German healthcare system, can request data collection alongside use in clinical practice (AbD) for such drugs. The G-BA can commission IQWiG to develop an AbD concept, which specifies the methodological requirements for data collection and evaluates the suitability of existing registries within the indication area. IQWiG has introduced a new methodological framework for creating these AbD concepts and generating RWE in the General Methods version 7.0.