Cost-benefit assessment in Germany: IQWiG publishes revised version of the methods draft

An editorially revised version of the methods draft on the assessment of the cost-benefit relations of drugs was published by the German Institute for Quality and Efficiency in Health Care (IQWiG) on 14 October 2008. Version 1.1 primarily clarifies misunderstandings and reacts to questions raised by the draft presented in January 2008 (Version 1.0). All comments on Version 1.0 submitted to the Institute, the scientific reply, as well as three technical appendices highlighting key aspects of the practical implementation of the efficiency frontier methodology are now completely available online. With the publication, IQWiG intends to constructively support the ongoing lively discussion among experts and in the media about the appropriateness of the costs of medical services.

Basic statements remain unchanged

A total of 46 comments on the methods draft on efficiency frontiers (Version 1.0), published on 24 January 2008, were received on time by the end of March. Parties submitting comments included associations of the pharmaceutical industry as well as companies, medical organizations, scientific societies, hospitals, patients, and other private persons. About 20% of the comments originated from abroad and were written in English. In addition, the German Federal Ministry of Health, as well as the IQWiG Board of Trustees, provided comments outside the framework of the formal commenting procedure.

Compared with Version 1.0, the basic statements of Version 1.1 remain unchanged. However, the new version now presented formulates individual statements more clearly and is therefore more precise. The Institute thereby also reacts to queries and misunderstandings addressed in the comments. In a separate document ("Scientific Reply”), IQWiG and its international expert panel respond to the arguments and objections frequently presented in the comments.

Model calculations are necessary for the cost side

Three technical appendices presented simultaneously aim to contribute to an understanding of the proposed methodology. They specify three important aspects for the implementation of the methodology: modelling, cost estimation, and uncertainty.

When considering costs and benefits, the time period investigated should reflect the course of disease appropriately. However, clinical trials are often considerably shorter, which is why model calculations may be necessary for the cost side. However, as with every prediction, model calculations are extremely uncertain, as specific assumptions have to be made. The technical appendix "Modelling” therefore describes, among other things, principles for the development of models and their implementation in health care. The technical appendix "Cost estimation” addresses the issue of how costs are made up and how they can be determined from different perspectives, for example, that of statutory health insurance (SHI) or society as a whole. In the technical appendix "Uncertainty”, it is primarily discussed how information on the degree of bias can be gained in the estimation of efficiency frontiers.

With the publication of Version 1.1 together with the comments, the scientific reply, and the technical appendices, the Institute aims to ensure the greatest possible transparency in the methods development and involve a large circle of experts, in particular health economists. As all documents are available both in the English and German languages, international experts can also participate in the scientific discussion, or at least follow it.

Final version of the methods should be available in the summer of 2009

In the first stage of the methods development, the Institute commissioned a group of well-known health economists from eight countries. In this way, the Institute aimed to ensure that the methodology complied with internationally accepted standards, which are also required by law. From now on, IQWiG's Scientific Advisory Board will be even more closely involved in the consultations. For this purpose, the Scientific Advisory Board has formed its own working group. In order to ensure continuity and the involvement of international expertise on the one hand, and to add weight to health economics of German character on the other, the Scientific Advisory Board also appointed external researchers. These researchers are members of the Working Group: Methods of Health Economic Evaluation (AG MEG) of the German Society for Social Medicine and Prevention (DGSMP); the Panel for Health Economics in the Society for Social Policy; and IQWiG's international health economic expert panel.

This working group will advise IQWiG's Scientific Advisory Board, and its advice will be incorporated in the methods draft 2.0, which will also be open to comments. In parallel, IQWiG will test the practicability of the method for the German setting in several dry runs. If this process runs in an optimal manner, the future final methods 1.0 could be available in the second quarter of 2009 and be the binding basis for the assessment of the relations of the costs and benefits of drugs. However, only the general procedure will be described. For each assessment, the specific project-related methodology will be discussed initially with all interested parties on the basis of a preliminary report plan, and will then be specified in a binding manner in the final report plan.