[Comments by the Working Group for Methods of Economic Evaluation in Health Care (AG MEG) to IQWiG's Draft Guidelines "Methods for Assessment of the Relation of Benefits to Costs in the German Statutory Health Care System"].

Since the coming into force of the GKV-Wettbewerbsstärkungsgesetz ("Act to strengthen competition in the statutory health insurance system") in April 2007, the Gemeinsame Bundesausschuss (G-BA "Federal Joint Committee") can commission the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG--Institute for Quality and Efficiency in Health Care") with the assessment of costs and benefits of drugs. In January 2008, IQWiG published a working document for consultation describing the proposed methods for carrying out those evaluations. This commentary by the AG Methoden der Gesundheitsökonomischen Evaluation (AG MEG--"Working Group for methods of economic evaluation in health care") provides a critical appraisal and recommendations for the further development of IQWIG's draft guidelines. The core statements of the commentary are as follows: (1) The draft guidelines are unbalanced. Instead of providing comprehensive methodological guidance for health technology assessment, which is the actual task of IQWiG, they deal predominantly with the methods of technology appraisal which is in the responsibility of the decision-making bodies, i.e. of the G-BA and the Spitzenverband Bund der Krankenkassen ("Central Federal Association of Health Insurance Funds"). (2) IQWiG intends to compare the cost-effectiveness of alternative treatment options only within a given therapeutic area. The rationale for this restriction is not clear, as the decision-makers have to determine ceiling prices across therapeutic areas and diseases and effectively the overall volume of health care expenditure, as well. (3) IQWiG aims at carrying out an economic evaluation only if in a preceding benefit assessment a drug has been judged to be superior. Therefore, it has to be assured that the benefit assessment is performed in such a way that its results may be used for the economic assessment. This requires the application of summary scores for the joint measurement of multidimensional endpoints (as, e.g., QALYs), to evaluate community effectiveness instead of efficacy, and to choose a time horizon that is sufficiently long to reflect any differences in the health benefits between the technologies being compared. Furthermore, the comment hints at some additional problems embodied in the draft guidelines and a number of key methodological issues which are not discussed at all in the working document. In summary, the methods currently proposed by IQWiG are not up to the task of conducting economic evaluations. It is strongly recommended to perform a public consultation process for the revised draft guidelines anew.