The paper presents the methodological challenges of the introduction of cost-benefit assessment by the German legislative (Competition Enhancement Act). Based on the standards for health economic evaluation accepted by the international scientific health economic community, this paper provides a minimum catalogue of methods and criteria to meet the legal German requirements. The methodological framework presented in this paper discusses the perspective to be used to evaluate cost and benefits, lists the appropriate study form, names the usage of primary or secondary data, the description of the cost and benefit calculation, shows the specific need on modelling and how to handle uncertainties and calls for a disclosure of potential conflict of interests.
Further more, the paper contains detailed recommendations for the assessment-process in Germany. According to the new Competition Enhancement Act, the German Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) has to evaluate the cost-benefit ratio of pharmaceuticals in Germany. The process should be organised within two sequently parts: At first the development of a reporting plan that defines the comparative interventions to be included, the target criteria, assessment methods and the schedule to be observed, and secondly the implementation of the cost-benefit assessment.
Journal of Economics and Statistics is a scientific journal published in Germany since 1863. The Journal publishes papers in all fields of economics and applied statistics. A specific focus is on papers combining theory with empirical analyses.