Health Technology Assessment of Biomarker Tests in Personalized Medicine
Franz Hessel,
Programme Director,
SRH University
Health Technology Assessment (HTA) is a comprehensive evaluation of all relevant short- and long-term consequences of the application of a specific medical technology. It covers clinical, societal, economic, ethical and legal aspects, based on the available scientific evidence.
Although there are some special issues to be considered all principles of HTA are equally valid for the evaluation of biomarker tests and personalized medicine technologies. All requirements of evidence-based medicine remain and causality should and could only be demonstrated with high-quality controlled studies, preferably with randomized design. The multimodality of the intervention and smaller sample sizes lead to increased uncertainty. Besides the test strategy, itself also questions of test or sample quality, laboratory size, and the platform used must be taken into consideration. The fundamental principles of HTA and health economic evaluation are also valid and feasible for the evaluation of genetic biomarker tests, but careful adaptations of the existing guidelines are required.
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