Constructive Technology Assessment of Gene Expression Profiling for Breast Cancer

Constructive Technology Assessment (CTA) can be used as a complementary approach to Health Technology Assessment (HTA), especially for the early and dynamic introduction of new technologies in a controlled way. CTA is based on the idea that during the course of technology development, choices are constantly being made about the form, the function, and the use of that technology. In this dissertation the mixed method approach of CTA covers an integral assessment of clinical, economic, patient-related, ethical/juridical, and organizational domains. Diffusion scenarios, which are commonly applied in industry to anticipate on their strategies concerning future development, have been adapted to monitor the dynamics in this study. The aim of this dissertation was to contribute to the knowledge on early stage HTA by performing a CTA for the introduction and diffusion of gene expression profiling for breast cancer patients. As a clinical case, the introduction and diffusion of the 70-gene prognosis signature (MammaPrintTM) using microarray analysis was evaluated. The research objectives were twofold: first to develop the CTA method in early stages of technology development and second, to apply the CTA method to the case of the 70-gene signature for breast cancer, in order to support and anticipate on the introduction of this new diagnostic test, specified in different CTA aspects. This study showed that the CTA methodology can be a useful tool to guide controlled early implementation of a promising technology and its possible use for coverage decisions, in this case the 70-gene signature for breast cancer patients. The patient information regarding the 70-gene signature appeared to be clear and satisfactory and resulted in a good understanding of (the consequences of) the genomic profile. In general, the 70-gene signature seems most cost-effective in terms of quality adjusted life years; the slightly more sensitive tests deliver more life years, but leads to a substantial larger amount of adjuvant chemotherapy and hence higher costs, thus demanding a higher willingness to pay. Developing the 70-gene signature based on paraffin instead of fresh frozen tissue could establish a higher cost-effectiveness and could thus be a worthwhile investment. Finally, when incorporating scenarios in the decision model, it became apparent that early anticipation on certain aspects is necessary to reach the potential costeffectiveness.