Study design of a medical device pre-market assessment: a case study on electrochemotherapy

Final goal of the study is to estimate the cost-e ectiveness of electrochemotherapy for the tre- atment of basal-cell carcinoma and skin melanoma. Paper consists of two parts: the first part presents basic principles and concepts of health technology assessment and cost-e ectiveness analysis, and the second part reports an early cost-e ectiveness analysis of electrochemothe - rapy for the treatment of basal-cell carcinoma and skin melanoma that we are developing. Few cost-e ectiveness analyses of electrochemotherapy have already been done, but with a lack of information about intervention e ectiveness in terms of quality of life, which may result in inac- curate or even inadequate conclusions. In order to obtain the most realistic results, two general Markov models and their reduced versions for initial calculations are presented. The models were designed specifically to assess electrochemotherapy of basal-cell carcinoma and skin me- lanoma. Also, data required for successful calculations have been identified, some of which are missing and will be collected within di erent studies which are still under way, including rando- mized control trials. Additionally, recommendations for data collection process and follow-up reporting are made. With this paper we want to raise awareness about the importance of nume- ric quality of life reporting and usefulness/meaning of EQ-5D questionnaire that might not be self-evident at first sight, but are crucial for cost-e ectiveness analysis.