Abstract
Health Technology Assessment developed out of pharmacoeconomy; although it is routinely used for all health technologies incl. therapeutic interventions, preventive measures etc., its methodology fits best for drugs. Medical devices have their specificities that affect significantly all processess, where they are involved. The differences between medical devices and drugs from the perspective of HTA have led to a special methodology used by NICE. However, the main challenge remains to be how to calculate and express the effects (outcomes) of a particular device. The generally used QALY concept is not much suitable for medical devices, as they frequently do not directly affect the quality of life and/or life years of the pacient. The efficiency of a device depends not only on the device itself, but also how it is used (the skill and experience of the surgeon, organization of work on the clinic, etc.). Its effect can be lower radiation, more comfort for the clinician or the patient, better image resolution. We recommend to calculate standard CEA, where the effects are evaluated by means of a combination of value engineering methods and multiple-criteria decision analysis, while costs are evaluted directly (ideally by the micro-costing method). The paper discusses specific features of medical devices, and provides example of a solution.