Health Technology Assessment (HTA) for Medical Devices Do the same rules apply?

Aim of this paper is to analyze whether medical devices can and should be assessed (as drugs) via a health technology assessment (HTA) approach meaning a methodologically standardized e.g. clinical and economic assessment. The discussion of specific issues relevant for the very heterogeneous field of medical devices compared to drugs results in the finding that there remain questions for the setting of the German health care system. For a large proportion of medical device products a formalized HTA approach aiming at giving health policy guidance on reimbursement decisions seems not feasible or not needed as other regulations or structures seem to work more efficient or are more adequate. Nevertheless, for some product groups HTA seems to offer valuable information, but the methodology of conducting such studies should be modified, as e.g. for some products randomized, controlled, double blinded trials are not possible due to methodological reasons. Hence, it should be further analyzed how existing and well established HTA methods could be modified in order to reflect specific product characteristics of some product groups. The main outcomes out of the theoretical analysis were transformed into a decision tree. With the help of that tree decision makers may analyse if for a specific product or product group a formal HTA makes sense. The latter term refers to whether a HTA is necessary from a clinical perspective, efficient from an economic perspective, and also if it is possible taking specific characteristics of the respective product into account. The decision tree was constructed to especially reflect the specific decision situation within the German health care system.