Economic Evaluation as a Tool in Emerging Technology Assessment.

Medical technologies are part of health technologies and they include medical devices (MD) and in vitro diagnostics (IVD). They have become a vital part of modern healthcare. Framework for introduction of new technology in the healthcare system includes a few steps: analytical and clinical accuracy assessment, clinical utility determination and economic evaluation. In addition, payers are interested whether new technology is adequate for reimbursement. There are fairly enough specific guidelines for implementation of economic methods at the early stage of IVD development. Searching the available literature in this field, this paper discusses the economic evaluations of emerging medical technologies with focus on point of care testing (POCT) and genetic testing. Results of POCT economy studies depend on investigated perspective (payers, policy makers or society), used effectiveness values (utility, effectiveness or consequence estimated as monetary value) and understanding of clinical pathway. There is a need for better understanding of the care pathway, resource utilisation and how they change with the introduction of POCT. Introduction of genetic testing before drug therapy was recommended with the aim to improve treatment benefit and to reduce costs of adverse drug reaction. Clinical utility and cost-effectiveness analyses should be considered for novel genetic testing - guided treatments. Most of the studies considering genetic testing - guided treatments showed that those combinations were cost-saving or cost-effective compared to standard care. For medical tehnology there is no universal guidance for outcomes measurement, cost calculation, performance requirements, use of a certain type of economic studies and economic thresholds.