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Health technology assessment has significantly improved the decision-making process via the thorough and systematic evaluation of the clinical utility and cost-effectiveness of new drugs and health technologies. However, the device industry faces a significant challenge in meeting the evidentiary demands of the health technology assessment process, particularly given the small size of the Canadian market and device manufacturers. This is further compounded by the somewhat short-sighted nature of health care budgets, which see medical devices as a cost-driver given the sometimes significant upfront investment required to implement a technology producing downstream benefits in the long-term. Industry is the research and development of the health care system, but innovative development could be stifled unless the health technology assessment process recognizes the risk of manufacturers. The authors propose that health technology assessment can be improved by recognizing the challenges that device manufacturers face and by sharing the risk associated with evaluations of effectiveness. Health technology assessment is a powerful tool that can be used to evaluate new and potentially obsolete technologies alike, with the goal of meeting the needs of patients as customers of both the device industry and the health care system.

Objective: The aim of this paper is to present an economic evaluation of diagnostic technologies using Helicobacter pylori screening strategies for the prevention of gastric cancer as an illustration., Methods: A Markov model was constructed to compare the lifetime cost and effectiveness of 4 potential strategies: no screening, the serology test by enzyme-linked immunosorbent assay (ELISA), the stool antigen test (SAT), and the (13)C-urea breath test (UBT) for the detection of H. pylori among a hypothetical cohort of 10,000 Canadian men aged 35 years. Special parameter consideration included the sensitivity and specificity of each screening strategy, which determined the model structure and treatment regimen. The primary outcome measured was the incremental cost-effectiveness ratio between the screening strategies and the no-screening strategy. Base-case analysis and probabilistic sensitivity analysis were performed using the point estimates of the parameters and Monte Carlo simulations, respectively., Results: Compared with the no-screening strategy in the base-case analysis, the incremental cost-effectiveness ratio was $33,000 per quality-adjusted life-year (QALY) for the ELISA, $29,800 per QALY for the SAT, and $50,400 per QALY for the UBT. The probabilistic sensitivity analysis revealed that the no-screening strategy was more cost effective if the willingness to pay (WTP) was <$20,000 per QALY, while the SAT had the highest probability of being cost effective if the WTP was >$30,000 per QALY. Both the ELISA and the UBT were not cost-effective strategies over a wide range of WTP values., Conclusion: Although the UBT had the highest sensitivity and specificity, either no screening or the SAT could be the most cost-effective strategy depending on the WTP threshold values from an economic perspective. This highlights the importance of economic evaluations of diagnostic technologies.

Economic evaluations involve the comparison of alternative courses of action in terms of both their costs and their consequences. In response to increasing health care costs, economic evaluations of competing technologies, including radiologic interventions, are increasingly used to inform resource allocation decisions. It is therefore crucial that radiologists have a thorough understanding of the methods. The objective of this paper is to present a detailed overview of the principles and methods of economic evaluations of health technologies, including recent methodologic developments. For the purpose of this paper, the key elements of an economic evaluation are divided into 5 broad sections: 1) types of economic evaluations (eg, cost-effectiveness analysis, cost-utility analysis), 2) study perspectives (ie, temporal and cost perspectives), 3) analysis of costs and effects (eg, incremental cost-effectiveness ratios, cost-effectiveness planes), 4) conducting economic evaluations alongside trials or using decision-analytic models, and 5) dealing with the different forms of uncertainty in economic evaluations (eg, sampling uncertainty in trials, parameter uncertainty in models). Examples from the recent radiology literature are used to explain the key concepts. This review improves upon the previous educational papers published in radiologic journals, as it covers recent methodologic advances regarding the treatment of uncertainty.

Decision makers are faced with the task of allocating health resources to maximize patients' health under budget constraints. To offer structure to the complexity of the decision-making process, the field of health technology assessment (HTA) was developed. This paper offers an introduction to the fundamental aspects of HTA and acts as a guide to the conduct of HTA for radiologists. First, the authors define HTA and describe how it is linked to the field of diagnostics. Second, a basic 11-step framework for the conduct of an HTA is outlined. The framework begins with the identification of the problem and proceeds through to the dissemination and impact of an HTA. Third, the authors provide a real-world example of an HTA in the field of diagnostics. Last, they describe the challenges and barriers faced in HTA.