Heath Technology Assessment (HTA) is a scientific research area that makes informed clinical as well as policy decisions on the use of health technologies, which include pharmaceuticals, medical devices, diagnostics, procedures and other clinical, public health and organizational interventions. (1)
Recently, ‘early HTA’ is progressively being promoted as a perspective to determine added value of potential new technologies early in the development channel. Such kind of assessment would be useful to (1) make decision for further development of the technology, (2) to fix minimum performance thresholds for the new technology compared to currently available technologies and, (3) to sustain pricing and reimbursement in early stages of development. It thus considers existing regulatory requirements as well as mechanisms for obtaining reimbursement depending on the added value produced. Early HTA differs from mainstream HTA with respect to informed decisions made by R&D instead of government (agencies) about coverage. (2)
Health economic assessments during early stage informs decisions on the commercial viability of new medical technologies, thus allowing companies to discontinue further development if results suggest possible failure of the product. Evidence shows increasing number of researchers stressing on early HTA of medical devices. While most of the former work is about informing decisions in drug development, there has been a rapid increase in studies evaluating medical devices since last decade. (3,4) This is owing to the global trend building strong regional medical technology innovation clusters with support of (local) governments. Success of a medical technology hugely depends on the value created in the health system in terms of patient outcomes, convenience, or sustainability of care. Getting hold of information at an early stage can certainly improve the device during the development process, thus creating the most beneficial medical technology for society. The major difference between classical and early medical HTA is that, the former supports decision-making by regulators, payers and patients about the overall value of a technology; while the latter method helps manufacturers and investors to decide about the management of the development, as well as their regulatory and reimbursement strategy. (5,6)
Various tools are available to perform early HTA studies such as, early health economic modeling, clinical trial simulation and multi-criteria decision analysis; however, very few published articles exist to support this. In the past few years, some researchers have understood that early economic analyses/modeling during the development process help obtain optimal future results, which would help produce technologies to get market approval and reimbursement from the national health insurers.vi Another method is the ‘headroom method’, which is a relatively simple threshold approach that estimates the maximum possible cost of technology and yet still be considered cost-effective, thereby making avoiding misguided investments in those technologies that will never be cost-effective. (7) Bayesian statistics is yet another tool that has been increasingly used in health economic evaluations over the past years. It is certainly a useful tool for early HTAs, since it allows evaluations to be performed repeatedly as the knowledge base evolves. (8)
Furthermore, clinical trial simulation (CTS) is a procedure which applies available knowledge about the technology under development using mathematical relationships and models. (9) This procedure estimates different efficiency and tolerability profiles ahead of the clinical data acquisition. Its use can therefore help manufacturers minimize the duration and costs of technology development. In addition, multi-criteria decision analysis (MCDA) is a method to support decisions between two or more discrete alternatives. (10) It helps decision-makers in data organization and transparent decision making and consists of many validated methods, including analytic hierarchy process (AHP), conjoint analysis and contingent valuation. However, AHP is the only one that has been applied in early HTAs of medical devices. Another method is value of information (VOI) analysis, which is based on the underlying principle of comparing the costs and benefits of collection of additional information. (11)
There is a possibility that that the most appropriate early HTA approach might vary among technologies in both devices and tests. The concept of early HTA represents a new way to evaluate technologies that should receive more attention in the future. Early HTA can help reduce the time and investments required in developing new technology, and also in development of more effective and cost-effectiveness medical technologies.
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