Assessment of health technologies at early stages of development before design finalization

The early stage HTA (eHTA) is an assessment of health technologies at the stage of research and development. Lately, it has been an intensely investigated area of health technology assessment, most commonly used as a tool for identifying economic predictions of health technologies at an early stage of development, before clinical testing, and even before design finalization. Early stage models can be used to gain information for the design and management stage of new health technologies to mitigate the risks associated with placing the technology on the market and its inclusion into the public insurance reimbursement systems.

Production of medical devices is a very dynamic branch with permanent changes and short lifetime of products. Due to the short lifetime of medical devices, their frequent modifications, and the existence of “learning curves”, there is unlikely to be a substantial steady-state period, during which the device could be evaluated in a randomized controlled trial. Moreover, prices are likely to change over time, because new better products enter the market, or because of the ways, in which procurement takes place in many health care systems. Thus, running clinical trials and full HTA studies for medical devices is an expensive and uncertain issue, as its results can be outdated already at the moment when it is finalized.

On the other hand, the new Medical Devices European Regulation (MDR) calls on the manufacturer to subject their products to clinical trials, and many national regulations require also HTA studies. In this situation, there is a growing need for a full-scale implementation of a methodological process that would allow for health technology assessment (or at least its crucial parts) at an early stage of development, before clinical testing, and even before design finalization.

Such a solution might be provided (not only for medical devices, but also for pharmaceuticals or other technologies) by the eHTA that possesses powerful tools to manage the manufacturer’s investment risks and to improve the device design. There are three main methodological frames suggested for the eHTA: modelling, stakeholder preference elicitation, or employing real-world data of a similar known technology. However, all these methods are only being studied, and used in pilot applications (the eHTA studies are, however, seldom published, so that it is not clear how often they are actually used). Recently, the essence of eHTA was studied by Scottish researchers. They recommended to replace the term early HTA by development-focused HTA, which can stress the differences with “traditional” use-focused HTA. In another paper they recommend guidelines for application of the development-focused HTA, which can substantially help in its more frequent application.