Health technology assessment (HTA) can occur at different stages of a technology’s lifecycle. In the accompanying paper, Grutters and colleagues present a consensus definition of “early HTA” as a health technology assessment conducted to inform decisions about subsequent development, research, and/or investment by explicitly evaluating the potential value of a conceptual or actual health technology. Early HTA is particularly relevant to non-medicine technologies, which are often developed more iteratively than medicines. This article explores some of the ways in which early HTA is already being conducted on non-medicine technologies in the United Kingdom, as well as future perspectives and possible challenges in using early HTA.

The HTAi Health Technology Assessment (eHTA) Working Group’s (WG) development of a consensus definition of early eHTA, as reported in Grutters et al. (1), represents a major step towards the establishment of eHTA as a distinct subdiscipline of HTA. In a global landscape in which growth in pharmaceutical spending is driven by the increasing number of high-cost specialty drugs (2–6), and where the cost of new entrants is not systematically associated with their clinical benefit (7;8), broader uptake of eHTA by pharmaceutical innovators offers a route to improving the value delivered by our collective investments in drug research and development (R&D). As we argue in this commentary, the WG’s report provides a coherent framework within which to further define appropriate eHTA methods for specific use cases as well as eHTA’s relationship to other decision-making tools currently used by health technology innovators and funders.

This commentary examines how early health technology assessment can mitigate risks during the development of innovative technologies.

This article presents the first consensus-based definition of early health technology assessment (HTA): “an HTA conducted to inform decisions about subsequent development, research, and/or investment by explicitly evaluating the potential value of a conceptual or actual health technology.” The definition was developed and refined through the involvement of relevant stakeholders in the field, a working group, and a survey panel, aiming to reach a consensus. An important part of this work was distinguishing between early HTA and related concepts, such as early awareness, dialogue, and scientific advice; thus, clarifying its unique role in HTA. Furthermore, the authors discuss how early HTA may guide investment decisions in development and reduce research waste. In addition, the consensus-based definition may enhance clarity for developers in producing early decision support to reach healthcare providers and policymakers. Finally, the article emphasizes the need for standardized terminology to increase the visibility of research, development, and policy in early HTA.

The field of health care has evolved from an emphasis on evidence-based medicine, with a focus on efficacy, safety, and tolerability, to the pursuit of evidence-based efficiency and sustainable innovation in many respects (healthcare budgets, carbon print, etc.). This evolution can be attributed, in part, to the contributions of health technology assessment (HTA) bodies, which have facilitated the incorporation of various factors into the decision-making process (1). These factors include comparative effectiveness, quality of life, efficiency, budgetary impact, and organizational impact, among others. Within the domain of health care, irrespective of the perspective of each entity (e.g., Food and Drug Administration (FDA), European Medicines Agency, etc.), there is an imperative for the presence of evidence and its assessment in the most transparent manner possible, with the objective of ensuring the incorporation of healthcare technologies.

Translating emerging health technologies towards adoption and patient benefit requires timely and effective research and development decisions. Early health technology assessment has a key role to play in supporting these decisions. A new consensus definition of early health technology assessment is a welcome contribution to help bring these activities toward wider use in the field. In parallel, the opportunities to perform early health technology assessment activities are increasing as new types of health technologies begin to enter healthcare systems globally. A greater focus on transparency of reporting, improving awareness around how early health technology assessment can impact decision-making, increased resourcing for these activities, expanding training for analysts, and encouraging collaboration between individuals across healthcare systems will be vital to strengthen the uptake of early health technology assessment from this point forward.