Changes and challenges in health technology assessment

Abstract

In recent years, health technology assessment (HTA) has established itself globally as a crucial part of healthcare. While various definitions exist, the aim of HTA remains consistent: to facilitate health policy decision-making.1-6 The key principles have remained constant since the concept of HTA was introduced in the 1970s and 80s.2, 7 These include transparency, reduction of bias, and consideration of economic value and health outcomes.8-10 Over time, the methods, tools, frameworks and approaches for best-practice HTA have evolved and developed. Some notable examples being the standards for systematic literature search and selection,11 tools for the assessment of study bias,12 methods for summarizing and rating review outcomes,13 economic evaluation focusing on patient outcomes,14, 15 and adaptations in HTA practices for different contexts and settings (e.g., disease agnostic assessments and hospital HTAs). Crucial in the development and adoption of these practices has been the various international and regional HTA bodies such as Health Technology Assessment international (HTAi), the International Network of Agencies for Health Technology Assessment (INAHTA), the Cochrane Collaboration, HTAsiaLink, and the European Network for Health Technology Assessment (EUNetHTA), as well as country-specific organizations and agencies.1, 16, 17 In Australia, the Australian Safety and Efficacy Register of New Interventional Procedures–Surgical (ASERNIP–S) commenced in 1998 as an HTA unit within the Royal Australasian College of Surgeons, following a request from the federal government to establish a body to assess new surgical procedures.17, 18 The group has worked with stakeholders across a variety of assessment topics and method developments, forging many international and regional collaborations. ASERNIP–S is one of the most longstanding HTA service providers both in Australia and internationally. Despite ongoing efforts in global collaboration, challenges for HTA remain. Healthcare costs continue to rise and novel technologies continually challenge the status quo, stretching the needs of policymakers.19, 20 HTA agencies such as ASERNIP–S must keep abreast of these changes to provide advice to stakeholders. Many of the issues currently facing HTA were discussed at the recent annual HTAi meeting (2023) in Adelaide, Australia. This meeting, “The Road to Clinical and Policy Integration,” focused on areas such as building pathways for fostering innovation while minimizing risk, how to harmonize HTA processes between similar jurisdictions, assessing the feasibility of aligning technology evaluation processes, and decisions in an era of sustainable development. The meeting was well attended with registrants from Australia and across the world. ASERNIP–S, as a key contributor to the conference, exchanged views and discussed many topical themes with fellow HTA practitioners and stakeholders. An important conference theme was the challenges that new and disruptive technologies bring to traditional HTA frameworks and methodologies. These health technologies feature novel characteristics, such as being disease agnostic (e.g., gene panel tests), having complex and non-transparent functionalities (e.g., artificial intelligence-powered medical imaging triage systems), evolving rapidly (e.g., digital technologies with machine-learning capabilities), having high purchase and maintenance costs (e.g., robot-assisted surgery), requiring high-cost medicines for rare diseases (e.g., chimeric antigen receptor-T cell therapy [CAR-T]), and incorporating precision medicine (e.g., gene therapy using viral vectors). While decision-makers are still concerned with the same policy questions of whether the technologies are safe, effective and cost-effective, answering these questions now must deal with large, complex non-conventional datasets or limited unpublished evidence or even no data at all. As noted in the keynote speech by the chief executive of the Nation