Key points are not available for this paper at this time.
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 National Institute for Health and Care Excellence (NICE), these technologies are very different to the more traditional health technologies commonly assessed. The rapidly evolving landscape of digital health technology (DHT) serves as a salient example of the opportunities and challenges confronting conventional HTA frameworks and methodologies. One of the unique features of this field is that it will allow more opportunities for patients to participate in and contribute to the HTA process. DHT can deliver personalized healthcare tailored to individual needs; patients can generate real-world data to provide feedback on the effectiveness and user experience. To incorporate and evaluate patient-specific data using the current HTA framework is no easy task. DHTs can also involve novel fields such as big data, internet of things (IoT), robotic technologies and artificial intelligence. Conventional HTA frameworks may not be equipped for their assessment. Using the example of mobile medical applications, the evaluation required additional considerations such as cybersecurity and misinformation, and the responsibilities of patients and medical practitioners.21 Offering advice on market access and reimbursement decisions is a basic function of HTAs. Indeed, these decisions must be made in a timely manner before the health technology evolves to the next iteration, effectively rendering the advice outdated.22, 23 Inefficiency has been one of the many criticisms of government processes and HTA frameworks in Australia due to the sequential steps of regulation and funding.24 With the emergence of disruptive health technologies and the involvement of novel research areas, there is a need to review not only the HTA methods, but also the decision-making frameworks and the role and responsibility of governments as key stakeholders in regulatory and funding decisions. Innovation in HTA and health policy has occurred, such as allowing parallel reviewing processes between the regulatory body (e.g., the Therapeutic Goods Administration TGA) and HTA committees for reimbursement, as well as joint assessment of co-dependent technologies for diagnostics and therapy.25-27 Other efficiencies include regulatory agencies from different jurisdictions working together to share information (e.g., the European Medicines Agency and the TGA, Australia).28 In the context of uncommon and rare diseases, ASERNIP–S has been involved in developing new HTA methodologies as an alternative to condition-based assessment to address efficiency challenges. For the Australian Government Department of Health, ASERNIP–S investigated how to streamline the reimbursement decisions for positron emission tomography for the staging, treatment response monitoring and disease recurrence of uncommon and rare 18F-fluorodeoxyglucose-avid tumors using cancer agnostic modeling.29 Approaches such as this could potentially ease the burden on government frameworks without negatively impacting the rigor and requirements of HTA processes. HTA agencies continue to play an important role in working with governments to improve the efficiency of the healthcare system and eliminate potential barriers arising from rapidly evolving DHTs. Optimal integration of the health policy question and the clinical evidence evaluation will be more important than ever to speed assessments, allowing patients access to the most up-to-date medical technologies. Alun Cameron: Conceptualization; writing – original draft; writing – review and editing. Ning Ma: Conceptualization; writing – original draft; writing – review and editing. Wendy J. Babidge: Conceptualization; writing – original draft; writing – review and editing. Guy J. Maddern: Conceptualization; writing – original draft; writing – review and editing. Open access publishing facilitated by The University of Adelaide, as part of the Wiley - The University of Adelaide agreement via the Council of Australian University Librarians.
Cameron et al. (Mon,) studied this question.