A notable challenge to the institutionalization of priority setting and HTA identified in the roundtable discussion was a frequent lack of understanding of the vocabulary of HTA and its method among stakeholders in healthcare decision-making processes. This challenge is not surprising, given the HTA community itself is still struggling with definitions. In 2019, a task group was set-up with open consultation of HTA definition, a step forward to resolve this challenge, brought together several organisations working on HTA and the WHO to develop an updated definition that consolidates and simplifies the multiple existing definitions to reflect “current and emerging realities of HTA” ⁶ . The task group proposed the definition:

Participants of the roundtable noted that conceptualising priority-setting and HTA and explaining such concepts to the wider global health community must go beyond agreeing on the definition. It should include outlining what is included in the scope of HTA, as well as the priority setting process, which may include terms of engagement with stakeholders and the identification of topics for evidence review. HTA should be viewed as more than a merely technocratic exercise. It can at its best be a bridge to join professional technical assessment and professional policy decision-making in a fully integrated whole. Assessment tools must be designed to address the nature of the decisions that need to be taken and the policy decision making process to ensure critical political elements are taken into account in the tools’ design. This becomes much more than a matter of a definition of HTA, for it includes a role for context, scope and process. HTA, then, is both the portfolio of analytical tools for assessment (the “assessment” tools) and the broader range of topics that define context, objectives, barriers, conflicting interests that, taken together, amount to a kind of “political economy” of healthcare prioritization. On this view, while the technical attributes of “assessment”, like the meanings of opportunity cost, evidence, effectiveness or model building, are common to all practical applications of HTA, in any specific application, the objectives, the weights attached to them, the scope of costs and outcomes and the historical and cultural context which may make decisions and their implementation more or less possible, are particular to that application. In this sense, “one size does not fit all”, there is no universally correct “perspective” of a study and “cost-effectiveness” is a function of local circumstances: what is cost-effective in one place may or may not be cost effective in another. Roundtable participants noted that once consensus is reached in defining HTA, greater efforts must be made to communicate the agreed definition clearly and definitively to relevant stakeholders while concurrently connecting stakeholders to facilitate knowledge and information sharing required as part of such a multidisciplinary endeavour.

Many countries have struggled with rationing of health services to serve population needs ⁷ . In the absence of processes and methods for explicit rationing, decision-makers will find it easier to say ‘yes’ to health technologies including those that are novel and costly—decisions that may be politically favourable in the short run but prove financially unsustainable in the long run—and be reluctant to say ‘no’, with little consideration of effectiveness or cost-effectiveness. Evidence-informed priority-setting in comparison forces decision makers and their constituents to consider the trade-offs of any decision and helps decision maker justify what healthcare and resources are not to be included. HTA agencies across countries, notably the National Institute for Health and Care Excellence (NICE) in England, have driven up spending and put necessary pressure on health budgets. As such, it was noted in discussions that HTA need not only result in rejections. For example, HTA has been successfully used as a tool to inform price negotiations, procurement of commodities as well as in adjusting healthcare packages (i.e. what is provided to whom and under what circumstances?). It can thus drive governments’ and development partners’ Best Buys agendas, and such benefits must be more clearly communicated.

LMIC governments and healthcare payers have many needs for capacity and strengthened systems in priority-setting for UHC ⁸ , and there is a proliferation of global initiatives and organisations providing technical assistance. However, when many different donor-funded organisations are providing technical assistance, often in an uncoordinated manner, this can overwhelm LMIC governments and healthcare payers whose capacities are typically already overstretched ⁹ . Such disorganisation is exacerbated by the existence of multiple health packages, decision makers, donor funds, and insurance schemes in each country. A clearer narrative around priority setting, HTA and how it can assist governments in achieving UHC is overdue, as is communication between domestic and global organisations working in these areas. The roundtable discussed the need for developing a new publication which might build on discussions in What’s In, What’s Out: Designing Benefits for Universal Health Coverage ¹⁰ , addressing the current issues facing the HTA movement, how to link priority setting to upstream financing and downstream payment, the possible means of engaging with governments and budget holders in practical activities such as procurement. Linking the exercise of HTA to realisable savings was flagged as a priority. We try to offer such examples of practical applications of HTA in Figure 1.

Another major challenge relates to how traditional academic researchers and organizations whose roles are primarily in providing technical assistance can work together to serve partner LMICs in a responsive, demand-driven manner. For instance, these groups are required to work together in building capacity for the production and use of HTA evidence; and in understanding whether and how international evidence can be applicable locally. International development partners are investing in data collection and synthesis, notably through initiatives like the Disease Control Priories Network (DCPN), funded by BMGF, which promotes and assists in the use of economic evaluation for priority setting at global and country levels. DCPN most recently published Disease Control Priorities, Third Edition, a review of evidence on cost-effective interventions to address the burden of disease in LMICs ¹¹ . However, the next phase of work for DCPN and other organizations in the HTA community, must bring together academics, data and technical assistance together to explore how evidence outputs can be applied in practical, locally-owned priority setting.

The roundtable suggested that the WHO could be a “knowledge broker”, connecting decision-makers who require evidence or practical support to help them make difficult decisions with those who are in a position to provide such evidence or support. The WHO hosted Decide Health Decision hub, a platform established in June 2019 with the objective of hosting a virtual space to dedicated to supporting collaboration in the field of data-driven health decision making, through HTA, economic evaluation, investment cases or any other process encouraging fair and transparent decision making, could be an ideal platform to enable this ¹² . The roundtable endorsed the development of the platform and called for all partners to support the WHO in its coordination efforts. Strong leadership in the development of the HTA movement is crucial to the sustainability of HTA, as is long term financing in government ministries.

There is a secondary need to ensure that monitoring and evaluation mechanisms exist to measure and understand success. It was noted that the configuration of global health financing is changing, with an increasing reliance on concessional loans and less on donor funding as aid transition takes effect. As such, governments need to take responsibility for the development of strong and sustainable health systems. They need to recognize and seek out individuals and organizations with the skills to assist where gaps in knowledge and skills exist. In response to these needs, the roundtable endorsed the development of a unified Theory of Change for the major initiatives and organizations working in priority setting and HTA. Developing a Theory of Change involves working backward from a long-term goal, mapping out the causal pathways (including outputs and intermediate outcomes) toward that goal, and the assumptions—factors that would facilitate or impede the achievement of the goal ¹³ . The proposed Theory of Change will outline a mutual goal related to HTA for UHC, with clear and measurable milestones and/or indicators to ensure successful and appropriate progression. The Theory of Change could build on the iDSI Theory of Change, outlining how facilitation of effective partnerships focused on institutional and technical capacity-building leads to institutionalization of evidence-informed priority-setting at the country level, ultimately resulting in better decision-making and sustainable health impact ¹⁴ .