Prevailing unfamiliarity with the vocabulary of HTA by stakeholders was identified as a notable challenge to the institutionalization of HTA as a means of setting priorities. This is hardly surprising since the HTA community itself is still struggling with definitions. In 2019, a task group was set up to bring together several organizations working on HTA, including the WHO, to develop an agreed definition that codified the many existing definitions and reflected the “current and emerging realities of HTA” ⁶ . The task group proposed the definition:

Roundtable participants elaborated that the definition must be clarified in order to reduce confusion concerning the scope of HTA, the process of priority setting, the terms of engagement with stakeholders and the selection of topics for evidence review. It was emphasized that HTA is more than a merely technocratic exercise. At its best it is a bridge joining professional technical assessment and political policy decision-making as a fully integrated whole. Assessment tools should therefore be designed to make clear the nature of the decisions that need to be taken, and the policy decision-making processes that would ensure that critically important political elements could be taken into account This is more than a matter of defining HTA, for it must include systematic consideration of context, scope and process, all of which will be conditioned by local history, culture and politics, but which might also need modification and adaptation if the objectives of HTA and UHC are to be delivered. HTA, then, was seen as both the portfolio of analytical tools for assessment (the “assessment” tools) and the broader range of topics that define context. This includes 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. Of course, there are differences in the methods applied across different contexts, and as such, there is value in having a reference case for HTA ⁷ . Notably, the roundtable largely focused discussions on definitions and processes rather than methods. Roundtable participants concluded that, once consensus is reached in defining HTA, greater efforts should be devoted to communicating it authoritatively to stakeholders while concurrently striving to reach a consensus on the “political economy”: the elements that make HTA so much more than merely CEA, and the best ways of integrating those elements into the design of decision-making processes and the conduct of what is considered within them.

Many countries have struggled with the rationing of health services to serve population needs ⁸ . Evidence-informed priority-setting by HTA forces decision-makers and their advisors to be explicit when considering trade-offs when objectives clash, controversial value judgements emerge, and the means of implementation are limited. In so doing, HTA also provides credible justifications when decision-makers are called to account. It is important to note the judicialization of the right to health has played a role in challenging rational priority setting mechanisms, yet such challenges ensure that governments abide by international human rights ⁹ . Dittrich et al. (2016) note that rational priority setting, based on evidence and with a focus on equity, is the best way to safeguard an ethical allocation of scarce healthcare resources ⁹ . Without such processes decision-makers may find it easier to say “yes” when honesty requires a “no”. Such a decision, may avoid short term embarrassment, but is likely also to be damaging to health and, most probably, its distribution – and with little defensive armor remaining by way of dutiful adherence to principle and protocol, or to the evidence when the consequential unsustainable outcomes reveal themselves. However, with proper HTA processes, decisions that may be to some group’s disadvantage can be readily shown nonetheless to have considered all interests and made fair judgments, to have evaluated the evidence properly, consulted the country’s best experts, and followed procedure.

It is therefore important to make decision-makers aware of the purpose and power of HTA. Awareness of what HTA is not is no less important. HTA’s purpose is not to cut costs nor to cut services: only those that are a demonstrable waste. In fact, HTA helps drive efficient resource allocation, and at least in the case of the National Institute for Health and Care Excellence (NICE) in England and Wales, has also probably been critical in supporting (confidential) price discounts on a range of potentially very expensive technologies ^{10, 11} . As such, the emphasis is on enhancing system efficiency and quality through HTA and HTA-related (e.g. Standard Treatment Guidelines (STGs)) evidence. Participants of the roundtable emphasized the importance of ensuring that everyone understands that HTA is there to make it easier for decision-makers to reject service improvements and innovation where needed. For example, HTA in India has been focused on improving the quality of healthcare services. Since 2009 iDSI has worked at the national and state level in India introduce HTA, develop institutional structures with clear goals, including the development of STGs ¹² .

Moreover, decision-makers should learn as a practical matter, that HTA, especially when combined with budget impact analysis, has been successfully used as a tool to inform price negotiations and efficient procurement ¹³ . When apparently ‘cost-effective’ interventions appear unaffordable in a particular context, recalibrating the threshold or staging the roll out of the intervention based on budget impact concerns might be warranted. One example of this kind of analysis in action was a cost utility analysis of pneumococcal conjugate vaccines for the Philippine context ¹⁴ . In addition to presenting incremental cost-effectiveness ratios (cost per QALY gained) that showed that PCV could be cost-effective, the results showed that universal vaccination would cost 1.6 to 1.8 times the budget of the existing national vaccination program. The analysis highlighted the interplay between price, cost-effectiveness and budget impact, and in particular the challenges presented by fragmented health system financing. Such analytical approaches can underpin governments’ and development partners’ “Best Buys” agendas with solid data and consistent arguments that make sense for a given context.

The need for enlarged research and analytical capacity, together with strengthened systems, is widespread in LMICs ¹⁵ . The proliferation of global initiatives and organizations providing technical assistance is often uncoordinated, and managing aid programs can overwhelm governments and healthcare payers whose capacities are typically already overstretched ¹⁶ . Further disorganization arises from there being multiple health packages, parallel decision-making, single topic donor funds, and client specific insurance schemes. A clearer narrative for systematic and open priority setting is needed. Participants discussed the need for developing a new publication which might build on What’s In, What’s Out: Designing Benefits for Universal Health Coverage ¹⁷ , that would address current issues facing the UHC movement, help link priority setting to upstream service financing, actuarial initiatives, and provide a means of engaging with governments and budget holders in practical activities such as procurement and regional purchasing budget settings. We offer examples of practical applications of HTA in Figure 1.

Another major challenge is getting traditional academic researchers and organizations, whose HTA role lies primarily in providing technical assistance, to work together to serve LMICs governments in a responsive, demand-driven manner. Their roles are of critical importance in the fields of research reviews, foreign evidence interpretation, model estimation and re-estimation, primary research, and training. Some of this support might usefully be organized regionally. International development partners are already 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 for addressing the burden of disease in LMICs ¹⁸ . However, the next phase of work for DCPN and other organizations in the HTA community, should bring together academics, data and technical assistance to ensure that their work is locally owned, focused on the real needs of local policy, and that it exploits economies of scale and scope ¹⁵ .

The roundtable suggested that the WHO might become an explicit “knowledge broker”, connecting decision-makers with common demands for evidence or practical support and assistance when making difficult decisions. There are several excellent examples of data-driven collaboration including the CEVR Global Health Cost Effectiveness Analysis (GH CEA) registry, a database of CEA studies evaluating health interventions from around the world ¹⁹ . Most recently, the WHO hosted Decide Health Decision hub, a platform established in June 2019 with the objective of hosting a virtual space for collaboration in data-driven health decision-making ²⁰ . The hub will be a useful platform for HTA, other economic and social evaluation, creating investment and disinvestment cases, or indeed any other policy territory that needs fair and transparent decision-making. The roundtable endorsed the development of the platform and called for all partners to support the WHO in its coordination efforts. The WHO could be a source of strong leadership and sustained support.

There is a secondary need to ensure that monitoring and evaluation mechanisms are in place for measuring and learning from mistakes. The changing configuration of global health financing means increasing reliance on loans and less on donor funding. Governments consequently 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 exist. The roundtable endorsed the idea of a unified Theory of Change (ToC) for the major initiatives and organizations using HTA in priority setting. Developing a ToC involves working back from a long-term goal, like maximizing the impact of healthcare on health, 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 – that such modelling involves ²¹ . The ToC would outline a mutually agreed goal related to HTA for UHC, with clear and measurable milestones and/or indicators to enable the monitoring of progression, with adjustments as one goes along. It could build on the existing iDSI Theory of Change, outlining how facilitation of effective partnerships, with purpose-driven institutional and technical capacity-building, results in better decision-making and sustainable health impact ²² .