To systematize the information and perspectives shared during the 2024 LATAM policy forum, which explored advancements in horizon scanning and early dialogue processes in the region, by analyzing the main discussion and identifying the main lessons.

This article is based on the discussions and background materials provided during the 1.5 days in-person 2024 Latin American Policy Forum (59 representatives from 11 countries). We gathered and systematized the information shared during the forum, including the results of a pre-forum survey. The Forum agenda included keynote presentations, breakout group activities, and plenary discussions to identify the main lessons and key messages from all different stakeholders’ points of view.

The forum highlighted the growing recognition of the need for structured horizon scanning and early dialogue processes in Latin America. Key barriers were identified, including the absence of clear legal frameworks, limited data availability, and the need for capacity-building. Potential solutions included fostering regional cooperation, improving transparency, and creating pilot programs for early engagement. Engaging patients and the pharmaceutical industry was deemed essential for trust and foster alignment between HTA agencies and regulators.

Horizon scanning and early dialogue represent critical tools for improving health system preparedness and aligning innovation with local needs. Their implementation, however, requires coordinated efforts across multiple stakeholders, enhanced dialogue, and the development of supportive legal and regulatory frameworks.

Healthcare stakeholders in Latin America, including payers, manufacturers, and patients, seek to expedite access to technologies. However, uncertainty sometimes surrounds their true benefits and budgetary implications. Managed entry agreements (MEAs) are proposed to address this uncertainty by redistributing risks among key actors.

The objective of Health Technology Assessment International’s 2023 Latin American Policy Forum was to examine the potential utility of MEA in technology reimbursement and decision-making processes in the region.

This article is based on a background document, a survey, and the deliberative work of the country representatives and others who participated in the Policy Forum.

Interest in MEA in Latin America is increasing, with financial agreements being more prevalent than those based on clinical outcomes. During the Policy Forum, potential barriers to MEA implementation were identified, such as the lack of legal frameworks, insufficient reliable data, and, in some cases, distrust among stakeholders. Some potential solutions were also identified, including early stakeholder involvement to enhance dialogue and understanding, and piloting shorter-duration MEA to facilitate the revision of agreement terms, especially in situations of epidemiological uncertainty.

The Policy Forum served as a valuable platform for discussing the importance of flexible MEA implementation that acknowledges data uncertainty, promotes transparent dialogue to incorporate opinions and values from all stakeholders, and develops legal frameworks to support effective technology access schemes in Latin America.

The aim of the 2022 Health Technology Assessment International (HTAi) Asia Policy Forum (APF) was to discuss experiences and challenges around health technology assessment (HTA) capacity building for both HTA agencies and companies in the Asia region and to identify possible solutions as part of a capacity building roadmap.

Discussions during the 2022 APF, informed by a pre-meeting survey of HTA agencies and industry attendees from the region, form the basis of this paper.

HTA is an essential element of priority-setting in healthcare; however, the scarcity of skilled technical HTA practitioners is a rate-limiting step in the conduct of HTA. The lack of investment in HTA and the political will to mandate the use of HTA in decision-making may be due to a lack of understanding of the value of the HTA process, and how HTA is interpreted and used in the healthcare decision-making process.

Increased demand for HTA is created when the value of HTA is recognized. HTA capacity-building challenges may be mitigated by educating stakeholders, particularly policymakers, on the value of, and the need to invest in, HTA as a transparent process to ensure equitable access to health care for all. Investigating a means of funding and implementing an HTA intern program between agencies, in partnership with industry, to facilitate a supportive environment to foster HTA skills and knowledge, build capacity or strengthen existing capacity should be a priority.

The 2021 Health Technology Assessment International (HTAi) Asia Policy Forum (APF) aimed to explore the challenges and opportunities presented by the global COVID-19 pandemic for health systems and industry in the Asia region, to discuss how HTA changed during the pandemic, and what its role may be moving forward into a postpandemic era.

Discussions during the virtual 2021 APF, informed by a premeeting survey of HTA agencies and industry attendees from the region describing their experience during the pandemic, form the basis of this paper.

During the pandemic, regulatory approval for COVID-related technologies was fast-tracked with fewer evidentiary requirements, and little or no HTA being conducted before these technologies were implemented in health systems in the region. “Living HTA” incorporating real-world evidence (RWE) as it was generated became part of the HTA landscape. In comparison, non-COVID technologies experienced regulatory approval and HTA delays. A major concern of APF members was future pandemic preparedness, and to ensure that lessons are learned from COVID-19. Governments need to continue to invest in innovation and allow early regulatory approvals with the increased use of RWE. Capacity building was identified as a key investment, including capacity in HTA, modeling, as well as local production of necessary supplies and equipment. Finally, collaboration at all levels of the health system was viewed as vital.

Post-COVID, different forms of HTA must be embraced as part of the new HTA landscape in addition to increased intra- and intercountry collaboration across all sectors of the health system, including regulatory bodies.

There is no health system that has the resources to evaluate all technologies. The presence of a clear process to prioritize health technologies for assessment by health technology assessment (HTA) agencies is a good practice principle recognized at the international level. The objective of Health Technology Assessment International's 2020 Latin American Policy Forum (LatamPF) was to explore how to improve the way HTA agencies in Latin America identify and prioritize technologies for assessment.

This paper is based on a background document, a survey, and the deliberations of the members of the LatamPF (forty-six participants from eleven countries) using a design thinking methodology.

Participants agreed that a lack of clear prioritization mechanisms results in HTA processes and decisions that are perceived to be of low transparency and overly exposed to political or interest group pressures. The LatamPF identified barriers and recommended actions to improve HTA prioritization mechanisms in Latin America. The criteria identified as the most important to be taken into consideration by HTA agencies in the region when prioritizing a technology for assessment were: the burden of illness, the potential clinical benefit, the alignment with national health priorities, the potential impact on equity, a lack of treatment alternatives for patients, and the potential economic impact.

Forum participants agreed that the establishment of transparent prioritization processes is a key element for all health systems. Improvements in these processes will strengthen HTA and provide greater legitimacy to decision making.

As health technology assessment (HTA) seeks to combine complex sets of evidence, values, and perspectives to support open, accountable, and transparent decision making, uncertainty is inherent. Uncertainty is present in the clinical and economic inputs that inform HTA and is a critical factor during context-specific deliberations where the evidence is weighed and decisions are made, taking uncertainty into account through either financial or evidence-generation mechanisms. The presence and impact of uncertainty must also be communicated to all relevant stakeholders during the HTA output stage. This article summarizes the 2021 HTAi Global Policy Forum discussion on “Considering and Communicating Uncertainty in HTA” that debated some of the key challenges and opportunities regarding uncertainty in HTA. Through a combination of small and large group discussions, core themes related to the topic of uncertainty in HTA were identified. These discussions revealed that: utilization of a life cycle/HTA management approach helps manage uncertainty; genuine stakeholder input and engagement (and not just consultation) can clarify uncertainty; tolerance of risk, the relationship of risk to uncertainty, and the context in which uncertainty is considered is critical; transparent and early dialogues could be increased to further reduce the uncertainty during HTA; and communicating uncertainty in HTA outputs is critical. The paper ends with suggested next steps that HTA agencies and stakeholders (such as industry, patients, regulators, payers, and others) might take to move the field forward. The paper promotes further discussion on aspects of uncertainty that should be more openly discussed, debated, and addressed.

The 2019 Health Technology Assessment International (HTAi) Asia Policy Forum (HAPF) discussed the role of horizon scanning (HS) and health technology reassessment (HTR) in supporting sustainable healthcare in Asia.

Discussions and presentations at the 2019 HAPF, informed by a literature review, results of a premeeting survey, and case studies of HTA agencies from the region form the basis of this paper.

Five of the fourteen HTA agencies surveyed have established or are developing HS systems (HSSs), and six reported some experience with HTR. Although there were many differences in the respective HSSs, all were proactive and identified technologies within a 1–3-year time horizon. Commonalities included the criteria used to prioritize the technologies including burden and rarity of the disease, and cost to the health system and patients. Experience in HTR was not as extensive with most HTR activity being conducted on an ad hoc basis. Challenges for both HS and HTR include a lack of HTA capacity and good quality data, as well as a need for transparency and collaboration with industry.

With developing universal health care and HTA capacity in many countries in Asia, HS and HTR are in their infancy. Whilst several countries in the region are experienced in all facets of HTA, other countries are developing their HTA skill base. As such, there was a clear appetite for setting up a collaborative network in the Asia region to facilitate information sharing around HTA activities, and more specifically, HS and HTR methodologies, experiences, and assessments.

One of the good practice principles for health technology assessment (HTA) is having a clear link between the assessment and decision making. The objective of the 2019 Latin American Policy Forum (LatamPF) of Health Technology Assessment International was to explore different models of connection between HTA and decision making and to discuss the potential applicability of such models in Latin America.

This paper is based on a background document and the deliberations of the members of the LatamPF (fifty-four participants from twelve countries) where a design-thinking methodology was used.

The participants agreed that insufficient links between HTA and decision making undermine the legitimacy of decisions, expose the HTA process to excessive political and judicial influence, and promote the exclusion of some stakeholders from participating in the assessment process and decision making. High priority aspects of the HTA process that could feasibly be improved and which hold the greatest potential to generate positive changes in the health systems in the region were identified. The majority of these aspects were associated with the appropriate institutionalization of HTA, a greater degree of participation by different stakeholders, and improved transparency in the HTA process.

The LatamPF identified barriers and recommended actions to strengthen the link between HTA and decision making. Participants emphasized that there is now a window of opportunity in the region as many societal actors see this as a priority. For this reason, health system stakeholders must take this opportunity to increase efforts toward strengthening the link between HTA and decision making.

Real-world evidence (RWE), derived from real-world data (RWD), is already used, to some extent, for health technology assessment (HTA) purposes. With the increased availability of RWD, there is potential for more widespread use but also challenges ensuring reliable RWE for HTA. Opportunities to overcome key challenges, identified at a scoping meeting, were discussed during the 2019 HTA international (HTAi) Global Policy Forum (GPF).

Reflection of discussions using Design Thinking (an interactive process aimed to solve complex problems) between seventy-three representatives from not-for-profit, for-profit organizations, and HTAi leadership. The discussions were informed by a background paper, and presentations from three invited keynote speakers and eleven GPF members.

Several options were listed for addressing the identified key challenges: quality and acceptability, governance and accountability, transferability, and informing decision making. The GPF emphasized that the HTA community should first understand what questions could be answered with RWE. Additionally, more clarity on methods, standards, streamlining RWD collection, data sharing across jurisdictions, replication of RWD, and expert analysis were mentioned as important priorities.

The HTA community is currently standing at a cross-road as it is not yet fully equipped to address these key challenges. It is, therefore, time for action. The community should start aligning on what is the best source of evidence according to purpose and how the data should be collected to create reliable evidence. It should also initiate the development of actions and guidance to properly develop and manage RWD/RWE to inform decision making across the technology lifecycle.

Discussions at the Health Technology Assessment International (HTAi) Asia Policy Forum (HAPF) aimed to understand the meaning of “high-cost technologies,” and to explore mechanisms to increase access to these technologies in publicly funded health systems in the Asia region.

Discussions and presentations at the 2018 HAPF, informed by a literature review and a premeeting survey of HTA agencies and industry, form the basis of this paper.

Challenges payers in the public health system face when investing in high-cost technologies include a lack of data, especially real-world data, affordability, and the budgetary impact of high-cost technologies. Managed entry schemes (MES) are one means to enable earlier access to high-cost technologies, or at reduced cost to the system. Most countries surveyed had used an MES to introduce a new health technology and most industry representatives had experience with financial-based MES, such as discounts or rebates, with most put in place to increase access to pharmaceuticals. Little experience of outcome-based or evidence-generation MES was reported.

Although it is early days in the implementation of MES in Asia, they have the potential to play an important role enabling access to new, mainly pharmaceutical, health technologies. The development of a “road map” of MES in the region should outline the intent and need for a MES, articulating the “rules of engagement” for all stakeholders—patients, providers, payers, and industry—which will assist countries to clearly identify the problem trying to be solved, and how an MES can be part of the solution.

The recent development of value frameworks to inform healthcare resource allocation responds to a demand to make the decision-making process more inclusive and explicit. The objectives of the 2018 Latin American (LAtam) Health Technology Assessment International (HTAi) Policy Forum were to explore the current international experiences and to discuss the potential application of value frameworks in Latin America.

A background paper, presentations, and group discussions of Policy Forum members (43 participants, 12 LAtam countries represented) at the 2018 HTAi Policy Forum meeting informed this paper.

Participants agreed that HTA and decision making based on more comprehensive and inclusive value frameworks could improve health system effectiveness, efficiency, sustainability, and equity; promote transparency in the decision process; sustain a more comprehensive assessment of technologies; and facilitate stakeholder participation as well as accountability of decisions. Criteria that were identified as essential to be included in a value framework for LAtam were burden of illness and severity of the disease, effectiveness and safety of the technology, quality of the evidence, cost-effectiveness, and budget impact. Potential challenges identified for the application of value frameworks in LAtam, included scarcity of human resources and delays in the assessment process.

Forum participants agreed that the next steps should be to identify appropriate processes and methodologies, adapted to the context of each country, regarding the application of value frameworks to improve the link between HTA and decision making.