Andres Pichon-Riviere

Objectives: The role of health technology assessment (HTA) is evolving. Once seen primarily as a gatekeeper, HTA is increasingly viewed as a potential shaper of health system transformation. The first plenary session of the HTA International 2025 Annual Meeting explored the potential for HTA to adopt this broader role. Methods: Drawing on perspectives from across the globe, it was discussed how HTA can help shape more equitable, responsive, and sustainable health systems by informing benefit package design, supporting universal health coverage, and addressing systemic inequities from a societal perspective. Results: Audience polling and live commentary underscored a shared sense of urgency, as well as recognition of the methodological, political, and practical constraints to this evolution. Rather than a binary choice, a continuum of roles was suggested depending on the context in which HTA is applied. Conclusions: Ultimately, HTA can shape health systems – not through ambition alone, but through evidence-informed, inclusive, and context-aware decision-making.

Este estudo buscou estimar a carga da doença, social e econômica do tabagismo no Brasil em 2022 e prever os benefícios do aumento de impostos, com a inclusão dos efeitos do mercado ilegal. Aplicou-se um modelo de microsimulação probabilística de Markov no qual indivíduos a partir de 35 anos foram acompanhados em coortes hipotéticas, quantificando as mortes, os eventos de saúde, o custo direto da assistência médica e o custo indireto por perda de produtividade. Foi desenvolvido um modelo para estimar os ganhos em termos de saúde e econômicos a partir de cenários de aumento de impostos em dez anos. Obteve-se os dados de prevalência do tabagismo, da estrutura demográfica brasileira, de mortalidade e morbidade em bases de dados oficiais e na literatura. Os recursos de saúde utilizados foram obtidos por meio da literatura e de consultas a especialistas. O tabagismo causou 174 mil mortes e 5,7 milhões de anos de vida perdidos por morte prematura e por incapacidade. A carga econômica foi de R$ 153 bilhões, sendo R$ 67 bilhões atribuídos ao custo direto e R$ 45 bilhões ao custo indireto. O custo do cuidador informal alcançou R$ 41 bilhões. No cenário com o mercado ilegal de produtos do tabaco, um aumento de 50% no preço dos cigarros tem o potencial de gerar benefícios econômicos de R$ 161 bilhões em dez anos. A Reforma Tributária atualmente em curso é oportuna para que o país possua uma política de preços e impostos permanente.

Objectives: Value frameworks play a crucial role in bridging the gap between evidence and decision making in health care, particularly in settings with limited resources as low- and middle-income countries (LMIC). In this study, we present the development of a value framework (VF) targeted to provide coverage recommendations in rapid health technology assessment reports (rHTA) as well as its first 5 years of implementation. Methods: We performed an exhaustive literature search with the aim to identify existing VFs and their dimensions followed by the generation of a VF proposal through a mixed methods, qualitative–quantitative approach including a Delphi panel to weigh the criteria and correlate them with the subsequent recommendations. To describe its implementation, we present the results of 264 rHTA reports from 2017 to 2022. Results: The value framework has three main domains (quality of evidence, net benefit, and economic impact). We adapted widely used methodologies for quality of evidence and net benefit domains. The economic impact domain was the most complex to assess, so an ad hoc method was developed. Analysis of 265 HTAs revealed the distribution of recommendations across different criteria and technology types. Most were for drugs (40.5 percent) or therapeutic procedures (36 percent). With a five-category final recommendation, 0.8 percent were favorable, 19.7 percent were uncertain, and 44 percent were unfavorable. Conclusion: The VF demonstrated its versatility and practicality in meeting the needs of rHTA audience, and can facilitate evidence-informed decision making. This VF serves as a valuable tool for conducting adaptive rHTAs and supports decision-making processes in Argentina and similar LMIC contexts.

Objective: 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. Methods: 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. Results: 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. Conclusions: 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.

Objectives. To estimate the economic burden and disease burden associated with tobacco use in Peru and the projected effect of strengthening specific tobacco control measures. Materials and methods. We used a Markov microsimulation model to assess smoking-attributable mortality, disease events, economic costs, and projected benefits over ten years, considering the implementation of measures such as plain packaging, full enforcement of smoke-free laws, a complete ban on tobacco advertising, promotion, and sponsorship, and increased cigarette taxes. Results. Each year in Peru, approximately 22,350 deaths and 126,000 disease events are attributable to tobacco use, accounting for 19% of all deaths from heart disease, 18% of deaths from stroke, and 515,768 years of life lost. In addition, approximately 1.28% of gross domestic product is lost annually due to smoking. Over ten years, the implementation of plain packaging could prevent 6,218 deaths, 31,700 events, and save 576 million USD. Full compliance with smoke-free places would prevent 4,982 deaths, 25,400 events, and save 461 million USD. Banning advertising, promotion, and sponsorship could prevent 8,767 deaths, 44,700 events, and save 812 million USD. Increasing cigarette prices by 50% could prevent 20,400 deaths, 658,400 healthy life years lost, and an economic benefit of more than 3.3 billion USD. Conclusions. The economic and disease burden of tobacco use in Peru is significant. Greater efforts to control tobacco would significantly reduce this burden.

Context: 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. Objectives: 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. Methods: 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. Results: 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. Conclusions: 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 Tunisian Health Technology Assessment (HTA) body, INEAS, conducted a cost-effectiveness analysis (CEA) of vemurafenib in the treatment of locally advanced or metastatic BRAF V600-mutated melanoma. The objective of this analysis was to enable the use of value-based pricing as a new approach to price negotiation. This study was part of a broader HTA report that was prepared in response to a joint request from the regulatory authorities and the CNAM, Tunisia’s compulsory insurance scheme. Our analysis was based on a probabilistic Markov cohort model that calculated the costs and quality-adjusted life years (QALY) associated with vemurafenib compared to the standard of care from a public payer perspective. The CEA indicated that vemurafenib provides a gain of 0.38 life years (1.78 vs. 1.4) for an incremental cost of USD 101,106.62 from the perspective of the main public payer (CNAM). This study revealed an incremental cost-effectiveness ratio (ICER) of 163,311.40 USD/QALY and 163,911.46 USD/QALY, respectively, from the CNAM and public health facilities’ perspectives. Vemurafenib cannot be considered cost-effective in terms of what has normally been considered a reasonable willingness to pay (WTP) in Tunisia. A significant price reduction would be necessary to bring the incremental cost-effectiveness ratio to an acceptable level.