Toward the Implementation of a Value Framework for Diagnostic Technologies: Operationalization, Piloting, and Validation in Latin America.

OBJECTIVES: In 2020, a group of 30 stakeholders from Latin America established 15 criteria for a diagnostic technologies value framework (D-VF) to help assess and inform decisions on diagnostic technologies. This article aims to present the operationalization, piloting, and initial validation of the framework for its implementation. METHODS: This work was carried out collaboratively with a variety of stakeholders. Three sequential phases were undertaken: (1) operationalization of the D-VF through a literature search for conceptual definitions and assessment tools, (2) piloting of the D-VF through a rapid health technology assessment document applying the methodology of the framework, and (3) a face validation process conducted through a virtual workshop, where usefulness and implementation aspects of the framework were assessed. RESULTS: The operationalization of the framework was conducted, and a methodological user guide was published. The D-VF criteria were applied in a health technology assessment document on human papilloma virus testing in cervical cancer screening. Also, an open-access training program was developed. Stakeholders agreed on the usefulness of the D-VF for assessment and decision-making stages of diagnostic technologies. However, they highlighted the need to improve technical capacities and the potential for added complexity when applying a D-VF with many criteria. The absence of an established value framework for diagnostic technologies in Latin America and the potential for strengthening technical capacities made the project valuable to those involved. CONCLUSIONS: The diagnostic technologies value framework was shown to be fit for implementation in real-life decision-making settings after the operationalization, piloting, and initial validation phases. Further experiences are important to support its implementation.

Real-world evidence: experiences and challenges for decision making in Latin America.

OBJECTIVE: The Health Technology Assessment (HTA) process aims to optimize health system funding of technologies. In recent years there has been an increase in what is known as Real-World Evidence (RWE) as a complement to clinical trials. The objective of Health Technology Assessment International's Latin American Policy Forum 2022 was to explore the utility of incorporating RWE into HTA and decision-making processes in the region. METHODS: This article is based on a background document, survey, and the deliberative work of the country representatives who participated in the Forum. RESULTS: There is a growing interest in the use of Real-World Data / Real-World Evidence in HTA processes in Latin America, although currently there are no specific local guidelines for RWE use by HTA agencies. At present, its use is limited to certain areas such as adding context to HTA reports, the evaluation of adverse events, or cost estimation.Potential future uses of RWE were identified, including the creation of risk-sharing agreements, the assessment of technology performance in routine practice, providing information on outcomes that are not so easily evaluated in clinical trials (e.g., the identification of specific subpopulations or quality of life), and the estimation of input parameters for economic evaluations. CONCLUSIONS: The participants agreed that there are several areas presenting significant potential to expand the application of RWD/RWE and that the development of normative frameworks for its use could be helpful.

What does our region need in order to strengthen public policies on sugar-sweetened beverages? decision-makers' dialogue. / ¿Qué necesita nuestra región para fortalecer políticas públicas sobre bebidas azucaradas? diálogo de decisores.

In order to prioritize public policies to reduce the consumption of sugar-sweetened beverages in Argentina, Brazil, El Salvador and Trinidad and Tobago and to identify information gaps related to the burden of disease attributable to their consumption, a policy dialogue was held with government members, civil society organizations, researchers and communicators from Latin American and Caribbean countries. Presentations and deliberative workshops were conducted using semi-structured data collection tools and group discussions. The prioritized interventions were tax increases, front labeling, restriction of advertising, promotion and sponsorship, and modifications regarding the school environment. The main perceived barrier was the interference from the food industry. This dialogue among decision-makers led to the identification of priority public policies to reduce the consumption of sugar-sweetened beverages in the region.

Con el objetivo de priorizar políticas públicas para disminuir el consumo de bebidas azucaradas en Argentina, Brasil, El Salvador y Trinidad y Tobago e identificar las necesidades de información relacionadas con la carga de enfermedad atribuible a su consumo se realizó un diálogo de políticas en el que participaron miembros de gobierno, organizaciones de la sociedad civil, investigadores y comunicadores de países de Latinoamérica y el Caribe. Se llevaron a cabo exposiciones y talleres deliberativos utilizándose herramientas de recolección de datos semiestructuradas y discusiones grupales facilitadas. Las intervenciones priorizadas fueron el incremento de impuestos, el etiquetado frontal, la restricción de la publicidad, promoción y patrocinio y las modificaciones del entorno escolar. La principal barrera percibida fue la interferencia de la industria alimentaria. La realización de este diálogo de decisores permitió la identificación de las políticas públicas prioritarias para disminuir el consumo de bebidas azucaradas en la región.

Determining the efficiency path to universal health coverage: cost-effectiveness thresholds for 174 countries based on growth in life expectancy and health expenditures.

BACKGROUND: Assessment of the efficiency of interventions is paramount to achieving equitable health-care systems. One key barrier to the widespread use of economic evaluations in resource allocation decisions is the absence of a widely accepted method to define cost-effectiveness thresholds to judge whether an intervention is cost-effective in a particular jurisdiction. We aimed to develop a method to estimate cost-effectiveness thresholds on the basis of health expenditures per capita and life expectancy at birth and empirically derive these thresholds for 174 countries. METHODS: We developed a conceptual framework to assess how the adoption and coverage of new interventions with a given incremental cost-effectiveness ratio will affect the rate of increase of health expenditures per capita and life expectancy at the population level. The cost-effectiveness threshold can be derived so that the effect of new interventions on the evolution of life expectancy and health expenditure per capita is set within predefined goals. To provide guidance on cost-effectiveness thresholds and secular trends for 174 countries, we projected country-level health expenditure per capita and life expectancy increases by income level based on World Bank data for the period 2010-19. FINDINGS: Cost-effectiveness thresholds per quality-adjusted life-year (QALY) ranged between US$87 (Democratic Republic of the Congo) and $95 958 (USA) and were less than 0·5 gross domestic product (GDP) per capita in 96% of low-income countries, 76% of lower-middle-income countries, 31% of upper-middle-income countries, and 26% of high-income countries. Cost-effectiveness thresholds per QALY were less than 1 GDP per capita in 168 (97%) of the 174 countries. Cost-effectiveness thresholds per life-year ranged between $78 and $80 529 and between 0·12 and 1·24 GDP per capita, and were less than 1 GDP per capita in 171 (98%) countries. INTERPRETATION: This approach, based on widely available data, can provide a useful reference for countries using economic evaluations to inform resource-allocation decisions and can enrich international efforts to estimate cost-effectiveness thresholds. Our results show lower thresholds than those currently in use in many countries. FUNDING: Institute for Clinical Effectiveness and Health Policy (IECS).

¿Qué necesita nuestra región para fortalecer políticas públicas sobre bebidas azucaradas? diálogo de decisores / What does our region need in order to strengthen public policies on sugar-sweetened beverages? decision-makers' dialogue

Con el objetivo de priorizar políticas públicas para disminuir el consumo de bebidas azucaradas en Argentina, Brasil, El Salvador y Trinidad y Tobago e identificar las necesidades de información relacionadas con la carga de enfermedad atribuible a su consumo se realizó un diálogo de políticas en el que participaron miembros de gobierno, organizaciones de la sociedad civil, investigadores y comunicadores de países de Latinoamérica y el Caribe. Se llevaron a cabo exposiciones y talleres deliberativos utilizándose herramientas de recolección de datos semiestructuradas y discusiones grupales facilitadas. Las intervenciones priorizadas fueron el incremento de impuestos, el etiquetado frontal, la restricción de la publicidad, promoción y patrocinio y las modificaciones del entorno escolar. La principal barrera percibida fue la interferencia de la industria alimentaria. La realización de este diálogo de decisores permitió la identificación de las políticas públicas prioritarias para disminuir el consumo de bebidas azucaradas en la región.

In order to prioritize public policies to reduce the consumption of sugar-sweetened beverages in Argentina, Brazil, El Salvador and Trinidad and Tobago and to identify information gaps related to the burden of disease attributable to their consumption, a policy dialogue was held with government members, civil society organizations, researchers and communicators from Latin American and Caribbean countries. Presentations and deliberative workshops were conducted using semi-structured data collection tools and group discussions. The prioritized interventions were tax increases, front labeling, restriction of advertising, promotion and sponsorship, and modifications regarding the school environment. The main perceived barrier was the interference from the food industry. This dialogue among decision-makers led to the identification of priority public policies to reduce the consumption of sugar-sweetened beverages in the region.

Deliberative processes in decision making informed by health technology assessment in Latin America.

OBJECTIVE: The objective of Health Technology Assessment International's 6th Latin America Policy Form, held in 2021, was to explore the implementation of deliberative processes in the framework of health technology assessment (HTA) and how agencies in the region could involve stakeholders in this process. METHODS: This paper is based on a preparatory survey, a background document, and the deliberative work of participants at the virtual Forum conducted in 2021. There were ninety-one participants in the open session and fifty-two in the closed sessions, representing twelve countries and diverse areas of the health sector. RESULTS: While there are mechanisms in most countries in Latin America to consider stakeholder involvement to some degree, it remains reduced or limited to a consultative role, making true participative involvement rare. There are significant barriers and structural and contextual limitations that have impeded or slowed progress toward deliberative processes. Relatively low levels of institutionalization and knowledge about HTA, as well as the lack of trust among stakeholders are important challenges. This situation has impacted health systems by diminishing the legitimacy of decisions and the very structures and processes of HTA. CONCLUSION: The Forum's broad group of participants identified barriers, facilitators, and recommendations to improve the use of deliberative processes in Latin America to foster improved fairness and reasonableness in HTA and decision making.

Evidence-Informed Update of Argentina's Health Benefit Package: Application of a Rapid Review Methodology.

OBJECTIVES: Argentina has a fragmented healthcare system with social security covering almost two thirds of the population. Its benefit package-called compulsory medical program (PMO; by its Spanish acronym Programa Médico Obligatorio)-has not been formally and widely updated since 2005. However, laws, clinical practice guidelines (CPGs), and a high-cost technology reimbursement fund complement it. Our objective was to comprehensively review such a PMO and propose an update considering the corresponding complementary sources. METHODS: We followed four steps: (i) identification of health technologies from the current PMO and complementary sources, (ii) prioritization, (iii) assessment through rapid health technology assessment (HTA), and (iv) appraisal and recommendations. We evaluated three value domains: quality of evidence, net benefit, and economics, which were summarized in a five-category recommendation traffic-light scale ranging from a strong recommendation in favor of inclusion to a strong recommendation for exclusion. RESULTS: Eight hundred fifty technologies were identified; 164 of those, considered as high priority, were assessed through rapid HTAs. Those technologies mentioned in laws and CPGs were mostly outpatient essential medicines, whereas those from the reimbursement system were mostly high-cost drugs; of these 101 technologies, 50 percent were recommended to be kept in the PMO. The other 63 (identified by the Superintendence of Health Services, technology producers, and patients) were mostly medical procedures and high-cost drugs; only 25 percent of those resulted in a favorable recommendation. CONCLUSIONS: A methodology based on four clearly identified steps was used to carry out a comprehensive review of an outdated and fragmented benefit package. The use of rapid HTAs and a traffic-light recommendation framework facilitated the deliberative evidence-based update.

Estándares Consolidados de Reporte de Evaluaciones Económicas Sanitarias: adaptación al español de la lista de comprobación CHEERS 2022.

OBJECTIVES: Health economic evaluations (HEEs) are comparative analyses of courses of action in terms of both costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) original version and its adaptation to Spanish were published in 2013. Its objectives were to promote that the HEEs are identifiable, interpretable, and useful for decision making and serve as a reporting guide. The new CHEERS 2022 replaces the previous one and tries to be more easily applied to any HEE and incorporates recent methodological advances and the importance of stakeholder involvement including patients and the general public. METHODS: For the present adaptation, the following stages were followed: (1) independent translations of the original list into Spanish, (2) blind back-translations, (3) evaluation of their quality, (4) preparation of a new version in Spanish, (5) review and improvement by the author team, (6) preparation of a new version in Spanish, (7) distribution of the preliminary Spanish version and the original one to the American HTA Network (Red de las Américas de Evaluación de Tecnologías Sanitarias) and Spanish-speaking experts for evaluation and feedback, (8) monitoring of changes to the original list under peer review at BritishMedicalJournal, and (9) consolidation of the final adaptation of the Spanish CHEERS 2022 checklist. RESULTS: In this article, we detail the process and the Spanish adaptation of the 28-item CHEERS 2022 checklist and its recommendations. CONCLUSIONS: This list is intended for researchers reporting HEE in peer-reviewed journals and reviewers, editors, and, among others, health technology assessment bodies.

[Mecanismos de identificación y priorización de las tecnologías sanitarias a ser evaluadas por las Agencias de ETESA para decisiones de cobertura en Latino America].

OBJETIVO: Ningún sistema de salud cuenta con los recursos necesarios para evaluar todas las tecnologías. Contar con un proceso claro para priorizar qué tecnologías serán evaluadas por las agencias de evaluación de tecnologías sanitarias (ETESA) constituye un principio de buena práctica reconocido a nivel internacional. El objetivo del Foro de Políticas en Latino América (LatamPF) 2020 de Health Technology Assessment International fue explorar cómo puede mejorarse la forma en que las agencias de ETESA de Latino América identifican y priorizan las tecnologías a ser evaluadas. MÉTODOS: Este manuscrito está basado en un documento base, una encuesta, y en el trabajo deliberativo realizado por los miembros (cuarenta y seis participantes, once países) que participaron del LatamPF, a través de la metodología design-thinking. RESULTADOS: Los participantes coincidieron en que la falta de mecanismos claros de priorización trae como consecuencia una falta de legitimidad de las decisiones y procesos de ETESA, que son percibidos como poco transparentes y demasiado expuestos a presiones políticas o de grupos de interés. También se identificaron barreras y acciones para mejorar los mecanismos de priorización de ETESA en América Latina. Los criterios identificados como más importantes para ser tenidos en cuenta por las agencias de ETESA de la región al momento de priorizar una tecnología para ser evaluada fueron la carga de enfermedad, el potencial beneficio clínico, la alineación con prioridades de salud nacionales, el potencial impacto en la equidad, ausencia de otras alternativas para los pacientes, y el potencial impacto económico. CONCLUSIONES: Los participantes del Foro coincidieron en que el establecimiento de procesos transparentes de priorización es un elemento clave para todos los sistemas de salud. Las mejoras en este proceso fortalecerán la ETESA en Latino América y darán mayor legitimidad a sus decisiones.

Identification and selection of health technologies for assessment by agencies in support of reimbursement decisions in Latin America.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

A Value Framework for the Assessment of Diagnostic Technologies: A Proposal Based on a Targeted Systematic Review and a Multistakeholder Deliberative Process in Latin America.

OBJECTIVES: there are very few value frameworks (VFs) to assess health technologies that are focused on diagnostic tests; they usually do not reflect a multistakeholder process; and they are all developed in high-income countries. Our project performed a targeted systematic review, with the objective of proposing an evidence-based, up-to-date VF informed by a multinational multistakeholder group working in the health technology assessment (HTA) space. METHODS: (1) A targeted systematic review, with the aim to identify existing VFs and their dimensions; and (2) generation a VF proposal through a mixed-methods, qualitative-quantitative approach. RESULTS: From 73 citations identified, 20 met our inclusion criteria and served to provide the initial list of dimensions for our VF. An initial list of criteria and subcriteria for a preliminary VF was proposed. After a full-day deliberative face-to-face meeting with 30 relevant stakeholders from seven Latin American countries and the United Kingdom, the final VF was defined, consisting of 15 criteria: five "essential or core," six highly relevant, three moderately relevant, and one of low relevance. Barriers and facilitators of value assessment of diagnostic technologies were also discussed. CONCLUSIONS: We propose a VF oriented to diagnostic technologies based on a targeted systematic review and a participatory process with key HTA stakeholders. It is the first to be produced in a lower and middle income setting but can also be potentially useful in other contexts aimed to assist decision-making processes with these particularly complex health technologies.

Impacto esperado en la niñez de la prohibición de la publicidad, promoción y patrocinio de bebidas Azucaradas / Expected impact on children of the ban on advertising, promotion and sponsorship of sugary drinks

INTRODUCCIÓN El consumo de bebidas azucaradas (BA) es elevado en Argentina y se asocia con el desarrollo de obesidad y otras enfermedades a corto y largo plazo. OBJETIVO Evaluar el impacto en la reducción de obesidad y en la morbilidad y mortalidad a largo plazo así como el impacto económico de lograr una reducción del consumo de azúcares en niñas, niños y adolescentes (NNyA) mediante la prohibición de la publicidad, promoción y patrocinio (PPPP) de BA en Argentina y en Río Negro. MÉTODOS Se adaptó un modelo matemático de evaluación de riesgo comparativo para estimar el impacto del consumo de BA en el sobrepeso y obesidad en NNyA, su morbilidad, mortalidad e impacto económico a largo plazo. Se programó un módulo para estimar el impacto esperado de la PPPP basados en una revisión sistemática. RESULTADOS El consumo promedio de BA en NNyA fue de 352 ml por día. Se estima que en 2022 en Argentina, 257.307 NNyA tienen sobrepeso y 135.797 obesidad que puede atribuirse al consumo de BA. Esto podría representar 1.026.836 de casos de sobrepeso y obesidad en la adultez, 260.747 de diabetes, 68.628 de enfermedad cardio y cerebrovascular, 107.998 trastornos osteomusculares, 97.842 de enfermedad renal crónica y 83.979 de cáncer y otras patologías. El sistema de salud gastará $ 89.838 millones de pesos cada año para la atención de estas enfermedades. La implementación de la nueva ley de etiquetado de advertencias, PPPP y regulación del entorno escolar podría disminuir el consumo de BA en un 23,7% y se evitarían a corto plazo 104.540 casos de exceso de peso en NNyA, y a largo plazo 285.059 casos en la adultez, 73.738 casos de diabetes, 19.104 de enfermedad cardio y cerebro vascular, 29.624 trastornos osteomusculares, 27.340 enfermedad renal crónica y 23.276 cáncer y otras. Se evitaría gastar $26.530 millones por año. DISCUSIÓN La carga de enfermedad en NNyA atribuible al consumo de BA es muy elevada. La implementación de la ley podría generar enormes beneficios en la salud y económicos.

Health and Economic Impact of Health Warnings and Plain Tobacco Packaging in Seven Latin American Countries: Results of a Simulation Model.

INTRODUCTION: The burden of disease attributable to tobacco use in Latin America is very high. Our objective was to evaluate the 10-year potential impact of current legislation related to cigarette packaging and warnings and expected effects of moving to a higher level of strategies implementing cigarette plain packaging on health and cost outcomes in Argentina, Bolivia, Brazil, Chile, Colombia, Mexico, and Peru, using a microsimulation model. AIMS AND METHODS: We used a probabilistic state-transition microsimulation model, considering natural history, costs, and quality of life losses associated with main tobacco-related diseases. We followed up individuals in hypothetical cohorts and calculated health outcomes annually to obtain aggregated long-term population health outcomes and costs. We performed a literature review to estimate effects and analyzed studies and information from ministries, relevant organizations, and national surveys. We calibrated the model comparing the predicted disease-specific mortality rates with local statistics. RESULTS: Current graphic warnings already in place in each country could avert, during 10 years, 69 369 deaths and 638 295 disease events, adding 1.2 million years of healthy life and saving USD 5.3 billion in the seven countries. If these countries implemented plain packaging strategies, additional 155 857 premature deaths and 4 133 858 events could be averted, adding 4.1 million healthy years of life and saving USD 13.6 billion in direct health care expenses of diseases attributable to smoking. CONCLUSIONS: Latin American countries should not delay the implementation of this strategy that will alleviate part of the enormous health and financial burden that tobacco poses on their economies and health care systems. IMPLICATIONS: Tobacco smoking is the single most preventable and premature mortality cause in the world. The Framework Convention on Tobacco Control, supported by the World Health Organization, introduced a package of evidence-based measures for tobacco control. This study adds evidence on the potential health effects and savings of implementing cigarette plain packaging in countries representing almost 80% of the Latin American population; findings are valuable resources for policy makers in the region.

[Vínculo Entre La Evaluación De Tecnologías Sanitarias y La Toma De Decisión Para La Asignación De Recursos Sanitarios en Latino-América].

OBJETIVOS: Un vínculo claro entre la evaluación y la toma de decisión constituye un principio de buena práctica en evaluación de tecnologías sanitarias (ETESA) reconocido a nivel internacional. El objetivo del Foro de Políticas en Latino-América (LatamPF) 2019 de Health Technology Assessment International fue explorar los diferentes modelos que vinculan la ETESA y la toma de decisión y discutir su potencial aplicabilidad en Latino-América. MÉTODOS: Este manuscrito está basado en un documento base y en el trabajo deliberativo realizado por los miembros (54 participantes, 12 países) que asistieron al LatamPF, a través de la metodología design thinking. RESULTADOS: Los participantes coincidieron en que la relación inapropiada entre la ETESA y la toma de decisión atenta hoy contra la legitimidad de las decisiones, expone al proceso de ETESA a una excesiva influencia política y judicial, y condiciona que algunos actores se sientan relegados del proceso de evaluación y toma de decisión. Se identificaron los atributos del proceso de ETESA más prioritarios y factibles de ser mejorados en la región, y con el mayor potencial para generar un cambio positivo en los sistemas de salud. La mayor parte de estos están vinculados con la apropiada institucionalización de la ETESA, ampliar la participación de los diferentes actores y mejorar la transparencia de los procesos de ETESA. CONCLUSIONES: El LatamPF ha identificado barreras y recomendado acciones para reforzar el vínculo entre ETESA y la decisión. A su vez, existe en estos momentos una ventana de oportunidad en la región, ya que el tema es visualizado como una prioridad por gran parte de los actores de la sociedad. Por ello, los diferentes actores de los sistemas sanitarios deberían ahora tomar esta oportunidad para avanzar en el fortalecimiento del vínculo entre ETESA y toma de decisión.

The link between health technology assessment and decision making for the allocation of health resources in Latin America.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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 in Healthcare Decision Making: Global Trends and Case Studies From Latin America.

BACKGROUND: Real-world evidence (RWE) is increasingly used to inform health technology assessments for resource allocation, which are valuable tools for emerging economies such as in America. Nevertheless, the characteristics and uses in South America are unknown. OBJECTIVES: To identify sources, characteristics, and uses of RWE in Argentina, Brazil, Colombia, and Chile, and evaluate the context-specific challenges. The implications for future regulation and responsible management of RWE in the region are also considered. METHODS: A systematic literature review, database mapping, and targeted gray literature search were conducted to identify the sources and characteristics of RWE. Findings were validated by key opinion leaders attending workshops in 4 South American countries. RESULTS: A database mapping exercise revealed 407 unique databases. Geographic scope, database type, population, and outcomes captured were reported. Characteristics of national health information systems show efforts to collect interoperable data from service providers, insurers, and government agencies, but that initiatives are hampered by fragmentation, lack of stewardship, and resources. In South America, RWE is mainly used for pharmacovigilance and as pure academic research, but less so for health technology assessment decision making or pricing negotiations and not at all to inform early access schemes. CONCLUSIONS: The quality of real-world data in the case study countries vary and RWE is not consistently used in healthcare decision making. Authors recommend that future studies monitor the impact of digitalization and the potential effects of access to RWE on the quality of patient care.

Definiendo el valor de las tecnologías sanitarias en Latino-América: desarrollo de marcos de valor para informar la priorización de recursos sanitarios.

ResumenObjetivosEl reciente desarrollo de marcos de valor responde a una demanda por hacer más explícito e inclusivo el proceso de toma de decisiones sobre asignación de recursos sanitarios. El objetivo del Foro de Políticas en Latino América 2018 de Health Technology Assessment International fue explorar las experiencias internacionales y discutir la potencial aplicación de marcos de valor en la región.MétodosEste manuscrito está basado en un documento base y en las presentaciones y discusiones mantenidas por los miembros del Foro (43 participantes, 12 países) durante el Foro del 2018.ResultadosLos participantes coincidieron en que un proceso de evaluación y toma de decisión basado en marcos de valor más inclusivos y abarcativos podría mejorar la efectividad, eficiencia, sustentabilidad y equidad; promover la transparencia y una evaluación más completa de las tecnologías, mejorar la rendición de cuentas de las decisiones y la participación de actores. Se identificaron como criterios esenciales para ser incluidos en marcos de valor en la región a la carga de enfermedad y severidad de la condición, la efectividad y seguridad de la tecnología, la calidad de la evidencia, la costo-efectividad e impacto presupuestario. Los potenciales desafíos para su implementación identificados incluyeron la escasez de recursos humanos y las demoras en el proceso de evaluación que se podrían producir.ConclusionesLos participantes remarcaron que los próximos pasos deberían ser identificar procesos y metodologías apropiadas, adaptadas al contexto de cada país, para facilitar la aplicación de marcos de valor y mejorar el vínculo entre la evaluación y la toma de decisiones.

Defining the Value of Health Technologies in Latin America: Developments in Value Frameworks to Inform the Allocation of Healthcare Resources.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Bevacizumab en degeneración macular relacionada a la edad (Julio de 2018) / Bevacizumab in Age-Related Macular Degeneration (July 2018)

CONTEXTO CLÍNICO: La degeneración macular asociada a la edad (DMAE) se caracteriza por una serie de alteraciones a nível de la mácula, (zona de mejor visión), que evolucionan frecuentemente a una disminución de la agudeza visual, pudiendo ser causa de ceguera. Afecta al 4% de la población mayor de 55 años, y su prevalência alcanza el 8% en mayores de 75 años. Las formas precoces se caracterizan por la presencia de geodas (manchas amarillentas en el fondo de ojo que son producto del depósito de glicoproteínas entre la retina y la coroides, a nivel de la membrana de Bruch), y áreas de hiper y/o hipopigmentación del epitelio pigmentario, siendo estos cambios benignos y su presencia no implica necesariamente la evolución a estadíos más avanzados. Entre las formas avanzadas se describen dos tipos: una forma seca (90%) y otra, húmeda o exudativa (10%). TECNOLOGÍA: El bevacizumab es un anticuerpo monoclonal completo (porción Fc y Fab) dirigido contra el factor de crecimiento derivado del endotelio (FCEV), capaz de unirse a todas sus isoformas, inhibiendo parcialmente la angiogénesis. Fue desarrollado para el tratamiento de diversos tumores como pulmón, colon y riñón. 6 Si bien hasta hace unos meses no contaba con la aprobación para su uso intravítreo, su uso off label se encuentra extendido mundialmente desde el primer reporte de su utilización para DMAE en 2005, circunstancia promovida por el alto costo de otros agentes antiangiogénicos. OBJETIVO: El objetivo del presente informe es evaluar la evidencia disponible acerca de la eficacia, seguridad y aspectos relacionados a las políticas de cobertura del uso de bevacizumab para degeneración macular asociada a la edad. MÉTODOS: Se realizó una búsqueda en las principales bases de datos bibliográficas, en buscadores genéricos de internet, y financiadores de salud. Se priorizó la inclusión de revisiones sistemáticas (RS), ensayos clínicos controlados aleatorizados (ECAs), evaluaciones de tecnologías sanitarias (ETS), evaluaciones económicas, guías de práctica clínica (GPC) y políticas de cobertura de diferentes sistemas de salud. RESULTADOS: Se incluyeron una RS, tres GPC, seis informes de ETS, y ocho informes de políticas de cobertura de bevacizumab para degeneración macular asociada a la edad. CONCLUSIONES: Evidencia de moderada calidad sugiere que Bevacizumab mejora la agudeza visual y retrasa la progresión de la degeneración macular asociada a la edad. Asimismo, no muestra diferencias em mortalidad, ni eventos trombóticos, aunque tendría mayor probabilidad de presentar al menos um evento adverso serio al compararlo con ranibizumab y aflibercept. Las guías de práctica clínica relevadas coinciden en que su eficacia y seguridad es similar a otros agentes antiangiogénicos. Se encuentra aprobado solo por las agencias regulatorias de Brasil y Canadá, las cuales financian su uso para esta indicación. Sin embargo, su uso off-label ha sido sustentado por la evidencia y ampliamente utilizado dado su similar efecto y menor costo que comparadores. También presta cobertura un financiador privado de salud estadounidense. Si bien no se encontraron estudios de costo-efectividad o análisis de impacto presupuestario em nuestro país, el costo es marcadamente inferior al de sus comparadores.