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.

A Systematic Review of Value Criteria for Next-Generation Sequencing/Comprehensive Genomic Profiling to Inform Value Framework Development.

OBJECTIVES: To comprehensively identify and map an exhaustive list of value criteria for the assessment of next-generation sequencing/comprehensive genomic profiling (NGS/CGP), to be used as an aid in decision making. METHODS: We conducted a systematic review to identify existing value frameworks (VFs) applicable to any type of healthcare technology. VFs and criteria were mapped to a previously published Latin American (LA) VF to harmonize definitions and identify additional criteria and or subcriteria. Based on this analysis, we extracted a comprehensive, evidence-based list of criteria and subcriteria to be considered in the design of a NGS/CGP VF. RESULTS: A total of 42 additional VFs were compared with the LA VF, 88% were developed in high-income countries, 30% targeted genomic testing, and 16% specifically targeted oncology. A total of 242 criteria and subcriteria were extracted; 227 (94%) were fully/partially included in the LA VF; and 15 (6%) were new. Clinical benefit and economic aspects were the most common criteria. VFs oriented to genomic testing showed significant overlap with other VFs. Considering all criteria and subcriteria, a total of 18 criteria and 36 individual subcriteria were identified. CONCLUSIONS: Our study provides an evidence-based set of criteria and subcriteria for healthcare decision making useful for NGS/CGP as well as other health technologies. The resulting list can be beneficial to inform decision making and will serve as a foundation to co-create a multistakeholder NGS/CGP VF that is aligned with the needs and values of health systems and could help to improve patient access to high-value technologies.

Estimating the Effectiveness of Health Warnings on Cigarette Packaging in Nigeria: A Modeling Study.

INTRODUCTION: Tobacco consumption is associated with nearly 30 000 deaths annually in Nigeria alongside other adverse health and economic effects. Our objective was to estimate the health and economic implications of the current cigarette labeling policies (text-only HWs); new health warnings policies in the country (adding graphic health warnings with up to 60% coverage), and plain packaging policy as recommended by the World Health Organization. AIMS AND METHODS: We used a probabilistic state-transition individual microsimulation model, considering natural history, healthcare costs, and quality-of-life losses associated with main tobacco-attributable diseases; and the potential effects of packaging and labeling policies. We used three scenarios: (1) text-only health warnings (HWs) covering 50% of the pack, (2) introduction of graphic HWs of 50% (and later increasing to 80%) of the pack, and (3) plain packaging with HWs covering 80% of the pack. RESULTS: A total of 748 deaths are averted in the current situation; 7478 and 14 208 deaths can be averted with the new policy and with plain packaging, respectively. The number of cardiac, cerebrovascular, and cancer events that could be averted by adopting text and graphic HWs are 3093, 5093, and 1346, respectively; increasing to 5876, 9676, and 2557, respectively, with plain packaging. Up to 251 794 years were lost because of early deaths and disability, and ₦144.6 billion (USD 469 million) in health costs could be saved with HWs covering 50% to 80% of the pack over 10 years. With plain packaging and graphic HWs covering 80% of the package 478,408 years and ₦274.7 billion (USD 895 million) would be saved. CONCLUSIONS: The new cigarette labeling policy in Nigeria may yield significant health and economic benefits over 10 years. Moving the current policy to plain packaging can significantly improve these benefits. IMPLICATIONS: The new cigarette labeling policy that Nigeria is implementing should aim to achieve 100% compliance with its current regulation and the logical next step: Plain packaging with large warnings. The present study adds evidence of the potential health effects and cost savings of these levels of implementation, which is valuable for local policymakers.

Cost-effectiveness of COVID-19 vaccination in Latin America and the Caribbean: an analysis in Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, and Peru.

OBJECTIVE: Our study analyzes the cost-effectiveness of the COVID-19 vaccination campaigns in Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, and Peru. METHODS: Using a previously published SVEIR model, we analyzed the impact of a vaccination campaign (2021) from a national healthcare perspective. The primary outcomes were quality adjusted life years (QALYs) lost and total costs. Other outcomes included COVID-19 cases, hospitalizations, deaths, and life years. We applied a discount rate of 3% for health outcomes. We modeled a realistic vaccination campaign in each country (the realistic country-specific campaign). Additionally, we assessed a standard campaign (similar, "typical" for all countries), and an optimized campaign (similar in all countries with higher but plausible population coverage). One-way deterministic sensitivity analyses were performed. FINDINGS: Vaccination was health improving as well as cost-saving in almost all countries and scenarios. Our analysis shows that vaccination in this group of countries prevented 573,141 deaths (508,826 standard; 685,442 optimized) and gained 5.07 million QALYs (4.53 standard; 6.03 optimized). Despite the incremental costs of vaccination campaigns, they had a total net cost saving to the health system of US$16.29 billion (US$16.47 standard; US$18.58 optimized). The realistic (base case) vaccination campaign in Chile was the only scenario, which was not cost saving, but it was still highly cost-effective with an ICER of US$22 per QALY gained. Main findings were robust in the sensitivity analyses. INTERPRETATION: The COVID-19 vaccination campaign in seven Latin American and Caribbean countries -that comprise nearly 80% of the region- was beneficial for population health and was also cost-saving or highly cost-effective.

The health, economic and social burden of smoking in Argentina, and the impact of increasing tobacco taxes in a context of illicit trade.

Tobacco tax increases, the most cost-effective measure in reducing consumption, remain underutilized in low and middle-income countries. This study estimates the health and economic burden of smoking in Argentina and forecasts the benefits of tobacco tax hikes, accounting for the potential effects of illicit trade. Using a probabilistic Markov microsimulation model, this study quantifies smoking-related deaths, health events, and societal costs. The model also estimates the health and economic benefits of different increases in the price of cigarettes through taxes. Annually, smoking causes 45,000 deaths and 221,000 health events in Argentina, costing USD 2782 million in direct medical expenses, USD 1470 million in labor productivity loss costs, and USD 1069 million in informal care costs-totaling 1.2% of the national gross domestic product. Even in a scenario that considers illicit trade of tobacco products, a 50% cigarette price increase through taxes could yield USD 8292 million in total economic benefits accumulated over a decade. Consequently, raising tobacco taxes could significantly reduce the health and economic burdens of smoking in Argentina while increasing fiscal revenue.

Health, economic and social burden of tobacco in Latin America and the expected gains of fully implementing taxes, plain packaging, advertising bans and smoke-free environments control measures: a modelling study.

OBJECTIVE: To investigate the tobacco-attributable burden on disease, medical costs, productivity losses and informal caregiving; and to estimate the health and economic gains that can be achieved if the main tobacco control measures (raising taxes on tobacco, plain packaging, advertising bans and smoke-free environments) are fully implemented in eight countries that encompass 80% of the Latin American population. DESIGN: Markov probabilistic microsimulation economic model of the natural history, costs and quality of life associated with the main tobacco-related diseases. Model inputs and data on labour productivity, informal caregivers' burden and interventions' effectiveness were obtained through literature review, surveys, civil registrations, vital statistics and hospital databases. Epidemiological and economic data from January to October 2020 were used to populate the model. FINDINGS: In these eight countries, smoking is responsible each year for 351 000 deaths, 2.25 million disease events, 12.2 million healthy years of life lost, US$22.8 billion in direct medical costs, US$16.2 billion in lost productivity and US$10.8 billion in caregiver costs. These economic losses represent 1.4% of countries' aggregated gross domestic products. The full implementation and enforcement of the four strategies: taxes, plain packaging, advertising bans and smoke-free environments would avert 271 000, 78 000, 71 000 and 39 000 deaths, respectively, in the next 10 years, and result in US$63.8, US$12.3, US$11.4 and US$5.7 billions in economic gains, respectively, on top of the benefits being achieved today by the current level of implementation of these measures. CONCLUSIONS: Smoking represents a substantial burden in Latin America. The full implementation of tobacco control measures could successfully avert deaths and disability, reduce healthcare spending and caregiver and productivity losses, likely resulting in large net economic benefits.

Making visible the cost of informal caregivers' time in Latin America: a case study for major cardiovascular, cancer and respiratory diseases in eight countries.

BACKGROUND: Informal care is a key element of health care and well-being for society, yet it is scarcely visible and rarely studied in health economic evaluations. This study aims to estimate the time use and cost associated with informal care for cardiovascular diseases, pneumonia and ten different cancers in eight Latin American countries (Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico and Peru). METHODS: We carried out an exhaustive literature review on informal caregivers' time use, focusing on the selected diseases. We developed a survey for professional caregivers and conducted expert interviews to validate this data in the local context. We used an indirect estimate through the interpolation of the available data, for those cases in which we do not found reliable information. We used the proxy good method to estimate the monetary value of the use of time of informal care. National household surveys databases were processed to obtain the average wage per hour of a proxy of informal caregiver. Estimates were expressed in 2020 US dollars. RESULTS: The study estimated approximately 1,900 million hours of informal care annually and $ 4,300 million per year in average informal care time cost for these fifteen diseases and eight countries analyzed. Cardiovascular diseases accounted for an informal care burden that ranged from 374 to 555 h per year, while cancers varied from 512 to 1,825 h per year. The informal care time cost share on GDP varied from 0.26% (Mexico) to 1.38% (Brazil), with an average of 0.82% in the studied American countries. Informal care time cost represents between 16 and 44% of the total economic cost (direct medical and informal care cost) associated with health conditions. CONCLUSIONS: The study shows that there is a significant informal care economic burden -frequently overlooked- in different chronic and acute diseases in Latin American countries; and highlights the relevance of including the economic value of informal care in economic evaluations of healthcare.

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.

[Burden of disease and economic burden attributable to the consumption of sugar-sweetened beverages in El SalvadorCarga de morbidade e econômica atribuível ao consumo de bebidas açucaradas em El Salvador]. / Carga de enfermedad y económica atribuible al consumo de bebidas azucaradas en El Salvador.

Objective: To estimate the burden of disease and economic burden attributable to the consumption of sugar-sweetened beverages in El Salvador. Methods: A comparative risk model was used to estimate the effects on deaths, health events, disability-adjusted life years (DALYs), and direct medical costs attributable to the consumption of sugar-sweetened beverages. Results: A total of 520 deaths (8 per 100 000 individuals), 214 082 health events (3 220 per 100 000 individuals) and 16 643 DALYs could be attributable to the consumption of sugar-sweetened beverages in El Salvador, representing US$69.35 million in direct medical costs for the year 2020. In particular, type 2 diabetes (T2DM) events attributable to the consumption of sugar-sweetened beverages could represent more than 20% of total T2DM cases in the country. Conclusion: A high number of deaths, events, and costs could be attributed to the consumption of sugar-sweetened beverages in El Salvador.

Objetivo: Estimar a carga de morbidade e econômica atribuível ao consumo de bebidas açucaradas em El Salvador. Métodos: Foi utilizado um modelo de risco comparativo para estimar os efeitos sobre óbitos, eventos de saúde, anos perdidos devido a morte prematura ou vividos com incapacidade (AVAI) e custos médicos diretos atribuíveis ao consumo de bebidas açucaradas. Resultados: Um total de 520 mortes (8 por 100 00 indivíduos), 214 082 eventos de saúde (3 220 por 100 000 indivíduos) e 16 643 AVAI podem ser atribuídos ao consumo de bebidas açucaradas em El Salvador, o que representa US$ 69,35 milhões em custos médicos diretos para o ano de 2020. Os eventos de diabetes mellitus tipo 2 (DM2) atribuíveis ao consumo de bebidas açucaradas, em especial, podem representar mais de 20% do total de casos de DM2 no país. Conclusões: Um número elevado de mortes, eventos de saúde e custos pode ser atribuído ao consumo de bebidas açucaradas em El Salvador.

Designing and Implementing Deliberative Processes for Health Technology Assessment: A Good Practices Report of a Joint HTAi/ISPOR Task Force.

OBJECTIVES: Deliberative processes for health technology assessment (HTA) are intended to facilitate participatory decision making, using discussion and open dialogue between stakeholders. Increasing attention is being given to deliberative processes, but guidance is lacking for those who wish to design or use them. Health Technology Assessment International (HTAi) and ISPOR-The Professional Society for Health Economics and Outcomes Research initiated a joint Task Force to address this gap. METHODS: The joint Task Force consisted of 15 members with different backgrounds, perspectives, and expertise relevant to the field. It developed guidance and a checklist for deliberative processes for HTA. The guidance builds upon the few, existing initiatives in the field, as well as input from the HTA community following an established consultation plan. In addition, the guidance was subject to 2 rounds of peer review. RESULTS: A deliberative process for HTA consists of procedures, activities, and events that support the informed and critical examination of an issue and the weighing of arguments and evidence to guide a subsequent decision. Guidance and an accompanying checklist are provided for (i) developing the governance and structure of an HTA program and (ii) informing how the various stages of an HTA process might be managed using deliberation. CONCLUSIONS: The guidance and the checklist contain a series of questions, grouped by 6 phases of a model deliberative process. They are offered as practical tools for those wishing to establish or improve deliberative processes for HTA that are fit for local contexts. The tools can also be used for independent scrutiny of deliberative processes.

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.

Disruptive technologies in health care disenchanted: a systematic review of concepts and examples.

OBJECTIVES: To clarify the concept of disruptive technologies in health care, provide examples and consider implications of potentially disruptive technologies for health technology assessment (HTA). METHODS: We conducted a systematic review of conceptual and empirical papers on healthcare technologies that are described as "disruptive." We searched MEDLINE and Embase from 2013 to April 2019 (updated in December 2021). Data extraction was done in duplicate by pairs of reviewers utilizing a data extraction form. A qualitative data analysis was undertaken based on an analytic framework for analysis of the concept and examples. Key arguments and a number of potential predictors of disruptive technologies were derived and implications for HTA organizations were discussed. RESULTS: Of 4,107 records, 28 were included in the review. Most of the papers included conceptual discussions and business models for disruptive technologies; only few papers presented empirical evidence. The majority of the evidence is related to the US healthcare system. Key arguments for describing a technology as disruptive include improvement of outcomes for patients, improved access to health care, reduction of costs and better affordability, shift in responsibilities between providers, and change in the organization of health care. A number of possible predictors for disruption were identified to distinguish these from "sustaining" innovations. CONCLUSIONS: Since truly disruptive technologies could radically change technology uptake and may modify provision of care patterns or treatment paths, they require a thorough evaluation of the consequences of using these technologies, including economic and organizational impact assessment and careful monitoring.

Designing and Implementing Deliberative Processes for Health Technology Assessment: A Good Practices Report of a Joint HTAi/ISPOR Task Force.

OBJECTIVES: Deliberative processes for health technology assessment (HTA) are intended to facilitate participatory decision making, using discussion and open dialogue between stakeholders. Increasing attention is being given to deliberative processes, but guidance is lacking for those who wish to design or use them. Health Technology Assessment International (HTAi) and ISPOR-The Professional Society for Health Economics and Outcomes Research initiated a joint Task Force to address this gap. METHODS: The joint Task Force consisted of fifteen members with different backgrounds, perspectives, and expertise relevant to the field. It developed guidance and a checklist for deliberative processes for HTA. The guidance builds upon the few, existing initiatives in the field, as well as input from the HTA community following an established consultation plan. In addition, the guidance was subject to two rounds of peer review. RESULTS: A deliberative process for HTA consists of procedures, activities, and events that support the informed and critical examination of an issue and the weighing of arguments and evidence to guide a subsequent decision. Guidance and an accompanying checklist are provided for (i) developing the governance and structure of an HTA program and (ii) informing how the various stages of an HTA process might be managed using deliberation. CONCLUSIONS: The guidance and the checklist contain a series of questions, grouped by six phases of a model deliberative process. They are offered as practical tools for those wishing to establish or improve deliberative processes for HTA that are fit for local contexts. The tools can also be used for independent scrutiny of deliberative processes.

Health-Related Quality of Life in Patients with Breast Cancer in Latin America and the Caribbean: A Systematic Review and Meta-Analysis.

BACKGROUND AND OBJECTIVES: Breast cancer (BC) is the most common cancer in women. It imposes a huge disease burden and a significant impact on health-related quality of life (HRQoL). Our study focused on HRQoL of patients with BC in Latin America and the Caribbean (LAC). We conducted a systematic review to identify relevant articles published between 2008 and August 2018. We conducted several meta-analyses and subgroup analyses by country, disease stage, and instrument used (Prospective Register Of Systematic Reviews registration number: CRD42018106835). RESULTS: From 2,265 initial references, we finally included 75 articles (8,806 participants) that assessed HRQoL. The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 and B23 modules (34 studies; 8 countries; 4,866 participants) were the most used instruments, followed by the Short Form 36-item, the abbreviated version of the World Health Organization Quality of Life instrument, and the Functional Assessment of Cancer Therapy - Breast instrument. Only four studies reported specific HRQoL data of patients with metastatic disease. Half the studies were rated as having moderate quality (38/75), and 38% (29/75) as high quality. We identified substantial heterogeneity. As expected, the meta-analyses revealed that patients with metastatic disease reported lower HRQoL values and high symptom burden compared with patients at earlier stages. Similar results can be observed when we compared patients with early breast cancer in active treatment phases versus those in follow-up. CONCLUSION: This study provides a synthesis of breast cancer HRQoL reported in LAC and exposes existing evidence gaps. Patients with BC in active treatment or with metastatic disease had worse HRQoL compared with survivors during the follow-up period. IMPLICATIONS FOR PRACTICE: This systematic review provides an exhaustive synthesis of breast cancer health-related quality of life in women in the Latin American and Caribbean region. Patients with breast cancer in active treatment or with metastatic disease had worse health-related quality of life compared with survivors during the different follow-up periods. This study also shows important evidence and methods gaps that can help inform future research.

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.

Improving the monitoring of chronic heart failure in Argentina: is the implantable pulmonary artery pressure with CardioMEMS Heart Failure System cost-effective?

BACKGROUND: The CardioMEMS® sensor is a wireless pulmonary artery pressure device used for monitoring symptomatic heart failure (HF). The use of CardioMEMS was associated with a reduction of hospitalizations of HF patients, but the acquisition cost could be high in low-and-middle income countries. Evidence of cost-effectiveness is needed to help decision-makers to allocate resources according to "value for money". This study is aimed at estimating the cost-effectiveness of CardioMEMS used in HF patients from the third-party payer perspective -Social Security (SS) and Private Sector (PS)- in Argentina. METHODS: A Markov model was developed to estimate the cost-effectiveness of CardioMEMS versus usual medical care over a lifetime horizon. The model was applied to a hypothetical population of patients with HF functional class III with at least one hospitalization in the previous 12 months. The main outcome was the incremental cost-effectiveness ratio (ICER). To populate the model we retrieved clinical, epidemiological and utility parameters from the literature, whilst direct medical costs were estimated through a micro-costing approach (exchange rate USD 1 = ARS 76.95). Uncertainties in all parameters were assessed by deterministic, probabilistic and scenario sensitivity analysis. RESULTS: Compared with the usual medical care, CardioMEMS increased quality-adjusted life years (QALY) by 0.37 and increased costs per patient by ARS 1,081,703 for SS and ARS 919,051 for PS. The resultant ICER was ARS 2,937,756 per QALY and ARS 2,496,015 per QALY for SS and PS, respectively. ICER was most sensitive to the hazard ratio of HF hospital admission and the acquisition price of CardioMEMS. The probability that CardioMEMS is cost-effective at one (ARS 700,473), three (ARS 2,101,419,) and five (ARS 3,502,363) Gross Domestic Product per capita is 0.6, 17.9 and 64.1% for SS and 5.4, 33.3 and 73.2% for PS. CONCLUSIONS: CardioMEMS was more effective and more costly than usual care in class III HF patients. Since in Argentina there is no current explicit threshold, the final decision to determine its cost-effectiveness will depend on the willingness-to-pay for QALYs in each health subsector.

Sugar sweetened beverages attributable disease burden and the potential impact of policy interventions: a systematic review of epidemiological and decision models.

BACKGROUND: Around 184,000 deaths per year could be attributable to sugar-sweetened beverages (SSBs) consumption worldwide. Epidemiological and decision models are important tools to estimate disease burden. The purpose of this study was to identify models to assess the burden of diseases attributable to SSBs consumption or the potential impact of health interventions. METHODS: We carried out a systematic review and literature search up to August 2018. Pairs of reviewers independently selected, extracted, and assessed the quality of the included studies through an exhaustive description of each model's features. Discrepancies were solved by consensus. The inclusion criteria were epidemiological or decision models evaluating SSBs health interventions or policies, and descriptive SSBs studies of decision models. Studies published before 2003, cost of illness studies and economic evaluations based on individual patient data were excluded. RESULTS: We identified a total of 2766 references. Out of the 40 included studies, 45% were models specifically developed to address SSBs, 82.5% were conducted in high-income countries and 57.5% considered a health system perspective. The most common model's outcomes were obesity/overweight (82.5%), diabetes (72.5%), cardiovascular disease (60%), mortality (52.5%), direct medical costs (57.35%), and healthy years -DALYs/QALYs- (40%) attributable to SSBs. 67.5% of the studies modelled the effect of SSBs on the outcomes either entirely through BMI or through BMI plus diabetes independently. Models were usually populated with inputs from national surveys -such us obesity prevalence, SSBs consumption-; and vital statistics (67.5%). Only 55% reported results by gender and 40% included children; 30% presented results by income level, and 25% by selected vulnerable groups. Most of the models evaluated at least one policy intervention to reduce SSBs consumption (92.5%), taxes being the most frequent strategy (75%). CONCLUSIONS: There is a wide range of modelling approaches of different complexity and information requirements to evaluate the burden of disease attributable to SSBs. Most of them take into account the impact on obesity, diabetes and cardiovascular disease, mortality, and economic impact. Incorporating these tools to different countries could result in useful information for decision makers and the general population to promote a deeper implementation of policies to reduce SSBs consumption. PROSPERO PROTOCOL NUMBER: CRD42020121025 .

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.

[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.