[Comparative economic evaluation of renal replacement therapies in Argentina, Costa Rica, and UruguayAvaliação econômica comparativa de terapias de substituição renal na Argentina, na Costa Rica e no Uruguai]. / Evaluación económica comparativa sobre terapias de reemplazo renal en Argentina, Costa Rica y Uruguay.

OBJECTIVE: Evaluate differences in the cost and prevalence of renal replacement therapies (RRTs) such as transplants, peritoneal dialysis, and hemodialysis in Argentina, Costa Rica, and Uruguay, based on cost-effective dissemination strategies. METHODS: Costs and prevalence obtained from the main financers and providers in each country; analysis of cost-effectiveness using a Markov model with a five-year horizon, evaluating resource allocation strategies for their incremental cost-effectiveness ratio expressed as quality-adjusted years of life. RESULTS: There is observed dispersion among countries in terms of access to and beneficial value of RRTs, affecting their prevalence and monetary breakeven point. From the cost standpoint, it is more efficient to promote transplants and peritoneal dialysis, and to discourage hemodialysis, although the availability of each RRT in each country required a specific evaluation. CONCLUSIONS: Promoting transplants saves costs, but the variable breakeven points make it necessary to determine different cost-effectiveness thresholds for each country. In Argentina and Uruguay, RRTs would be more cost-effective with an increase in the number of patients in peritoneal dialysis and higher donation rates for transplants. In Costa Rica (where there is a high transplant rate and large budgetary margin), the use of dialysis is aligned with demand and with the incidence of patients with terminal chronic kidney disease.

OBJETIVO: Avaliar as diferenças de custos e prevalência das terapias de substituição renal (TSR) como o transplante, a diálise peritoneal e a hemodiálise na Argentina, na Costa Rica e no Uruguai, mediante estratégias de difusão custo-efetivas. MÉTODOS: Foram avaliados custos e prevalência dos principais financiadores e prestadores por país, e realizada análise de custo-efetividade mediante modelo de Markov para 5 anos, avaliando estratégias de alocação de recursos expressas pela razão de custo-efetividade incremental por ano de vida ajustado por qualidade. RESULTADOS: Foi observada, entre os países, dispersão no acesso e nos valores prestacionais de TSR, afetando sua prevalência e o ponto de equilíbrio monetário. Do ponto de vista dos custos, é mais eficiente promover a realização de transplantes e de diálise peritoneal e desestimular a indicação de hemodiálise, embora a disponibilidade de cada TSR por país tenha exigido avaliações específicas. CONCLUSÕES: Promover a realização de transplantes economiza custos, embora os pontos de equilíbrio variáveis requeiram a determinação de diferentes limiares de custo-efetividade por país. Na Argentina e no Uruguai, a administração de TSR melhoraria sua eficiência se a quantidade de pacientes em diálise peritoneal e as taxas de doação para transplantes aumentassem. Na Costa Rica (onde há taxas elevadas de transplantes e margem orçamentária), a incorporação de técnicas dialíticas é ajustada por demanda e incidência de pacientes com DRCT.

Health technology assessment process of a cardiovascular medical device in four different settings.

AIM: Health technology assessment (HTA) is a tool to help the decision-making process. The aim is to describe methods and processes used in the reimbursement decision making for drug-eluting stents (DES) in four different settings. METHODS: DES as a technology under study was selected according to different criteria, all of them agreed by a working group. A survey of key informants was designed. RESULTS: DES was evaluated following well-structured HTA processes. Nonetheless, scope for improvement was observed in relation to the data considered for the final decision, the transparency and inclusiveness of the process as well as in the methods employed. CONCLUSION: An attempt to describe the HTA processes of a well-known medical device.

Adoption of the HPV vaccine: a case study of three emerging countries.

BACKGROUND: The human papillomavirus (HPV) vaccine has recently attracted considerable attention in emerging countries, due to its potential to reduce the impact of HPV-related diseases. This case study sheds new light about the variety of HTA arrangements, methods and processes involved in the adoption and use of HPV vaccines in a selected sample of central, eastern and southern Europe and Latin America and the Caribbean, all of them emerging in the use of HTA. MATERIALS & METHODS: A multi-country case study was designed. Mixed methods, document review, semi-structured surveys and personal communication with experts, were used for data collection and triangulation. RESULTS: This study shows that common elements of good practice exist in the processes and methods used, with all countries arriving at the same appraisal recommendations. However, the influence of socio-politico-economic factors appears to be determinant on the final decisions and restrictions to access made. CONCLUSION: This case study intends to draw useful lessons for policymakers in emerging settings interested in the adoption of the HPV vaccine supported by evidence-informed processes, such as those offered by institutionalized HTA. Future studies are also recommended to elucidate the specific roles that social values and uncertainties play in vaccine decision-making across different societies.

Strengthening and implementing health technology assessment and the decision-making process in the Region of the Americas.

OBJECTIVE: Health technology assessment (HTA) has been adopted by countries in order to improve allocative efficiency in their health systems. This study aimed to describe and analyze the HTA decision-making process in the Region of the Americas. METHODS: A literature review was done to better understand the HTA situation in the Region. Also, in 2014 and 2015, individuals responsible for conducting HTA in countries of the Americas were identified and received a questionnaire on HTA and the decision-making process. RESULTS: A total of 46 questionnaire responses were obtained, from 30 countries. The respondents were similar in terms of their institutions, main funding sources, and technology types assessed. Of the 46 respondents, 23 (50%) work for their respective ministry of health. Also, 36 (78%) undertake and/or coordinate HTA through coverage and reimbursement/pricing decisions and other HTA-related activities, while 24 (52%) use HTA for emerging technologies. While some countries in the Region have created formal HTA units, there is a weak link between the HTA process and decision-making. Most of the countries with recognized HTA institutions are members of the Health Technology Assessment Network of the Americas (RedETSA). Despite the advances in the Region overall, most countries in Central America and the Caribbean are still at the early stages of implementing HTA to support decision-making. CONCLUSIONS: Many countries in the Americas have benefited from the exchange and capacity-building opportunities within RedETSA. However, there are still many challenges to overcome in the Region in terms of the discussion and creation of HTA-related policies.

Strengthening and implementing health technology assessment and the decision-making process in the Region of the Americas / Fortalecimiento y ejecución de la evaluación de las tecnologías sanitarias y del proceso de toma de decisiones en la Región de las Américas / Fortalecer e implementar a avaliação de tecnologias em saúde e o processo decisório na Região das Américas

ABSTRACT Objective Health technology assessment (HTA) has been adopted by countries in order to improve allocative efficiency in their health systems. This study aimed to describe and analyze the HTA decision-making process in the Region of the Americas. Methods A literature review was done to better understand the HTA situation in the Region. Also, in 2014 and 2015, individuals responsible for conducting HTA in countries of the Americas were identified and received a questionnaire on HTA and the decision-making process. Results A total of 46 questionnaire responses were obtained, from 30 countries. The respondents were similar in terms of their institutions, main funding sources, and technology types assessed. Of the 46 respondents, 23 (50%) work for their respective ministry of health. Also, 36 (78%) undertake and/or coordinate HTA through coverage and reimbursement/pricing decisions and other HTA-related activities, while 24 (52%) use HTA for emerging technologies. While some countries in the Region have created formal HTA units, there is a weak link between the HTA process and decision-making. Most of the countries with recognized HTA institutions are members of the Health Technology Assessment Network of the Americas (RedETSA). Despite the advances in the Region overall, most countries in Central America and the Caribbean are still at the early stages of implementing HTA to support decision-making. Conclusions Many countries in the Americas have benefited from the exchange and capacity-building opportunities within RedETSA. However, there are still many challenges to overcome in the Region in terms of the discussion and creation of HTA-related policies.

RESUMEN Objetivo Muchos países han adoptado la evaluación de tecnologías sanitarias (ETS) para mejorar la eficiencia distributiva en sus sistemas de salud. Este estudio tuvo por objeto describir y analizar el proceso de toma de decisiones basado en ETS en la Región de las Américas. Métodos Se hizo una revisión bibliográfica para comprender mejor la situación de la ETS en la Región. Además, en el 2014 y el 2015 se identificaron las personas responsables de realizar la ETS en los países de la Región, quienes recibieron un cuestionario sobre las ETS y el proceso de toma de decisiones. Resultados Se recibieron 46 cuestionarios respondidos en total, procedentes de 30 países. Los encuestados eran similares en cuanto a sus instituciones, principales fuentes de financiamiento y tipos de tecnología que evaluaban. De los 46 encuestados, 23 (50%) trabajan para el ministerio de salud de su país. Además, 36 (78%) realizan o coordinan la ETS mediante decisiones relativas a la cobertura y los reembolsos o fijación de precios, mientras que 24 (52%) usan la ETS para las tecnologías emergentes. Si bien algunos países de la Región han creado unidades formales de ETS, la vinculación entre el proceso de la ETS y la toma de decisiones es débil. La mayoría de los países que cuentan con instituciones reconocidas de ETS son miembros de la Red de Evaluación de Tecnologías Sanitarias de las Américas (RedETSA). No obstante el progreso de la Región en términos generales, la mayoría de los países de Centroamérica y el Caribe se encuentran todavía en las fases iniciales de la aplicación de la ETS para apoyar la toma de decisiones. Conclusiones Muchos países de la Región de las Américas se han beneficiado de las oportunidades de intercambio y formación de capacidad que brinda RedETSA. Sin embargo, persisten muchos retos que es necesario superar en la Región en torno al debate y la formulación de políticas relacionadas con la ETS.

RESUMO Objetivo A avaliação de tecnologias em saúde (ATS) foi adotada pelos países visando melhorar a eficiência alocativa dos próprios sistemas de saúde. O propósito deste estudo foi descrever e analisar o processo decisório de ATS na Região das Américas. Métodos Realizou-se uma revisão da literatura científica para aprofundar o conhecimento sobre a situação da ATS na Região. Em 2014 e 2015, os responsáveis pela ATS nos países das Américas foram identificados e um questionário sobre ATS e o processo decisório foi aplicado". Resultados Ao todo, foram respondidos 46 questionários provenientes de 30 países. Os participantes apresentavam semelhanças quanto às instituições de trabalho, principais fontes de financiamento e tipos de tecnologias avaliadas. Dos 46 participantes, 23 (50%) trabalhavam no ministério da Saúde do país; 36 (78%) executavam e/ou coordenavam a ATS tomando decisões sobre cobertura e reembolso/precificação e realizando outras atividades relacionadas e 24 (52%) realizavam a ATS de tecnologias emergentes. Embora tenham sido instituídas unidades formais de ATS em alguns países na Região, o vínculo entre o processo de ATS e a tomada de decisão é frágil. A maioria dos países que reconhecidamente instituíram a ATS integra a Rede de Avaliação de Tecnologias em Saúde das Américas (RedETSA). Apesar do progresso na Região, a maior parte dos países na América Central e Caribe ainda está nos estágios iniciais de implementação da ATS para apoiar o processo decisório. Conclusões Muitos países nas Américas se favorecem com o intercâmbio e as oportunidades de capacitação da RedETSA. Porém, a Região ainda precisa superar muitos desafios em termos do debate e formulação de políticas em torno da ATS.

[Regulation of medical devices in the Region of the Americas]. / Situación de la regulación de los dispositivos médicos en la Región de las Américas.

Objective To describe and analyze the current status of and the challenges involved in the regulation of medical devices in the Region of the Americas and to present the results of the regional mapping exercise, progress toward the development of advanced assessment indicators, and the achievements of the Regional Working Group. Methods Creating a regional profile on the regulation of medical devices in the Americas is a priority for the Working Group. To this end a tool composed of 45 questions organized into six sections was developed and distributed among 15 countries for self-assessment (the participation rate was 100%). Based on the data received, nine basic indicators were established and an agreement was reached to develop advanced indicators for measuring the extent to which regulatory programs for medical devices were being implemented. Results Of the 15 countries, 93% have an agency in charge of regulating medical devices. An analysis of individual country performance shows wide variability, with some countries meeting all indicators and others meeting as few as 11%. The mapping also made it possible to generate information on collaborative partnerships, training, and regulation. Conclusions The results show significant heterogeneity at the regional level. Implementation of advanced indicators will help to identify areas of opportunity and strengths for the development of the regulatory profile. Although progress has been made toward strengthening regulatory programs for medical devices, remaining gaps need to be bridged through strategies and initiatives to be led by the Working Group.

Adoption of trastuzumab for breast cancer in four emerging countries in the use of health technology assessment: a case study.

AIM: To describe processes for the adoption of trastuzumab in four countries in the use of health technology assessment (HTA): Poland, Albania, Brazil and Colombia. MATERIALS & METHODS: Mixed methods were used for collection and triangulation of data. Data were examined following a conceptual framework connecting HTA process steps and key principles. RESULTS: Trastuzumab was generally assessed following well-structured HTA processes. Nonetheless, areas of improvement were detected in terms of transparency and inclusiveness, as well as in methods used. The extent to which different criteria influenced decisions was unclear. CONCLUSION: This study covers an area in which information may not always be available, and sets the example for emerging countries interested in HTA. Further studies to gain a better understanding on decision-making across settings are warranted.

Situación de la regulación de los dispositivos médicos en la Región de las Américas / Regulation of medical devices in the Region of the Americas

RESUMEN Objetivo Describir y analizar la situación actual y los desafíos de la regulación de dispositivos médicos en la Región de las Américas, así como presentar los resultados del Mapeo Regional, los avances en la construcción de indicadores avanzados de evaluación y los logros obtenidos por el Grupo de Trabajo Regional. Métodos Elaborar un perfil regional sobre la regulación de dispositivos médicos en las Américas es una prioridad del Grupo de Trabajo. Para ello, se desarrolló una herramienta de evaluación integrada por 45 preguntas organizadas en seis secciones, que se distribuyó en 15 países para su autoevaluación (la tasa de participación fue 100%). A partir de los datos recibidos se establecieron nueve indicadores básicos y se acordó el desarrollo de indicadores avanzados para medir el nivel de implementación de los programas regulatorios de dispositivos médicos. Resultados El 93% de 15 países cuenta con una institución responsable de la regulación de dispositivos médicos. Al analizar el desempeño por país, se observa variabilidad: desde países que cumplen todos los indicadores, hasta aquellos que únicamente cumplen 11%. El mapeo también permitió generar información sobre alianzas colaborativas, capacitación y reglamentación. Conclusiones Los resultados muestran una heterogeneidad significativa a nivel regional. La implementación de indicadores avanzados contribuirá a identificar áreas de oportunidad y fortalezas para la creación del perfil regulatorio. Aunque se ha avanzado en el fortalecimiento de los programas regulatorios de dispositivos médicos, aún hay brechas que deben reducirse mediante estrategias e iniciativas que serán lideradas por el Grupo de Trabajo.

ABSTRACT Objective To describe and analyze the current status of and the challenges involved in the regulation of medical devices in the Region of the Americas and to present the results of the regional mapping exercise, progress toward the development of advanced assessment indicators, and the achievements of the Regional Working Group. Methods Creating a regional profile on the regulation of medical devices in the Americas is a priority for the Working Group. To this end a tool composed of 45 questions organized into six sections was developed and distributed among 15 countries for self-assessment (the participation rate was 100%). Based on the data received, nine basic indicators were established and an agreement was reached to develop advanced indicators for measuring the extent to which regulatory programs for medical devices were being implemented. Results Of the 15 countries, 93% have an agency in charge of regulating medical devices. An analysis of individual country performance shows wide variability, with some countries meeting all indicators and others meeting as few as 11%. The mapping also made it possible to generate information on collaborative partnerships, training, and regulation. Conclusions The results show significant heterogeneity at the regional level. Implementation of advanced indicators will help to identify areas of opportunity and strengths for the development of the regulatory profile. Although progress has been made toward strengthening regulatory programs for medical devices, remaining gaps need to be bridged through strategies and initiatives to be led by the Working Group.

Understanding the Role and Evidence Expectations of Health Technology Assessment and Coverage/Payer Bodies: What Are They Looking for, and How and Why Does This Differ From What Regulators Require?

Pharmaceutical companies have a good understanding of the needs and requirements of regulatory bodies, but the evidence expectations of health technology assessment (HTA) and coverage/payer bodies are less well understood and addressed. This paper seeks to improve this understanding by providing an overview of the expectations of HTA and coverage/payer bodies, explaining how and why these differ from those of regulators, and describing the extent and limitations of work on harmonization. The article goes on to describe ways in which HTA and coverage/payer bodies' expectations can be addressed, and to encourage industry to interact with HTA and coverage/payer bodies to increase mutual understanding and hence promote more efficient development of and access to innovative medicines.