Access in all areas? A round up of developments in market access and health technology assessment: part 1.

In this new series reviewing recent developments in market access, we highlight publications investigating health technology assessment (HTA) guidance, review processes and outcomes across the world and discuss how forthcoming changes in the HTA and regulatory environment in the European Union may allow for more consistency in decision making.

Current stage of the intensive care unit structure in Argentina: results from the Sociedad Argentina de Terapia Intensiva self-assessment survey of intensive care units. / Cenário atual da estrutura das unidades de terapia intensiva na Argentina: resultados do inquérito de autoavaliação de unidades de terapia intensiva da Sociedad Argentina de Terapia Intensiva.

OBJECTIVE: To describe and compare the structure of Argentinean intensive care units that completed the "self-assessment survey of intensive care units" developed by the Sociedad Argentina de Terapia Intensiva. METHODS: An observational crosssectional study was conducted using an online voluntary survey through the Sociedad Argentina de Terapia Intensiva member database and other social media postings. Answers received between December 2018 and July 2020 were analyzed. Descriptive statistics and nonparametric tests were used. RESULTS: A total of 392 surveys were received, and 244 were considered for the analysis. Seventy-seven percent (187/244) belonged to adult intensive care units, and 23% (57/244) belonged to pediatric intensive care units. The overall completion rate was 76%. The sample included 2,567 ICU beds (adult: 1,981; pediatric: 586). We observed a clear concentration of intensive care units in the Central and Buenos Aires regions of Argentina. The median number of beds was 10 (interquartile range 7 - 15).The median numbers of multiparameter monitors, mechanical ventilators, and pulse oximeters were 1 per bed with no regional or intensive care unit type differences (adult versus pediatric). Although our sample showed that the pediatric intensive care units had a higher mechanical ventilation/bed ratio than the adult intensive care units, this finding was not linearly correlated. CONCLUSION: Argentina has a notable concentration of critical care beds and better structural complexity in the Buenos Aires and Centro regions for both adult and pediatric intensive care units. In addition, a lack of accurate data reported from the intensive care unit structure and resources was observed. Further improvement opportunities are required to allocate intensive care unit resources at the institutional and regional levels.

OBJETIVO: Descrever e comparar a estrutura das unidades de terapia intensiva argentinas que responderam ao inquérito de autoavaliação de unidades de terapia intensiva desenvolvido pela Sociedad Argentina de Terapia Intensiva. MÉTODOS: Foi realizado um estudo transversal observacional com uso de um inquérito voluntário online por meio do banco de dados de membros da Sociedad Argentina de Terapia Intensiva e outras publicações em mídias sociais. Foram analisadas as respostas recebidas entre dezembro de 2018 e julho de 2020. Foram utilizados testes não paramétricos e estatística descritiva. RESULTADOS: Foram recebidos 392 inquéritos, sendo 244 considerados para a análise. Eram de unidades de terapia intensiva adulto 77% (187/244), e 23% (57/244) eram de unidades de terapia intensiva pediátrica. A taxa de participação foi de 76%. A amostra incluiu 2.567 leitos de unidades de terapia intensiva (1.981 adulto e 586 pediátrica). Observamos nítida concentração de unidades de terapia intensiva nas regiões Centro e Buenos Aires, Argentina.A mediana de leitos foi de dez (intervalo interquartil 7 - 15). A mediana de monitores multiparamétricos, ventiladores mecânicos e oxímetros de pulso foi de um por leito, sem diferenças regionais ou de tipo de unidade de terapia intensiva (adulto ou pediátrica). Embora nossa amostra tenha evidenciado que as unidades de terapia intensiva pediátrica apresentaram proporção de ventilação mecânica/leito maior do que as unidades de terapia intensiva adulto, esse achado não foi linearmente correlacionado. CONCLUSÃO: A Argentina tem concentração notável de leitos de cuidados intensivos e complexidade estrutural superior nas regiões de Buenos Aires e Centro, tanto de unidades de terapia intensiva adulto quanto pediátrica. Além disso, observou-se ausência de dados precisos informados sobre a estrutura e os recursos de unidades de terapia intensiva. São necessárias mais opções de melhoria para alocar os recursos de unidades de terapia intensiva nos níveis institucional e regional.

Cenário atual da estrutura das unidades de terapia intensiva na Argentina: resultados do inquérito de autoavaliação de unidades de terapia intensiva da Sociedad Argentina de Terapia Intensiva / Current stage of the intensive care unit structure in Argentina: results from the Sociedad Argentina de Terapia Intensiva self-assessment survey of intensive care units

RESUMO Objetivo: Descrever e comparar a estrutura das unidades de terapia intensiva argentinas que responderam ao inquérito de autoavaliação de unidades de terapia intensiva desenvolvido pela Sociedad Argentina de Terapia Intensiva. Métodos: Foi realizado um estudo transversal observacional com uso de um inquérito voluntário online por meio do banco de dados de membros da Sociedad Argentina de Terapia Intensiva e outras publicações em mídias sociais. Foram analisadas as respostas recebidas entre dezembro de 2018 e julho de 2020. Foram utilizados testes não paramétricos e estatística descritiva. Resultados: Foram recebidos 392 inquéritos, sendo 244 considerados para a análise. Eram de unidades de terapia intensiva adulto 77% (187/244), e 23% (57/244) eram de unidades de terapia intensiva pediátrica. A taxa de participação foi de 76%. A amostra incluiu 2.567 leitos de unidades de terapia intensiva (1.981 adulto e 586 pediátrica). Observamos nítida concentração de unidades de terapia intensiva nas regiões Centro e Buenos Aires, Argentina. A mediana de leitos foi de dez (intervalo interquartil 7 - 15). A mediana de monitores multiparamétricos, ventiladores mecânicos e oxímetros de pulso foi de um por leito, sem diferenças regionais ou de tipo de unidade de terapia intensiva (adulto ou pediátrica). Embora nossa amostra tenha evidenciado que as unidades de terapia intensiva pediátrica apresentaram proporção de ventilação mecânica/leito maior do que as unidades de terapia intensiva adulto, esse achado não foi linearmente correlacionado. Conclusão: A Argentina tem concentração notável de leitos de cuidados intensivos e complexidade estrutural superior nas regiões de Buenos Aires e Centro, tanto de unidades de terapia intensiva adulto quanto pediátrica. Além disso, observou-se ausência de dados precisos informados sobre a estrutura e os recursos de unidades de terapia intensiva. São necessárias mais opções de melhoria para alocar os recursos de unidades de terapia intensiva nos níveis institucional e regional.

ABSTRACT Objective: To describe and compare the structure of Argentinean intensive care units that completed the "self-assessment survey of intensive care units" developed by the Sociedad Argentina de Terapia Intensiva. Methods: An observational crosssectional study was conducted using an online voluntary survey through the Sociedad Argentina de Terapia Intensiva member database and other social media postings. Answers received between December 2018 and July 2020 were analyzed. Descriptive statistics and nonparametric tests were used. Results: A total of 392 surveys were received, and 244 were considered for the analysis. Seventy-seven percent (187/244) belonged to adult intensive care units, and 23% (57/244) belonged to pediatric intensive care units. The overall completion rate was 76%. The sample included 2,567 ICU beds (adult: 1,981; pediatric: 586). We observed a clear concentration of intensive care units in the Central and Buenos Aires regions of Argentina. The median number of beds was 10 (interquartile range 7 - 15). The median numbers of multiparameter monitors, mechanical ventilators, and pulse oximeters were 1 per bed with no regional or intensive care unit type differences (adult versus pediatric). Although our sample showed that the pediatric intensive care units had a higher mechanical ventilation/bed ratio than the adult intensive care units, this finding was not linearly correlated. Conclusion: Argentina has a notable concentration of critical care beds and better structural complexity in the Buenos Aires and Centro regions for both adult and pediatric intensive care units. In addition, a lack of accurate data reported from the intensive care unit structure and resources was observed. Further improvement opportunities are required to allocate intensive care unit resources at the institutional and regional levels.

Has Latin America achieved universal health coverage yet? Lessons from four countries.

BACKGROUND: Seven years after the commitment to United Nations' call for Universal Health Coverage, healthcare services in Argentina, Brazil, Colombia, Mexico are generally accessible and affordable; but they still struggle to meet population health demands and address the rising health care costs. We aim to describe measures taken by these four countries to commit by Universal Health Coverage, addressing their barriers and challenges. METHODS: Scoping literature review, supplemented with targeted stakeholders survey. RESULTS: The four countries analysed achieved an overall index of essential coverage of 76-77%, and households out of pocket health expenditures fall below 25%. Services coverage was improved by expanding access to primary healthcare systems and coverage for non-communicable diseases, while provided community outreach by the increase in the number of skilled healthcare workers. New pharmaceutical support programs provided access to treatments for chronic conditions at zero cost, while high-costs drugs and cancer treatments were partially guaranteed. However, the countries lack with effective financial protection mechanisms, that continue to increase out of pocket expenditure as noted by lowest financial protection scores, and lack of effective financial mechanisms besides cash transfers. CONCLUSIONS: Argentina, Brazil, Colombia, and Mexico have made progress towards UHC. Although, better financial protection is urgently required.

Telemammography for breast cancer screening: a cost-effective approach in Argentina.

OBJECTIVES: Argentina is a low and middle-income country (LMIC) with a highly fragmented healthcare system that conflicts with access to healthcare stated by the country's Universal Health Coverage plan. A tele-mammography network could improve access to breast cancer screening decreasing its mortality. This research aims to conduct an economic evaluation of the implementation of a tele-mammography program to improve access to healthcare. METHODS: A cost-utility analysis was performed to explore the incremental benefit of annual tele-mammography screening for at-risk Argentinian women over 40 years old. A Markov model was developed to simulate annual mammography or tele-mammography screening in two hypothetical population-based cohorts of asymptomatic women. Parameter uncertainty was evaluated through deterministic and probabilistic sensitivity analysis. Model structure uncertainty was also explored to test the robustness of the results. RESULTS: It was estimated that 31 out of 100 new cases of breast cancer would be detected by mammography and 39/100 by tele-mammography. The model returned an incremental cost-effectiveness ratio (ICER) of £26 051/quality-adjusted life-year (QALY) which is lower than the WHO-recommended threshold of £26 288/QALY for Argentina. Deterministic sensitivity analysis showed the ICER is most sensitive to the uptake and sensitivity of the screening tests. Probabilistic sensitivity analysis showed tele-mammography is cost-effective in 59% of simulations. DISCUSSION: Tele-mammography should be considered for adoption as it could improve access to expertise in underserved areas where adherence to screening protocols is poor. Disaggregated data by province is needed for a better- informed policy decision. Telemedicine could also be beneficial in ensuring the continuity of care when health systems are under stress like in the current COVID-19 pandemic. CONCLUSION: There is a 59% chance that tele-mammography is cost-effective compared to mammography for at-risk Argentinian women over 40- years old, and should be adopted to improve access to healthcare in underserved areas of the country.

Value Assessment Frameworks in Latin America: "Il buono, il brutto e il cattivo".

OBJECTIVES: Using a taxonomy previously developed, we assessed the strengths and limitations of available value assessment frameworks (VAF) in Latin America. METHODS: Systematic review of peer-reviewed journals, gray literature review, and surveys to ISPOR Latin America Industry Committee members were done to identify and select current VAF. Once selected, independent reviewers, organized by pairs, assessed each framework's input, methodology, and outputs. RESULTS: We assessed 7 of 9 VAF in the region, excluding 2 that were not currently in use. The review included 1 framework developed by a regional entity, and 6 country frameworks for either price assessment or to inform reimbursement. Most of these frameworks had a clear definition of the purpose (6 of 7) but could provide more details on the conceptual approach, including perspectives, methods for obtaining preferences, and the ability to incorporate multiple value dimensions (2 of 7). Most lacked information about inclusions/exclusions of elements included in the framework, and whether it assumes a base case comparator and how it is selected. The description of the evaluation of data sources and their scientific validity was inconsistently reported (3 of 7). Few included an assessment of the intervention's effect on total costs of treating a defined population (2 of 7), or a description of how uncertainty could be incorporated (3 of 7). Finally, potential conflicts of interest among those creating the framework are not sufficiently addressed (0 of 7). CONCLUSIONS: In the 7 frameworks assessed in Latin America, there are opportunities to improve dimensions, methods, and scope. Addressing these issues will strengthen these VAF for policy and clinical decision making.

Does "Flattening the Curve" Affect Critical Care Services Delivery for COVID-19? A Global Health Perspective.

During this coronavirus disease 2019 (COVID-19) global pandemic, nations are taking bold measures to mitigate the spread of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in order to avoid the overwhelming its critical care facilities. While these "flattening the curve" initiatives are showing signs of impeding the potential surge in COVID-19 cases, it is not known whether these measures alleviate the burden placed on intensive care units. Much has been made of the desperate need for critical care beds and medical supplies, especially personal protective equipment (PPE). But while these initiatives may provide health systems time to bolster their critical care infrastructure, they do little to protect the most essential element - the critical care providers. This article examines bolder initiatives that may be needed to both protect crucial health systems and the essential yet vulnerable providers during this global pandemic.

[Recommendations for resource management in intensive care units during the COVID-19 pandemic]. / Recomendaciones para la gestión de recursos en las unidades de cuidados intensivos durante la pandemia de COVID-19.

This document aims to provide evidence-based recommendations to estimate the personal protective equipments (PPE), medical devices, and drugs commonly used in the Intensive Care Unit during the COVID-19 pandemic. A systematic literature review and gray literature assessment was performed, and the evidence was categorized using the GRADE methodology. Then a predictive model was built to support the estimation of resources needed during 30 days of the pandemic. In the development of these recommendations, 33 publications were included, with variable quality of evidence (low to very low quality). They refer to the use of PPE according to the risk of exposure; management and reuse of PPE, and the stock of drugs and medical devices needed for the care of patients with COVID-19. It is important to remark the difficult in estimating and managing the number of essential supplies and equipment required during a pandemic. The model allowed us to predict the resources required to provide critical care during 30 days of pandemic activity. Given the constant evolution of COVID-19, these recommendations might change as evidence evolves.

El presente documento tiene como fin proporcionar recomendaciones basadas en la evidencia para estimar los equipos de proteccion personal (EPP), los dispositivos médicos y los medicamentos comúnmente utilizados en la Unidad de Cuidados Intensivos durante la pandemia de COVID-19. Se llevó a cabo una revisión sistemática de la literatura y evaluación de la literatura gris. La evidencia se clasificó utilizando la metodología GRADE. Luego, se construyó un modelo predictivo para apoyar la estimación de recursos durante 30 días de la pandemia. En el desarrollo de estas recomendaciones se incluyeron 33 publicaciones con calidad de evidencia variable (calidad baja a muy baja), acerca del uso de EPP según el riesgo de exposición; manejo y re-uso de EPP, y las necesidades de fármacos y dispositivos médicos para la atención de pacientes con COVID-19. Es destacable lo difícil que resulta estimar y administrar la cantidad de suministros y equipos esenciales necesarios durante una pandemia. El modelo nos permitió predecir los recursos necesarios para proporcionar cuidados críticos durante 30 días de actividad pandémica. Dada la evolución constante de COVID-19, estas recomendaciones pueden cambiar a medida que evolucione la evidencia.

Recomendaciones para la gestión de recursos en las unidades de cuidados intensivos durante la pandemia de COVID-19 / Recommendations for resource management in intensive care units during the COVID-19 pandemi

El presente documento tiene como fin proporcionar recomendaciones basadas en la evidencia para estimar los equipos de proteccion personal (EPP), los dispositivos médicos y los medicamentos comúnmente utilizados en la Unidad de Cuidados Intensivos durante la pandemia de COVID-19. Se llevó a cabo una revisión sistemática de la literatura y evaluación de la literatura gris. La evidencia se clasificó utilizando la metodología GRADE. Luego, se construyó un modelo predictivo para apoyar la estimación de recursos durante 30 días de la pandemia. En el desarrollo de estas recomendaciones se incluyeron 33 publicaciones con calidad de evidencia variable (calidad baja a muy baja), acerca del uso de EPP según el riesgo de exposición; manejo y re-uso de EPP, y las necesidades de fármacos y dispositivos médicos para la atención de pacientes con COVID-19. Es destacable lo difícil que resulta estimar y administrar la cantidad de suministros y equipos esenciales necesarios durante una pandemia. El modelo nos permitió predecir los recursos necesarios para proporcionar cuidados críticos durante 30 días de actividad pandémica. Dada la evolución constante de COVID-19, estas recomendaciones pueden cambiar a medida que evolucione la evidencia.

This document aims to provide evidence-based recommendations to estimate the personal protective equipments (PPE), medical devices, and drugs commonly used in the Intensive Care Unit during the COVID-19 pandemic. A systematic literature review and gray literature assessment was performed, and the evidence was categorized using the GRADE methodology. Then a predictive model was built to support the estimation of resources needed during 30 days of the pandemic. In the development of these recommendations, 33 publications were included, with variable quality of evidence (low to very low quality). They refer to the use of PPE according to the risk of exposure; management and reuse of PPE, and the stock of drugs and medical devices needed for the care of patients with COVID-19. It is important to remark the difficult in estimating and managing the number of essential supplies and equipment required during a pandemic. The model allowed us to predict the resources required to provide critical care during 30 days of pandemic activity. Given the constant evolution of COVID-19, these recommendations might change as evidence evolves.

Implementing Health Technology Assessments in Latin America: Looking at the Past, Mirroring the Future. A Perspective from the ISPOR Health Technology Assessment Roundtable in Latin America.

OBJECTIVES: In the last two decades, several countries in Latin America (LA) have shown an interest in developing health technology assessments (HTAs), but the process has not been uniform and has often been challenged by the health systems characteristics and the political or economic idiosyncrasies of these countries. METHODS: This article summarizes the discussions held by the participants at the 40th ISPOR HTA Council Roundtable for LA. An additional literature review was carried out to support some of the concepts included. RESULTS: This article includes a brief description of the implementation of HTA over the last 30 years and then a conceptual analysis using examples of the broader use of HTA to support procurement decisions and risk-sharing agreements, which might play a future role in healthcare priority-setting in LA. CONCLUSIONS: Formerly, HTA processes and methods played important although mostly isolated roles (with drug licensing or reimbursement being examples of this). Nowadays, with more and more innovative technologies and the establishment of value frameworks to support the priority setting in healthcare, HTA features a promising panorama for the health systems sustainability.

Value-Based Pricing in Latin America: How Far Away Are We?

In February and September of 2017, the International Society for Pharmacoeconomics and Outcomes Research Health Technology Assessment Council held roundtables focused on Latin America to discuss health technology assessment best practices, collaboration opportunities, and regional experiences regarding health policies to improve the affordability of and access to healthcare technologies. The access to high-cost technologies, increased social pressure to achieve universal coverage, population aging, and the limits of traditional mechanisms to control costs create political pressure to begin considering other pricing alternatives, including value-based pricing, in Latin America. This article attempts to conceptualize key stakeholders' perceptions of their experiences, opportunities, and barriers to implementing value-based pricing in Latin America.

End-Stage Renal Disease Models in the Americas: Optimizing Resources to Achieve Better Health Outcomes.

End-stage renal disease, the last and most severe stage of chronic kidney disease, represents a major and rising concern for countries in Latin America, driven in large part by aging populations and the near-epidemic rises in diabetes, obesity, and hypertension. This places a great clinical, economic, and social burden on the region's health systems. During the ISPOR 6th Latin America Conference held in Sao Paulo, Brazil, in September 2017, an educational forum debated on value-based decision making in the treatment of end-stage renal disease in Latin America. We summarize the current state and how to build strategies and implement actions to move to a more patient-centered, outcomes-based approach for renal care in the region, taken from the discussions in the conference and also from a literature review. Models of renal care used in Ontario (Canada), Colombia, and a Chilean hospital stress the importance of empowering and supporting patients and their families, allowing for a better coordination between primary care providers and specialists, providing financial incentives to health units, and establishing an entity that holds insurers and providers accountable for health outcomes and costs of treatment. The study uses the framework of value-based health care for the evaluation of different dialysis options-peritoneal dialysis, hemodialysis, home dialysis, and so forth-and calls for the countries to adopt an integrated care model. We emphasize that countries in Latin America need to recognize the chronic kidney disease challenge and develop health systems and efficient renal care models to be able to reduce the burden of the disease.

Medical devices: from licensing to coverage. highlights from Argentina, Brazil, Colombia and Mexico.

OBJECTIVES: To describe and compare the requirements for medical devices licensing and reimbursement in four Latin-American countries. METHODS: We conducted a literature search in major databases, and generic Internet engines, and interviewed key informants. RESULTS: We included all publications describing regulation and/or coverage and enriched them with key informant's interviews. We found that licensing processes are similar. The decision-making process for coverage is not formally different than the one used for drugs. Although countries differ, Brazil, Colombia and Mexico have an explicit process informed by Health Technology Assessment. In general, coverage policies are defined for procedures and don´t specify device brand or model, and for that reason they may reimburse without explicit one by one device evaluation. CONCLUSIONS: The process for licensing and reimbursement is broadly similar but less stringent than that for drugs. It allows the adoption of medical devices without individual comprehensive assessment.