A critical approximation to the use of cost-effectiveness evaluation for Vaccines inclusion in Immunization Programs: the case of pneumococcal vaccines in Latin America

ilustraciones

Autores:
Castañeda-Orjuela, Carlos Andrés
Tipo de recurso:
Doctoral thesis
Fecha de publicación:
2023
Institución:
Universidad Nacional de Colombia
Repositorio:
Universidad Nacional de Colombia
Idioma:
eng
OAI Identifier:
oai:repositorio.unal.edu.co:unal/84139
Acceso en línea:
https://repositorio.unal.edu.co/handle/unal/84139
https://repositorio.unal.edu.co/
Palabra clave:
610 - Medicina y salud
330 - Economía
Vacunas
Política de salud
Vaccines
Health Policy
Immunization
Pneumococcal vaccines
Latin America and the Caribbean
Cost-effectiveness
Decision making
Vacunación
Vacunas contra neumococo
Latinoamérica y el Caribe
Costo-efectividad
Toma de decisiones
Rights
openAccess
License
Atribución-NoComercial-SinDerivadas 4.0 Internacional
id UNACIONAL2_4f6486e96b2e9a796b9b36a8c32f5803
oai_identifier_str oai:repositorio.unal.edu.co:unal/84139
network_acronym_str UNACIONAL2
network_name_str Universidad Nacional de Colombia
repository_id_str
dc.title.eng.fl_str_mv A critical approximation to the use of cost-effectiveness evaluation for Vaccines inclusion in Immunization Programs: the case of pneumococcal vaccines in Latin America
dc.title.translated.spa.fl_str_mv Aproximación crítica al uso de evaluaciones de costo-efectividad para inclusión de vacunas en los programas nacionales de inmunización: el caso de la vacunación contra neumococo en Latinoamérica
title A critical approximation to the use of cost-effectiveness evaluation for Vaccines inclusion in Immunization Programs: the case of pneumococcal vaccines in Latin America
spellingShingle A critical approximation to the use of cost-effectiveness evaluation for Vaccines inclusion in Immunization Programs: the case of pneumococcal vaccines in Latin America
610 - Medicina y salud
330 - Economía
Vacunas
Política de salud
Vaccines
Health Policy
Immunization
Pneumococcal vaccines
Latin America and the Caribbean
Cost-effectiveness
Decision making
Vacunación
Vacunas contra neumococo
Latinoamérica y el Caribe
Costo-efectividad
Toma de decisiones
title_short A critical approximation to the use of cost-effectiveness evaluation for Vaccines inclusion in Immunization Programs: the case of pneumococcal vaccines in Latin America
title_full A critical approximation to the use of cost-effectiveness evaluation for Vaccines inclusion in Immunization Programs: the case of pneumococcal vaccines in Latin America
title_fullStr A critical approximation to the use of cost-effectiveness evaluation for Vaccines inclusion in Immunization Programs: the case of pneumococcal vaccines in Latin America
title_full_unstemmed A critical approximation to the use of cost-effectiveness evaluation for Vaccines inclusion in Immunization Programs: the case of pneumococcal vaccines in Latin America
title_sort A critical approximation to the use of cost-effectiveness evaluation for Vaccines inclusion in Immunization Programs: the case of pneumococcal vaccines in Latin America
dc.creator.fl_str_mv Castañeda-Orjuela, Carlos Andrés
dc.contributor.advisor.none.fl_str_mv De la Hoz-Restrepo, Fernando Pio
dc.contributor.author.none.fl_str_mv Castañeda-Orjuela, Carlos Andrés
dc.contributor.researchgroup.spa.fl_str_mv Grupo de Epidemiología y Evaluación en Salud Pública
dc.contributor.orcid.spa.fl_str_mv 0000-0002-8735-6223
dc.contributor.cvlac.spa.fl_str_mv https://scienti.minciencias.gov.co/cvlac/visualizador/generarCurriculoCv.do?cod_rh=0001124145
dc.contributor.scopus.spa.fl_str_mv 35769124700
dc.contributor.researchgate.spa.fl_str_mv https://www.researchgate.net/profile/Carlos-Castaneda-Orjuela
dc.contributor.googlescholar.spa.fl_str_mv https://scholar.google.com/citations?user=XESiWzMAAAAJ&hl=es&oi=ao
dc.subject.ddc.spa.fl_str_mv 610 - Medicina y salud
330 - Economía
topic 610 - Medicina y salud
330 - Economía
Vacunas
Política de salud
Vaccines
Health Policy
Immunization
Pneumococcal vaccines
Latin America and the Caribbean
Cost-effectiveness
Decision making
Vacunación
Vacunas contra neumococo
Latinoamérica y el Caribe
Costo-efectividad
Toma de decisiones
dc.subject.decs.spa.fl_str_mv Vacunas
Política de salud
dc.subject.decs.eng.fl_str_mv Vaccines
dc.subject.lemb.eng.fl_str_mv Health Policy
dc.subject.proposal.eng.fl_str_mv Immunization
Pneumococcal vaccines
Latin America and the Caribbean
Cost-effectiveness
Decision making
dc.subject.proposal.spa.fl_str_mv Vacunación
Vacunas contra neumococo
Latinoamérica y el Caribe
Costo-efectividad
Toma de decisiones
description ilustraciones
publishDate 2023
dc.date.accessioned.none.fl_str_mv 2023-07-04T21:53:59Z
dc.date.available.none.fl_str_mv 2023-07-04T21:53:59Z
dc.date.issued.none.fl_str_mv 2023-06
dc.type.spa.fl_str_mv Trabajo de grado - Doctorado
dc.type.driver.spa.fl_str_mv info:eu-repo/semantics/doctoralThesis
dc.type.version.spa.fl_str_mv info:eu-repo/semantics/acceptedVersion
dc.type.coar.spa.fl_str_mv http://purl.org/coar/resource_type/c_db06
dc.type.content.spa.fl_str_mv Text
dc.type.redcol.spa.fl_str_mv http://purl.org/redcol/resource_type/TD
format http://purl.org/coar/resource_type/c_db06
status_str acceptedVersion
dc.identifier.uri.none.fl_str_mv https://repositorio.unal.edu.co/handle/unal/84139
dc.identifier.instname.spa.fl_str_mv Universidad Nacional de Colombia
dc.identifier.reponame.spa.fl_str_mv Repositorio Institucional Universidad Nacional de Colombia
dc.identifier.repourl.spa.fl_str_mv https://repositorio.unal.edu.co/
url https://repositorio.unal.edu.co/handle/unal/84139
https://repositorio.unal.edu.co/
identifier_str_mv Universidad Nacional de Colombia
Repositorio Institucional Universidad Nacional de Colombia
dc.language.iso.spa.fl_str_mv eng
language eng
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dc.publisher.faculty.spa.fl_str_mv Facultad de Medicina
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spelling Atribución-NoComercial-SinDerivadas 4.0 Internacionalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccesshttp://purl.org/coar/access_right/c_abf2De la Hoz-Restrepo, Fernando Pioa4ff4711f1654f6ce6ed74b0af24ba87Castañeda-Orjuela, Carlos Andrésd28b552ea14eba5afabeb720ec5d3912Grupo de Epidemiología y Evaluación en Salud Pública0000-0002-8735-6223https://scienti.minciencias.gov.co/cvlac/visualizador/generarCurriculoCv.do?cod_rh=000112414535769124700https://www.researchgate.net/profile/Carlos-Castaneda-Orjuelahttps://scholar.google.com/citations?user=XESiWzMAAAAJ&hl=es&oi=ao2023-07-04T21:53:59Z2023-07-04T21:53:59Z2023-06https://repositorio.unal.edu.co/handle/unal/84139Universidad Nacional de ColombiaRepositorio Institucional Universidad Nacional de Colombiahttps://repositorio.unal.edu.co/ilustracionesBackground: Worldwide, vaccination is considered a very successful and cost-effective pu- blic health strategy to prevent a wide range of communicable diseases, especially in children. New vaccines are available but at higher costs than those originally included in the basic Expanded Program on Immunization (EPI). Latin American and the Caribbean (LAC) is a region with a great commitment with the inclusion of new vaccines, supported mainly by the Pan American Health Organization (PAHO), however, budget impact of universal immunization is still a challenge for national EPIs. The present research considered both po- sitive and normative dimensions of decision making (DM) in health, particularly in settings with limited resources such as LAC countries, to explore the key rationalities considered to make investment decisions in public health. Pneumococcal conjugated vaccines (PCVs) were selected for the case study to approximate the way in that DM are done at national EPIs with public funds. The exploration of DM frameworks in public health, particularly in low- and middle-income countries (LMIC) settings, is very scarce in the scientific litera- ture, but health-care system around the world are continuously choosing and financing new interventions. It is important to approach to the rationalities involved in the DM process, to evaluate the knowledge of the stakeholders about the arguments and evaluations exposed in the discussion, and to propose improvements in the DM from a democratic perspective. An advance in this sense could give to public health practitioners several tools to guarantee better decisions and more points of view to be included in the discussion, as well as identify potential pitfalls of the available methods, most of them from an utilitarian perspective, to inform the DM in public health. Aim: To critically address how PCVs have been included in the EPIs and the role played by the economic evaluations of their introduction in low- and middle-income countries from the LAC region. Methods: A combination of methodologies was performed to carry out the present research project: 1) A proposal of conceptual reference framework to identify the potential utility of cost-effectiveness analyses (CEAs) in a DM was discussed from our experience of its use in developing countries at the national EPIs. 2) A systematic review of literature about the PCVs’ CEAs in children from LAC countries to understand how they informed the DM about their inclusion in national EPIs was carried out. We evaluated several characteristics and quality of the published CEAs as well as the recommendations of introductions generated by the authors. 3) A survey to EPI managers, participants at National Immunization Advisory Groups (NITAGs), was carried out to review the DM process for new vaccine introduction in LAC, evaluating the role and knowledge about CEAs. 4) In addition, a CEA of switch to PCV13 versus continue PCV10 in Colombian children was run as update of previous one, now including more recent evidence and new serotype distribution after the initial adoption of PCV10. 5) Finally, a cost-effectiveness re-estimation for the identified PCVs’ CEAs in LAC was performed integrating information provided in published analyses and additional data from international databases for demographic and mortality parameters, making the comparison in a competitive scenario, guaranteeing the theoretical approach, and validating the conclusions reached by the authors in the original CEA. A narrative synthesis of the findings was performed and recommendations generated according with the dialogue with the published evidence and results of diverse analyses performed. Results: According to implemented methodologies the main findings were: 1) CEAs are valuable inputs in the negotiation process between different actors with different legitimate interests (i.e., producers of health technologies finding profits and decision makers at the health system investing public resources to reach maximize the population well-being). New vaccine introduction is a good example to approximate the use of CEA in DM, and LAC countries are the setting where the approach of inform the DM with economic evaluations is encouraged by several stakeholders: PAHO, national authorities and donors. 2) The sys- tematic review of literature evidenced that more than a half of published PCVs’ CEAs in LAC were sponsored by pharmaceutical industry with some potential bias in the results and recommendations provided. We arise concerns about quality and conflict of interest involved in the realization of CEAs to inform DM about the selection between PCV10 and PCV13, with contradictory results, for example in countries with simultaneous CEAs performed of industry and independent researchers. Nevertheless, cost-effectiveness profiles of PCVs intro- duction in LAC children showed that it is a good value for money investment of public funds. To inform the best economic profile for different vaccine formulation (10 vs. 13 valences) re- quires include unbiased parameters in the model, and discusses the normative framework such as the agreement about the willingness to pay (WTP) threshold to DM. 3) The survey to EPI managers shows that introduction of new vaccine in national EPIs from the region is a process of discussion with participation of several actors where economic rationalities had a high role in the DM, but limitations in the technical capacity was identified and many of the local key parameters to performed a CEA were reported as lacking. 4) The upda- ted analysis of PCVs CEA in Colombian evidenced that a national immunization strategy based in Switch-to PCV13 was found to be good value for money and prevent additional burden of pneumococcal disease saving additional treatment costs, when compared with to Keep-PCV10. 5) The effort to validate the published CEAs from the original parameters and replicating the models used showed that implemented evaluations correspond in many cases to black-boxes hard to replicate and in a half of cases obtaining recommendations different to originally reported by the authors. Conclusion: The relevance of rationalities beyond economical are highlighted in the DM ans particularly for new vaccine introduction in nationals EPIs from LAC region, but also noted the centrality that CEAs has been gained in the recent years, with different technical capacities in the countries. Interests such as pharmaceuticals should be kept away in the evaluation and discussion of PCVs CEAs, because today the industry is the main sponsor of CEAs in the region, potentially biasing the discussion to their interests. It is necessary to strengthen the technical capacity to understand economical inputs to inform DM and advocate to include other rationalities as important in the discussion. However additional criteria to decision making must be taken into account. (Texto tomado de la fuente)Introducción: En todo el mundo, la vacunación se considera una estrategia de salud pública muy exitosa y rentable para prevenir una amplia gama de enfermedades transmisibles, especialmente en los niños. Las vacunas nuevas están disponibles, pero a costos más altos que aquellas incluidos originalmente en el Programa Ampliado de Inmunizaciones (PAI) básico. América Latina y el Caribe (ALC) es una región con un gran compromiso con la inclusión de nuevas vacunas, apoyada principalmente por la Organización Panamericana de la Salud (OPS), sin embargo, el impacto presupuestal de la inmunización universal sigue siendo un desafío para los PAI nacionales. La presente investigación consideró las dimensiones tanto positiva como normativa de la toma de decisiones en salud, particularmente en entornos con recursos limitados como los países de ALC, para explorar las racionalidades clave consideradas para tomar decisiones de inversión en salud pública. Las vacunas conjugadas contra neumococo (VCN) fueron seleccionadas para el estudio de caso para aproximarnos a la forma en que se realizan la toma de decisiones en los PAI nacionales financiados con fondos públicos. La exploración de los marcos de toma de decisiones en salud pública, particularmente en escenarios de países de bajos y medianos ingresos (LMIC, por sus siglas en inglés), es muy escasa en la literatura científica, pero los sistemas de atención de la salud en todo el mundo eligen y financian continuamente nuevas intervenciones. Es importante acercarse a las racionalidades involucradas en el proceso de DM, evaluar el conocimiento de los actores sobre los argumentos y valoraciones expuestos en la discusión, y proponer mejoras en la toma de decisión desde una perspectiva democrática. Un avance en este sentido podría dar a los profesionales de la salud pública varias herramientas para garantizar mejores decisiones y más puntos de vista para ser incluidos en la discusión, así como identificar posibles escollos de los métodos disponibles, la mayoría de ellos desde una perspectiva utilitaria, para informar la toma de decisiones en salud pública. Objetivo: Abordar críticamente la forma en que se han incluido las vacunas antineumocócicas conjugadas en los PAI y el papel que han jugado las evaluaciones económicas en su introducción en países de ingresos bajos y medios de la región de ALC. Métodos: Se realizó una combinación de metodologías para el desarrollo de la presente investigación. 1) Se discutió una propuesta de marco de referencia conceptual para identificar la utilidad potencial de los análisis de costo-efectividad (ACE) en la toma de decisiones a partir de nuestra experiencia de su uso en los PAI nacionales de países en desarrollo. 2) Se realizó una revisión sistemática de la literatura sobre los ACE de las VCN en niños de países de ALC para entender cómo informaban a la toma de decisiones sobre su inclusión en los PAI nacionales. Evaluamos varias características y la calidad de los ACE publicados, así como las recomendaciones de introducciones generadas por los autores. 3) Se realizó una encuesta a los gerentes del PAI, participantes de los Grupos Asesores Nacionales de Inmunización (CNPI por su sigla en Colombia), para revisar el proceso de toma de decisiones para la introducción de nuevas vacunas en ALC, evaluando el rol y el conocimiento de los ACE. 4) Además, se realizó un ACE del cambio a VCN13 versus continuar con VCN10 en niños colombianos como actualización del anterior ACE, incluyendo evidencia más reciente y la nueva distribución de serotipos después de la adopción inicial de VCN10. 5) Finalmente, se realizó una reestimación de la costo-efectividad de los ACE de las VCN identificadas en ALC integrando información proporcionada en análisis publicados y datos adicionales de bases de datos internacionales para parámetros demográficos y de mortalidad, haciendo la comparación en un escenario competitivo, garantizando el enfoque teórico y validando las conclusiones alcanzadas por los autores en el ACE original. Se realizó una síntesis narrativa de los hallazgos y se generaron recomendaciones de acuerdo con el diálogo con la evidencia publicada y los resultados de los diversos análisis realizados. Resultados: Con respecto a los enfoques metodológicos implementados se encontró que: 1) los ACE son insumos valiosos en el proceso de negociación entre diferentes actores con diferentes intereses legítimos (productores de tecnologías sanitarias que encuentran ganancias y tomadores de decisiones en el sistema de salud que invierten recursos públicos para alcanzar el máximo bienestar de la población). La introducción de nuevas vacunas es un buen ejemplo para aproximarse a comprender el uso de ACE en la toma de decisiones y los países de ALC son el escenario donde el enfoque (informar al tomador de decisiones con evaluaciones económicas) es alentado por varias partes interesadas: OPS, autoridades nacionales y donantes. 2) La revisión sistemática de la literatura evidenció que más de la mitad de los ACE de VCN publicados en ALC fueron patrocinados por la industria farmacéutica con algún sesgo potencial en los resultados y recomendaciones proporcionadas. Surgen inquietudes sobre la calidad y el conflicto de intereses involucrado en la realización de los ACE para informar la toma decisiones sobre la selección entre VCN10 y VCN13, con resultados contradictorios, por ejemplo, en países con ACE simultáneos realizados por la industria e investigadores independientes. Sin embargo, los perfiles de costo-efectividad de la introducción de VCN en niños de ALC es una inversión de fondos públicos con una buena eficiencia. Para informar el mejor perfil económico para diferentes formulaciones de vacunas (10 frente a 13 valencias) es necesario incluir parámetros imparciales en el modelo y analizar la dimensión normativa de la evaluación (valores inmersos), como la definición del umbral de disposición a pagar para la toma de decisiones. 3) La encuesta a los gerentes del PAI muestra que la introducción de nuevas vacunas en los PAI nacionales de la región es un proceso de discusión con participación de varios actores donde las racionalidades económicas jugaron un papel importante en la toma de decision, pero se identificaron limitaciones en la capacidad técnica y muchas de las autoridades informaron que faltaban parámetros clave para realizar un ACE. 4) El análisis actualizado del ACE de las VCN en Colombia evidenció que una estrategia de inmunización nacional basada en cambiar a VCN13 resultó tener una buena relación costo-efectividad en prevenir una carga adicional de enfermedad neumocócica ahorrando costos de tratamiento adicionales, en comparación con mantener VCN10. 5) El esfuerzo por validar los ACE publicados a partir de los parámetros originales y replicando los modelos utilizados mostró que las evaluaciones implementadas corresponden en muchos casos a cajas negras difíciles de replicar y en la mitad de los casos obtienen recomendaciones diferentes a las reportadas originalmente por los autores. Conclusión: Se destaca la relevancia de las racionalidades más allá de la económica en la toma de decisiones y particularmente para la introducción de nuevas vacunas en los EPI nacionales de la región de ALC, pero también se señala la centralidad que han ganado los CEA en los últimos años, con diferentes capacidades técnicas en los países. Intereses como los de la industria farmacéuticos deben mantenerse alejados en la evaluación y discusión de los CEA de las VCN, porque hoy en día la industria es la principal fundadora de los ACE en la región, lo que potencialmente sesga la discusión a favor de sus intereses. Es necesario fortalecer la capacidad técnica para comprender los insumos económicos para informar la toma de decisiones y abogar por incluir otras racionalidades igualmente importantes en la discusión, sin embargo, se deben tener en cuenta criterios adicionales para la toma de decisiones.Esta tesis corresponde a una compilación de artículos publicados y por publicar en revistas indexadasThis thesis is a compilation of research papers published and to be published in indexed journals.DoctoradoDoctor en Salud PúblicaSe realizó una combinación de metodologías para el desarrollo de la presente investigación. 1) Se discutió una propuesta de marco de referencia conceptual para identificar la utilidad potencial de los análisis de costo-efectividad (ACE) en la toma de decisiones a partir de nuestra experiencia de su uso en los PAI nacionales de países en desarrollo. 2) Se realizó una revisión sistemática de la literatura sobre los ACE de las VCN en niños de países de ALC para entender cómo informaban a la toma de decisiones sobre su inclusión en los PAI nacionales. Evaluamos varias características y la calidad de los ACE publicados, así como las recomendaciones de introducciones generadas por los autores. 3) Se realizó una encuesta a los gerentes del PAI, participantes de los Grupos Asesores Nacionales de Inmunización (CNPI por su sigla en Colombia), para revisar el proceso de toma de decisiones para la introducción de nuevas vacunas en ALC, evaluando el rol y el conocimiento de los ACE. 4) Además, se realizó un ACE del cambio a VCN13 versus continuar con VCN10 en niños colombianos como actualización del anterior ACE, incluyendo evidencia más reciente y la nueva distribución de serotipos después de la adopción inicial de VCN10. 5) Finalmente, se realizó una reestimación de la costo-efectividad de los ACE de las VCN identificadas en ALC integrando información proporcionada en análisis publicados y datos adicionales de bases de datos internacionales para parámetros demográficos y de mortalidad, haciendo la comparación en un escenario competitivo, garantizando el enfoque teórico y validando las conclusiones alcanzadas por los autores en el ACE original. Se realizó una síntesis narrativa de los hallazgos y se generaron recomendaciones de acuerdo con el diálogo con la evidencia publicada y los resultados de los diversos análisis realizados.Economía de la Saludxxi, 42 páginasapplication/pdfengUniversidad Nacional de ColombiaBogotá - Medicina - Doctorado en Salud PúblicaDoctorado Interfacultades en Salud PúblicaFacultad de MedicinaBogotá,ColombiaUniversidad Nacional de Colombia - Sede Bogotá610 - Medicina y salud330 - EconomíaVacunasPolítica de saludVaccinesHealth PolicyImmunizationPneumococcal vaccinesLatin America and the CaribbeanCost-effectivenessDecision makingVacunaciónVacunas contra neumococoLatinoamérica y el CaribeCosto-efectividadToma de decisionesA critical approximation to the use of cost-effectiveness evaluation for Vaccines inclusion in Immunization Programs: the case of pneumococcal vaccines in Latin AmericaAproximación crítica al uso de evaluaciones de costo-efectividad para inclusión de vacunas en los programas nacionales de inmunización: el caso de la vacunación contra neumococo en LatinoaméricaTrabajo de grado - Doctoradoinfo:eu-repo/semantics/doctoralThesisinfo:eu-repo/semantics/acceptedVersionhttp://purl.org/coar/resource_type/c_db06Texthttp://purl.org/redcol/resource_type/TDBaker L, Birnbaum H, Geppert J, Mishol D, Moyneur E. 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[PubMed Central:PMC6041503] [DOI:10.1016/j.healthpol.2018.04.011] [PubMed:29759682].Aproximación crítica al uso de evaluaciones de costo-efectividad para inclusión de vacunas en los programas nacionales de inmunización: el caso de la vacunación contra neumococo en Latinoamérica.Universidad Nacional de ColombiaEstudiantesGrupos comunitariosInvestigadoresMaestrosMedios de comunicaciónPúblico generalResponsables políticosLICENSElicense.txtlicense.txttext/plain; charset=utf-85879https://repositorio.unal.edu.co/bitstream/unal/84139/1/license.txteb34b1cf90b7e1103fc9dfd26be24b4aMD51ORIGINALTesis_PhD_Salud_Pública Carlos Castañeda-Orjuela_Rev.pdfTesis_PhD_Salud_Pública Carlos Castañeda-Orjuela_Rev.pdfTesis de Doctorado en Salud Públicaapplication/pdf4914295https://repositorio.unal.edu.co/bitstream/unal/84139/2/Tesis_PhD_Salud_P%c3%bablica%20Carlos%20Casta%c3%b1eda-Orjuela_Rev.pdf480746cd4bbcba46c8fddfdaaea45c6cMD52THUMBNAILTesis_PhD_Salud_Pública Carlos 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