Comprehensive economic evaluation of thermotherapy for the treatment of cutaneous leishmaniasis in Colombia

Background: Cutaneous leishmaniasis causes a high disease burden in Colombia, and available treatments present systemic toxicity, low patient compliance, contraindications, and high costs. Objective: To estimate the cost-effectiveness of thermotherapy versus Glucantime in patients with cutaneous leishmaniasis in Colombia. Methods: Cost-effectiveness study from an institutional perspective in 8,133 incident cases. Data on therapeutic efficacy and safety were included, calculating standard costs; the outcomes were disability adjusted life years (DALYs) and the number of patients cured. The information sources were the Colombian Public Health Surveillance System, disease burden studies, and one meta-analysis of controlled clinical trials. Incremental cost-effectiveness was determined, and uncertainty was evaluated with tornado diagrams and Monte Carlo simulations. Results: Thermotherapy would generate costs of US$501,621; the handling of adverse effects, US$ 29,224; and therapeutic failures, US$300,053. For Glucantime, these costs would be US$ 2,731,276, US$58,254, and US$ 406,298, respectively. With thermotherapy, the cost would be US$2,062 per DALY averted and US$ 69 per patient cured; with Glucantime, the cost would be US$4,241 per DALY averted and US$ 85 per patient cured. In Monte Carlo simulations, thermotherapy was the dominant strategy for DALYs averted in 67.9% of cases and highly cost-effective for patients cured in 72%. Conclusion: In Colombia, thermotherapy can be included as a cost-effective strategy for the management of cutaneous leishmaniasis. Its incorporation into clinical practice guidelines could represent savings of approximately US$10,488 per DALY averted and costs of US$ 116 per additional patient cured, compared to the use of Glucantime. These findings show the relevance of the incorporation of this treatment in our country and others with similar parasitological, clinical, and epidemiological patterns

Cost-effectiveness analysis of thermotherapy versus pentavalent antimonials for the treatment of cutaneous leishmaniasis

Introduction: The treatment of cutaneous leishmaniasis is toxic, has contraindications and a high cost. Objective: To estimate the cost-effectiveness of thermotherapy versus pentavalent antimonials for the treatment of cutaneous leishmaniasis. Methods: Effectiveness was the proportion of healing, and safety with the adverse effects; these parameters were estimated from a controlled clinical trial and a meta-analysis. A standard costing were conducted. Average and incremental cost-effectiveness ratios were estimated. The uncertainty regarding effectiveness, safety and costs was determined through sensitivity analyses. Results: The total costs were $66,807 with Glucantime and$14,079 with thermotherapy. The therapeutic effectiveness rates were 64.2% for thermotherapy and 85.1% for Glucantime. The average cost-effectiveness ratios ranged between $721 and$1,275 for Glucantime and between $187 and$390 for thermotherapy. Based on the meta-analysis thermotherapy may be a dominant strategy. Conclusion: The excellent cost-effectiveness ratio of thermotherapy shows the relevance of its inclusion in guidelines for the treatment

Análisis de costo-efectividad de la Termoterapia, en comparación con el Glucantime, para el tratamiento de pacientes con Leishmaniasis cutánea en Colombia 2015

Introducción: Leishmaniasis cutánea genera una elevada carga de la enfermedad en Colombia y los tratamientos disponibles presentan toxicidad sistémica, baja adherencia, contraindicaciones y alto costo -- Objetivo: Estimar la de costo-efectividad de la termoterapia, en comparación con el Glucantime, en pacientes con leishmaniasis cutánea de Colombia 2015 -- Métodos: Estudio de costo-efectividad desde la perspectiva institucional en 8.113 casos incidentes -- Se incluyeron datos de eficacia y seguridad terapéuticas, se realizó un costeo estándar y los desenlaces fueron los Años de Vida Ajustados por Discapacidad (DALYs) y el número de pacientes curados -- Las fuentes de información fueron el Sistema de Vigilancia en Salud Pública de Colombia, estudios de carga de la enfermedad y un metanálisis desarrollado por el investigador principal de este estudio -- Se estableció la costo-efectividad en términos incrementales y se evaluó la incertidumbre con el gráfico de tornado y simulaciones de Monte Carlo -- Resultados: La aplicación de termoterapia cuesta $1.530.444.433, el manejo de los efectos adversos$89.162.112 y el de las fallas terapéutica $915.460.665, mientras que en Glucantime fueron$8.333.121.916, $177.733.234 y$1.239.616.610, respectivamente -- Con Termoterapia cada DALY evitado cuesta $6.290.510 y cada paciente curado$214.835, en Glucantime $12.936.660 por DALY evitado y$258.231 por paciente curado -- En las simulaciones de Monte Carlo la termoterapia fue dominante para los DALYs evitados en el 67,9% de los casos y fue altamente costo-efectiva para los pacientes curados en un 72% -- Conclusión: En Colombia la termoterapia puede incluirse como una estrategia costo-efectiva para el manejo de la Leishmaniasis cutánea en, su incorporación en las guías de práctica clínica podría representar ahorros de aproximadamente 32 millones de pesos por cada DALY evitado y gastos de $352.830 por cada paciente curado adicional, en comparación con el uso del Glucantime; esto evidencia la relevancia de su incorporación en nuestro país y otros con patrones parasitológicos, clínicos y epidemiológicos similare

Strengthening cutaneous leishmaniasis control in Guatemala: policy recommendations

The country incidence rate of cutaneous leishmaniasis (CL) in Guatemala has increased from 3.14 per 100,000 inhabitants in 2011 to 6.24 per 100,000 inhabitants in 2019, (Fig.1) (1), probably due to a combination of improved active surveillance (2), climate changes (3,4), and occupational activities involving continued forest contact (5) among others. A national control program has been in place since 2003, but continued efforts are generating uneven results for the different endemic communities. Nationwide actions for CL control include active and passive surveillance, diagnosis and treatment offered free of cost by the Ministry of Health (MoH) and awareness-raising activities. We explored barriers and facilitators of CL control in Guatemala as experienced and perceived by service users and providers in order to inform evidence-based strategies to strengthen CL control in the country

Economic evaluations addressing diagnosis and treatment strategies for neglected tropical diseases: an overview

Neglected tropical diseases (NTDs) are those affecting vulnerable people and causing additional social and economic burden. The aim of this study was to carry out a general overview of the health economic assessments involving the diagnosis and treatment of six NTDs: cutaneous leishmaniasis (CL), Chagas disease, cysticercosis, filariasis, schistosomiasis and visceral leishmaniasis (VL). The literature search was based on two of the main medical literature databases (Medline and SciELO) and identified 46 studies. Twenty-six studies (57%) addressed therapeutic strategies, while other 20 (43%) assessed diagnostic or both diagnostic and therapeutic approaches. The studies were published between 1994 and 2021, and 57% of them (26/46) were carried out in four countries. Cost-effectiveness analyses were conducted in 59% (27/46) of the studies. Economic studies of NTDs have timidly increased in recent years. Despite the improvement of analytical methods, completeness and accuracy of information, there are few new technologies applied to NTDs and public health systems. In addition, economic studies for NTDs are concentrated in a few countries. Thus, this review points out the need for investment in research, development and training of human resources dedicated to the economic analysis in health, especially on NTDs, as a strategy to reduce inequalities by optimizing the use of health resources

the complexity of host's effective immune response against a polymorphic parasitic disease

This review is aimed at providing a comprehensive outline of the immune response displayed against cutaneous leishmaniasis (CL), the more common zoonotic infection caused by protozoan parasites of the genus Leishmania. Although of polymorphic clinical presentation, classically CL is characterized by leishmaniotic lesions on the face and extremities of the patients, which can be ulcerative, and even after healing can lead to permanent injuries and disfigurement, affecting significantly their psychological, social, and economic well-being. According a report released by the World Health Organization, the disability-adjusted life years (DALYs) lost due to leishmaniasis are close to 2.4 million, annually there are 1.0-1.5 million new cases of CL, and a numerous population is at risk in the endemic areas. Despite its increasing worldwide incidence, it is one of the so-called neglected tropical diseases. Furthermore, this review provides an overview of the existing knowledge of the host innate and acquired immune response to cutaneous species of Leishmania. The use of animal models and of in vitro studies has improved the understanding of parasite-host interplay and the complexity of immune mechanisms involved. The importance of diagnosis accuracy associated with effective patient management in CL reduction is highlighted. However, the multiple factors involved in CL epizoology associated with the unavailability of vaccines or drugs to prevent infection make difficult to formulate an effective strategy for CL control.publishersversionpublishe

Vaccine value profile for leishmaniasis

Leishmania infections are global, occurring in 98 countries and all World Health Organization (WHO) regions with 600 million to 1 billion people at risk of infection. Visceral leishmaniasis is associated with almost 20,000 reported deaths annually, with children under 5 years of age being at the greatest risk of mortality. Amongst WHO-recognised Neglected Tropical Diseases (NTDs), leishmaniasis is one of the most important in terms of mortality and morbidity. With an increasing global burden of disease and a growing threat from climate change, urbanisation and drug resistance, there remains an imperative to develop leishmaniasis vaccines. New tools to understand correlates of protection and to assess vaccine efficacy are being developed to ease the transition into larger scale efficacy trials or provide alternate routes to licensure. Early indications suggest a diverse portfolio of manufacturers exists in endemic countries with an appetite to develop leishmaniasis vaccines. This Vaccine Value Profile (VVP) provides a high-level, comprehensive assessment of the currently available data to inform the potential public health, economic, and societal value of leishmaniasis vaccines. The leishmaniasis VVP was developed by a working group of subject matter experts from academia, public health groups, policy organizations, and non-profit organizations. All contributors have extensive expertise on various elements of the leishmaniasis VVP and have collectively described the state of knowledge and identified the current gaps. The VVP was developed using only existing and publicly available information

Delivering infectious disease interventions to women and children in conflict settings: A systematic review

Background: Conflict has played a role in the large-scale deterioration of health systems in low-income and middle-income countries (LMICs) and increased risk of infections and outbreaks. This systematic review aimed to synthesise the literature on mechanisms of delivery for a range of infectious disease-related interventions provided to conflict-affected women, children and adolescents.Methods: We searched Medline, Embase, CINAHL and PsychINFO databases for literature published in English from January 1990 to March 2018. Eligible publications reported on conflict-affected neonates, children, adolescents or women in LMICs who received an infectious disease intervention. We extracted and synthesised information on delivery characteristics, including delivery site and personnel involved, as well as barriers and facilitators, and we tabulated reported intervention coverage and effectiveness data.Results: A majority of the 194 eligible publications reported on intervention delivery in sub-Saharan Africa. Vaccines for measles and polio were the most commonly reported interventions, followed by malaria treatment. Over two-thirds of reported interventions were delivered in camp settings for displaced families. The use of clinics as a delivery site was reported across all intervention types, but outreach and community-based delivery were also reported for many interventions. Key barriers to service delivery included restricted access to target populations; conversely, adopting social mobilisation strategies and collaborating with community figures were reported as facilitating intervention delivery. Few publications reported on intervention coverage, mostly reporting variable coverage for vaccines, and fewer reported on intervention effectiveness, mostly for malaria treatment regimens.Conclusions: Despite an increased focus on health outcomes in humanitarian crises, our review highlights important gaps in the literature on intervention delivery among specific subpopulations and geographies. This indicates a need for more rigorous research and reporting on effective strategies for delivering infectious disease interventions in different conflict contexts

Análisis de Costo-Efectividad de los tratamientos incluidos en la Guía de Atención Integral del Ministerio de Protección Social de 2010 en pacientes adultos con Leishmaniasis Cutánea y Mucocutánea en Colombia

Antecedentes: El Ministerio de Salud y Protección Social publicó en el año 2010 una nueva versión de la guía para la atención de la Leishmaniasis cutánea y Mucocutánea, una enfermedad que ha sido clasificada por la OMS como una enfermedad tropical “olvidada” y sobre la cual ha instado a esfuerzos para que las prioridades de investigación se centren en estudios clínicos de nuevos fármacos y/o asociaciones existentes así como en la realización de evaluaciones de costo/efectividad en diferentes escenarios. Es en el marco de esta necesidad es que nace este estudio cuyo alcance se presenta a continuación: Tipo de Estudio: Evaluación económica de Intervenciones sanitarias: Costo-efectividad Objetivo: Estimar el costo efectividad de los tratamientos incluidos en la Guía de Atención Integral del Ministerio de Protección Social Población: Hombres en edades de 15 a 60 años zonas de riesgo geográfico. Intervenciones: Antimoniales Pentavalentes, Miltefosina, Pentamidina y Amfotericina Desenlaces: Años de vida ajustados por Discapacidad y Paciente curados. Perspectiva: Sistema de salud, específicamente el tercer pagador. Datos de Efectividad: Leishmaniasis Cutánea (LC): Se realizó una Comparación Mixta (Directa e indirecta), Leishmaniasis Mucocutánea (LM): Se Realizó una Comparación no ajustadas Datos de Recursos: Costos Directos Médicos Resultados: LC por L. panamensis: AVAD: En la frontera de eficiencia, la opción con el mayor beneficio dentro del umbral de costo-efectividad de 3PIB per cápita($48’000.000)/AVAD es el Antimonial Pentavalente, con un ICER frente a “no acceder a tratamiento” de$30'265.453 por AVAD evitado. la Miltefosina resulta dominada en este desenlace. Paciente Curado: El costo de tratar un paciente y curarlo con antimoniales pentavalentes es de $3’516.702 y con Miltefosina es de$3’581.030. En este escenario de “paciente curado” la Miltefosina no es dominada y resulta prácticamente equivalente a los antimoniales. LC por L.brasilensis: AVAD: En la frontera de eficiencia, la opción con el mayor beneficio dentro del umbral de costo-efectividad de 3PIB per cápita/AVAD es nuevamente el Antimonial Pentavalente, con un ICER frente a Miltefosina de $44.369.022 por AVAD evitado. La Pentamidina resulto dominada en este desenlace. Paciente Curado: El Costo de tratar un paciente y curarlo con antimoniales pentavalentes es de$3’056.816, con Miltefosina es de $2’970.310, con Pentamidina$3’046.091 y con Amfotericina Liposomal $41’821.860. En este escenario la opción con el mayor beneficio dentro la frontera de eficiencia es la Pentamidina. LM:AVAD: La amfotericina dispersión coloidal resultó ser la opción con el mayor benefició dentro de la frontera de eficiencia. El ICER frente a la Pentamidina (la segunda mejor opción) es de de$7.068.514,18 por AVAD evitado, lo que lo hace una opción muy costo-efectiva al ser inferior a 1 PIB per cápita/AVAD evitado. Los Antimoniales pentavalentes, La Amfotericina deoxicolato, y la Liposomal resultaron dominados al ser menos eficaces y más costosos. Paciente Curado: El costo de tratar un paciente y curarlo con antimoniales pentavalentes es de $10’908.438, con Miltefosina de$4´795.888, Con Pentamidina $8’033.271(Dominada), Amfotericina deoxicolato$22’800.576(dominada), Dispersión Coloidal $17’706.008 y Liposomal$108’724.642(dominada). En este escenario de “Paciente curado” la opción con el mayor beneficio dentro la frontera de eficiencia también fue la Amfotericina Dispersión Coloidal.Abstract. Background: The Ministerio de Salud y Proteccion Social ("M.S.P.S", Department of Public Health and Social Protection) published in 2010 a new version of the Guide for the care of Cutaneous and mucocutaneous Leishmaniasis. The WHO has classified this diseaseas a tropical neglected". The WHO has urged to increase the efforts in order to ensure that research priorities are focused on clinical trials of new drugs and / or existing partnerships as well as in conducting cost / effectiveness in different cases. This study comes within the framework of this need, and its scope is as follows: Type of Study: Economic Evaluation of Health Interventions: Cost-effectiveness Objective: To estimate the cost effectiveness of the treatments included in the Guidelines for Comprehensive Care of the Ministerio de Protección Social Population: Men ages 15 to 60 years of geographical risk areas. Interventions: meglumine antimoniate, pentamidine, amphotericin, miltefosine Outcomes(pay-off): Disability adjusted Life Years (DALY) and Patient cured. Perspective: Health system, specifically third payer. Effectiveness Data: Cutaneous Leishmaniasis (CL): Comparison Mixed (direct and indirect), Mucocutaneous leishmaniasis (ML): Comparison unadjusted Resource Data: Direct Medical Costs Results: LC by L. panamensis: DALY: In the efficient frontier, meglumine antimoniate is the option with the greatest benefit in the cost-effectiveness threshold of 3 GDP per capita ($48'000.000)/per DALY averted. It was estimated an ICER of COP$ 30'265.453 per DALY averted in favour of meglumine antimoniate when compared with "no access treatment". In this outcome Miltefosine was dominated. Patient Cured: The cost of treating and cure a patient was estimated as follow: meglumine antimoniate $3'516.702 and Miltefosine$3'581.030. In this scenario, miltefosine is not dominated and is almost equivalent to meglumine antimoniate. LC by L.brasilensis: DALY: Again in the efficient frontier, meglumine antimoniate is the option with the greatest benefit in the cost-effectiveness threshold of 3 GDP per capita /per DALY averted. It was estimated an ICER of $44,369,022 per DALY averted in favour of meglumine antimoniate when compared with Miltefosine. In this outcome Pentamidine was dominated. Patient Cured: The cost of treating and cure a patient was estimated as follow: meglumine antimoniate COP$ 3'056.816, Miltefosine COP$2'970.310, Pentamidine COP$3'046.091 and Liposomal Amphotericin $41'821.860. In this scenario, Pentamidina has the greatest benefit into the efficient frontier. LM: DALY: Colloidal dispersion Amphotericin was the option with the greatest benefit in the efficient frontier. It was estimated an ICER of$7’068,514.18 per DALY averted in favour of Amphotericin, when compared with pentamidine (second best). It means that Colloidal dispersion Amphotericin is a very cost-effective strategy because it shows a value lesser than 1 GDP per capita /per DALY averted. In this outcome meglumine antimoniate, amphotericin deoxycholate and liposomal were less effective and more expensive, i.e. dominated Patient Cured: The cost of treating and cure a patient was estimated as follow: meglumine antimoniate $10'908.438, Miltefosine$4'795.888, Pentamidine $8'033.271 (Dominated), Amphotericin deoxycholate$22'800.576(dominated), Colloidal Dispersion $17'706.008 and Liposomal:$108'724.642 (dominated). In this scenario of "Patient cured" the option with the greatest benefit in the efficient frontier was also Colloidal Dispersion Amphotericin.Maestrí