The Predictive Value of PD-L1 Expression Level in Evaluating the Cost-Effectiveness of Atezolizumab/Pembrolizumab.

Objective: Recently, the significant improvement of atezolizumab and pembrolizumab over chemotherapy for treatment-naïve stage IV non-small cell lung cancer (NSCLC) has been demonstrated, but the cost-effectiveness of these regimens remains unknown. Methods: A Markov model was adapted from the US healthcare perspective to assess the cost-effectiveness of atezolizumab, pembrolizumab, and chemotherapy in treatment-naïve NSCLC. Pseudo-individual patient data were generated from digitized Kaplan-Meier curves. Direct medical costs and utility values were sourced from the database and literature. Quality-adjusted life-years (QALYs), total costs, and incremental cost-effectiveness ratios (ICERs) were computed. Sensitivity analyses and budgetary impact analyses were calculated. Results: In any and high programmed cell death 1-ligand 1 (PD-L1) expression populations, with chemotherapy, atezolizumab provided ICERs of $234,990 and $130,804 per QALY, while pembrolizumab yielded ICERs of $424,797 and $140,873 per QALY. The ICER of atezolizumab vs. pembrolizumab was $56,635 and $115,511.82 in any and high PD-L1 expression population, respectively. The critical drivers of ICERs included the cost of atezolizumab and pembrolizumab. The accumulated incremental budgetary impact of atezolizumab vs. chemotherapy increased to approximately $39.1 million in high PD-L1 expression patients over 5 years. Conclusions: In the high PD-L1 expression population, both atezolizumab and pembrolizumab were cost-effective for stage IV NSCLC compared to chemotherapy, which is contrary to that in any PD-L1 expression population. Atezolizumab shows a higher acceptability in both populations. Treating with immune checkpoint inhibitors (ICIs) has a substantial budgetary impact on the medical burden. The PD-L1 expression level has the potential to be a predictor for the economics of ICIs.

The budgetary impact of alemtuzumab in multiple sclerosis in Quito, Ecuador. Payer's perspective.

Introduction: Multiple sclerosis is a neurological condition that causes disabilities and is most common in young adults. It imposes high financial costs affecting the quality of life of patients, families, and society. It is critical to measure the budgetary impact of new technologies to treat this disease. Objective: The aim of the article is to estimate the budgetary impact of introducing alemtuzumab as an escalation therapy in patients diagnosed with Recurrent Remitting Multiple Sclerosis and treated in Quito, Ecuador. Materials and methods: A cohort of 85 patients receiving treatment with disease-modifying therapies was used, within a 5-year timeframe, between 2021 and 2025. The baseline scenario, including the percentages of administration of the different drugs, is compared with the alternative scenario, including alemtuzumab. The cost assessment included only direct medical resources. To obtain local resources for management of the disease, a neurologist and clinical expert who treats most of the patients in Quito was consulted. Results: Considering a cohort of 85 patients with active Recurrent Remitting Multiple Sclerosis, the average global budget impact in 5 years would be USD 10,603,230.00 in the base case and USD 9,995,817.00 in the alemtuzumab scenario. Conclusion: The inclusion of alemtuzumab as escalation therapy represents budgetary savings over the next 5 years (2021-2025).

Cladribina oral para o tratamento da esclerose múltipla remitente-recorrente altamente ativa: análise de impacto orçamentário sob a perspectiva do sistema brasileiro de saúde suplementar / Cladribine tablets for the treatment of highly active recurrent multiple sclerosis: budget impact analysis from the perspective of the Brazilian supplementary health system

Objetivo: Avaliar o impacto orçamentário da inclusão da cladribina oral no tratamento de esclerose múltipla remitente-recorrente em alta atividade da doença (EMRR HDA) no Sistema de Saúde Suplementar (SSS). Métodos: Foi conduzida uma análise de impacto orçamentário, sob a perspectiva do SSS, com horizonte temporal de quatro anos, considerando a abordagem de coorte aberta na qual o número de pacientes elegíveis para tratamento varia em cada ano com a introdução de novos pacientes diagnosticados de EMRR HDA e a retirada de indivíduos prevalentes devido a morte ou progressão secundária. Foram considerados custos médicos diretos, incluindo a aquisição e administração de medicamentos, monitoramento, eventos adversos e surtos. Os comparadores utilizados na análise foram: alentuzumabe, fingolimode, natalizumabe e ocrelizumabe. Os custos foram apresentados em real brasileiro (BRL). Resultados: O custo incremental da inclusão da cladribina oral para o SSS foi estimado em 463.265 BRL, 739.691 BRL, -1.414.963 BRL, -3.719.007 BRL, nos anos 1, 2, 3 e 4, respectivamente. Isso resultou em um custo incremental total de -3.931.015 BRL no período analisado, representando 1,5% da redução orçamentária total no tratamento de EMRR HDA. Conclusão: A inclusão da cladribina oral para o tratamento de pacientes com diagnóstico de EMRR HDA poderia gerar uma economia substancial para o sistema brasileiro de saúde suplementar, atingindo um valor de cerca de 3,9 milhões de BRL em um período de quatro anos

Objective: To evaluate the budget impact of adopting cladribine tablets as a treatment strategy for relapsing remitting multiple sclerosis with high disease activity (RRMS HDA), from the Brazilian private healthcare system perspective. Methods: A budget impact analysis, under private healthcare system perspective, with a 4-years time horizon was conducted, considering the open cohort approach in which the number of patients eligible for treatment varies each year with the introduction of newly diagnosed RRMS HDA patients and the drop out of prevalent individuals due to death or secondary progression. Direct medical costs, including acquisition, drug administration, monitoring, adverse events and relapses were considered. Comparators used in the analysis were: alentuzumab, fingolimod, natalizumab and ocrelizumab. Costs were presented in Brazilian real (BRL). Results: The incremental cost of incorporating cladribine tablets into the private healthcare system was estimated at 463,265BRL, 739,961BRL, -1,414,963 BRL, -3,716,007 BRL, in years 1, 2, 3 and 4, respectively. This resulted in a total incremental cost of -3,931,015 BRL over the period analyzed, representing 1.5% of the total budget reduction in the treatment of RRMS HDA. Conclusion: Incorporation of cladribine tablets for the management of RRMS HDA could generate substantial savings for the private healthcare system, reaching a value of approximately 3.9 million BRL in a 4-years period

Budgetarry impact of the incorporation of claritromycin in the treatment of infection by new coronavirus / Impacto presupuestario de la incorporación de claritromicina en el tratamiento de la infección por nuevos coronavirus / Impacto orçamentário da incorporação da claritromicina no tratamento da infecção pelo novo coronavírus

Introduction: In Brazil, the use of third generation cephalosporins associated with a macrolide (azithromycin or clarithromycin), has been recommended at admission. Objective: To estimate the budgetary impact of the use of clarithromycin as a supporting macrolide in the empirical treatment scheme for patients with Severe Acute Respiratory Syndrome. Method: Budgetary Impact Analysis. Unified Health System perspective, local level. 5-year time horizon. Used the Brazilian Budget Impact Analysis Worksheet. Three alternative scenarios and one reference were analyzed. Results: The five-year cost in the reference scenario was R$ 2,504,887.92. Conclusion: The incorporation of clarithromycin in alternative scenarios may represent an average incremental cost of more than 22% of the budget available for the acquisition of azithromycin in 5 years, which may be economically unfeasible to offer to all patients in hospitals, without having loss in meeting other demands.

Introducción: en Brasil, se recomienda el uso de cefalosporinas de tercera generación asociadas con un macrólido (azitromicina o claritromicina) al ingreso. Objetivo: estimar el impacto presupuestario del uso de claritromicina como un macrólido de apoyo en el esquema de tratamiento empírico para pacientes con síndrome respiratorio agudo severo. Método: Análisis de impacto presupuestario. Perspectiva del Sistema Único de Salud, nivel local. Horizonte temporal de 5 años. Se utilizó la hoja de trabajo de análisis de impacto presupuestario brasileño Se analizaron tres escenarios alternativos y una referencia. Resultados: El costo a cinco años en el escenario de referencia fue de R $ 2.504.887,92. Conclusión: La incorporación de claritromicina en escenarios alternativos puede representar un costo incremental promedio de más del 22% del presupuesto disponible para la adquisición de azitromicina en 5 años, lo que puede ser económicamente inviable para ofrecer a todos los pacientes en hospitales, sin tener pérdida en el cumplimiento de otras demandas.

Introdução: No Brasil, o uso de cefalosporinas de terceira geração associadas a um macrolídeo (azitromicina ou claritromicina), tem sido recomendada na internação. Objetivo: Estimar o impacto orçamentário do uso da claritromicina como macrolídeo coadjuvante no esquema de tratamento empírico de pacientes com Síndrome Respiratória Aguda Grave. Método: Análise de Impacto Orçamentário. Perspectiva do Sistema Único de Saúde, nível local. Horizonte temporal de 5 anos.  Utilizou a Planilha Brasileira de Análise de Impacto Orçamentário. Analisados três cenários alternativos e um de referência. Resultados: O custo em cinco anos no cenário de referência foi de R$2.504.887,92. Conclusão: A incorporação da claritromicina nos cenários alternativos pode representar um custo incremental médio superior a 22% do orçamento disponível para a aquisição de azitromicina em  5 anos, o que podendo ser economicamente inviável a sua oferta para todos os pacientes nos hospital, sem que houvesse prejuízo no atendimento de outras demandas.

Nimotuzumab (CIMAher®) en pacientes cubanos con cáncer de cabeza y cuello estadios III/IV: Análisis de impacto presupuestario / Nimotuzumab (CIMAher®) in Cuban patients with head and neck cancer stage III/IV: Budget impact analysis

En Cuba, el cáncer es la segunda causa de muerte con 24.902 defunciones en el 2018; de ellas, 795 fueron por tumores de laringe y 826 por tumores de labio, cavidad bucal y faringe. El anticuerpo monoclonal nimotuzumab (CIMAher®) está registrado como tratamiento combinado con radioterapia o quimioterapia para el cáncer de células escamosas de cabeza y cuello estadios avanzados. Del mismo se conoce su efectividad y perfil de seguridad, no así el impacto económico que acarrearía la incorporación del mismo al Sistema Nacional de Salud (SNS) cubano; de forma tal de asignar y reajustar presupuestos en la esfera de medicamentos. Por tanto, se hizo necesario realizar un análisis de impacto presupuestario, con el objetivo de estimar el impacto financiero de la incorporación del nimotuzumab (CIMAher®) al paquete de beneficios del SNS cubano. Se tomaron los datos de prevalencia e incidencia de la enfermedad en los estadios III/IV. Se estableció un escenario actual con la terapia radio/quimioterapia secuencial y una tasa de penetración de 100%. El escenario futuro fue radio/quimioterapia secuencial + nimotuzumab (CIMAher®) con tasa anual de penetración 20, 40, 60, 80 y 100 por ciento. La perspectiva fue desde el SNS y un horizonte temporal de 5 años (2019-2023). El análisis de impacto presupuestal mostró que, desde perspectiva, horizonte y tasa de penetración establecidos, el SNS debe invertir aproximadamente de 10 a 65 millones de pesos cubanos (CUP); cifras menores al presupuesto destinado a salud pública(AU)

In Cuba, cancer is the second cause of death with 24,902 deaths in 2018; 795 were due to laryngeal tumors and 826 due to tumors of the lip, oral cavity and pharynx. The monoclonal antibody nimotuzumab (CIMAher®) is registered as a combined treatment with radiotherapy or chemotherapy for advanced squamous cell carcinoma of the head and neck. Its effectiveness and safety profile are known, but not their economic impact into the Cuban National Health System (NHS); in order to allocate and readjust budgets in the field of medicines. Therefore, it was necessary to perform a budget impact analysis in order to estimate the financial impact of the incorporation of nimotuzumab (CIMAher®) into the benefits package of the Cuban NHS. Data on prevalence and incidence of the disease in stages III / IV were taken into account. The current scenario was with the therapy radio/sequential chemotherapy and penetration rate of 100 percent. The future scenario was radio/sequential chemotherapy + nimotuzumab (CIMAher®) and annual penetration rate of 20, 40, 60, 80 and 100 percent. The perspective was from the NHS and a time horizon of five years (2019-2023). The budget impact analysis showed that from an established perspective, horizon and penetration rate, the NHS must invest 10-65 million Cuban pesos (CUP) approximately; lower values than the budget allocated to Public Health(AU)