ABSTRACT
Objetivos: Este estudo teve como objetivo avaliar desfechos clínico-econômicos associados à vacina contra influenza quadrivalente baseada em células (QIVc) versus a vacina trivalente atualmente utilizada (TIVe) para prevenção sazonal de influenza no Programa Nacional de Imunizações (PNI) brasileiro. Métodos: Um modelo estático de árvore de decisão foi usado. Considerou-se um total de 54.071.642 indivíduos vacinados em 2019; a circulação de influenza por subtipo foi baseada em dados de vigilância epidemiológica. A efetividade da vacina (EV) TIVe foi extraída de metanálises publicadas; já a EV relativa da QIVc foi retirada de um estudo observacional retrospectivo. A incompatibilidade antigênica da vacina com vírus circulantes foi baseada em fontes retrospectivas internacionais. O uso de recursos baseou-se em estudos do mundo real. Custos unitários foram retirados de tabelas-padrão publicados em 2019 em reais (BRL). Resultados: Substituir a TIVe pela QIVc pode evitar, anualmente, casos sintomáticos (452.065) e reduzir visitas ambulatoriais (118.735), hospitalizações (15.466), mortes (2.753), custos médicos (-BRL 46.677.357) e custos indiretos (-BRL 59.962.135). O número anual de anos de vida ajustados por qualidade de vida (QALYs) pode aumentar em 96.129. Resultados de base a partir da perspectiva do pagador mostram uma razão de custo-efetividade incremental (RCEI) de BRL 17.293/QALY e, da perspectiva da sociedade, o RCEI obtido foi de um ganho de BRL 16.669/QALY. Usando o Produto Interno Bruto (PIB) brasileiro como um limiar (BRL 34.533/QALY), trocar a TIVe pela QIVc no PNI pode ser uma estratégia altamente custo-efetiva. Conclusões: O uso da QIVc pelo PNI tem potencial para ser altamente custo-efetivo tanto da perspectiva do pagador quanto da sociedade
Objectives: This study aimed to estimate health and economic outcomes associated to cell-based quadrivalent influenza vaccine (QIVc) versus current trivalent influenza vaccines (TIVe) for seasonal influenza prevention in the Brazilian National Immunization Program (NIP), from the societal and public payer perspectives. Methods: A 1-year static decision-tree model based on literature was used. 54,071,642 total vaccinated individuals in 2019 were considered; influenza subtype circulation was based on Brazilian epidemiologic data (2009-2019). TIVe vaccine effectiveness (VE) was extracted from a published meta-analysis and QIVc relative VE from an international retrospective observational study. A/H3N2 egg-adaptation and B mismatch to recommended strain were gathered from international retrospective sources. Resource use was obtained from real-world studies. Inputs were adjusted to influenza subtype and multiple age groups with Brazilian literature. Unit costs were retrieved from published standard tables in 2019 Brazilian Reais (BRL). Results: Replacing TIVe with QIVc, can annually avert symptomatic cases (452,065) and reduce outpatient visits (118,735); hospitalizations (15,466), deaths (2,753), overall medical direct costs (-BRL 46,677,357) and indirect costs (-BRL 59,962,135). The annual number of quality-adjusted life-years (QALYs) could be increased by 96,129. Base case results from the payer perspective show an incremental cost-effectiveness ratio (ICER) of BRL 17,293/QALY gained and from the societal perspective the ICER obtained was BRL 16,669/QALY gained. Using the Brazilian Gross Domestic Product (GDP) as a threshold (BRL 34,533/QALY) switching TIVe with QIVc in the NIP can be a highly cost-effective strategy, leading to a high QALY increment and preventing medical and indirect costs. Conclusions: The use of QIVc by the NIP has the potential to be highly cost-effective in the payer and society perspective
Subject(s)
Influenza Vaccines , Immunization Programs , Cost-Effectiveness AnalysisABSTRACT
Abstract Background: In Brazil, we are facing an alarming epidemic scenario of Yellow fever (YF), which is reaching the most populous areas of the country in unvaccinated people. Vaccination is the only effective tool to prevent YF. In special situations, such as patients with chronic immune-mediated inflammatory diseases (CIMID), undergoing immunosuppressive therapy, as a higher risk of severe adverse events may occur, assessment of the risk-benefit ratio of the yellow fever vaccine (YFV) should be performed on an individual level. Main body of the abstract: Faced with the scarcity of specific orientation on YFV for this special group of patients, the Brazilian Rheumatology Society (BRS) endorsed a project aiming the development of individualized YFV recommendations for patients with CIMID, guided by questions addressed by both medical professionals and patients, followed an internationally validated methodology (GIN-McMaster Guideline Development). Firstly, a systematic review was carried out and an expert panel formed to take part of the decision process, comprising BRS clinical practitioners, as well as individuals from the Brazilian Dermatology Society (BDS), Brazilian Inflammatory Bowel Diseases Study Group (GEDIIB), and specialists on infectious diseases and vaccination (from Tropical Medicine, Infectious Diseases and Immunizations National Societies); in addition, two representatives of patient groups were included as members of the panel. When the quality of the evidence was low or there was a lack of evidence to determine the recommendations, the decisions were based on the expert opinion panel and a Delphi approach was performed. A recommendation was accepted upon achieving ≥80% agreement among the panel, including the patient representatives. As a result, eight recommendations were developed regarding the safety of YFV in patients with CIMID, considering the immunosuppression degree conferred by the treatment used. It was not possible to establish recommendations on the effectiveness of YFV in these patients as there is no consistent evidence to support these recommendations. Conclusion: This paper approaches a real need, assessed by clinicians and patient care groups, to address specific questions on the management of YFV in patients with CIMID living or traveling to YF endemic areas, involving specialists from many areas together with patients, and might have global applicability, contributing to and supporting vaccination practices. We recommended a shared decision-making approach on taking or not the YFV.