Cost-Effectiveness Analysis of Bezlotoxumab Added to Standard of Care Versus Standard of Care Alone for the Prevention of Recurrent Clostridium difficile Infection in High-Risk Patients in Spain

Fecha de publicación: 01/11/2018

Autores de IIS La Fe

Miguel Salavert Lletí

Autor

Participantes ajenos a IIS La Fe

Cobo, J
Pascual, A
Aragon, B
Maratia, S
Jiang, YL
Aceituno, S
Grau, S

Grupos

Infección Grave

Investigador Principal

María Ángeles Tormo Mas

Abstract

IntroductionClostridium difficile infection (CDI) is the major cause of infectious nosocomial diarrhoea and is associated with considerable morbidity, mortality and economic impact. Bezlotoxumab administered in combination with standard of care (SoC) antibiotic therapy prevents recurrent CDI. This study assessed the cost-effectiveness of bezlotoxumab added to SoC, compared to SoC alone, to prevent the recurrence of CDI in high-risk patients from the Spanish National Health System perspective.MethodsA Markov model was used to simulate the natural history of CDI over a lifetime horizon in five populations of patients at high risk of CDI recurrence according to MODIFY trials: (1)65years old; (2) severe CDI; (3) immunocompromised; (4)1 CDI episode in the previous 6months; and (5)65years old and with1 CDI episode in the previous 6months. The incremental cost-effectiveness ratio (ICER) expressed as cost per quality-adjusted life-year (QALY) gained was calculated. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were performed.ResultsIn all patient populations (from 1 to 5), bezlotoxumab added to SoC reduced CDI recurrence compared to SoC alone by 26.4, 19.5, 21.2, 26.6 and 39.7%, respectively. The resulting ICERs for the respective subgroups were Euro12,724, Euro17,495, Euro9545, Euro7386, and Euro4378. The model parameters with highest impact on the ICER were recurrence rate (first), mortality, and utility values. The probability that bezlotoxumab was cost-effective at a willingness-to-pay threshold of Euro21,000/QALY was 85.5%, 54.1%, 86.0%, 94.5%, 99.6%, respectively.ConclusionThe results suggest that bezlotoxumab added to SoC compared to SoC alone is a cost-effective treatment to prevent the recurrence of CDI in high-risk patients. The influence of changes in model parameters on DSA results was higher in patients 65years old, with severe CDI and immunocompromised. Additionally, PSA estimated that the probability of cost-effectiveness exceeded 85% in most subgroups.FundingMerck Sharp & Dohme Corp.

Datos de la publicación

ISSN/ISSNe:: 0741-238X, 1865-8652
Tipo:: Article
Páginas:: 1920-1934
DOI:: 10.1007/s12325-018-0813-y
Factor de Impacto:: 1,037 SCImago ℠
Cuartil:: Q1 SCImago ℠

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Filiaciones

Salavert, M:: Hosp Univ La Fe, Infect Dis Unit, Valencia, Spain
Cobo, J:: Hosp Univ Ramon & Cajal, IRYCIS, Dept Infect Dis, Madrid, Spain
Pascual, A:: Univ Seville, Inst Biomed Sevilla IBIS, Hosp Univ Virgen Macarena, Clin Microbiol & Infect Dis Unit, Seville, Spain
Aragon, B:: Merck Sharp & Dohme Corp, Madrid, Spain
Maratia, S:: Chiltern Int Spain, Madrid, Spain
Jiang, YL:: Merck Sharp & Dohme Ltd, Hoddesdon, Herts, England
Aceituno, S:: Outcomes 10, Castellon de La Plana, Spain
Grau, S:: Univ Autonoma Barcelona, Hosp del Mar, Dept Pharm, Barcelona, Spain