Evidence map›Paper›PMID 30328061›Full record

ArticleAdvances in therapy2018

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.

Miguel Salavert, Javier Cobo, Álvaro Pascual, Belén Aragón, Stefano Maratia, Yiling Jiang, Susana Aceituno, Santiago Grau

Open access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.6field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 19 citations in OpenAlex.

  1. Encapsulation protocol for fecal microbiota transplantation.Frontiers in cellular and infection microbiology · 2024
    Article
  2. Review
  3. Review
  4. The Role of Bezlotoxumab for the Prevention of RecurrentAntibiotics (Basel, Switzerland) · 2022
    Review
  5. Cost-effectiveness of bezlotoxumab and fidaxomicin for initial Clostridioides difficile infection.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2021
    Article
  6. Article
  7. Journal of clinical medicine · 2021
    Review
  8. Review
  9. Doctor, my patient has CDI and should continue to receive antibiotics. The (unresolved) risk of recurrent CDI.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2019
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 7 institutions in 2 countries.

Miguel SalavertInfectious Diseases Unit, Hospital Universitario La Fe, Valencia, Spain. salavert_mig@gva.es.
Javier CoboInfectious Diseases Department, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain.
Álvaro PascualClinical Microbiology and Infectious Diseases Unit, Hospital Universitario Virgen Macarena, Instituto de Biomedicina de Sevilla (IBIS), Universidad de Sevilla, Seville, Spain.
Belén AragónMerck Sharp & Dohme Corp, Madrid, Spain.
Stefano MaratiaChiltern International Spain, Madrid, Spain.
Yiling JiangMerck Sharp & Dohme Ltd, Hoddesdon, Hertfordshire, UK.
Susana AceitunoOutcomes'10, Castellón de la Plana, Spain.
Santiago GrauPharmacy Department, Hospital del Mar, Universidad Autónoma de Barcelona, Barcelona, Spain.
Consorcio Hospitalario Provincial de Castellón · ESHospital Universitari i Politècnic La Fe · ESInstituto Ramón y Cajal de Investigación Sanitaria · ESMSD (Spain) · ESMSD (UK) Limited (United Kingdom) · GBUniversidad de Sevilla · ESUniversitat Autònoma de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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) ≥ 65 years old; (2) severe CDI; (3) immunocompromised; (4) ≥ 1 CDI episode in the previous 6 months; and (5) ≥ 65 years old and with ≥ 1 CDI episode in the previous 6 months. 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 €12,724, €17,495, €9545, €7386, and €4378. 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 €21,000/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  ≥ 65 years old, with severe CDI and immunocompromised. Additionally, PSA estimated that the probability of cost-effectiveness exceeded 85% in most subgroups.

fundingMerck Sharp & Dohme Corp.

Indexed as

Antibodies, MonoclonalAntibodies, NeutralizingClostridioides difficileClostridium InfectionsSecondary PreventionAgedAnti-Bacterial AgentsBroadly Neutralizing AntibodiesCost-Benefit AnalysisDrug Therapy, CombinationFemaleHealth Care CostsHumansMaleMiddle AgedSpainAnti-Bacterial AgentsAntibodies, MonoclonalAntibodies, NeutralizingbezlotoxumabBroadly Neutralizing AntibodiesBezlotoxumabClostridium difficile infectionCost-effectiveness

Identifiers

PMID30328061
PMCPMC6223985
OpenAlexW2897125298

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.