Cost-effectiveness of Bezlotoxumab Compared With Placebo for the Prevention of Recurrent Clostridium difficile Infection

Clin Infect Dis. 2018 Jan 18;66(3):355-362. doi: 10.1093/cid/cix809.

Abstract

Background: Clostridium difficile infection (CDI) is the most commonly recognized cause of recurrent diarrhea. Bezlotoxumab, administered concurrently with antibiotics directed against C. difficile (standard of care [SoC]), has been shown to reduce the recurrence of CDI, compared with SoC alone. This study aimed to assess the cost-effectiveness of bezlotoxumab administered concurrently with SoC, compared with SoC alone, in subgroups of patients at risk of recurrence of CDI.

Methods: A computer-based Markov health state transition model was designed to track the natural history of patients infected with CDI. A cohort of patients entered the model with either a mild/moderate or severe CDI episode, and were treated with SoC antibiotics together with either bezlotoxumab or placebo. The cohort was followed over a lifetime horizon, and costs and utilities for the various health states were used to estimate incremental cost-effectiveness ratios (ICERs). Both deterministic and probabilistic sensitivity analyses were used to test the robustness of the results.

Results: The cost-effectiveness model showed that, compared with placebo, bezlotoxumab was associated with 0.12 quality-adjusted life-years (QALYs) gained and was cost-effective in preventing CDI recurrences in the entire trial population, with an ICER of $19824/QALY gained. Compared with placebo, bezlotoxumab was also cost-effective in the subgroups of patients aged ≥65 years (ICER of $15298/QALY), immunocompromised patients (ICER of $12597/QALY), and patients with severe CDI (ICER of $21430/QALY).

Conclusions: Model-based results demonstrated that bezlotoxumab was cost-effective in the prevention of recurrent CDI compared with placebo, among patients receiving SoC antibiotics for treatment of CDI.

Keywords: C. difficile infection; Markov model; bezlotoxumab; cost-effectiveness.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anti-Bacterial Agents / economics
  • Anti-Bacterial Agents / therapeutic use*
  • Antibodies, Monoclonal / economics
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Neutralizing / economics
  • Antibodies, Neutralizing / therapeutic use*
  • Broadly Neutralizing Antibodies
  • Clostridioides difficile / drug effects
  • Clostridium Infections / economics
  • Clostridium Infections / mortality
  • Clostridium Infections / prevention & control*
  • Cohort Studies
  • Cost-Benefit Analysis
  • Female
  • Humans
  • Male
  • Markov Chains
  • Middle Aged
  • Quality-Adjusted Life Years
  • Recurrence
  • Secondary Prevention / economics
  • Vancomycin / economics
  • Vancomycin / therapeutic use

Substances

  • Anti-Bacterial Agents
  • Antibodies, Monoclonal
  • Antibodies, Neutralizing
  • Broadly Neutralizing Antibodies
  • bezlotoxumab
  • Vancomycin