Bezlotoxumab, A Cost-Effective Option for At-Risk C. difficile Patients

study author, Vimalanand Prabhu, M.Mgmt, Ph.D. associate principal scientist, Merck

Vimalanand Prabhu, M.Mgmt, PhD

According to a new report, bezlotoxumab is a cost-effective treatment for the prevention of recurrent Clostridium difficile (C. difficile) infections.

Researchers from Merck & Co. in Kenilworth, N.J., observed a group of patients with mild to moderate C. difficile infection in order to assess the cost-effectiveness of bezlotoxumab concurrently with the standard of care. The researchers then compared the bezlotoxumab treated patients to those who received standard care alone, in groups categorized by risk of recurrent C. difficile infection. The study author added that in the past, bezlotoxumab has demonstrated the ability to reduce C. difficile infection recurrence when used concurrently with antibiotics.

In the study, patients were either treated with standard of care antibiotics plus either bezlotoxumab or a placebo. The researchers followed the cohort over their lifetime to monitor patients’ costs and overall health.

Using bezlotoxumab reduced the first recurrence by 10.1%, the researchers observed and reduced overall recurrences by 16.7%. The 180-day mortality was decreased by 1.1%, the study authors added.

The researchers also estimated that their discounted incremental costs were about $2,444 per patient who received bezlotoxumab. The drug was also associated with a 0.12 quality-adjusted life-years gained.

Bezlotoxumab was also cost effective for the prevention of C. difficile infection, as demonstrated by the incremental cost effectiveness ratios that showed $19,824 quality adjusted life years gained. Compared to placebo plus standard care, the use of bezlotoxumab was also cost effective among the following patient subgroups: those aged 65 years or older (who saw an incremental cost effectiveness ratio of $15,298 quality adjusted life years); immunocompromised patients (an incremental cost effectiveness ratio of $12,597 quality adjusted life years); and patients with severe cases of C. difficile infection (the biggest incremental cost effectiveness ratio, at $21,430 quality adjusted life years).

Because of the observation that the incremental cost effectiveness ratio was lower for some of the subgroups with the highest risk for recurrent infection, as listed, than for the entire clinical trial population, the researchers concluded that the drug was more likely to be cost effective for patients who probably need it the most, study author Vimalanand Prabhu explained to MD Magazine.

“If a physician thinks a patient is at high risk for recurrent C. difficile infection, then she or he should consider using this drug to lower the risk of recurrent C. difficile infection,” Dr. Prabhu said.

Another point of the study is that the researchers showed the MODIFY I/II trials, where the cohort came from, may have underestimated the numbers needed to treat to prevent an episode of recurrent C. difficile infection, Dr. Prabhu added.

“In reality, patients who experience a recurrence may have subsequent recurrent episodes, which are captured in our model and may need further evaluation through well-designed clinical trials or real-world cohort analysis,” he concluded.

The paper, titled “Cost-effectiveness of Bezlotoxumab Compared With Placebo for the Prevention of Recurrent Clostridium difficile Infection,” was published in the journal Clinical Infectious Diseases.

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