Decision Analysis: Omadacycline Relative to Moxifloxacin Among Hospitalized Community-Acquired Bacterial Pneumonia Patients at Risk of Clostridioides difficile Infection

Abstract

Background and Objective

Omadacycline is an aminomethylcycline antibiotic approved in the USA as once-daily intravenous/oral monotherapy for adults with community-acquired bacterial pneumonia (CABP). Omadacycline demonstrated noninferiority to the fluoroquinolone moxifloxacin in a phase III CABP trial; adverse-event rates were similar between treatment groups except for Clostridioides difficile infection (CDI), which occurred in 2% of moxifloxacin-treated patients and 0% of patients on omadacycline. Conceptual healthcare-decision analytic models were developed to better understand the economic implications of antibiotic selection and CDI risk in acute-care facilities.

Methods

A conceptual healthcare-decision analytic model was created to estimate incremental costs associated with treating 100 hospitalized CABP patients with an initial 5-day inpatient regimen of omadacycline instead of moxifloxacin. The underlying model assumption was that treatment with omadacycline has the potential to reduce CDI events relative to moxifloxacin. The model included excess costs associated with each treatment group from admission through discharge. Attributable CDI cost per case in the moxifloxacin group varied from $15,000 to $45,000 (US$). Omadacycline acquisition cost was $300–600/day for 5 days.

Results

At a CDI attributable cost per case of $30,000 (base-case analyses), the incremental treatment cost (US$) per 100 patients ranged from $300,000 to $− 120,000 (cost savings). The excess CDI incidence in moxifloxacin-treated patients would need to be 5–10% for omadacycline to be cost-saving, assuming the attributable CDI cost is approximately $30,000.

Conclusion

Targeted omadacycline use may reduce economic burden associated with hospitalized CABP patients treated with moxifloxacin if it can reduce excess cases of moxifloxacin-associated CDI.

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Acknowledgements

The authors thank the PAREXEL Access RWE team, who provided real-world data used in this study. Medical editorial assistance, funded by Paratek Pharmaceuticals, Inc., was provided by Holly Tomlin, MPH, CMPP for Innovative Strategic Communications.

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Correspondence to Thomas P. Lodise.

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Funding

This work was supported by Paratek Pharmaceuticals, Inc.

Conflict of interest

KLP is a former employee of Paratek Pharmaceuticals, Inc. TL and KLP have been employed as consultants by Paratek Pharmaceuticals, Inc. RM and KY are former employees of PAREXEL, which provided consulting services to Paratek Pharmaceuticals, Inc.

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Data availability

Paratek Pharmaceuticals has a commitment to ensure that access to clinical trial data is available to regulators, researchers, and trial participants, when permitted, feasible and appropriate. Requests for de-identified patient-level data may be submitted to medinfo@paratekpharma.com for review.

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Author contributions

TPL generated the study concept; was involved in developing the model structure, inputs, and outputs; and participated in manuscript writing, preparation, and publication. RM and KY developed the analysis, interpreted the data, and revised and reviewed the manuscript. KLP developed the decision models and performed the decision analysis; and participated in manuscript writing, preparation, and publication. All authors approved the final version.

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Lodise, T.P., Mistry, R., Young, K. et al. Decision Analysis: Omadacycline Relative to Moxifloxacin Among Hospitalized Community-Acquired Bacterial Pneumonia Patients at Risk of Clostridioides difficile Infection. Clin Drug Investig (2021). https://doi.org/10.1007/s40261-021-01005-w

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