RESUMO
BACKGROUND: Omadacycline is an oral and intravenous (IV) once-daily aminomethylcycline antibiotic that is approved in the United States for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI). It has broad-spectrum activity against common causative pathogens of ABSSSI, including methicillin-resistant Staphylococcus aureus. Omadacycline has been shown to be noninferior to linezolid for the treatment of adults with ABSSSI across 2 phase 3 clinical trials. To date, no studies have assessed the budget impact for omadacycline in the treatment of ABSSSI. OBJECTIVES: To estimate the potential budget impact of introducing omadacycline as a treatment option in patients who present to the emergency department (ED) with ABSSSI from the hospital perspective (Medicare payer) in the United States. The ED's and observation units were assumed to be hospital-owned. METHODS: The base case of this decision model-based analysis was conducted from the perspective of a hospital for a theoretical cohort of 1 million covered Medicare members over a 3-year time horizon. Scenario analyses included the economic impact of (1) shifting inpatient care to the outpatient setting with omadacycline and (2) reducing hospital length of stay (LOS) among hospitalized patients with omadacycline IV to oral therapy relative to the current inpatient standard of care. Costs are presented in 2017 US dollars with no adjustments for inflation, based on the cost model estimates. RESULTS: The annual total incremental cost following the introduction of omadacycline as a treatment of ABSSSI was $11,168, $39,918, and $88,777 in years 1, 2, and 3, respectively. The incremental cost per member treated (cost per case) rose by $0.49, $1.74, and $3.86 over 3 years. Reducing hospital LOS by 1 day among hospitalized patients with omadacycline resulted in incremental costs of $4311, $15,231, and $33,919 in years 1, 2, and 3, respectively. Under the assumption that patients may be discharged sooner when an oral formulation of the same drug with which they are being treated is available, reducing hospital LOS by 2 days reduced costs by $2546, $9455, and $20,939 in years 1, 2, and 3, respectively. Shifting inpatient care to the outpatient setting with omadacycline reduced costs by $38,777, $139,885, and $310,784 in years 1, 2, and 3, respectively. CONCLUSION: This hypothetical, model-based study determined that omadacycline would result in a modest increase in total cost over 3 years when introduced as a treatment for ABSSSI in adults who present to the ED for their care.
RESUMO
BACKGROUND: Community-acquired bacterial pneumonia (CABP) is an acute, lower respiratory bacterial infection. Despite advances in medical care, CABP remains associated with considerable morbidity, mortality, and healthcare costs; early empiric treatment is recommended by the Infectious Diseases Society of America and by the American Thoracic Society. Omadacycline is an oral and intravenous (IV) once-daily aminomethylcycline antibiotic that is approved in the United States for the treatment of adult patients with CABP. OBJECTIVE: To estimate the budget impact of introducing omadacycline as a treatment option among patients with suspected or documented CABP from a US hospital perspective. METHODS: A budget impact model was developed in Microsoft Excel® 2010. Population, clinical, and cost inputs were based on the available literature, clinical trial data, and real-world evidence databases. Emergency departments and observation units were assumed to be hospital-owned as part of the analyses. Sensitivity analyses assessed the impact of key parameters on the model results, and scenario analyses were explored to analyze the budget impact of reducing length of hospital stay and avoiding hospitalization. RESULTS: The introduction of omadacycline as a treatment resulted in a total budget increase of $20,643 over 3 years. This increase was mainly attributed to treatment acquisition costs. In a scenario where the length of hospital stay was reduced by 1 day (under the assumption that an antibiotic with IV and oral formulations can facilitate earlier discharge from inpatient care), the 3-year total budget decreased to $2384; reducing the hospital stay by 2 days resulted in 3-year cost-savings of $15,875. Shifting inpatient care to the outpatient setting with omadacycline resulted in 3-year cumulative cost-savings of $112,843. CONCLUSION: This is the first omadacycline budget impact model developed for adult patients with suspected or documented CABP. The model projected a modest budget increase with the introduction of omadacycline, mainly due to treatment acquisition costs.