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Budget Impact of Omadacycline for the Treatment of Patients with Community-Acquired Bacterial Pneumonia in the United States from the Hospital Perspective.

ABSTRACT: 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.

SUBMITTER: LaPensee K

PROVIDER: S-EPMC6442092 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Budget Impact of Omadacycline for the Treatment of Patients with Community-Acquired Bacterial Pneumonia in the United States from the Hospital Perspective.

LaPensee Kenneth K Mistry Rohit R Lodise Thomas T

American health & drug benefits 20190201 1-Supplement 1

<h4>Background</h4>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 treatmen ...[more]

PMID: 30996766

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Project description:ObjectivesMultiple randomized controlled trials exploring the outcomes of patients with ventilator-associated bacterial pneumonia and hospital-acquired bacterial pneumonia have noted that hospital-acquired bacterial pneumonia patients who require subsequent ventilated hospital-acquired bacterial pneumonia suffered higher mortality than either those who did not (nonventilated hospital-acquired bacterial pneumonia) or had ventilator-associated bacterial pneumonia. We examined the epidemiology and outcomes of all three conditions in a large U.S. database.DesignRetrospective cohort.SettingTwo hundred fifty-three acute-care hospitals, United States, contributing data (including microbiology) to Premier database, 2012-2019.PatientsPatients with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia identified based on a slightly modified previously published International Classification of Diseases, 9th Edition/International Classification of Diseases, 10th Edition-Clinical Modification algorithm.InterventionsNone.Measurements and main resultsAmong 17,819 patients who met enrollment criteria, 26.5% had nonventilated hospital-acquired bacterial pneumonia, 25.6% vHAPB, and 47.9% ventilator-associated bacterial pneumonia. Ventilator-associated bacterial pneumonia predominated in the Northeastern United States and in large urban teaching hospitals. Patients with nonventilated hospital-acquired bacterial pneumonia were oldest (mean 66.7 ± 15.1 yr) and most likely White (76.9%), whereas those with ventilator-associated bacterial pneumonia were youngest (59.7 ± 16.6 yr) and least likely White (70.3%). Ventilated hospital-acquired bacterial pneumonia was associated with the highest comorbidity burden (mean Charlson score 4.1 ± 2.8) and ventilator-associated bacterial pneumonia with the lowest (3.2 ± 2.5). Similarly, hospital mortality was highest among patients with ventilated hospital-acquired bacterial pneumonia (29.2%) and lowest in nonventilated hospital-acquired bacterial pneumonia (11.7%), with ventilator-associated bacterial pneumonia in-between (21.3%). Among survivors, 24.5% of nonventilated hospital-acquired bacterial pneumonia required a rehospitalization within 30 days of discharge, compared with 22.5% among ventilated hospital-acquired bacterial pneumonia and 18.8% ventilator-associated bacterial pneumonia. Unadjusted hospital length of stay after infection onset was longest among ventilator-associated bacterial pneumonia and shortest among nonventilated hospital-acquired bacterial pneumonia patients. Median total hospital costs mirrored length of stay: ventilator-associated bacterial pneumonia $77,657, ventilated hospital-acquired bacterial pneumonia $62,464, and nonventilated hospital-acquired bacterial pneumonia $39,911.ConclusionsBoth hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia remain associated with significant mortality and cost in the United States. Our analyses confirm that of all three conditions, ventilated hospital-acquired bacterial pneumonia carries the highest risk of death. In contrast, ventilator-associated bacterial pneumonia remains most costly. Nonventilated hospital-acquired bacterial pneumonia survivors were most likely to require a readmission within 30 days of discharge.

Project description:BackgroundA paucity of studies have assessed the epidemiology of community-acquired pneumonia (CAP) that require ICU admission. We conducted a study on this group of patients with the primary objective of defining the incidence, epidemiology, and mortality rate of CAP in the ICUs in Louisville, Kentucky. The secondary objective was to estimate the number of patients who were hospitalized and the number of deaths that were associated with CAP in ICU in the United States.Research questionsWhat is epidemiology of CAP in the ICU in Louisville, Kentucky, and the projected incidence in the United States?Study design and methodsThis was a secondary analysis of a prospective population-based cohort study. The setting was all nine adult hospitals in Louisville, Kentucky. The annual incidence of CAP in the ICU per 100,000 adults was calculated for the whole adult population of Louisville. The number of patients who were hospitalized because of CAP in ICU in the United States was estimated by multiplying the Louisville incidence rate of CAP in ICU by the 2014 US adult population.ResultsFrom a total of 7,449 unique patients who were hospitalized with CAP, 1,707 patients (23%) were admitted to the ICU. The incidence of CAP in the ICU was 145 cases per 100,000 population of adults. Cases of CAP in the ICU were clustered in patients from areas of the city with high poverty. The mortality rate of patients with CAP in ICU was 27% at 30 days and 47% at one year. In the United States, the estimated number of patients who were hospitalized with CAP requiring the ICU was 356,326 per year, and the estimated number of deaths at 30 days and one year were 96,206 and 167,474, respectively.InterpretationAlmost one in five patients who are hospitalized with CAP requires intensive care. Poverty is associated with CAP in the ICU. Nearly one-half of patients with CAP in the ICU will die within one year. Because of its significant burden, CAP in the ICU should be a high priority in research agenda and health policy.

Project description:BackgroundSeverity/mortality risk scores and disease characteristics may assist in deciding whether patients with community-acquired bacterial pneumonia (CABP) require outpatient treatment or hospitalization. The phase 3 OPTIC (Omadacycline for Pneumonia Treatment In the Community) study enrolled patients with Pneumonia Outcomes Research Team (PORT) risk class II-IV. Omadacycline demonstrated noninferiority to moxifloxacin in adults with CABP, at early clinical response (ECR) and posttreatment evaluation (PTE). We assessed efficacy of omadacycline versus moxifloxacin in these patients based on disease severity.MethodsPatients were randomized 1:1 to receive intravenous (IV) omadacycline (100 mg every 12 hours for 2 doses followed by 100 mg daily [q24h], with optional transition to omadacycline 300 mg orally q24h after 3 days of IV treatment) or moxifloxacin IV 400 mg q24h (with optional transition to 400 mg orally q24h after 3 days of IV treatment). Total treatment duration was 7-14 days. We compared rates of early clinical success (72-120 hours after first dose) and investigator-assessed clinical success at PTE (5-10 days after last dose) in subgroups based (1) on severity/mortality risk scores (PORT, CURB-65, systemic inflammatory response syndrome, quick Sequential [Sepsis-related] Organ Failure Assessment, modified ATS, SMART-COP) and (2) on presence of baseline radiographic characteristics, chronic obstructive pulmonary disease (COPD)/asthma, or bacteremia.ResultsAltogether, 774 patients (omadacycline, n = 386; moxifloxacin, n = 388) were randomized. Clinical success rates (ECR/PTE) were similar between treatment groups (across all subgroups). Efficacy across treatment groups was similar in patients with baseline radiographic characteristics or COPD/asthma, but moxifloxacin had higher clinical success rates in patients with bacteremia.ConclusionsEfficacy of omadacycline was similar to that of moxifloxacin, regardless of disease severity/mortality risk and disease characteristics.

Project description:IntroductionThe 2019 American Thoracic Society/Infectious Disease Society of America guidelines recommend respiratory fluoroquinolones to treat community-acquired bacterial pneumonia (CABP) in adults with comorbidities. Fluoroquinolones are effective against both typical and atypical pathogens. However, fluoroquinolone treatment has a risk of adverse effects, and the Food and Drug Administration has issued black box safety warnings for their use. Inpatient use of fluoroquinolones has reduced as a result; however, most antibiotic courses are completed as outpatients and discharge prescriptions account for the majority of fluoroquinolone use. As such, a new treatment option is needed to replace fluoroquinolones. Omadacycline is an aminomethylcycline antibiotic with a broad spectrum of activity and is available as a once-daily intravenous or bioequivalent oral formulation.MethodsThis study assessed the safety and clinical efficacy of omadacycline compared with moxifloxacin for the treatment of adult CABP patients with Pneumonia Severity Index (PSI) risk class II/III and ≥1 comorbidity through a post-hoc analysis of the phase 3 OPTIC study (NCT02531438).ResultsIn total, 239 omadacycline- and 222 moxifloxacin-treated patients were assessed. The median age was similar between groups (omadacycline: 57 years; moxifloxacin: 58 years), with 26.0% and 26.6%, respectively, ≥65 years of age. Early clinical response was 91.6% for patients with ≥1 comorbidity treated with omadacycline and 91.4% for those treated with moxifloxacin. Post-treatment evaluation results for overall response were 89.1% in the omadacycline group and 87.4% in the moxifloxacin group.ConclusionSafety warnings have reduced inpatient use of fluoroquinolones; however, outpatient and discharge prescriptions account for the majority of fluoroquinolone use. Outpatients with comorbidities need an efficacious alternative to fluoroquinolones. Omadacycline maintains the similar efficacy and benefits of fluoroquinolones as a once-daily, monotherapy, bioequivalent oral option with potent in vitro activity against the most common CABP pathogens, including S. pneumoniae and atypical pathogens, but offers a materially different safety profile consistent with its tetracycline heritage. In conclusion, both omadacycline and moxifloxacin exhibited similar efficacy in patients with PSI risk class II/III and comorbidities. Omadacycline fulfills an unmet need as an oral monotherapy treatment option for adult patients with CABP, which will further reduce the use of fluoroquinolones.Clinical trial registrationhttps://www.clinicaltrials.gov/study/NCT02531438, identifer: NCT02531438; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-004071-13, identifier: EudraCT #2013-004071-13.

Dataset Information

Budget Impact of Omadacycline for the Treatment of Patients with Community-Acquired Bacterial Pneumonia in the United States from the Hospital Perspective.

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Budget Impact of Omadacycline for the Treatment of Patients with Community-Acquired Bacterial Pneumonia in the United States from the Hospital Perspective.

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