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      Use of Oritavancin in Moderate-to-Severe ABSSSI Patients Requiring IV Antibiotics: A U.S. Payer Budget Impact Analysis

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          Abstract

          BACKGROUND:

          It is estimated that acute bacterial skin and skin structure infections (ABSSSI) account for nearly 10% of hospital admissions and 3.4-3.8 million emergency department visits per year in the United States. Analyses of hospital discharge records indicate 74% of ABSSSI admissions involve empiric treatment with methicillin-resistant Staphylococcus aureus (MRSA) active antibiotics. Analysis has shown that payer costs could be reduced if moderate-to-severe ABSSSI patients were treated to a greater extent in the observational unit followed by discharge to outpatient parenteral antibiotic therapy (OPAT). Oritavancin is a lipoglycopeptide antibiotic with bactericidal activity against gram-positive bacteria, including MRSA.

          OBJECTIVE:

          To estimate the impact on a U.S. payer's budget of using single-dose oritavancin in ABSSSI patients with suspected MRSA involvement who are indicated for intravenous antibiotics.

          METHODS:

          A decision analytic model based on current clinical practice was developed to estimate the economic value of decreased hospital resource consumption by using single-dose oritavancin over a 1-year time horizon. Use of antibiotics was informed by an analysis of the Premier Research Database. Demographic and clinical data were derived from a targeted literature review. Emergency department, observation, laboratory, and administration costs used were Medicare National Limitation amounts. Drug costs were 2014 wholesale acquisition costs.

          RESULTS:

          For a hypothetical U.S. payer with 1,000,000 members, it is expected that approximately 14,285 members per year will be diagnosed with ABSSSI severe enough to indicate intravenous antibiotics with MRSA activity. Based on this simulation, use of single-dose oritavancin in 26% of these patients was estimated to reduce the number of inpatient admissions, reduce length of stay for patients requiring admission, and reduce the number of days a patient needs to receive daily infusions in the OPAT clinic. The total patient days decreased from 171,125 to 133,435 with a total annual budget impact of -$12,550,000 or -$1.05 per member per month (PMPM). Total inpatient and outpatient costs were reduced by $9,970,000 (19.7%) and $2,580,000 (4.2%), respectively. Inpatient cost savings were derived from a reduction in admissions, length of stay, and lower drug administration burden. Outpatient costs were reduced by lower drug administration burden in the OPAT setting. A sensitivity analysis demonstrated that the model was most sensitive to population estimates.

          CONCLUSIONS:

          Use of single-dose oritavancin in moderate-to-severe ABSSSI patients, including those with suspected MRSA, was projected to deliver an estimated cost reduction to U.S. payers of $1.05 PMPM by avoiding hospitalization in appropriate patients and reducing outpatient costs associated with multiday parenteral antibiotic therapy.

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          Most cited references34

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          Methicillin-resistant S. aureus infections among patients in the emergency department.

          Methicillin-resistant Staphylococcus aureus (MRSA) is increasingly recognized in infections among persons in the community without established risk factors for MRSA. We enrolled adult patients with acute, purulent skin and soft-tissue infections presenting to 11 university-affiliated emergency departments during the month of August 2004. Cultures were obtained, and clinical information was collected. Available S. aureus isolates were characterized by antimicrobial-susceptibility testing, pulsed-field gel electrophoresis, and detection of toxin genes. On MRSA isolates, we performed typing of the staphylococcal cassette chromosome mec (SCCmec), the genetic element that carries the mecA gene encoding methicillin resistance. S. aureus was isolated from 320 of 422 patients with skin and soft-tissue infections (76 percent). The prevalence of MRSA was 59 percent overall and ranged from 15 to 74 percent. Pulsed-field type USA300 isolates accounted for 97 percent of MRSA isolates; 74 percent of these were a single strain (USA300-0114). SCCmec type IV and the Panton-Valentine leukocidin toxin gene were detected in 98 percent of MRSA isolates. Other toxin genes were detected rarely. Among the MRSA isolates, 95 percent were susceptible to clindamycin, 6 percent to erythromycin, 60 percent to fluoroquinolones, 100 percent to rifampin and trimethoprim-sulfamethoxazole, and 92 percent to tetracycline. Antibiotic therapy was not concordant with the results of susceptibility testing in 100 of 175 patients with MRSA infection who received antibiotics (57 percent). Among methicillin-susceptible S. aureus isolates, 31 percent were USA300 and 42 percent contained pvl genes. MRSA is the most common identifiable cause of skin and soft-tissue infections among patients presenting to emergency departments in 11 U.S. cities. When antimicrobial therapy is indicated for the treatment of skin and soft-tissue infections, clinicians should consider obtaining cultures and modifying empirical therapy to provide MRSA coverage. Copyright 2006 Massachusetts Medical Society.
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            Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children: executive summary.

            Evidence-based guidelines for the management of patients with methicillin-resistant Staphylococcus aureus (MRSA) infections were prepared by an Expert Panel of the Infectious Diseases Society of America (IDSA). The guidelines are intended for use by health care providers who care for adult and pediatric patients with MRSA infections. The guidelines discuss the management of a variety of clinical syndromes associated with MRSA disease, including skin and soft tissue infections (SSTI), bacteremia and endocarditis, pneumonia, bone and joint infections, and central nervous system (CNS) infections. Recommendations are provided regarding vancomycin dosing and monitoring, management of infections due to MRSA strains with reduced susceptibility to vancomycin, and vancomycin treatment failures.
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              National trends in ambulatory visits and antibiotic prescribing for skin and soft-tissue infections.

              Community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) has emerged as a common cause of skin and soft-tissue infections (SSTIs) in the United States. It is unknown whether this development has affected the national rate of visits to primary care practices and emergency departments (EDs) and whether changes in antibiotic prescribing have occurred. We examined visits by patients with SSTIs to physician offices, hospital outpatient departments, and EDs using the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey from 1997 to 2005. We estimated annual visit rates for all SSTIs and a subset classified as abscess/cellulitis. For abscess/cellulitis visits, we examined trends in characteristics of patients and clinical settings and in antibiotic prescribing. Overall rate of visits for SSTIs increased from 32.1 to 48.1 visits per 1000 population (50%; P = .003 for trend), reaching 14.2 million by 2005. More than 95% of this change was attributable to visits for abscess/cellulitis, which increased from 17.3 to 32.5 visits per 1000 population (88% increase; P < .001 for trend). The largest relative increases occurred in EDs (especially in high safety-net-status EDs and in the South), among black patients, and among patients younger than 18 years. Use of antibiotics recommended for CA-MRSA increased from 7% to 28% of visits (P < .001) during the study period. Independent predictors of treatment with these antibiotics included being younger than 45 years, living in the South, and an ED setting. The incidence of SSTIs has rapidly increased nationwide in the CA-MRSA era and appears to disproportionately affect certain populations. Although physicians are beginning to modify antibiotic prescribing practices, opportunities for improvement exist, targeting physicians caring for patients who are at high risk.
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                Author and article information

                Journal
                J Manag Care Spec Pharm
                J Manag Care Spec Pharm
                jmcsp
                Journal of Managed Care & Specialty Pharmacy
                Academy of Managed Care Pharmacy
                2376-0540
                2376-1032
                June 2016
                : 22
                : 6
                : 10.18553/jmcp.2016.22.6.752
                Affiliations
                [1 ]ICON Health Economics, Cambridge, Massachusetts.
                [2 ]Outcomes Research, The Medicines Company, Parsippany, New Jersey.
                [3 ]Albany College of Pharmacy and Health Sciences, Albany, New York.
                [4 ]Center for Anti-Infective Research & Development, Hartford Hospital, Hartford, Connecticut.
                [5 ]Pharmaceutical Services & Ambulatory Infusion Center, Beaumont Health System, Troy, Michigan.
                [6 ]Economics, Reimbursement & Market Access, The Medicines Company, Waltham, Massachusetts.
                Author notes
                [* ]AUTHOR CORRESPONDENCE: Katherine A. Sulham, MPH, The Medicines Company, 400 Fifth Ave., Waltham, MA 02451. Tel.: 781.48 7.5132; E-mail: kate.sulham@ 123456themedco.com .

                This work was funded by The Medicines Company. Jensen, Wu, and Cyr are employees of ICON Health Economics, which provides consulting services to the biopharmaceutical industry, including The Medicines Company. Fan and Sulman are employees and shareholders of The Medicines Company. Dufour and Lodise have provided consulting services to The Medicines Company. Nicolau provided model input but did not receive an honorarium for contributions on this project. Nicolau is a speaker for The Medicines Company.

                Study concept and design were contributed by Jensen and Wu, along with the other authors. Jensen, Wu, Fan, and Sulham collected the data, with assistance from Cyr. Data interpretation was performed by Sulham, Jensen, Wu, and Fan, assisted by Lodise, Nicolau, and Dufour. The manuscript was written by Jensen, Wu, and Sulham, with assistance from Cyr, and revised by Lodise, Nicolau, and Dufour, with assistance from the other authors.

                Article
                10.18553/jmcp.2016.22.6.752
                10397907
                27231802
                71769816-e1b5-4cc7-8988-adde70709039
                © 2016, Academy of Managed Care Pharmacy. All rights reserved.

                This article is licensed under a Creative Commons Attribution 4.0 International License, which permits unrestricted use and redistribution provided that the original author and source are credited.

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