US-Focused Conceptual Health Care Decision-Analytic Models Examining the Value of Pivmecillinam Relative to Current Standard-of-Care Agents Among Adult Patients With Uncomplicated Urinary Tract Infections due to Enterobacterales.

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dc.contributor.authorLodise, Thomas P
dc.contributor.authorHenriksen, Anne Santerre
dc.contributor.authorHadley, Thomas
dc.contributor.authorPatel, Nimish
dc.contributor.orcidhttps://orcid.org/0000-0002-4730-0655
dc.date.accessioned2025-02-11T19:49:22Z
dc.date.available2025-02-11T19:49:22Z
dc.date.issued2021-10
dc.description.abstractBackground: Pivmecillinam is approved for the treatment of adults with uncomplicated urinary tract infection (uUTI) in Canada and Europe and is pending United States (US) Food and Drug Administration submission for consideration for approval. US-focused health care decision-analytics were developed to define the value of an agent like pivmecillinam relative to current standard-of-care (SOC) agents among adult patients with Enterobacterales uUTIs based on its improved microbiologic activity against common Enterobacterales. Methods: The model population was 100 theoretical adult outpatients with Enterobacterales uUTIs under 4 different uUTI first-line empiric treatment scenarios (ie, pivmecillinam, nitrofurantoin, trimethoprim-sulfamethoxazole [SXT], or fluoroquinolones). The total mean uUTI-related 30-day costs, including inappropriate treatment costs, were calculated for each regimen. The range of pivmecillinam regimen costs that conferred cost savings relative to the current SOC agents based on its potentially improved microbiologic activity against common Enterobacterales was determined. Results: The 30-day uUTI-related costs associated with nitrofurantoin, SXT, and fluoroquinolones were $655.61, $687.57, and $659.69, respectively. The pivmecillinam neutral regimen cost thresholds that resulted in the same uUTI-related 30-day per-patient costs for nitrofurantoin, SXT, and fluoroquinolones were $83.50, $115.45, and $87.58, respectively. The overall antimicrobial susceptibility improvement required with pivmecillinam fixed at $200/regimen, for it to be cost savings relative to SOC agents, was 28%. Conclusions: The analyses suggests that an agent like pivmecillinam, if approved in the US, has the potential to reduce the economic burden associated with inappropriate treatment of adult outpatients with uUTIs, especially in patients at high risk for an Enterobacterales uUTI that is resistant to SOC agents.
dc.description.urihttps://doi.org/10.1093/ofid/ofab380
dc.description.urihttp://www.ncbi.nlm.nih.gov/pmc/articles/pmc8516593
dc.identifier.citationLodise TP, Henriksen AS, Hadley T, Patel N. US-Focused Conceptual Health Care Decision-Analytic Models Examining the Value of Pivmecillinam Relative to Current Standard-of-Care Agents Among Adult Patients With Uncomplicated Urinary Tract Infections due to Enterobacterales. Open Forum Infect Dis. 2021 Oct 15;8(10):ofab380. doi: 10.1093/ofid/ofab380. PMID: 34660834; PMCID: PMC8516593.
dc.identifier.issn2328-8957
dc.identifier.other34660834
dc.identifier.urihttps://hdl.handle.net/20.500.14303/865
dc.language.isoen
dc.publisherOxford University Press
dc.relation.ispartofOpen Forum Infectious Diseases
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dc.subjectUTI
dc.subjectmodeling
dc.subjectoutcomes
dc.subjectpivmecillinam
dc.subjecttreatment
dc.titleUS-Focused Conceptual Health Care Decision-Analytic Models Examining the Value of Pivmecillinam Relative to Current Standard-of-Care Agents Among Adult Patients With Uncomplicated Urinary Tract Infections due to Enterobacterales.
dc.typeArticle
local.departmentprogramDepartment of Pharmacy Practice
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