Clinical Benefits and Budget Impact of Lenzilumab plus Standard of Care Compared with Standard of Care Alone for the Treatment of Hospitalized Patients with COVID-19 in the United States from the Hospital Perspective
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Abstract
The study estimated the clinical benefits and budget impact of lenzilumab plus standard of care (SOC) compared with SOC alone in the treatment of hospitalized COVID-19 patients from the United States hospital perspective.
Materials and Methods
An economic model was developed to estimate the clinical benefits and costs for an average newly hospitalized COVID-19 patient, with a 28-day time horizon for the index hospitalization. Clinical outcomes from the LIVE-AIR trial included failure to achieve survival without ventilation (SWOV), mortality, time to recovery, intensive care unit (ICU) admission, and invasive mechanical ventilation (IMV) use. Base case costs included drug acquisition and administration for lenzilumab and hospital resource costs based on the level of care required. The inclusion of 1-year rehospitalization costs was examined in a scenario analysis.
Results
In the base case and all scenarios, treatment with lenzilumab plus SOC improved all specified clinical outcomes over SOC alone. Adding lenzilumab to SOC was also estimated to result in cost savings of $3,190 per patient in a population aged <85 years with CRP <150 mg/L and receiving remdesivir (base case). Per-patient cost savings were also estimated in the following scenarios: 1) aged <85 years with CRP <150 mg/L, with or without remdesivir ($1,858); 2) Black and African American patients with CRP <150 mg/L ($13,154); and 3) Black and African American patients from the full population ($2,763). In the full mITT population, a budget impact of $4,952 was estimated. When adding rehospitalization costs to the index hospitalization, a total per-patient cost savings of $5,154 was estimated.
Conclusions
The results highlight the clinical benefits for SWOV, ventilator use, time to recovery, mortality, time in ICU, and time on IMV, in addition to a favorable budget impact from the United States hospital perspective associated with adding lenzilumab to SOC for patients with COVID-19 pneumonia.
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SciScore for 10.1101/2021.10.06.21264651: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Model Structure and Calculations: An economic model was developed in Microsoft® Excel to estimate the clinical benefits and budget impact of adding lenzilumab to SOC versus SOC alone for newly hospitalized patients with COVID-19 pneumonia. Microsoft® Excelsuggested: (Microsoft Excel, RRID:SCR_016137)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected …SciScore for 10.1101/2021.10.06.21264651: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Model Structure and Calculations: An economic model was developed in Microsoft® Excel to estimate the clinical benefits and budget impact of adding lenzilumab to SOC versus SOC alone for newly hospitalized patients with COVID-19 pneumonia. Microsoft® Excelsuggested: (Microsoft Excel, RRID:SCR_016137)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Despite these limitations, a scenario analysis was conducted to assess potential long-term cost savings with lenzilumab by incorporating rehospitalizations over one year after initial hospitalization into the analysis. The results indicated that adding lenzilumab to SOC may result in total cost savings of $5,154 associated with reduction in IMV use during the index hospitalization. The sensitivity analyses suggested that model results were robust to changes reflecting a reasonable level of uncertainty (±10%) in key inputs including hospital resource costs, patient distributions to different levels of care, and time to recovery. Based on these analyses, time to recovery had the greatest impact on the results of the model. Decreasing the time to recovery by 10% for the lenzilumab plus SOC arm resulted in an 88.8% increase in cost savings relative to the base case. By comparison varying hospital resource costs and patient distributions to different levels of care had less impact on the cost savings associated with adding lenzilumab to SOC. As with any model-based analysis, this study had several limitations. The analysis used data from the LIVE-AIR Phase 3 clinical trial, which would not be fully generalizable to a real-world US hospital population. Patient data from LIVE-AIR were censored after 28 days following trial enrollment. This is noteworthy because patients with COVID-19 who are critically ill and/or who require IMV typically have extended time to recovery, sometimes be...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04351152 Active, not recruiting Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab … Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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