Clinical and economic benefits 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

Abstract

Aims

Estimate the clinical and economic benefits of lenzilumab plus standard of care (SOC) compared with SOC alone in the treatment of patients hospitalized with COVID-19 pneumonia from the United States (US) hospital perspective.

Materials and methods

A per-patient cost calculator was developed to report the clinical and economic benefits associated with adding lenzilumab to SOC in newly hospitalized COVID-19 patients over 28 days. Clinical inputs were based on the LIVE-AIR trial, including 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 the anticipated list price of lenzilumab, drug administration, and hospital resource costs based on the level of care required. A scenario analysis examined projected one-year rehospitalization costs.

Results

In the base case and all scenarios, lenzilumab plus SOC improved all specified clinical outcomes relative to SOC alone. Lenzilumab plus SOC resulted in estimated cost savings of $3,190 per patient in a population aged <85 years with C-reactive protein (CRP) levels <150 mg/L and receiving remdesivir (base case). Per-patient cost savings were observed 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, regardless of CRP level ($2,763). In the full modified intent-to-treat population, an additional cost of $4,952 per patient 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 an economic benefit from the US hospital perspective associated with adding lenzilumab to SOC for COVID-19 patients.

Keywords:

• Economic analysis
• CRP
• coronavirus
• cytokine storm
• GM-CSF
• lenzilumab
• hospital costs
• ventilator-free survival
• survival without ventilation
• invasive mechanical ventilation

JEL CODES:

• I15
• I1
• I
• I19
• I00

Transparency

Declaration of funding

This work was supported by Humanigen Inc.

Declaration of financial/other interests

AK, EJ, DC, MA are employees of Humanigen Inc. AZ, KT, ANP, AH, MT are employees of EVERSANA which received funding from Humanigen Inc. to conduct this study.

Peer reviewers on this manuscript have received an honorarium from JME for their review work but have no other relevant financial relationships to disclose.

Author contributions

AK, EJ, AZ, KT, ANP, MT made substantial contributions to the conception and design of the calculator. Clinical data acquisition and analysis was conducted by DC. AZ, KT, ANP, AH conducted the literature review, developed the calculator structure, and prepared the manuscript. All authors reviewed the calculator and manuscript for interpretation of data and important intellectual content and have given their approval for the final version of the manuscript.

Acknowledgements

The authors acknowledge Cameron Durant (Humanigen Inc.), Ari Mendell (EVERSANA), and Karson Theriault (EVERSANA) for their specific contributions to this project.

Data availability statement

The data that support the findings of this study are available through the link below: https://doi.org/10.1101/2021.05.01.21256470

Notes

i Humanigen, Inc., Burlingame, CA, USA; manufactured by Calalent in the USA.

ii Microsoft Corporation, Redmond, WA, USA.

iii The mITT population was the analysis set used for the primary analysis of efficacy, defined as all randomized patients who received at least one dose of study drug under the documented supervision of the principal investigator or sub-investigator and excluding sites that experienced documented limitations to access of basic supportive care for COVID-19.

iv Time to recovery was a pre-specified secondary outcome of the clinical trial and was defined as the first day on which a patient was discharged or ready for discharge by satisfying one of the following 3 categories from the 8-point ordinal scale: hospitalized, not requiring supplemental oxygen, no longer requiring ongoing medical care; not hospitalized, limitation on activities and/or requiring home oxygen; not hospitalized, no limitations on activities.