Hospital Resource Utilization and Estimated Costs Associated with Nipocalimab: Post-hoc Analysis of the Placebo-Controlled VIVACITY-MG3 Trial in Generalized Myasthenia Gravis
Author(s)
Geoffroy Coteur, PhD1, Kavita Gandhi, MS2, Nida Imran, MBA, MS2, Ibrahim Turkoz, PhD3, Maria Ait-Tihyaty, PhD3, Jacqueline Pesa, MS, MSPH, PhD4, Zhiwen Liu, PhD3, John Vissing, MD5;
1iPATH Solutions BV, Wemmel, Belgium, 2Johnson & Johnson, Raritan, NJ, USA, 3Johnson & Johnson, Titusville, NJ, USA, 4Johnson & Johnson, Horsham, PA, USA, 5Department of Neurology, University of Copenhagen, Copenhagen, Denmark
1iPATH Solutions BV, Wemmel, Belgium, 2Johnson & Johnson, Raritan, NJ, USA, 3Johnson & Johnson, Titusville, NJ, USA, 4Johnson & Johnson, Horsham, PA, USA, 5Department of Neurology, University of Copenhagen, Copenhagen, Denmark
OBJECTIVES: Generalized myasthenia gravis (gMG) is a rare chronic neuromuscular disorder causing muscle weakness that may worsen (crises/exacerbations) and result in hospital admissions (HA) and emergency department visits (EDV). Nipocalimab, as add-on to standard-of-care (SOC), demonstrated stable and sustained efficacy versus placebo+SOC in a double-blind, 24-week, phase 3 study (VIVACITY-MG3) in adult patients with gMG. Evaluate all-cause hospital resource utilization and associated estimated costs among gMG patients on nipocalimab+SOC versus placebo+SOC.
METHODS: Details on HA, including length of stay (LoS), and EDV were collected every 12-weeks with the Hospital Resource Utilization Questionnaire (HRUQ). The incidence rate of HA and EDV was reported per 100 patient-years (pt-yrs) for patients treated with nipocalimab+SOC or placebo+SOC in double-blind phase and for those patients who continued treatment with nipocalimab+SOC in open-label extension (OLE) phase. Costs per hospital day and per EDV were estimated using data from published literature and from claims (Optum’s de-identified Clinformatics® DataMart) and extrapolated to 2023 US dollars.
RESULTS: During the double-blind phase, 9.1% and 15.8% of patients on nipocalimab+SOC (n=77) and placebo+SOC (n=76), respectively, experienced ≥1 HA/EDV event. The incidence rate of all-cause HA/EDV events was 51% lower with nipocalimab+SOC than with placebo+SOC (Incidence rate ratio [IRR]: 0.49; 95% confidence interval: 0.209-1.143): 23.4 vs 47.9 events/100pt-yrs, respectively, and the mean HA-LoS was 6 days shorter with nipocalimab+SOC than with placebo+SOC (8.4 vs 14.6 days, respectively). During the OLE phase, the incidence rate of HA/EDV with nipocalimab+SOC was maintained at 27.3 events/100pt-yrs over a median follow-up of 54.1 weeks. The associated incremental cost savings/patient/year with nipocalimab+SOC versus placebo+SOC ranged from $8,090 to $9,778 depending on cost source used.
CONCLUSIONS: The incidence rate of all-cause hospitalizations and ED visits, and the LoS per admission were lower with nipocalimab+SOC compared with placebo+SOC, leading to medical cost savings for the healthcare system.
METHODS: Details on HA, including length of stay (LoS), and EDV were collected every 12-weeks with the Hospital Resource Utilization Questionnaire (HRUQ). The incidence rate of HA and EDV was reported per 100 patient-years (pt-yrs) for patients treated with nipocalimab+SOC or placebo+SOC in double-blind phase and for those patients who continued treatment with nipocalimab+SOC in open-label extension (OLE) phase. Costs per hospital day and per EDV were estimated using data from published literature and from claims (Optum’s de-identified Clinformatics® DataMart) and extrapolated to 2023 US dollars.
RESULTS: During the double-blind phase, 9.1% and 15.8% of patients on nipocalimab+SOC (n=77) and placebo+SOC (n=76), respectively, experienced ≥1 HA/EDV event. The incidence rate of all-cause HA/EDV events was 51% lower with nipocalimab+SOC than with placebo+SOC (Incidence rate ratio [IRR]: 0.49; 95% confidence interval: 0.209-1.143): 23.4 vs 47.9 events/100pt-yrs, respectively, and the mean HA-LoS was 6 days shorter with nipocalimab+SOC than with placebo+SOC (8.4 vs 14.6 days, respectively). During the OLE phase, the incidence rate of HA/EDV with nipocalimab+SOC was maintained at 27.3 events/100pt-yrs over a median follow-up of 54.1 weeks. The associated incremental cost savings/patient/year with nipocalimab+SOC versus placebo+SOC ranged from $8,090 to $9,778 depending on cost source used.
CONCLUSIONS: The incidence rate of all-cause hospitalizations and ED visits, and the LoS per admission were lower with nipocalimab+SOC compared with placebo+SOC, leading to medical cost savings for the healthcare system.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
EE185
Topic
Economic Evaluation
Topic Subcategory
Trial-Based Economic Evaluation
Disease
SDC: Neurological Disorders