Abstract
PURPOSE: The anti-C5a complement factor blocker vilobelimab (Gohibic) is authorized for emergency use by the US Food and Drug Administration for the treatment of hospitalized adults with COVID-19 when initiated within 48 hours of starting invasive mechanical ventilation or extracorporeal membrane oxygenation. In the PANAMO phase 3 trial of vilobelimab vs standard of care (SoC) (corticosteroids and antithrombotic agents), a post hoc analysis showed that prior and/or concomitant treatment with immunomodulators (tocilizumab or baricitinib) provided additional survival benefit with vilobelimab (n = 34) but not with SoC (n = 37). The point estimate for 28-day all-cause mortality for these groups was 6.3% vs 40.9% (hazard ratio, 0.13; 95% confidence interval, 0.03-0.56; P = 0.006). The current analysis evaluated the cost-effectiveness of vilobelimab vs SoC for the subgroup in the PANAMO study receiving immunomodulators. METHODS: A short-term acute care decision tree followed by a postdischarge 2-state Markov cohort model was used to estimate quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER) of the treatment arms. The model simulated progression from severe COVID-19 to survival or death over a lifetime. Outcomes data (COVID-19 all-cause mortality) were incorporated from PANAMO. Posthospitalization mortality was based on CDC age-specific survival data. Utility values and hospital costs came from the literature, and the cost of vilobelimab was obtained from Red Book online. RESULTS: The total cost of care was $103,414 with SoC and $132,247 with vilobelimab, with an incremental cost of $28,833. SoC provided 6.05 QALYs vs 9.71 QALYs for vilobelimab (3.65 additional QALYs). The ICER for vilobelimab compared to SoC, both with immunomodulators, was $7,892/QALY. Probabilistic sensitivity analysis demonstrated the robustness of the cost-effectiveness result, as vilobelimab + SoC was favored at a willingness-to-pay threshold of $50,000/QALY in over 98% of iterations. CONCLUSION: Vilobelimab therapy provides a cost-effective option to treat severely ill, mechanically ventilated patients with COVID-19 with prior and/or concomitant treatment with immunomodulators at a value well below the commonly accepted willingness-to-pay threshold of $50,000/QALY.