Baloxavir marboxil versus oseltamivir phosphate: Efficacy, safety, and economics in patients with influenza.

AIMS: To evaluate the efficacy, safety, and cost-effectiveness of baloxavir marboxil tablets versus oseltamivir phosphate capsules for treatment of influenza from the health-care system perspective. MATERIALS AND METHODS: Influenza patients were assigned to receive baloxavir marboxil (baloxavir group) or oseltamivir phosphate (oseltamivir group) and followed prospectively. Clinical outcomes, adverse events, and direct medical costs during treatment were collected. A cost-effectiveness analysis was performed from the health-care system perspective. Incremental cost-effectiveness ratios (ICERs) were calculated using 48-hour and 5-day recovery rates as effectiveness measures. Sensitivity analyses assessed drivers of results. RESULTS: A total of 102 cases treated with baloxavir and 81 cases treated with oseltamivir were analyzed. There were no significant differences between groups in 5-day overall effectiveness (p = 0.111) or 5-day defervescence rate (p = 0.115). The baloxavir group showed significantly higher 48-hour effectiveness (p < 0.001), 48-hour recovery rate (p < 0.001), 48-hour defervescence rate (p < 0.001), and 5-day recovery rate (p = 0.023) compared with the oseltamivir group. Adverse event incidence was significantly lower in the baloxavir group (p < 0.001). Sensitivity analysis identified the antiviral agent as a significant driver of 48-hour effectiveness (p = 0.004), 48-hour recovery (p = 0.013), and 48-hour defervescence (p = 0.008). Results remained robust across analyses. Total outpatient and drug costs were significantly higher in the baloxavir group (both p < 0.001). Using 48-hour recovery and 5-day recovery as effectiveness endpoints, the ICERs for baloxavir versus oseltamivir were ¥92.23 and ¥794.29 per additional recovered patient, respectively. CONCLUSION: Baloxavir marboxil is superior to oseltamivir in efficacy, safety, and cost-effectiveness for influenza.