OBJECTIVES: Sotrovimab is a monoclonal antibody approved in Europe for the treatment of adults and adolescents (age ≥12 years) with COVID-19 who do not require oxygen supplementation and are at increased risk of progressing to severe COVID-19. We assessed the cost-effectiveness of sotrovimab versus standard of care (SOC) as an outpatient treatment for patients (aged ≥18 years, in line with the pivotal COMET-ICE trial) in Italy with mild-to-moderate COVID-19 at high risk of disease progression.

METHODS: A Markov cohort model with Discretely Integrated Condition Event simulation followed a cohort of 1,000 patients in 5-year, 10-year and lifetime (100 years) time horizons from an Italian National Health Service perspective. At model development, SOC consisted of treatments such as antipyretics. As sotrovimab was an add-on to SOC, no treatment-related cost was allocated to SOC. Sotrovimab’s treatment effect was obtained from the COMET-ICE trial, which showed a 79% relative risk reduction of all-cause hospitalizations ≥24 hours or death from any cause within 29 days of randomization. Cost, resource use and quality-of-life inputs were obtained from published literature and national/regional tariffs. The model was internally and externally validated.

RESULTS: The sotrovimab cohort was associated with 5-year, 10-year and lifetime quality adjusted life-year (QALY) gains of 143.66, 235.00 and 346.87, respectively, with increased lifetime direct healthcare costs of €2,537,956. Incremental cost-effectiveness ratios versus SOC were €17,667 (5-year), €10,800 (10-year) and €7,317 (lifetime) per QALY. Deterministic sensitivity analysis found that hospitalization rate and treatment cost had the largest impact on the ICER. In probabilistic sensitivity analysis, sotrovimab was cost-effective in 100% of iterations based on a willingness-to-pay threshold of €15,000 per QALY gained.

CONCLUSIONS: Sotrovimab was found to be cost-effective versus SOC for early treatment of high-risk patients with COVID-19 in Italy.