OBJECTIVES: Maribavir is a new therapeutic option for the treatment of post-transplant patients with refractory cytomegalovirus (CMV) infection. This study aims to estimate the cost-effectiveness of maribavir versus investigator-assigned therapy (IAT; valganciclovir/ganciclovir, foscarnet, or cidofovir) which is the current standard of care for the treatment of refractory CMV infection post-transplant in France.

METHODS: A cost-effectiveness analysis was developed using a two-stages model: 1) 0 – 78 weeks and 2) 78 weeks to a lifetime horizon. Stage 1 begins with the onset of refractory CMV infection and includes a three state Markov model with the states being clinically significant CMV infection (csCMV), non-clinically significant CMV infection (n-csCMV) and a dead state. Stage 2 includes a two state (alive – dead) Markov model. Transition probabilities and other relevant clinical outcomes related to maribavir and its comparators were derived from the Phase 3 SOLSTICE (NCT02931539) study and from the OTUS observational study. The price of maribavir was set to €45,000 for an 8-week treatment regimen. Costs were measured in 2021 euros and effects measured in quality-adjusted life years (QALYs). These were evaluated with a discount rate of 2.5% per annum according to French guidelines. Uncertainty associated to methodological assumptions and model parameters was addressed through scenario analyses and deterministic/probabilistic sensitivity analyses.

RESULTS: Over a lifetime horizon, maribavir versus IAT was associated with 0.4173 QALYs gained at a total incremental cost of 18,286€, resulting in an incremental cost-effectiveness ratio (ICER) of 43,824€/QALY. The probabilistic sensitivity analyses generated a minimal deviation of the deterministic ICER (+1.26%) and an 88.7% probability of being cost-effective based on a willingness to pay of 147,093€/QALY as estimated as final value of statistical QALY in Téhard et al^a.

CONCLUSIONS: These economic analyses indicate that maribavir is cost-effective in France compared with alternative anti-CMV therapies for the treatment patients with post-tranplant refractory CMV infection.