OBJECTIVES: Cytomegalovirus (CMV) infection is associated with morbidity and mortality following solid organ or hematopoietic cell transplant (SOT/HCT). Toxicities and development of refractory (with or without resistance [R/R]) CMV limit current anti-CMV agents use. In the Phase 3 SOLSTICE (NCT02931539) study of R/R CMV infection in SOT/HCT recipients, maribavir achieved superior efficacy (CMV viremia clearance) with an improved safety profile against investigator-assigned therapy (IAT; valganciclovir/ganciclovir, foscarnet, or cidofovir). This analysis investigates the cost-effectiveness of maribavir versus IAT for treatment of post-transplant R/R CMV.

METHODS: The model comprises two consecutive Markov models. A three-state model with 4-week cycles is used for 18 months, capturing transitions between clinically significant CMV (CMV DNA >lower limit of quantification [LLOQ] requiring treatment), non-clinically significant CMV (CMV DNA <LLOQ or CMV DNA >LLOQ not requiring treatment), and dead. From 18 months onwards, patients move to a two-state, alive/dead model with annual cycles. Clinical event rates and transition probabilities were largely informed by SOLSTICE and data from observational studies. In SOLSTICE, patients were aged 53 years (average); 60% received SOT and 40% received HCT. Utilities were from SOLSTICE and a utility vignette study. Costs were primarily estimated from the UK National Schedule of NHS Costs. The price of maribavir was converted to pounds from the US list price for an 8-week treatment regimen ($50,000; June 2022). Costs and outcomes were discounted by 3.5%.

RESULTS: Maribavir incurs an incremental cost of £4,461 for an incremental quality-adjusted life year (QALY) gain of 0.221. Relative to IAT, maribavir achieves an incremental cost-effectiveness ratio of £20,163, which would be considered cost-effective at a willingness-to-pay threshold range of £20,000 to £30,000 per QALY. In probabilistic sensitivity analysis, maribavir was cost-effective at the £30,000 threshold in 62% of iterations.

CONCLUSIONS: This analysis supports that maribavir provides a cost-effective alternative to IAT for treatment of post-transplant R/R CMV.