OBJECTIVES: To assess cost-utility of glofitamab for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, from the Italian Health Service perspective.

METHODS: A partitioned survival model of three mutually exclusive health-states – progression-free, post-progression and death – was developed to compare lifetime clinical outcomes and costs of patients treated with glofitamab and his main comparators: polatuzumab vedotin in association with rituximab and bendamustina (Pola-BR) or tafasitamab plus lenalidomide (Tafa+Lena), for patients non-eligible for CAR-T; tisagenlecleucel (Kym) or axicabtagene ciloleucel (Yesc) for the others. Progression-free survival (PFS) and overall (OS) were modelled independently for glofitamab and comparators using parametric survival curves obtained from inverse probability of treatment weighting (IPTW) or matching-adjusted indirect comparisons (MAIC). Health utilities values (for progression-free health-state on- and off-treatment and post-progression) were obtained by mapping EORTC QLQ-C30 scores to EQ-5D-3L values. Direct healthcare costs, including drug acquisition and administration, disease monitoring, adverse event management, and post-progression therapy were collected from Italian sources. Probabilistic sensitivity and scenario analysis evaluated the uncertainties on input parameters.

RESULTS: Glofitamab generated additional QALYs at a lower cost when compared with Pola-BR (0.048; -€6,878), Tafa-Lena (0.829; -€386,565) and Kym (0.311; -€294,949), resulting economically dominant. Instead, when comparing glofitamab with Yesc, the incremental net monetary benefit was estimated in €202,829, proving that glofitamab was a cost-effective option at willingness-to-pay threshold of €40,000 per QALY. Model results were generally robust across scenario and sensitivity analyses tested. However, there are some areas of uncertainty relating to the limited follow up of glofitamab clinical trial, utility values and residual bias from the ITCs.

CONCLUSIONS: Glofitamab can be considered a cost-effective option for Italian patients with 3L+ DLBCL, particularly for those who have exhausted currently available valid alternatives.