OBJECTIVES: To assess the cost-effectiveness of polatuzumab in combination with bendamustine and rituximab (BR) compared to BR in the treatment of patients with relapsed/ refractory (R/R) diffuse large B-cell lymphoma (DLBC), in the Portuguese setting.

METHODS: A partitioned survival model including progression-free, progressed disease and death health states was used to estimate the cost-effectiveness of polatuzumab in combination with BR, using data from the GO29365, a phase Ib/II, open-label trial. Utility weights by health state were obtained from published literature. Portuguese-specific disease management resource use was based on a panel of clinical experts and on Portuguese diagnosis-related group microdata. The main sources for unit costs were national legislation and official drug cost databases. The analysis was conducted from the National Health Service perspective, assuming a lifetime horizon and a 4% discount rate for both costs and effects. Deterministic and probabilistic sensitivity analyses were conducted to assess the robustness of results.

RESULTS: Polatuzumab+BR increases average life expectancy by 1.08 life years (LY) or 0.78 quality adjusted life years (QALY), with estimated incremental cost-effectiveness ratios (ICER) of 53,978€/LY and 74,560€/QALY. Considering just second-line treatment, polatuzumab+BR increases average life expectancy by 2.18 LY or 1.57 QALY allowing an ICER of 31,231€/LY or 43,408€/QALY. For third-line, polatuzumab+BR increases average life expectancy by 0.78 LY or 0.56 QALY, increasing the ICER to 73,483€/LY or 101,937€/QALY. Deterministic sensitivity analyses show that results are robust to most scenarios but sensitive to modelling options, vial sharing and time horizon.

CONCLUSIONS: Treatment with polatuzumab in combination with BR showed an incremental effectiveness both in terms of LY and QALY compared to BR alone. The cost-effectiveness model of polatuzumab in combination with BR in patients with untreated R/R-DLBC was considered valid to support a reimbursement decision in the Portuguese setting.