OBJECTIVES : Patients with asymptomatic follicular lymphoma (FL) can be monitored prior to initiating treatment [watch and wait (WW)] or receive early therapy with rituximab (RTX). RTX delays time to progression, reducing downstream treatment costs and potentially improving patient quality of life. RTX-pvvr, a biosimilar of RTX, has been approved in the US for FL with the potential to reduce treatment costs. This study explored the cost-effectiveness and budget impact of early RTX use (branded and RTX-pvvr) versus WW in the US.

METHODS : An area-under-the-curve Markov model was built using time-to-event data from a clinical trial over a lifetime, comparing RTX induction (RI), RTX induction plus maintenance (RIM) and WW for newly-diagnosed asymptomatic FL patients. The model considered five health states: progression-free, symptomatic and asymptomatic progressed disease, transformation and death. The model included up-front RTX treatment costs, three lines of subsequent treatment costs, along with monitoring, adverse event and end of life costs. Outcomes included life years (LYs), quality-adjusted life years (QALYs), progression-free life years (PFLYs) and incremental cost-effectiveness ratios (ICERs). The budget impact model included total and per-member per-month (PMPM) costs over a 5-year time horizon. Scenario analyses included varying transformation assumptions, subsequent treatment costs/market mix and utilities.

RESULTS : In the base case, RI and RIM were dominant treatment options compared to WW for ICER/QALY and ICER/PFLY, with PFLY gains of 1.17 and 3.36, respectively. The use of RTX-pvvr reduced total costs for all treatment arms. A 5% annual uptake of RTX-pvvr reduced the total budget impact, potentially amounting to a $64,925,020 ($-0.003 PMPM) reduction over 5 years for the US population (8,346 eligible patients). Sensitivity and scenario analyses found consistent cost savings; base case trends remained robust.

CONCLUSIONS : Early RTX-pvvr use is a dominant treatment option compared to WW in the US, reducing total lifetime FL treatment costs while increasing PFLY and QALYs.