OBJECTIVES: The objective is to assess the cost-effectiveness of voclosporin (VCS) in combination with mycophenolate mofetil (VCS+MMF) compared to MMF in patients with active lupus nephritis from a Swedish healthcare perspective.

METHODS: A de novo Markov model with a lifetime horizon was developed, consisting of seven health states: chronic kidney disease (CKD) stages 1-3a: active disease, partial response, complete response; CKD stages 3b-4: active disease; CKD stage 5: dialysis, transplant; and death. Health state occupancy and quality of life inputs were estimated from individual patient data and safety data taken from the pivotal AURORA 1 trial (NCT03021499) and the continuation study AURORA 2 (NCT03597464). The analysis was conducted from a Swedish payer perspective, with 3% discounting for costs and outcomes. Costs, quality-adjusted life-years (QALY), and an incremental cost-effectiveness ratio (ICER) were estimated. The willingness-to-pay threshold was 750,000 SEK, aligned to the threshold for diseases of high severity of The Dental and Pharmaceutical Benefits Agency (TLV). Deterministic and probabilistic sensitivity analysis in addition to scenario analyses assessed the robustness of results.

RESULTS: In the base case analysis, VCS+MMF resulted in 0.676 additional QALYs and additional costs of 191,800 SEK, with an ICER of 283,611 SEK/QALY compared to MMF. Additional time spent in complete response in the VCS+MMF arm was the primary source of additional QALYs, whereas incremental costs were driven by the acquisition costs for VCS. VCS+MMF remained cost-effective in a majority of sensitivity and scenario analyses.

CONCLUSIONS: Based on a willingness-to-pay threshold of 750,000 SEK, VCS+MMF is considered a cost-effective treatment compared to MMF for adults with lupus nephritis in Sweden.