Background and objectives: Despite existing therapies, people with lupus nephritis progress to kidney
failure and have reduced life expectancy. Belimumab and voclosporin are two new disease-modifying
therapies recently approved for the treatment of lupus nephritis.
Design, setting, participants, and measurements: A de novo economic model was developed to
estimate the cost-effectiveness of these therapies, including the following health states: “complete
response”, “partial response” and “active disease” defined by eGFR and proteinuria changes, kidney
failure, and death. Short-term data and mean cohort characteristics were sourced from pivotal clinical
trials of belimumab (BLISS-LN) and voclosporin (AURA-LV and AURORA). Risk of mortality and kidney
failure were based on survival modeling using published Kaplan-Meier data. Each drug was compared
to the standard of care as represented by the comparator arm in its respective pivotal trial(s), using
US health care sector perspective, with a societal perspective also explored.
Results: In the healthcare perspective probabilistic analysis, the incremental cost-effectiveness ratio
for belimumab compared to its control arm was estimated to be approximately $95,000 per quality adjusted life year (QALY). The corresponding incremental ratio for voclosporin compared to its control
arm was approximately $150,000/QALY. Compared to their respective standard care arms, the
probability of belimumab and voclosporin being cost effective at a threshold of $150,000/QALY were
69% and 49%, respectively. Cost-effectiveness was dependent on assumptions made regarding
survival in response states, costs and utilities in active disease, and the utilities in response states. In
the analysis from a societal perspective, the incremental ratio for belimumab was estimated to be
approximately $66,000/QALY and for voclosporin approximately $133,000/QALY.
Conclusions: Compared to their respective standard care arms, belimumab but not voclosporin met
willingness to pay thresholds of $100,000 per QALY. Despite potential clinical superiority in the
informing trials, there remains high uncertainty around the cost-effectiveness of voclosporin.
