LUPKYNIS® Proven Cost-Effective for Lupus Nephritis at 2024 Kidney Meeting

Aurinia Pharmaceuticals Inc. has unveiled findings from an updated cost-effectiveness analysis of LUPKYNIS (voclosporin), a second-generation calcineurin inhibitor used to treat lupus nephritis (LN). This analysis was presented at the annual National Kidney Foundation (NKF) Spring Clinical Meeting 2024 in Long Beach, California. The company also plans to share additional insights from its AURORA clinical program and the Enlight-LN registry.

The Institute for Clinical and Economic Review (ICER) initially confirmed the cost-effectiveness of LUPKYNIS for adults with active LN in March 2021. The latest analysis reaffirms this, demonstrating that LUPKYNIS remains a cost-effective treatment option for lupus nephritis. This updated evaluation utilized the ICER AnalyticsTM LN model, aligning most assumptions with the original 2021 analysis. New inputs included the 2023 cost of LUPKYNIS, treatment duration for non-responders, and expenses associated with managing LN patients with end-stage kidney disease.

LUPKYNIS' cost per quality adjusted life year (QALY) was pegged at $88,076, and $77,643 per equal value of life year gained (evLYG) for patients with active LN, significantly under ICER’s willingness-to-pay threshold of $150,000. ICER benchmarks cost-effectiveness across various treatments, using thresholds from $50,000 to $200,000 per QALY and per evLYG. The QALY metric gauges the effectiveness of medical treatments in improving life quality and longevity, while evLYG measures life length gains irrespective of quality enhancements.

A smaller subgroup analysis focusing on Black, Hispanic, and Latino patients—demographics disproportionately affected by LN—found the cost-effectiveness of LUPKYNIS comparable to other treatments for diabetes, blood pressure, and hyperlipidemia. The incremental cost for this subgroup was $77,436 per QALY and $67,828 per evLYG.

Dr. Greg Keenan, Chief Medical Officer of Aurinia, emphasized the importance of accessible, effective treatment options for lupus nephritis. He noted that the cost-effectiveness analysis, combined with long-term data from the AURORA clinical program, supports the use of LUPKYNIS in combination with MMF and steroids. This regimen has shown sustained renal response and reduced steroid use over three years compared to MMF and steroids alone.

The Enlight-LN registry provides further insights into baseline demographics and clinical characteristics of LN patients in the US, reflecting the broader LN population. This observational study aims to document the real-world effectiveness and usage patterns of LUPKYNIS.

A propensity analysis combining data from the Aspreva Lupus Management Study (ALMS), AURA-LV, and AURORA 1 studies indicated that LUPKYNIS plus standard care led to significant proteinuria reductions and lower exposure to toxicities compared to higher doses of mycophenolate mofetil (MMF) and glucocorticoids or cyclophosphamide and glucocorticoids alone. Patients treated with the LUPKYNIS-based regimen saw a more than 50% reduction in urine protein creatinine ratio from baseline, compared to their counterparts.

Aurinia's presentations at the NKF Spring Clinical Meeting 2024 included:
- “Evaluating the Cost-effectiveness of Voclosporin in the United States for the Treatment of Lupus Nephritis” by Ernie Lee, Victoria Atencio, Ronald Flauto, Vanessa Birardi, and Lisa Kennedy.
- “Enlight-LN Registry: Baseline Demographics and Clinical Characteristics of an Initial Cohort of Patients Treated with Voclosporin for Lupus Nephritis in the United States” by Stephen Myers, Michelle Zubrycki, Lily Cipolla, and Ron Flauto.
- “A propensity Analysis of AURA-LV plus AURORA 1 vs ALMS to Compare a Voclosporin-based, Triple Immunotherapy Regimen to High-dose Glucocorticoid-based Immunosuppressive Therapy” by Kenneth Kalunian, Anca Askanase, Maria Dall'Era, Neil Solomons, Matt Truman, Lucy S Hodge, and Ernie Yap.

LUPKYNIS is the first FDA and European Commission approved oral medication for treating adult patients with active lupus nephritis. It functions as an immunosuppressant and promotes kidney health, as demonstrated in the AURORA Clinical Program, which includes three years of treatment and follow-up data. Lupus nephritis is a severe complication of systemic lupus erythematosus (SLE), disproportionately affecting women and people of color, highlighting the need for effective therapies and better patient education.