LUPKYNIS (voclosporin)
Self Administration – Oral
Diagnosis considered for coverage:
- Lupus Nephritis - indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN).
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- Limitations of Use: Safety and efficacy of Lupkynis have not been established in combination with cyclophosphamide. Use of Lupkynis is not recommended in this situation.
Limitations of Use:
- The safety and efficacy of Lupkynis have not been established in combination with cyclophosphamide. The use of Lupkynis is not recommended in this situation.
Coverage Criteria:
For diagnosis of active lupus nephritis:
- Dose does not exceed 23.7 mg twice a day; AND
- Prescribed by or in consultation with a nephrologist or rheumatologist; AND
- Used in combination with immunosuppressive therapy (e.g., mycophenolate mofetil, prednisone, methylprednisolone).
Reauthorization Criteria:
For diagnosis of active lupus nephritis:
- Dose does not exceed 23.7 mg twice a day; AND
- Documentation of a positive clinical response to therapy.
Coverage Duration:
- Initial: up to 12 months
- Reauthorization: up to 12 months
Authorization is not covered for the following:
The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
Policy Updates:
- 06/15/2021 – New policy approved by P&T.
References:
Anders HJ, Saxena R, Zhao MH, et al. Lupus nephritis. Nat Rev Dis Primers. 2020: 23;6(1):7.
- Aurinia Press Release: FDA Approves Aurinia Pharmaceuticals’ Lupkynis (voclosporin) for adult patients with active lupus nephritis. Aurinia Pharmaceuticals Inc Web site. https://ir.auriniapharma.com/press-releases/detail/210/fda-approves-aurinia-pharmaceuticals-lupkynis. Accessed March 23, 2021.
- Fanouriakis A, Kostopoulou M, Cheema K, et al. 2019 Update of the Joint European League Against Rheumatism and European Renal Association– European Dialysis and Transplant Association (EULAR/ERA-EDTA) recommendations for the management of lupus nephritis. Annals of the Rheumatic Diseases. 2020;79:713–723.
- Food and Drug Administration. Lupkynis multi-discipline review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf. January 22, 2021. Accessed March 15, 2021.
- Hahn BH, McMahon MA, Wilkinson A, et al. American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res. 2012;64(6):797-808.
- Jadoul M, Winkelmayer WC, Arici M, et al. KDIGO Clinical Practice guideline on glomerular diseases. Kidney Disease Improving Global Outcomes, June 2020. https://kdigo.org/wp-content/uploads/2017/02/KDIGO-GN-GL-Public-Review-Draft_1-June-2020.pdf. Accessed March 15, 2021.
- Lupkynis [package insert], Victoria, British Columbia: Aurinia Pharma U.S., Inc.; January 2021.
- Rovin BH, Solomons N, Pendergraft WF et al. AURA-LV Study Group. A randomized, controlled double-blind study comparing the efficacy and safety of dose-ranging voclosporin with placebo in achieving remission in patients with active lupus nephritis. Kidney Int. 2019:95(1):219-231.
- Teng YO, Parikh SV, Saxena A, et al. 011 AURORA phase 3 study demonstrates voclosporin statistical superiority over standard of care in lupus nephritis (LN). Lupus Science & Medicine. 2020;7(Suppl 1):A14.
- Tice JA, Mandrik O, Thokala P, et al. Voclosporin and belimumab for lupus nephritis: Effectiveness and value; Draft evidence report. Institute for Clinical and Economic Review, January 22, 2021. https://icer.org/wp-content/uploads/2020/11/ICER_Lupus-Nephritis_Draft-Evidence-Report_012221.pdf. Accessed March 15, 2021.