Interventions of Interest:

  • voclosporin (Lupkynis™, Aurinia Pharmaceuticals)
  • belimumab (Benlysta®, GlaxoSmithKline)

ICER is assessing the comparative clinical effectiveness and value of voclosporin (Lupkynis™, Aurinia Pharmaceuticals) and belimumab (Benlysta®, GlaxoSmithKline) for the treatment of lupus nephritis. Voclosporin was approved for lupus nephritis in 2021, and belimumab is seeking a label expansion for the treatment of lupus nephritis.

The evidence suggests belimumab and voclosporin represent important new treatment options for lupus nephritis; there is substantial uncertainty regarding long-term use and outcomes, but at estimated net prices, both drugs appear priced in alignment with ICER’s recommended health-benefit price benchmark ranges. The majority of the New England CEPAC voted that the long-term value for money at current pricing is high for belimumab and intermediate for voclosporin.

At policy roundtable, experts emphasized the need for steps to reduce inequity in access to new therapies, including reductions in insurance barriers, avoidance of extending exclusivity periods through patented dosing algorithms, and by ensuring broader representation in clinical studies of racial and ethnic communities that bear a disproportionate burden from lupus nephritis. .

Date of review: March 2021

For questions, please contact info@icer.org.

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Final Documents

Final Evidence Report and Meeting SummaryDownload
Report-at-a-GlanceDownload
Policy RecommendationsDownload
Public Comments on Draft Evidence ReportDownload
Response to Public CommentsDownload

Steven D. Pearson, MD, MSc, ICER’s Presiden stated:

“Lupus nephritis is a serious chronic disease, one that has a disproportionately large impact on Black, Hispanic, and other communities of color in the US. Both belimumab and voclosporin are important new treatment options. Despite remaining uncertainty about both treatments’ longer-term outcomes, their estimated prices appear to be aligned with their anticipated clinical benefits. More research is needed to confirm these benefits, but for patients and clinicians to have responsibly priced options specifically indicated for lupus nephritis is a major win for patients and the entire health system.

One policy element that was discussed at the public meeting, however, is worth attention. Aurinia sought and achieved a late-stage patent on voclosporin’s dosing protocol. This unusual patent will likely deny patients access to a more affordable generic version of the treatment until 2037 – a full 10 years beyond what was previously expected. If extended patents through dosing algorithms becomes a new trend, we could see future budget headroom shrink for other innovative products, while patients and the entire health system struggle even more with affordability.”