April 20, 2021

At a public meeting in March led by the Institute for Clinical and Economic Review (ICER), an independent panel voted unanimously that both belimumab (Benlysta) and voclosporin (Lupkynis), newly approved to treat lupus nephritis, provide a health benefit over standard therapy alone. ICER’s policy recommendations for the use of these two medications reflect much of the feedback the Lupus Research Alliance (LRA) and others provided during the call for public comments.

ICER is an independent non-profit research institute that produces influential reports analyzing the effectiveness and value of drugs and other medical services. Both belimumab and voclosporin received a B+ rating in the final report Belimumab and Voclosporin for Lupus Nephritis: Effectiveness and Value.

In addition to this report, another outcome of this review process begun last August are policy recommendations. The March meeting concluded with a Policy Roundtable that included people with lupus, clinical researchers, representatives of GSK and Aurinia, and representatives of health insurers.

Representing the patient voice were Kathleen Arntsen, President & CEO, Lupus and Allied Diseases Association, Inc. and Christele Felix, Chief Operating Officer, LupusChat and member of the LRA’s Patient Advocates for Lupus Studies (PALs) program. Meggan Mackay, MD, MS, Investigator and Professor of Medicine, The Feinstein Institutes for Medical Research, Northwell Health and Brad Rovin, MD, Professor of Medicine and Pathology, Ohio State University Wexner Medical Center provided input from their perspectives as clinicians and researchers.

Key policy recommendations include:

• All stakeholders have a responsibility and an important role to play in ensuring that effective new treatment options for patients with lupus nephritis are introduced in a way that will help reduce health inequities.
• Both belimumab and voclosporin are judged to be priced in reasonable alignment with estimates of their benefits for patients. This consideration should guide payers to design coverage criteria that do not narrow coverage from the FDA label.
• Manufacturers should commit to expanding their research, both before and after regulatory approval, to include adequate representation of patients with lupus nephritis from Black and other non-white populations.

The Lupus Research Alliance submitted comments during all the open public comment periods. “We are grateful that ICER reached out to the lupus community and was receptive to our input. The LRA is committed to working toward elimination of the treatment barriers faced by people with lupus. Because of lupus heterogeneity, it is particularly helpful that the two new medications approved for lupus nephritis — belimumab and voclosporin – work differently with different routes of administration. Physicians and patients should be able to make decisions on treatment options for LN based on what is right for the individual patient,” noted Diane Gross, LRA’s National Director of Advocacy and Programs.

All the materials, in addition to LRA’s public comments, can be found here – Lupus Nephritis – ICER