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BOSTON, February 9, 2026 – The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sibeprenlimab (Voyxact®, Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and delayed-release budesonide (“Nefecon”, Tarpeyo®, Calliditas Therapeutics AB) for IgA nephropathy.
“IgA nephropathy has historically been thought of as a relatively benign form of kidney disease, but it has become increasingly recognized that it frequently progresses to end-stage kidney disease,” said ICER’s Chief Medical Officer, David Rind, MD. “Management of progressive disease has typically included treatments targeted at B-cells, but such therapies, such as systemic glucocorticoids, have serious side effects. New therapies offer the possibility of better outcomes with fewer harms.”
This Evidence Report will be reviewed at a virtual public meeting of the CTAF on February 26, 2026. The CTAF is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
Register here to watch the live webcast of the virtual meeting.
A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report and voting questions reflect changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.
Key Clinical Findings
ICER found that sibeprenlimab, atacicept, and Nefecon all have net health benefits that are “incremental or better” (B+) in comparison to no specific immunomodulatory therapy, but there remain uncertainties around the magnitude of long-term improvements in outcomes as well as around safety. In comparison to systemic glucocorticoids, all three therapies’ net health benefits were felt to be promising but inconclusive (P/I). There is inadequate evidence (I) to assess the net health benefit of the three therapies in comparison to each other.
Key Cost-Effectiveness Findings
ICER evaluated the cost-effectiveness of sibeprenlimab, Nefecon, and atacicept.
Sibeprenlimab was approved by the FDA under accelerated approval on November 25, 2025 and has an estimated annual net price of $292,500. ICER calculated a health benefit price benchmark (HBPB) between $61,000 and $81,000 per year.
Nefecon was approved by the FDA in 2023 and has an estimated net price of $133,741 for a single treatment course. ICER calculated a HBPB between $110,900 to $143,000 for a single treatment course of Nefecon.
Atacicept has not yet been approved by the FDA for IgA nephropathy, but a decision is expected in July of 2026. The manufacturers have not yet announced a US price for the therapy if approved. ICER calculated a HBPB between $60,000 and $80,000 per year.
ICER’s HBPB is a price range suggesting the highest US price a manufacturer should charge for a treatment, net of all rebates and discounts, based on the amount of improvement in overall health patients receive from that treatment, when a higher price would cause disproportionately greater losses in health among other patients in the health system due to rising overall costs of health care and health insurance. In short, it is the top price range at which a health system can reward innovation and better health for patients without doing more harm than good.
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