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BOSTON, March 31, 2026 – The Institute for Clinical and Economic Review (ICER) today released a Final 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.
ICER’s report on this therapy was the subject of the February 2026 public meeting of the California Technology Assessment Forum (CTAF), one of ICER’s three independent evidence appraisal committees.
Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations
“Even with greater recognition that IgA nephropathy often progresses to end-stage kidney disease, treatment options have been limited and have serious side effects,” said ICER’s Chief Medical Officer David Rind, MD, MSc. “New non-glucocorticoid therapies targeted at B-cells appear likely to provide greater efficacy with fewer side effects, although longer term data are needed. Despite this, the very high price for sibeprenlimab led the independent appraisal council to conclude that it provides low value for money. We hope that the price of atacicept aligns better with the benefits it provides.”
ICER’s Public Meeting: Voting Results on Clinical Effectiveness and Benefits Beyond Health
ICER assessed, and the independent appraisal committee voted on the evidence for the net health benefit of sibeprenlimab, atacicept, and Nefecon:
- The panelists unanimously found (14-0) that current evidence is adequate to demonstrate a net health benefit for sibeprenlimab when compared to no specific immunomodulatory therapy.
- A majority of panelists (13-1) found that current evidence is adequate to demonstrate a net health benefit for atacicept when compared to no specific immunomodulatory therapy.
- The panelists unanimously found (14-0) that current evidence is adequate to demonstrate a net health benefit for Nefecon when compared to no specific immunomodulatory therapy.
- A majority of panelists (9-5) found that current evidence is adequate to demonstrate a net health benefit for sibeprenlimab and for atacicept when each is compared to systemic glucocorticoids.
- A majority of panelists (9-5) found that current evidence is not adequate to demonstrate a net health benefit for Nefecon when compared to systemic glucocorticoids.
Panel members also weighed potential benefits and disadvantages beyond the direct health effects and weighed special ethical obligations. Voting highlighted the following as particularly important for payers and other policymakers to note:
- Sibeprenlimab and atacicept are likely to substantially improve caregivers’ quality of life and/or ability to pursue their own education, work, and family life; Nefecon would likely provide a small improvement.
ICER’s Public Meeting: Voting Results on Long-Term Value for Money
- A majority of panelists (12) found that at current pricing, sibeprenlimab represents “low” long-term value for money; 2 panelists found that sibeprenlimab represents “intermediate” long-term value for money.
- A majority of panelists (11) found that at current pricing, Nefecon represents “intermediate” long-term value for money; 3 panelists found that Nefecon represents “low” long-term value for money.
Access and Affordability Alert
At the current net price of sibeprenlimab ($292,500 per year), 6% of the eligible population could be treated before reaching the ICER potential budget impact threshold of $821 million. Therefore, ICER is issuing an access and affordability alert for sibeprenlimab.
The purpose of an ICER access and affordability alert is to signal to stakeholders and policymakers that the amount of added health care costs associated with a new service may be difficult for the health system to absorb over the short term without displacing other needed services, creating pressure on payers to sharply restrict access, or causing rapid growth in health care insurance costs that would threaten sustainable access to high-value care for all patients.
Key Policy Recommendations
ICER’s independent assessment of value informs the critical decisions that stakeholders across the US health system need to make around pricing and coverage. Following the voting session, a policy roundtable of experts — including clinical experts, patients and patient advocates, manufacturers, and a representative of US payers — convened to discuss the pricing implications and recommendations to ensure fair access. Key recommendations stemming from the roundtable discussion include:
- If the price of sibeprenlimab is reduced to a price aligned with value, and if the initial price of atacicept is aligned with value, payers should not require step therapy with systemic glucocorticoids or Nefecon before authorizing use of sibeprenlimab or atacicept for treatment of IgAN.
- Manufacturers should set prices that will foster affordability and good access for all patients by aligning prices with the patient-centered therapeutic value of their treatments. In the case of IgAN, substantial new hope with the availability of these therapies is diminished by the extremely high price of sibeprenlimab. Nefecon is also priced slightly above a value-based price.
- Research funding organizations should support pragmatic analyses assessing the feasibility and the effectiveness of large-scale screening for IgAN and other kidney diseases including among children, which would inform public health practices like school-based screening programs.
ICER’s detailed set of policy recommendations is available in the Final Evidence Report and in the standalone Policy Recommendations document.
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