Pharmacy Prior Authorization Criteria

Voyxact (sibeprenlimab-szsi)

Indications for Prior Authorization

Voyxact (sibeprenlimab)

• For diagnosis of Primary Immunoglobulin A Nephropathy (IgAN)
  Indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.

  This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

Criteria

Voyxact

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of primary immunoglobulin A nephropathy (IgAN)
AND
• Patient is at risk for disease progression (e.g., proteinuria of at least 0.5 g/day, or by other criteria such as clinical risk scoring using the International IgAN Prediction Tool)
AND
• Used to reduce proteinuria
AND
• One of the following:
• Patient has been on a minimum 90-day trial of a maximally tolerated dose and will continue to receive therapy with one of the following [2]:
• An angiotensin-converting enzyme (ACE) inhibitor (e.g., benazepril, lisinopril)
• An angiotensin II receptor blocker (ARB) (e.g., losartan, valsartan)
OR
• Patient has a contraindication or intolerance to both ACE inhibitors and ARBs
AND
• Prescribed by or in consultation with a nephrologist

Voyxact

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates a positive clinical response to therapy as demonstrated by a decrease in urine protein-to-creatinine ratio (UPCR) from baseline

P & T Revisions

2026-02-09, 2026-02-09

References

1. Voyxact Prescribing Information. Otsuka Pharmaceutical Co., Ltd. Rockville, MD. November 2025.
2. Kidney Disease: Improving Global Outcomes (KDIGO). KDIGO 2025 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV). Kidney Int. 2025;108(4S):S1–S71

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Revision History

• 2026-02-09: New Program
• 2026-02-09: New Program

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