Vanrafia™

Drug - Vanrafia™ (atrasentan) [Novartis Pharmaceuticals Corporation]

January 2026

Therapeutic Area - Primary immunoglobulin A nephropathy (IgAN)

Initial approval criteria

  • Age ≥ 18 years; AND
  • Diagnosis of primary immunoglobin A nephropathy (IgAN) confirmed by kidney biopsy; AND
  • ONE of the following:
    • Patient has a urine protein-to-creatinine ratio (UPCR) ≥ 0.44 g/g; OR
    • Patient has proteinuria ≥ 0.5 g/day; AND
  • Patient has an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2; AND
  • Patient does NOT have history of a hypersensitivity reaction to atrasentan or any component of Vanrafia; AND
  • ONE of the following:
    • Patient is taking a maximally tolerated angiotensin-converting enzyme inhibitor (ACEI) (e.g., benazepril, lisinopril) or angiotensin II blocker (ARB) (e.g., losartan) or a combination medication containing an ACEI or ARB for at least a 90-day duration of therapy AND patient will continue maximally tolerated ACEI or ARB, or combination medication containing an ACEI or ARB, in combination with Vanrafia; OR
    • Patient has intolerance, hypersensitivity, or FDA-labeled contraindication to all ACEIs or ARBs, or combination medications containing an ACEI or ARB; AND
  • Vanrafia is prescribed by or in consultation with a specialist in the area of the patient’s diagnosis; AND
  • Negative pregnancy status must be confirmed in patients of reproductive potential prior to initiation of Vanrafia; AND
  • Patients of reproductive potential should use effective contraception prior to initiation of Vanrafia, during treatment and for 2 weeks after discontinuation; AND
  • Prescriber has reviewed Vanrafia Warnings/Precautions and Drug Interactions and will monitor patient status as appropriate.
  • Initial approval is for 9 months

Renewal criteria

  • Patient must continue to meet the initial approval criteria; AND
  • Patient must have disease improvement and/or stabilization as indicated by ONE of the following:
    • Decrease from baseline (prior to treatment with Vanrafia) of UPCR ratio; OR
    • Decrease from baseline (prior to treatment with Vanrafia) in proteinuria; AND
  • Patient has NOT experienced any treatment-restricting adverse effects (e.g., clinically relevant aminotransferase elevations or aminotransferase elevations accompanied by bilirubin increase > 2 times upper limit of normal [ULN] or by clinical symptoms of hepatotoxicity).
  • Renewal approval is for 12 months

Quantity limits

  • 30 tablets per 30 days

Background

Vanrafia is an endothelin receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.  This indication is approved under accelerated approval based on a reduction of proteinuria. It has not been established whether Vanrafia slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

Questions

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