Vanrafia (atrasentan)

Indications for Prior Authorization

Vanrafia (atrasentan)
  • For diagnosis of Primary immunoglobulin A nephropathy (IgAN)
    Is 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.

Criteria

Vanrafia

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of primary immunoglobulin A nephropathy (IgAN)
  • AND
  • Diagnosis has been confirmed by all of the following: [A]
    • Kidney biopsy
    • Proteinuria of greater than or equal to 1 g/day
    • Estimated glomerular filtration rate (eGFR) of greater than or equal to 30 mL/min/1.73 m2
    AND
  • Patient is at risk for disease progression [e.g., generally a urine protein-to-creatinine ratio (UPCR) greater than or equal to 1.5 g/g, or by other criteria such as clinical risk scoring using the International IgAN Prediction Tool] [B]
  • AND
  • Used to reduce proteinuria
  • AND
  • Patient has been on a minimum 90-day trial of a maximally tolerated dose of one of the following:
    • An angiotensin-converting enzyme (ACE) inhibitor (e.g., benazepril, lisinopril)
    • An angiotensin II receptor blocker (ARB) (e.g., losartan, valsartan)
    AND
  • Prescribed by or in consultation with a nephrologist
Vanrafia

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

2025-06-16

  1. Vanrafia Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, New Jersey. April 2025.
  2. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021;100(4S):S1-S276.

  1. IgAN can only be diagnosed with a kidney biopsy. [2]
  2. The International IgAN Prediction Tool incorporates clinical information at the time of biopsy and is a valuable resource to quantify risk of progression and inform shared decision-making with patients [2]

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