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Vanrafia (atrasentan)Medica

Primary immunoglobulin A nephropathy (IgAN)

Initial criteria

  • Patient is age ≥ 18 years; AND
  • Diagnosis has been confirmed by biopsy; AND
  • Patient is at high risk of disease progression, defined by meeting BOTH of the following (a and b):
  • a) Patient meets ONE of the following: (1) Proteinuria ≥ 0.5 g/day; OR (2) Urine protein-to-creatinine ratio ≥ 1.5 g/g; AND
  • b) Patient has received or is currently receiving the maximum or maximally tolerated dose of ONE of the following for ≥ 12 weeks prior to starting Vanrafia: (1) Angiotensin converting enzyme inhibitor; OR (2) Angiotensin receptor blocker; AND
  • According to the provider, patient has received ≥ 3 months of optimized supportive care, including blood pressure management, lifestyle modification, and cardiovascular risk modification; AND
  • Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2; AND
  • Medication is prescribed by or on consultation with a nephrologist

Reauthorization criteria

  • Patient is age ≥ 18 years; AND
  • Diagnosis has been confirmed by biopsy; AND
  • According to the prescriber, patient has had a response to Vanrafia (e.g., reduction in urine protein-to-creatinine ratio from baseline or reduction in proteinuria from baseline); AND
  • Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2; AND
  • Medication is prescribed by or on consultation with a nephrologist

Approval duration

9 months