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