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Filspari (sparsentan)Medica

primary immunoglobulin A nephropathy (IgAN)

Initial criteria

  • age ≥ 18 years
  • diagnosis confirmed by biopsy
  • patient is at high risk of disease progression defined by meeting BOTH of the following: (a) proteinuria ≥ 0.5 g/day OR urine protein-to-creatinine ratio ≥ 0.8 g/g; AND (b) patient has received the maximum or maximally tolerated dose of an angiotensin converting enzyme inhibitor OR angiotensin receptor blocker for ≥ 12 weeks prior to starting Filspari
  • patient has received ≥ 3 months of optimized supportive care including blood pressure management, lifestyle modification, and cardiovascular risk modification according to prescriber
  • estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
  • will not be used in combination with any renin-angiotensin-aldosterone antagonists (e.g., angiotensin converting enzyme inhibitors or angiotensin receptor blockers), endothelin receptor antagonists, or aliskiren
  • prescribed by or on consultation with a nephrologist

Reauthorization criteria

  • age ≥ 18 years
  • diagnosis confirmed by biopsy
  • patient has had a response to Filspari according to the prescriber (e.g., reduction in urine protein-to-creatinine ratio from baseline or reduction in proteinuria from baseline)
  • estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
  • not used in combination with any renin-angiotensin-aldosterone antagonists, endothelin receptor antagonists, or aliskiren
  • prescribed by or on consultation with a nephrologist

Approval duration

1 year