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