sparsentan (Filspari)

following a full submission assessed under the orphan medicine process:

sparsentan (Filspari®) is accepted for restricted use within NHSScotland.

Indication under review: treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g*).
*equivalent to ≥85 mg/mmol

SMC restriction: patients whose condition has not responded adequately to current standard of care that is; maximally tolerated angiotensin converting enzyme inhibitor or angiotensin receptor blocker and sodium-glucose cotransporter-2 inhibitor, as appropriate. Patients should stop sparsentan at week 24 if no response to treatment.

In a double-blind phase III study, sparsentan, compared with an angiotensin receptor blocker, significantly reduced proteinuria and decline in renal function measured via annualised slope of estimated glomerular filtration rate (eGFR).

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.