NICE (UK) positive update for Filspari (sparsentan) for treating primary IgA nephropathy – CSL Vifor

NICE (UK): Sparsentan can be used as option to treat primary immunoglobulin A nephropathy (IgAN) in adults with a: i) urine protein-to-creatinine ratio (UPCR) of 85 mg/mmol or more, or ii) urine protein excretion of 1 g/day or more. It can only be used if the company provides it according to the commercial arrangement. Sparsentan should be stopped after 36 weeks if a person’s UPCR: i) is 199 mg/mmol or more, and ii) has not reduced by 20% or more since starting sparsentan. These recommendations are not intended to affect treatment with sparsentan that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.

Why the committee made these recommendations: Standard care for primary IgAN includes angiotensin-2 receptor blockers such as irbesartan. For this evaluation, the company specified that people should stop taking sparsentan if it has not lowered their UPCR (the amount of protein in the urine) enough by 36 weeks. This rule is not included in the licence for sparsentan but reflects how it would be used in the NHS. Clinical trial evidence shows that sparsentan reduces UPCR more than irbesartan. Evidence also suggests that sparsentan is better at maintaining kidney function than irbesartan, but this is uncertain. The cost-effectiveness estimates for sparsentan are within the range that NICE considers an acceptable use of NHS resources. So, sparsentan can be used.