budesonide modified release (Kinpeygo)

following a full submission:

budesonide (Kinpeygo®) is accepted for 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 ≥0.8 g/g*).
*equivalent to ≥90 mg/mmol]

In a phase III study of patients with primary IgAN with a urine protein excretion ≥1.0 g/day (urine protein-to-creatinine ratio ≥0.8 g/g [equivalent to ≥90 mg/mmol]) and on renin angiotensin system (RAS) inhibition, budesonide modified release treatment was associated with a statistically significant reduction in the decline of estimated glomerular filtration rate (eGFR) over 2 years compared with placebo.

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.