potassium citrate/potassium hydrogen carbonate (Sibnayal)

following a full submission assessed under the orphan equivalent medicine process:

potassium citrate and potassium hydrogen carbonate (Sibnayal®) is accepted for use within NHSScotland.

Indication under review: for the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older.

In a phase II/III open-label sequential study, potassium citrate/potassium hydrogen carbonate was non-inferior to standard alkalising agents measured by average blood bicarbonate levels during 3 days of treatment at steady state in patients with dRTA.

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.