empagliflozin (Jardiance)

following a full submission:

empagliflozin (Jardiance®) is accepted for restricted use within NHSScotland.

Indication under review: in adults for the treatment of chronic kidney disease.

SMC restriction: in patients having individually optimised standard care (including angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, unless these are contraindicated or not tolerated), and either, at the start of treatment:

• an estimated glomerular filtration rate (eGFR) of 20 mL/min/1.73m2 up to 45 mL/min/1.73m2, or
• an eGFR of 45 mL/min/1.73m2 up to 90 mL/min/1.73m2 and either:

o  A urine albumin-to-creatinine ratio (uACR) of 22.6 mg/mmol or more, or
o  Type 2 Diabetes Mellitus (T2DM).

In a randomised, double-blind, phase III study in patients with chronic kidney disease, treatment with empagliflozin added to standard of care significantly reduced the risk of first occurrence of progression of kidney disease or death from cardiovascular causes when compared with standard of care alone.