Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Chronic kidney disease

Patient must have a diagnosis of chronic kidney disease, defined as abnormalities of at least one of: (i) kidney structure, (ii) kidney function, present for at least 3 months, prior to initiating treatment with this drug; AND

Patient must have an estimated glomerular filtration rate of between 20 to 90 mL/min/1.73 m2 inclusive prior to initiating treatment with this drug; AND

Patient must have an estimated glomerular filtration rate of between 45 to 90 mL/min/1.73 m2 inclusive, with a urinary albumin to creatinine ratio of at least 200 mg/g (22.6 mg/mmol) prior to initiating treatment with this drug; or

Patient must have an estimated glomerular filtration rate of between 20 to 45 mL/min/1.73 m2 inclusive, with any level of urinary albumin to creatinine ratio prior to initiating treatment with this drug; AND

Patient must discontinue treatment with this drug prior to initiating renal replacement therapy, defined as dialysis or kidney transplant; AND

Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND

Patient must be stabilised, for at least 4 weeks, on either: (i) an ACE inhibitor or (ii) an angiotensin II receptor antagonist, unless medically contraindicated, prior to initiation of combination therapy with this drug.

Patients with polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis; patients requiring or with a recent history of cytotoxic or immunosuppressive therapy for kidney disease; and patients with an organ transplant are not eligible for treatment with this drug.