The Minister for Health and Ageing Mark Butler has announced dapagliflozin (Forxiga, Astrazeneca) will be available on the PBS to more Australians living with CKD.
It comes after the Pharmaceutical Benefits Advisory Committee (PBAC) determined at its September 2025 meeting that expanding the eligible population for PBS-listed dapagliflozin was in line with growing evidence for the benefits of the SGLT2 inhibitor, as previously reported in the limbic [link here].
“The PBAC acknowledged that the benefits of sodium-glucose cotransporter 2 (SGLT2) inhibitors such as dapagliflozin and empagliflozin extend to a broader CKD population and the support for the alignment of the dapagliflozin with empagliflozin restrictions was based on evidence from clinical trials, real world data and international clinical practice guidelines,” it said.
“Additionally, the PBAC agreed with the consumer inputs’ arguments that aligning dapagliflozin with empagliflozin restrictions would improve quality use of medicines and provide equitable access for patients and clinical clarity for prescribers for this class of medicine.”
The additional population for the expanded listing is patients with:
• eGFR 20 to <25 mL/min/1.73 m2 regardless of urinary albumin to creatinine ratio (UACR)
• eGFR 25 to <45 mL/min/1.73 m2 with UACR <200 mg/g
• eGFR 25 to 75 mL/min/1.73 m2 with UACR >5,000 mg/g
• eGFR >75 to 90 mL/min/1.73 m2 with UACR ≥200 mg/g.
A/Prof Brendon Neuen
Associate Professor Brendon Neuen, Director of Kidney Trials at the Royal North Shore Hospital, told the limbic that SGLT2 inhibitors were one of the most important therapeutic advances to prevent kidney failure, reduce hospitalisations, and save lives in people with CKD.
“The expansion of subsidised access means many more Australians who stand to benefit can now receive these medicines. This is a major opportunity to reduce the burden of kidney and cardiovascular disease at a population level, and it supports simpler, broader prescribing so that eligible patients are not missing out,” he said.
Associate Professor Neuen is Co-Chair of the SGLT2 Inhibitor Meta-Analysis Cardio-Renal Trialists’ Consortium (SMART-C) which last year published evidence supporting expansion of the eligibility criteria for SGLT2 inhibitors.
The meta-analyses were published in a suite of articles in JAMA [links here, here and here] and reported in the limbic [link here].