The PBAC has recommended expanding the eligible population for dapagliflozin in chronic kidney disease to align with its May 2025 recommendation for empagliflozin, broadening access across four additional patient subgroups.
The September 2025 decision extends PBS listing to patients with eGFR 20 to less than 25 mL/min/1.73 m² regardless of urinary albumin to creatinine ratio, and three other distinct populations based on eGFR and UACR combinations.
The additional populations included patients with eGFR 25 to less than 45 mL/min/1.73 m² with UACR less than 200 mg/g, those with eGFR 25 to 75 mL/min/1.73 m² with UACR greater than 5,000 mg/g, and patients with eGFR greater than 75 to 90 mL/min/1.73 m² with UACR at least 200 mg/g.
The PBAC “noted and welcomed consumer inputs from health care professionals and organisations received after the publication of the empagliflozin outcome from the May 2025 meeting.”
The committee acknowledged “the benefits of sodium-glucose cotransporter 2 inhibitors such as dapagliflozin and empagliflozin extend to a broader CKD population” based on evidence from clinical trials, real-world data and international clinical practice guidelines.
The PBAC agreed with consumer arguments that aligning dapagliflozin (Forxiga, AstraZeneca) 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 committee considered the submission provided adequate evidence to align the restrictions, including the updated Therapeutic Goods Administration approved indication for dapagliflozin, current clinical guidelines for CKD treatment with SGLT2 inhibitors, and real-world evidence showing similar benefit to empagliflozin in the requested additional population.
The PBAC recommended listing dapagliflozin on a cost-minimisation basis to empagliflozin (Jardiance), with equi-effective doses of empagliflozin 10 mg once per day and dapagliflozin 10 mg once per day.
The expanded listing represents a significant shift in PBS policy for CKD management, extending SGLT2 inhibitor access to patients with more advanced kidney disease (eGFR as low as 20) and those with preserved kidney function but significant proteinuria.
The recommendation follows growing international evidence supporting broader use of SGLT2 inhibitors in CKD, with benefits extending beyond glucose control to include cardiovascular and renal protection across a wider spectrum of kidney disease severity.