Empagliflozin will be made available to a broader group of Australians with chronic kidney disease from next month, after new PBS criteria extended access beyond patients with albuminuria – a move clinicians say could halve the rate of kidney decline when treatment begins early.

From 1 November, empagliflozin 10 mg (Jardiance) will be available to adults with an estimated glomerular filtration rate (eGFR) as low as 20 mL/min/1.73 m² – regardless of albuminuria – and to those with moderate kidney function who show elevated urinary albumin-to-creatinine ratios. The change aligns PBS eligibility with the population studied in the landmark EMPA-KIDNEY trial and is expected to more than double the number of Australians eligible for subsidised treatment.

Renal physician Professor Carol Pollock, from Royal North Shore Hospital, described the expanded PBS listing as “extremely welcome.”

“This will enable a broader group of patients than ever before to receive treatment to slow the progression of chronic kidney disease,” she said in a media statement.

“We now have an affordable therapy proven to provide significant renal benefits in patients with or without diabetes who have proteinuric or non-proteinuric chronic kidney disease.”

She stressed the importance of detecting kidney disease early and intervening before irreversible damage occurs adding that further kidney function decline can be reduced by half with early treatment.

“In fact, early treatment really can change the course of a patient’s life. We know that, depending on a patient’s level of disease, Jardiance could delay the need for dialysis by up to 27 years. That means that more than 4,100 dialysis sessions could potentially be avoided if treatment is started early in the disease course.”

Data from the EMPA-KIDNEY trial – the largest and broadest phase III SGLT-2 inhibitor study in CKD – showed a 28% relative risk reduction in the composite endpoint of kidney disease progression or cardiovascular death with empagliflozin compared to placebo (HR 0.72; 95% CI 0.64–0.82; p<0.0001). The benefits were consistent across patients with and without type 2 diabetes and across a wide range of kidney function down to 20 mL/min/1.73 m².

Professor Pollock said the risks associated with CKD extend far beyond the kidneys. “Most people with chronic kidney disease will die from cardiovascular disease,” she said. “The lower their kidney function, the higher their cardiovascular risk. Treatment must protect both the kidneys and the heart.”

The PBS expansion is expected to benefit around 70,000 patients, more than doubling the number currently eligible.

To maximise the impact of the change, Professor Pollock said more widespread kidney screening in primary care was essential.

“We need to do better at diagnosing chronic kidney disease early on. Patients at increased risk, including those with diabetes, hypertension, cardiovascular disease, a history of smoking or vaping, First Nations people and those with a family history of kidney disease, should all be regularly screened for signs of kidney damage.”

She also highlighted the need for both blood and urine testing.

“A kidney health check must involve both eGFR and uACR testing,” she said. “Currently, too many patients are missing out on uACR and therefore not receiving the treatment they require.”