PBAC greenlights broader access to Boehringer SGLT2i in landmark CKD recommendation

The Pharmaceutical Benefits Advisory Committee (PBAC) has issued a positive recommendation to expand the listing of Boehringer Ingelheim’s SGLT2 inhibitor, Jardiance (empagliflozin 10 mg), for the treatment of chronic kidney disease (CKD).

The expanded PBS listing would allow subsidised access to Jardiance for additional patient groups at high and very high risk of CKD progression, aligning with the full population studied in the pivotal EMPA-KIDNEY trial. When adopted, it will mark the widest PBS listing of an SGLT2 inhibitor for CKD to date.

“This recommendation is an important step toward ensuring Australians with chronic kidney disease can access effective treatment sooner. Jardiance has the potential to change the trajectory of kidney disease for tens of thousands of patients,” said Edward Hollywood, General Manager of Boehringer Ingelheim Australia and New Zealand.

While Jardiance already holds the broadest Therapeutic Goods Administration (TGA) indication for CKD among SGLT2 inhibitors, the new recommendation paves the way for further equitable access to this proven therapy. The expanded criteria could benefit at least 70,000 Australians annually, a significant step forward in addressing the national burden of kidney disease.

Under the PBS expansion, patients with an estimated glomerular filtration rate (eGFR) of 20 to 45 mL/min/1.73m², regardless of urine albumin creatinine ratio (uACR), as well as patients with eGFR 45 to 90 mL/min/1.73m² with uACR > 200 mg/g, would become eligible for reimbursed treatment.

The PBAC’s recommendation comes amid rising momentum for CKD reform, both locally and globally. It has been strongly supported by patient organisations and nephrologists who have long advocated for broader access to effective therapies.

“This recommendation comes at a pivotal time,” said Chris Forbes, CEO of Kidney Health Australia. “With the World Health Assembly recently passing the first-ever Kidney Health Resolution, kidney disease is now firmly on the global health agenda. In Australia, 2.7 million Australians are living with indicators of CKD and a staggering 2.5 million Australians remain undiagnosed.”

Forbes further added,” We need to take this seriously. Ultimately, early detection allows widely available and affordable treatments for the early management of CKD, which will give patients more years of quality life with fewer kidney and cardiovascular complications.

“Our ambition is a future where every Australian has the ability to enjoy good kidney health. This will only be possible through investment and innovation in early detection, management and research.”

The PBAC decision follows another recent milestone for Jardiance. As of 1 April, updated PBS criteria now allow its reimbursed use in combination with metformin, without glycaemic restrictions, for patients with type 2 diabetes and high cardiovascular risk – expanding access to its dual glycaemic and cardioprotective benefits.

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