Expanded PBS Criteria for Dapagliflozin

From 1 December 2024, the Pharmaceutical Benefits Scheme (PBS) criteria were expanded for dapagliflozin. Dapagliflozin is now subsidised for the treatment of type 2 diabetes in patients who either have cardiovascular disease, a high risk of a cardiovascular event, or who identify as Aboriginal or Torres Strait Islander. There is no longer a requirement for patients to have a specific unmet glycaemic target for dapagliflozin to be added to therapy. However, the criteria still require treatment to be in combination with metformin (unless contraindicated or intolerant). This change further aligns PBS criteria with the recommendations of the Australian Evidence-Based Clinical Guidelines for Diabetes.

Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT-2) inhibitor. Inhibition of this enzyme in the kidneys prevents the reabsorption of glucose from the glomerular filtrate, improving overall glycaemic control. Other beneficial effects may include a slight reduction in blood pressure, modest weight loss, and preservation of renal function.

The results of a large network meta-analysis, available in the Australian guidelines, found that SGLT-2 inhibitors are associated with lower odds of:

• Hospitalisation for heart failure compared to placebo, sulfonylureas, gliptins, or glucagon-like peptide-1 (GLP-1) analogues when added to background therapy;
• Cardiovascular mortality compared to placebo, gliptins, and sulfonylureas; and
• Major adverse cardiovascular events compared to placebo or GLP-1 analogues added to background therapy.