PBAC has recommended funding for empagliflozin in heart failure patients with preserved ejection fraction.
The SGLT2 inhibitor empagliflozin needs government funding for heart failure patients with preserved and mildly reduced left ventricular ejection fraction, the Pharmaceutical Benefits Advisory Committee has announced.
This endorsement marks another win for the drug, which has rapidly become as known for its heart benefits as its use in type 2 diabetes.
The changes follow a consensus statement published late last year, in which Australian experts urged clinicians to consider the SGLT2 inhibitor in patients with reduced ejection fraction heart failure, and pointed to growing evidence backing it in those with preserved and mildly reduced ejection fraction as well.
Then in January, the TGA approved the use of empagliflozin for the treatment of symptomatic heart failure, independent of changes to the ejection fraction.
Now, PBAC has recommended government funding for 10mg empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) in patients with an ejection fraction of 40% or more, saying there was a “high unmet clinical need for effective treatments for patients with this condition”.
“Empagliflozin when added to standard care provided a statistically significant improvement in efficacy over standard care alone in the EMPEROR-Preserved study which looked at time to first cardiovascular death or hospitalisation for people with heart failure,” it said in a statement.
The EMPEROR-Preserved trial, a randomised, double-blind, placebo-controlled trial published in the New England Journal of Medicine, found that empagliflozin reduced the risk of cardiovascular death or hospitalisation for heart failure in patients with heart failure and a preserved ejection fraction, compared with a placebo.
It is uncommon for a health minister to reject a PBAC recommendation.
The August consensus statement, published in the MJA, strongly recommended considering an SGLT2 inhibitor in patients with HFpEF to reduce the chances of cardiovascular mortality or hospitalisation for heart failure. The evidence was of a moderate quality, and strongest for empagliflozin, it said, pointing to the EMPEROR-Preserved trial.
The recommendations were the same for heart failure patients with mildly reduced ejection fraction (LVEF 41–49%).
Professor John Atherton, one of the consensus statement authors and director of cardiology at Royal Brisbane and Women’s Hospital, told TMR there were no plans yet to update the consensus statement as they had already recommended empagliflozin for HFmrEF and HFpEF based on the results in the EMPEROR-Preserved trial.
