The TGA indication for dapagliflozin (Forxiga) has been extended to include treatment of symptomatic heart failure with reduced ejection fraction (HFrEF) in adults as an adjunct to standard of care therapy.
The extended indication, beyond patients with diabetes, is largely based on the DAPA-HF trial published last year in the NEJM.
The data demonstrated a 26% reduction in the risk of the composite outcome of cardiovascular death or the worsening of heart failure above standard care versus placebo.
Cardiologist Professor Andrew Coats, from the Monash and Warwick Universities, told the limbic the impact of the SGLT2 inhibitor on heart failure admissions was impressive.
“It is one of the biggest effects we have seen of any drug class in terms of avoiding emergency HF admissions. HF admissions are an extremely expensive event in the healthcare system.”
He said given the drugs were not very expensive, everything was lining up for these being cost effective agents across most healthcare systems.
A recent study published in the European Journal of Heart Failure found dapagliflozin was likely to be a cost‐effective treatment for HFrEF in the UK, German and Spanish systems.
“These results were principally driven by reductions in cardiovascular and all‐cause mortality, resulting in significant life‐year and QALY gains for those treated with dapagliflozin,” the study said.
“The avoidance of HHF [hospitalisation for heart failure] was associated with more modest QALY gains but contributed to important cost‐savings, which partially offset the additional cost of dapagliflozin.”
The study found dapagliflozin was more cost‐effective in HFrEF outside the setting of type 2 diabetes due in part to the higher annual costs associated with comorbid diabetes.
Professor Coats, President of the Heart Failure Association of the European Society of Cardiology, said he believed dapagliflozin will be on the PBS for HFrEF in due course because of its “profoundly important effect”.
However there would be some medical education effort required given clinicians were more familiar with the drugs in the context of treating type 2 diabetes.
“This is a very substantial advance in the treatment of heart failure because it is an entirely new drug class and it’s an entirely different way of treating it,” he said.
“Every treatment to date for heart failure has been neurohormonal modulators. Whereas this is a metabolically active agent. It’s a totally different approach and in addition, and on top of everything else, it is profoundly effective. This is not a marginal benefit.”
While dapagliflozin is the first SGLT2 inhibitor to be approved in Australia for HFrEF, he said others such as empagliflozin were likely to follow.
Professor Coats has received consultancy fees from a number of pharmaceutical companies including AstraZeneca, the manufacturer of Forxiga.