Dapagliflozin for heart failure – what is the evidence behind the new PBS listing?

On 1 January 2022 dapagliflozin received a new PBS listing to manage heart failure with reduced ejection fraction as an add-on therapy to ‘optimal standard treatment’. A new RADAR article from NPS MedicineWise summarizes the evidence and suggests, although not required under the new PBS listing, a mineralocorticoid receptor antagonist (MRA) could be considered part of this optimal standard treatment for some patients.

Under the new PBS listing, dapagliflozin can be used for people with symptomatic heart failure with a reduced ejection fraction (LVEF≤ 40%) to supplement treatment with a beta blocker and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blockers (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI).

“The DAPA-HF trial was the key study in the PBS listing submission,” says Dr Kate Annear, NPS MedicineWise clinical advisor and GP.

“The study showed that when added to standard treatment for people with heart failure with reduced ejection fraction (LVEF ≤ 40%), dapagliflozin reduces the risk of cardiovascular death or heart failure-related hospitalisation,” she says.

The RADAR article also notes that there are differences between Australian guidelines and international guidance, approved TGA-indications and PBS listings for dapagliflozin, and that MRAs are also have an important role to play.

“MRAs are the least commonly prescribed of the treatments recommended in the Australian guidelines as optimal standard treatment and could be considered for trial before or with dapagliflozin,” says Dr Annear.

“Indeed, MRAs were used by over 70% of the participants of the DAPA-HF trial and can be added early in treatment for patients who are congested to aid in improving their fluid balance.

“The management of heart failure continues to evolve, with now more PBS-listed options available for consideration,” she says.

The RADAR article covers definitions and recommendations across national and international guidelines and the evidence around the role of dapagliflozin in the treatment of heart failure with a reduced ejection fraction.