Dapagliflozin PBS listing recommendation for HFrEF

Dapagliflozin’s (Forxiga) PBS listing could soon extend to heart failure with reduced ejection fraction (HFrEF) following the PBAC’s recent recommendation.

It comes after additional information from AstraZeneca proved estimated impacts of listing dapagliflozin for HFrEF on top of type 2 diabetes were “broadly reasonable” and “an appropriate basis for a risk sharing agreement”.

The PBAC agreed the drug added to standard care and, for some patients, “provides a significant improvement in efficacy over standard care alone” when it considered the listing back in July 2021. It also felt the listing would be “cost-effective at the price proposed in the pre-PBAC response” from that time.

Despite recognising dapagliflozin’s efficacy in chronic kidney disease, the PBAC has not recommended the drug’s listing extend further due to “high and uncertain” financial estimates and “significant” overestimations of the eligible population.

Cardiology professor commercialises oral milrinone

A slow-release, oral milrinone capsule that may help keep late-stage heart failure patients off IV infusions is being commercialised by the Baker Heart and Diabetes Institute.

The Institute recently licensed the treatment — developed by Professor David Kaye and colleagues —  to a European biopharma company which is seeking international regulatory approval for the drug’s clinical use.

“This advance builds on a successful track record in commercialisation by Professor Kaye, who also heads The Alfred Hospital’s Cardiology Department,” the Institute said in a statement.

“The bench to bedside model allowing Professor Kaye to spend his time between the Institute’s labs and the hospital clinics, which are directly linked by a physical walkway, has provided a conducive environment for bringing innovation to an important and growing area of cardiovascular disease where few effective therapies are available.”

Already, the US FDA “has agreed to an orphan designation for use in the lead clinical indication to treat patients with left ventricular assist devices that develop right heart failure”, the Institute wrote in a statement.

AMA calls for healthcare staff to receive boosters

The AMA has urged immunisation advisers to provide recommendations for COVID-19 booster doses for healthcare professionals.

AMA Victorian president Dr Rod McRae said the Australian Technical Advisory Group on Immunisation (ATAGI) should consider whether immunity may already be waning for medical staff who had their primary course of vaccinations at the start of the year.

“They should be looking after healthcare workers to ensure that they’re as protected as they possibly can be as they have made the decision to open up the community,” he said.

However Professor Robert Booy of the  National Centre for Immunisation Research and Surveillance (NCIRS) said there was no need to panic as evidence from overseas showed protection against the virus remained strong even if markers of immunity appeared to be waning.

“I’ve been doing vaccine research for over 30 years. I always see a decline in antibody at six to 12 months. That’s normal,” he said.

“If you’re a standard, run of the mill person who is reasonably healthy you retain immunity – and that’s after six to 12 months,” he said.

Professor Booy told the Nine Network that a booster would probably be delivered in after March 2022 at the same time as a flu jab.