Chronic heart failure medicine to move ahead with listing on the PBS

Pharma News: A chronic heart failure medicine has been recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) now that the sponsor has addressed the “outstanding issues identified at the November 2022 PBAC meeting via the proposed price reduction and risk sharing arrangement.”

Boehringer Ingelheim and Eli Lilly’s type 2 diabetes drug Jardiance (empagliflozin) is listed for the treatment of chronic heart failure in patients with reduced ejection fraction (LVEF ≤40%). This SGLT2 inhibitor must be an add-on therapy to optimal standard treatment of a beta blocker and ACE (angiotensin-converting enzyme) inhibitor or ARB (angiotensin receptor II blocker) or ARNI (angiotensin receptor neprilysin inhibitor), it is unless contraindicated or cannot be tolerated.

The new indication and clinical criteria for Jardiance are the same as for AstraZeneca’s Forxiga (dapagliflozin), whose PBS listing was changed in January 2022.

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Intriguingly, in the Australian guidelines for heart failure, there is no recommendation for the use of Jardiance or other SGLT2 inhibitors in the management of patients with HFrEF (heart failure with reduced ejection fraction) who do not have type 2 diabetes. The role of these medicines is limited to patients with both cardiovascular disease and type 2 diabetes with insufficient glycaemic control despite receiving metformin.

Importantly, the pharmacological management for people with HFrEF who have LVEF ≤ 40% was updated in the US, European and Canadian guidelines in 2021. They recommend that standard treatment for HFrEF with LVEF ≤ 40% include an SGLT2 inhibitor as a fourth medicine alongside standard therapy.

Professor Andrew Coats, Cardiologist from Melbourne and President of the Heart Failure Association said that the debilitating condition claims more than 60,000 Australian lives each year and is responsible for a revolving door of hospitalisations, many of which could be prevented.

“Many people with heart failure suffer greatly in their daily lives. They will certainly welcome news of the availability of a new treatment option,” he said.

A recent Australian trial was also the first head-to-head study comparing two classes of type 2 diabetes drugs – SGLT2 inhibitors (SGLT2i) and GLP-1 receptor agonists (GLP-1RA) – and found that SGLT2 inhibitors are associated with a greater reduction of major adverse cardiovascular events in men than in women.

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