Dapagliflozin gets new PBS listing for HFpEF

Medicines

Geir O'Rourke

By Geir O'Rourke

1 May 2026

Two drugs relevant to Australian cardiologists joined the PBS on 1 May 2026, with dapagliflozin (Forxiga) gaining a PBS listing for heart failure with preserved ejection fraction (HFpEF).

The dapagliflozin listing (item 15353C) covers the 10 mg tablet in a 28-tablet pack, with up to five repeats available under a streamlined authority. Both medical practitioners and nurse practitioners may prescribe under the listing.

Separately, the restriction on the apixaban 5 mg, 60-tablet pack (items 13525W and 2735Y) has been altered to reflect new deep vein thrombosis and pulmonary embolism indications. The existing 28-tablet apixaban item (10414D) has been deleted from the schedule simultaneously. The 60-tablet pack carries a DPMQ of $122.58 and a standard patient charge of $25.00, and is eligible for 60-day dispensing, meaning patients will require fewer prescriptions over time.

Apixaban was already PBS-listed for atrial fibrillation stroke prevention, but the restriction change expands the 60-tablet pack’s PBS reach to cover treatment and secondary prevention of DVT and PE, conditions frequently managed by cardiologists and haematologists alongside vascular and general physicians.

PBAC rejects tafamidis cap increase as ATTR-CM population swells

Meanwhile, the PBAC has declined to expand the risk-sharing arrangement expenditure caps for tafamidis (Vyndamax, Pfizer) for transthyretin amyloid cardiomyopathy, despite the treated population growing well beyond original estimates.

The committee acknowledged that newer bone scanning diagnostics have increased ATTR-CM diagnosis and expanded the number of patients receiving tafamidis above what was originally projected. However, it raised concerns that this expanded population may differ meaningfully from the population studied in the ATTRACT trial, particularly around diagnostic criteria and the growing use of SGLT2 inhibitors in heart failure with preserved ejection fraction.

The PBAC agreed a cap increase may ultimately be appropriate but not to the degree proposed, and required the sponsor to submit evidence supporting equivalence between ATTRACT trial diagnostic criteria and bone scanning across the full treated population.

Sponsors walk away from six PBS deals

Six previously recommended drugs had their positive recommendations rescinded after sponsors failed to accept the recommendations, including the influenza vaccine Flublok Quadrivalent (Sanofi-Aventis).

Elsewhere, the PBAC recommended tirzepatide (Mounjaro, Eli Lilly) for inadequately controlled type 2 diabetes after four rounds of consideration, available through community pharmacy. However, the drug company later said it would refuse to list the medicine, claiming the Australian Government’s price offer was  “unrealistic and unviable” and lower than any comparable healthcare system globally, including China’s [read our full story here].

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