The P2Y12 inhibitor prasugrel is set to return as a PBS-subsidised option for treatment of patients with acute coronary syndrome undergoing PCI after a four year hiatus, with the PBAC recommending the relisting of a generic version of the antiplatelet drug.

Prasugrel was removed from the PBS on 1 July 2020 after its sponsor decided to withdraw the Effient brand for business reasons, citing low uptake of the drug.

As previously reported in the limbic, clinicians said that prasugrel accounted for only a small number of prescriptions compared to clopidogrel and ticagrelor despite being deemed the most efficacious P2Y12 inhibitors after ACS.

However the PBAC has now recommended that Prasugrel SCP sponsored by Generic Health be given a PBS listing for use in combination with aspirin, for the treatment of ACS (myocardial infarction or unstable angina) managed by PCI.

At its July 2024 meeting (link here) the PBAC said it considered that prasugrel could be equally cost effective as ticagrelor and clopidogrel in this indication, although it did not accept trial evidence that prasugrel was superior to either ticagrelor or clopidogrel.

In its review of the application to re-list prasugrel, the PBAC said it believed usage would be low because the treatment of ACS is protocol driven and the use of dual antiplatelet therapy (DAPT) prior to angiography in STEMI and NSTEACS is standard.

“Unlike clopidogrel or ticagrelor, which have a broad ACS indication, prasugrel cannot be given in a number of situations, including to patients who have had a stroke or transient ischemic attack or to patients who do not receive a PCI,” it said.

The PBAC also noted that prasugrel requires dose adjustments for patients aged over 75 years or who weigh less than 60 kg.

In a paper published in Heart Lung and Circulation (link here) after the withdrawal of prasugrel from the PBS, cardiologists at Monash Health noted that it accounted for only 2.6% of the almost one million prescriptions for P2Y12  inhibitors in 2020.

Study author Dr Timothy Abraham said the withdrawal meant that Australian prescribers and patients “are missing an important agent in ACS management with the removal of prasugrel from the market.”

“Compared to other health care systems, Australian patients are deprived of a standard therapy that is cheaper and emerging as a more effective agent … European Society of Cardiology guidelines recommended prasugrel should be considered in preference to ticagrelor for Non-ST-segment-elevation ACS patients who proceed to PCI, which can no longer be offered in Australia,” he said.