Low-dose Xarelto has been listed on the PBS in combination with aspirin, for the prevention of major cardiovascular events in high-risk patients
While pharmacists have been familiar with Xarelto (rivaroxaban) in the wider cardiovascular space for over a decade, the drug is now available in a new low dose (2.5mg, twice daily) formulation, as a dual therapy along with aspirin (100mg once daily) for the prevention of major cardiovascular events in high-risk patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD).
It is the first non-vitamin K antagonist oral anticoagulant (NOAC) to be listed on the PBS for this indication, from 1 December 2020.
The listing is in line with treatment guidelines for CAD and PAD released by the European Society of Cardiology and Vascular Medicine, and was recommended by the independent Pharmaceutical Benefits Advisory Committee.
Up to 46,900 patients every year could benefit from this listing, said Health Minister Greg Hunt in an announcement. Without PBS subsidy, these patients would pay more than $790 per year for treatment.
“Coronary artery disease and peripheral artery disease are types of atherosclerosis, which occurs when arteries that supply blood to the heart or limbs become hardened and narrowed, due to a build-up of cholesterol and/or plaque fatty deposits,” said Minister Hunt.
“Coronary artery disease and peripheral artery disease increase risk of blood clots and reduce blood flow to key areas of the body such as the heart, brain or limbs,” he said.
“Australians who are living with these conditions have an increased risk of heart attack or stroke which can lead to disability, amputation or death.”
Associate Professor John Amerena, Cardiologist and Director Cardiology Research Department, University Hospital Geelong, said: “Despite significant advances in treatment for cardiovascular disease, thousands of Australians are still dying every year from preventable secondary cardiovascular events.
“We know from the Phase III COMPASS study, that despite the best available treatment, more can be done to prevent secondary cardiovascular events in these high-risk patients.”
Results from the Phase III COMPASS study showed that rivaroxaban (2.5mg) twice daily plus aspirin (100mg) once daily, significantly reduced (24%) major cardiovascular events, including composite of stroke, myocardial infarction and cardiovascular death (HR 0.76; 95% CI 0.66-0.86, p <0.001 compared to aspirin alone).
The study also found that rivaroxaban plus aspirin reduced mortality rates by 18%, compared to aspirin alone (3.4% vs 4.1%; HR 0.82; 95% CI 0.71-0.96, P = 0.01).
There was a significantly higher risk of major bleeding events in patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (HR 1.70; 95% CI, 1.40 to 2.05; P<0.001). However there was no significant difference in intracranial or fatal bleeding between the two groups.
See the full study in the NEJM here.
“Pharmacists play an important role in the management of patients with cardiovascular disease, especially when new therapies are introduced,” A/Professor Amerena told AJP.
“They often have more time to explain the benefits and potential adverse effects of new medications than the prescriber, and this provides reassurance to the patients and potentially improves compliance, and thus outcomes.”
Approved PI available at https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2009-PI-01020-3