A new treatment approach, Xarelto^® 2.5mg (rivaroxaban) when used with aspirin 100mg, has been listed on the Pharmaceutical Benefits Scheme (PBS) for the prevention of secondary heart attacks and strokes in high-risk Australians with coronary artery disease (CAD) and/or peripheral artery disease (PAD).^1,2 This is the first time a therapy of this class (a non-vitamin K antagonist oral anticoagulant, or ‘NOAC’) has been reimbursed for the treatment of patients with CAD and/or PAD.^1,3

CAD and PAD are common circulatory problems that result in narrowed arteries and reduced blood flow, which increases the risk of heart attack or stroke.4 1.2 million people in Australia who have heart disease are five to seven times more likely to have a secondary event and are twice as likely to die prematurely compared to the general population.4 Secondary cardiovascular events can also lead to significant disability, including brain damage or loss of limbs.4

Experts like Associate Professor John Amerena, Cardiologist and Director of the Cardiology Research Department at the University Hospital Geelong, are encouraging those Australians living with CAD and PAD, who are at high-risk of a secondary cardiovascular event, to speak with their specialist about treatment options available to them.

“Despite advances in treatment for CAD, thousands of Australians are still dying every year from secondary cardiovascular events.4 We should not be losing Australians as a result of cardiovascular events that are preventable. Having a new dual therapy approach for the first time is exciting, as it offers us another option to support prevention of dangerous secondary cardiovascular events in CAD patients,” said A/Prof Amerena.

“Up until now, aspirin and statins have been the mainstay treatment option available for people with PAD to support the prevention of secondary heart attacks and strokes.5,6 For the first time, we have a new treatment to add to aspirin to greater protect these high-risk patients. This is a really important advancement for a group of patients who previously had very limited options,” said A/Prof Amerena.
 

In addition to saving lives, better prevention of secondary cardiovascular events has the potential to reduce pressure on Australia’s healthcare system. There are over 500,000 hospitalisations in Australia each year due to cardiovascular admissions.4 Recurrent heart attack is also associated with worse prognosis than a single heart attack and results in substantial long-term cost of care. 7,8

“Bayer is committed to partnering with Australia’s medical, research and patient communities to tackle the burden of CVD. Innovating to expand treatment options and securing access to new treatments for Australian patients is one way we do this, and a strategy we’ll continue moving forward. We’re extremely pleased to welcome this new PBS listing and its potential to improve outcomes for eligible Australian patients,” said Ashraf Al-Ouf, Bayer Pharmaceuticals Australia & New Zealand General Manager.

About non-vitamin K antagonist oral anticoagulants (NOACs) and Xarelto (rivaroxaban)
NOACs are a type of anticoagulant medicine that help to prevent a blood clot, to reduce cardiovascular events like heart attack and stroke.3

Xarelto (rivaroxaban) is approved in Australia for the following indications:2

• The prevention of venous thromboembolism (VTE) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks).
• The prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke.
• The treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the prevention of recurrent DVT and PE.
• The prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD), in combination with aspirin.

As with all medicines, Xarelto (rivaroxaban) is associated with some side-effects. While uncommon, the most frequent adverse events include prolonged or excessive bleeding from gums, nose etc, dizziness, fainting, vomiting or coughing up blood, blood in the urine or stool, heavy menstrual bleeding, skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals, tiredness, bruising, feeling sick (nausea), headache, diarrhoea, indigestion or stomach pain, and fast heart beat. 9

Full Consumer Medicine Information can be accessed at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-CMI-03447-3

From 1 December 2020:

[1] Pharmaceutical Benefits Scheme. Xarelto® (Rivaroxaban).

[2] Australian Product Information. Xarelto® (Rivaroxaban). Available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2009-PI-01020-3. Accessed October 2020.

[3] Clinical Excellence Commission, Non-Vitamin K Antagonist Oral Anticoagulants (NOAC) Guidelines. Available at:

http://www.cec.health.nsw.gov.au/__data/assets/pdf_file/0007/326419/noac_guidelines.pdf. Accessed October 2020.

[4] The Baker Heart and Diabetes Institute, No Second Chances Report. Available at: https://www.baker.edu.au/impact/advocacy/no-second-chances. Accessed October 2020.

[5] Aboyans et al. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries. European Heart Journal 2018.39(9):763-816.

[6] Gerhard-Herman, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135(12):686-725.

[7] Gerber Y, Weston SA, Jiang R and Roger VL. The changing epidemiology of myocardial infarction in Olmsted County, Minnesota, 1995-2012. Am J Med. 2015;128:144-51.

[8] Shetty S, Halpern R and McCollam PL. Cost of care for new versus recurrent acute coronary syndrome patients. J Med Econ. 2008;11:81-99.

[9] Australian Consumer Medicine Information. Xarelto® (Rivaroxaban).Available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-CMI-03447-3. Accessed October 2020.