- On 1 December 2020, rivaroxaban 2.5 mg (Xarelto) was listed on the PBS General Schedule as an Authority Required (Streamlined) listing for patients with chronic stable atherosclerotic disease
Treatment must only be in combination with low-dose aspirin, not with any other antiplatelet medicine.
- Rivaroxaban 2.5 mg with aspirin reduces the risk of cardiovascular events for patients with stable atherosclerotic vascular disease, compared to aspirin alone
The benefits of receiving treatment with this combination are limited to a highly selected population.
- A person’s individual risk of bleeding must be considered before starting treatment with rivaroxaban
Rivaroxaban 2.5 mg with aspirin increases the risk of bleeding compared to aspirin alone in the specific population studied.
On 1 December 2020, rivaroxaban 2.5 mg was listed on the PBS General Schedule (Section 85) as an Authority Required (Streamlined) listing for patients with chronic stable atherosclerotic disease. Treatment must be in combination with aspirin, but not with any other antiplatelet therapy.1
The patient must have a diagnosis of either coronary artery disease (CAD) or peripheral artery disease (PAD), with a high risk of recurrent cardiovascular events and additional risk factors.2
See the PBS website for complete details for this item.
Why was the new listing made?
At the July 2020 PBAC meeting, rivaroxaban 2.5 mg (in combination with aspirin) was recommended for treatment of patients with chronic stable atherosclerotic disease.2
The PBAC considered there to be a moderate clinical need for effective treatments for secondary prevention of thrombotic events in high-risk patients. They were satisfied that rivaroxaban in combination with aspirin provides, for some patients, a significant improvement in efficacy over aspirin alone.2
Results from the COMPASS trial (n = 27,395) showed that for patients with stable atherosclerotic vascular disease, rivaroxaban 2.5 mg twice daily in combination with aspirin 100 mg once daily was associated with better cardiovascular outcomes than aspirin alone. The composite primary outcome (cardiovascular death, stroke or myocardial infarction) occurred in fewer patients in the rivaroxaban plus aspirin group compared to the aspirin-only group (HR = 0.76, 95% CI 0.66 to 0.86, p < 0.001).
Patients who were taking rivaroxaban 5 mg twice daily alone did not have better cardiovascular outcomes compared to aspirin alone, and this regimen also resulted in more major bleeding events.3
Will the changes affect current prescribing?
The UK National Institute for Health Care and Excellence (NICE) guidelines recommend rivaroxaban in combination with aspirin as an option for preventing atherothrombotic events in adults with CAD or symptomatic PAD who are at a high risk of ischaemic events. The guidelines note however that the COMPASS trial included a specific population and the benefits and risks are only known for this highly selected group.4
The clinical criteria in the PBS listing defines the high-risk patient subgroups who would derive most benefit from treatment with rivaroxaban plus aspirin. The combination should only be used for people who fit the specific clinical criteria in the PBS listing.2
Treatment must be initiated by a specialist physician or a physician who has consulted a specialist physician. Continuing treatment may be prescribed by a non-specialist prescriber without the need for consultation with a specialist.5
What else should health professionals know?
Changes to prescribing information and processes
Active ingredient prescribing
On 31 October 2019, active ingredient prescribing regulations were introduced by the PBS under the National Health Act 1953. Active ingredient prescribing is part of a wider government strategy to ensure consistent and standardised medicines information.6
Active ingredient prescribing aims to:6
- ensure the identification of active ingredient names on all PBS prescriptions
- increase patient understanding of the medicines they are taking
- promote the uptake of generic and biosimilar medicines.
Under the regulations, prescribers:6
- are required to include the active ingredient on all PBS prescriptions (excluding handwritten prescriptions, paper-based medication charts in residential aged care settings, and medicines with four or more active ingredients).
- can include a brand after the active ingredient on a prescription, if the medicine prescribed is likely to pose a patient safety risk if the brand is not specified or to ensure medicine continuance where a patient is familiar with a particular brand of their regular medicine.
A transition period has been arranged to ensure prescribers have sufficient time to update prescribing software to versions which meet the new active ingredient prescribing requirements.
Community level electronic prescriptions
On 31 October 2019, Commonwealth legislation changed to recognise electronic prescriptions as a legal prescription for the purpose of PBS-listed medicine supply. Electronic prescribing is part of a wider government strategy to support safer medicine management and improve the efficiency of the PBS. It will not be mandatory, but provides prescribers and their patients with a safe and secure alternative choice to paper prescriptions.
Electronic prescribing aims to:
- improve efficiency in prescribing and dispensing medications
- remove the need for handling and storing a physical paper prescription
- support digital health services such as telehealth services to ensure continuity of patient care
To support the legislative changes, technical upgrades are currently underway to ensure safe, secure and seamless transmission of information of electronic prescriptions between prescribing and dispensing clinical software and to PBS payment systems.
Once in place, two models will be available to support electronic prescription; Token and Active Script List.
More information about electronic prescriptions is available:
While the COMPASS trial showed reduced risk of cardiovascular outcomes for patients taking rivaroxaban in combination with aspirin, it also reported an increased risk of major bleeding events (HR = 1.70, 95% CI 1.40 to 2.05, p < 0.001) compared to aspirin alone. Most of the excess major bleeding events were into the gastrointestinal tract. There was no significant difference in the rates of fatal intracranial bleeding or symptomatic bleeding into a critical organ.3 The UK NICE guidelines recommend assessing a person’s risk of bleeding before considering rivaroxaban.4
Regular renal function monitoring is recommended for people receiving rivaroxaban, particularly for older people. Rivaroxaban may be used for patients with renal impairment but requires dose reduction and may be contraindicated depending on creatinine clearance.7
For more information, see the NPS MedicineWise RADAR article about using oral anticoagulants with aspirin.
For information about reporting adverse reactions to the TGA, or to report suspected adverse reactions online, see the TGA website.
What should patients know?
Patients prescribed the active ingredient rivaroxaban must not take other anticoagulant medicines at the same time, unless they have received specific instructions from their prescriber. Taking multiple anticoagulant medicines may increase the risk of uncontrolled or serious bleeding.8
There is currently no antidote for rivaroxaban, therefore patients must be vigilant in noting signs and symptoms of bleeding. Patients should notify their doctor immediately if they have unexplained bruising, bleeding, pink/red/dark brown urine and red or black faeces.7
- Patients can learn more about anticoagulant medicines on the NPS MedicineWise website
- Patients can learn more about their medicine by reading the relevant Consumer Medicine Information (CMI) leaflet (available through the Medicine Finder) or calling Medicines Line (1300 MEDICINE) (1300 633 424).
- Patients who wish to discuss or report adverse medicine experiences can also call the Adverse Medicine Events Line (1300 134 237).
- Pharmaceutical Benefits Scheme. PBS Schedule: Summary of changes (December 2020). Canberra: Australian Government Department of Health, 2020 (accessed 24 November 2020).
- Pharmaceutical Benefits Scheme. Public summary documents: Rivaroxaban (July 2020 PBAC meeting). Canberra: Australian Government Department of Health, 2020 (accessed 24 November 2020).
- Eikelboom JW, Connolly SJ, Bosch J, et al. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl J Med 2017;377:1319-30.
- National Institute for Health Care and Excellence. Rivaroxaban for preventing atherothrombotic events in people with coronary or peripheral artery disease. United Kingdom: NICE, 2019 (accessed 24 November 2020).
- Pharmaceutical Benefits Scheme. Rivaroxaban. Canberra: Australian Government Department of Health, 2020 (accessed 1 December 2020).
- Australian Government Minister for Health. Explanatory statement - National health (Pharmaceutical Benefits) amendment (Active Ingredient Prescribing) regulations 2019. Canberra: Australian Government Department of Health, 2019 (accessed 1 December 2020).
- Australian Medicines Handbook. Rivaroxaban. Adelaide: AMH Pty Ltd, 2020 (accessed 24 November 2020).
- Bayer Australia Ltd. Rivaroxaban (Xarelto) product information. Pymble, NSW: Bayer Australian Ltd, 2020 (accessed 24 November 2020).