RivaroxabanAPO-RIVAROXABAN
New pack sizes (2.5 mg 98-pack and 10 mg 14-pack) for existing indications: chronic stable atherosclerotic disease (chronic coronary artery disease and/or peripheral artery disease) for the 2.5 mg strength, and prevention of venous thromboembolism in total hip or knee replacement for the 10 mg strength.
Decisions on record
- Meeting Nov 2024 Recommended Prevention of venous thromboembolism; chronic stable atherosclerotic disease
- Meeting Jul 2020 Recommended Coronary Artery Disease (CAD) and Peripheral Artery Disease (PAD)
- Meeting Mar 2020 Deferred Coronary Artery Disease (CAD) and Peripheral Artery Disease (PAD)
- Meeting Mar 2019 Not recommended Coronary Artery Disease (CAD) and Peripheral Artery Disease (PAD)
- Meeting Nov 2018 Recommended Venous thromboembolism
- Meeting Nov 2012 Not recommended Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke.
- Meeting Mar 2012 Recommended Anti-thrombotic drug
- Meeting Mar 2012 Recommended Anti-thrombotic drug
3 earlier decisions
- Mar 2012 Not recommended Anti-thrombotic drug
- Mar 2010 Recommended Prevention of blood clot formation following surgery no PSD
- Mar 2009 Recommended Antithrombotic agent
Access path
- TGA registered · APO-RIVAROXABAN
TGA label narrower than the PBS population
- Mar 2009Recommended
vs enoxaparin
- Mar 2012Not recommended
ICER dropped $75,000 → $45,000 (-40%)
- ↻ resubmittedMar 2012Recommended · restricted
ICER dropped $75,000 → $45,000 (-40%)
- Mar 2012Recommended · restricted
ICER dropped $75,000 → $45,000 (-40%)
- Nov 2012Not recommended
post-hoc subgroup analysis not representative of target population, indirect comparison methodology questionable due to…
- ↻ resubmittedMar 2013Recommended · restricted
Comparator changed: aspirin → enoxaparin 80 mg twice daily followed by INR adjusted…
- Mar 2013Recommended
Comparator changed: aspirin → enoxaparin 80 mg twice daily followed by INR adjusted…
- Nov 2018Recommended · restricted
Comparator changed: aspirin (with warfarin considered but ultimately deemed inappropriate…
- Mar 2019Not recommended
Complex and poorly defined restriction with heterogeneous eligible population at varying cardiovascular risk levels…
- Mar 2020Deferred
Comparator changed: aspirin 100 mg once daily → aspirin 100 mg daily
- Jul 2020Recommended · restricted
Comparator changed: aspirin 100 mg daily → aspirin alone
- Nov 2024Recommended · restricted
Comparator changed: aspirin alone → existing pack sizes (Xarelto 2.5 mg 60-pack and…
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of rivaroxaban (Xarelto®) tablets 2.5 mg 98-pack (for treatment of chronic stable atherosclerotic disease (CSAD), chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD)) and 10 mg 14-pack (for prevention of venous thromboembolism (VTE) in total hip or knee replacement), as a General Schedule Authority Required (Streamlined) listing, as per the currently listed rivaroxaban 2.5 mg 60-pack and 10 mg …PSD · Nov 2024
6.2 The PBAC noted that the requested listing of the 10 mg 14-pack of rivaroxaban for the prevention of VTE in total hip replacement would supply 28 days of treatment while the recommended treatment regime is 35 days. The PBAC advised that 28 days of treatment was sufficient and considered the first 7 days of treatment would generally be managed through the hospital.PSD · Nov 2024
5.7 The submission presented a cost-minimisation analysis of the new Xarelto pack sizes compared with currently listed pack size of the same strength, on a price per tablet basis. As pack size is the only difference between the requested and current listings, the medicine is equivalent per mg.PSD · Nov 2024
5.8 The submission used an approved ex-manufacturer price (AEMP) that was estimated on the assumption of first new brand price reductions on 1 October 2024. The evaluation has replaced these estimated prices with the AEMP of Xarelto as at 1 November 2024.PSD · Nov 2024
5.4 The PBAC reiterated its previous advice that the claim of superior comparative effectiveness of rivaroxaban in combination with aspirin versus aspirin alone was reasonable, but that the magnitude of the benefit in the proposed PBS population was uncertain (paragraph 6.37, rivaroxaban PSD, March 2020).PSD · Jul 2020
5.5 The PBAC reiterated its previous advice that the claim of inferior comparative safety of rivaroxaban in combination versus aspirin alone was reasonable. However, the PBAC considered that the magnitude of the risk of bleeding was uncertain, noting that the risk was likely to vary depending on age, renal function, baseline risk and co-morbidities (paragraph 6.38, rivaroxaban PSD, March 2020).PSD · Jul 2020
5.3 The submission stated that the new Xarelto pack sizes (14-pack and 98-pack) were designed to minimise wastage and reduce the need for frequent prescriptions, leading to cost savings for the PBS. The 14-pack provides the exact required amount for treatment following a knee replacement, while the 98-pack allows for 49 days of treatment per dispensing. Under the requested increased MDQ listing, patients can access 98 days of treatment per dispensing.PSD · Nov 2024
5.4 The submission justified the new pack sizes stating that the Xarelto 10 mg 15-pack and Xarelto 2.5 mg 60-pack would be discontinued and the market supply would be depleted by 1 April 2025 and 1 December 2025 respectively. The submission stated that listing the new pack sizes would ensure patients continue to access their treatment after the discontinuation of the current pack sizes.PSD · Nov 2024
Cost-effectiveness
Cost-minimisation analysis only; no ICER calculated. Submission based on cost-per-tablet comparison of new pack sizes to existing pack sizes.
The PBAC considered that an ICER in the range of around $15,000 - $45,000 per QALY would be required for rivaroxaban to be considered suitably cost-effective. PBAC · 2020
Decision context
PopulationPatients with chronic stable atherosclerotic disease (chronic coronary artery disease and/or peripheral artery disease) for the 2.5 mg strength; patients undergoing total hip or knee replacement for the 10 mg strength.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended · restricted | existing pack sizes (Xarelto 2.5 mg 60-pack and Xarelto 10 mg 15-pack) | — | Cost-minimisation · Cost-minimisation |
| Jul 2020 | Recommended · restricted | aspirin alone | $15k–45k | RCT · Other |
| Mar 2020 | Deferred | aspirin 100 mg daily | — | RCT · Composite of cardiovascular death, ischaemic stroke, myocardial infarction |
| Mar 2019 | Not recommended | aspirin 100 mg once daily | — | RCT · Composite outcome of cardiovascular death, stroke, or myocardial infarction (efficacy); major bleeding (safety) |
| Nov 2018 | Recommended · restricted | rivaroxaban 20 mg and apixaban 2.5 mg | — | RCT · VTE recurrence |
| Mar 2013 | Recommended · restricted | enoxaparin 80 mg twice daily followed by INR adjusted warfarin | — | RCT · Recurrent VTE |
| Mar 2013 | Recommended | aspirin (with warfarin considered but ultimately deemed inappropriate for the target population) | $15k | RCT · Surrogate |
| Nov 2012 | Not recommended | aspirin | $15k | RCT, meta-analysis, indirect comparison · ischaemic stroke, haemorrhagic stroke, non-CNS embolism, haemoglobin/haematocrit drop, transfusion, critical organ bleeding, major bleeds resulting in death, minor bleeds |
| Mar 2012 | Not recommended | warfarin | $15k–45k | RCT | Registry · OS | PFS | DFS | ORR | QoL | Surrogate |
| Mar 2012 | Recommended · restricted | warfarin | $15k–45k | RCT · Stroke/SE |
| Mar 2012 | Recommended · restricted | enoxaparin followed by warfarin | — | RCT · VTE |
| Mar 2009 | Recommended | enoxaparin | $15k–75k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| COMPASS | Ph 3 | 27,395 | The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI)… | completed |
Consumer voice
An individual provided input regarding rivaroxaban treatment for pulmonary embolism, a condition for which rivaroxaban is already PBS-listed.
The PBAC noted and welcomed the input from an individual, but noted that this comment related to the treatment of pulmonary embolism, for which rivaroxaban is already PBS-listed. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to chronic stable atherosclerotic disease; TGA label includes acute coronary syndrome and other cardiovascular indications.