EnoxaparinClexane
Prevention of thrombo-embolic disorders of venous origin in patients undergoing orthopaedic and general surgery; prophylaxis of venous thromboembolism in medical patients bedridden due to acute illness; prevention of thrombosis in extra-corporeal circulation during haemodialysis; treatment of established deep vein thrombosis; treatment of unstable angina and non-Q-wave myocardial infarction; and treatment of acute ST-segment elevation myocardial infarction.
Decisions on record
- Meeting Mar 2026 Withdrawn Prevention and treatment of thromboembolic disorders, haemodialysis no PSD
- Meeting Jul 2025 Recommended VTE prevention/treatment, haemodialysis thrombosis prevention, acute coronary syndromes
- Meeting Jul 2023 Recommended Thrombo-embolic disorders
- Meeting Jul 2023 Noted Antithrombotic agent
- Meeting Nov 2022 Noted Prevention of deep vein thrombosis; haemodialysis no PSD
- Meeting Jul 2022 Noted Thromboembolic disorders, prophylaxis and treatment of venous thromboembolism no PSD
- Meeting Jul 2020 Recommended Prevention and treatment of deep vein thrombosis; Haemodialysis
- Meeting Jul 2019 Recommended Deep vein thrombosis
2 earlier decisions
- Mar 2019 Recommended Venous thromboembolism (VTE) prophylaxis
- Mar 2011 Recommended Anti-coagulant no PSD
Access path
- TGA registered · Clexane
TGA label narrower than the PBS population
- Mar 2019Recommended
- Jul 2019Recommended
- Jul 2023Recommended
Comparator changed: enoxaparin 100 mg (least costly alternative on per milligram basis) →…
- Jul 2025Recommended · restricted
Comparator changed: Clexane Safety-Lock → Clexane, Exarane
- PBS listing · Restricted
From the public summary
5.1 The PBAC recommended General Schedule (Restricted Benefit) listings of a new enoxaparin biosimilar (Enoxaject®) on a cost-minimisation basis and under the same circumstances as the existing PBS-listed biosimilar brands of enoxaparin (Clexane® and Exarane®), for the same indications.PSD · Jul 2025
5.2 The PBAC noted that the TGA has confirmed that Enoxaject is a biosimilar medicine to Clexane.PSD · Jul 2025
5.4 The Sponsor requested that the ex-manufacturer prices for Exarane 20 mg/0.2 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL and 100 mg/mL be equivalent to the price of the corresponding PBS-listed formulation of Clexane Safety-Lock.PSD · Jul 2023
5.5 This is based on the equi-effective dose of 1 mg Exarane = 1 mg of Clexane Safety- Lock.PSD · Jul 2023
5.3 The submission claimed that Exarane and Exarane Forte were non-inferior in terms of efficacy and safety to the comparator, Clexane Safety-Lock. The TGA Delegate’s 4PSD · Jul 2023
4.3 As per the Product Information, the TGA has confirmed that “Enoxaject is a biosimilar medicine to Clexane. The evidence for comparability supports the use of Enoxaject for the listed indications.”PSD · Jul 2025
Cost-effectiveness
Cost-minimisation basis; no ICER calculated as this is a biosimilar listing with expected price equivalence to existing enoxaparin brands.
The PBAC noted that the submission requested the addition of administrative advice reflecting the biosimilar update policy (i.e. encouraging uptake of biosimilar prescribing for treatment-naïve patients). PBAC · 2025
Decision context
PopulationAdults with indications for enoxaparin: prevention of thrombo-embolic disorders in orthopaedic and general surgery patients; prophylaxis of venous thromboembolism in bedridden medical patients; prevention of thrombosis during haemodialysis; treatment of deep vein thrombosis, unstable angina, non-Q-wave myocardial infarction, and acute ST-elevation myocardial infarction.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended · restricted | Clexane, Exarane | — | Other |
| Jul 2023 | Recommended | Clexane Safety-Lock | — | Cost-minimisation · Cost-minimisation |
| Jul 2019 | Recommended | enoxaparin 100 mg (least costly alternative on per milligram basis) | — | Cost-minimisation · Cost-minimisation |
| Mar 2019 | Recommended | — | — | Cost-minimisation · Cost-minimisation |
Consumer voice
One individual submitted a comment via the PBS website raising general safety concerns regarding biosimilar drugs.
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC excludes the requirement for aspirin concurrence in unstable angina/NQWMI and removes PCI management specification from STEMI indication.