Enoxaparin SodiumClexane
Prevention of thromboembolic disorders and treatment of established thrombotic conditions, including prevention in orthopaedic and general surgery, prophylaxis in bedridden medical patients, prevention in haemodialysis, treatment of deep vein thrombosis, treatment of unstable angina and non-Q-wave myocardial infarction, and treatment of acute STEMI.
Decisions on record
- Meeting Nov 2014 Recommended 20 mg/0.2 mL injection, 10 x 0.2 mL pre-filled syringes 40 mg/0.4 mL injection, 10 x 0.4 mL pre-filled syringes 60 mg/0.6 mL injection, 10 x 0.6 mL pre-filled syringes 80 mg/0.8 mL injection, 10 x 0.8 mL pre-filled syringes 100 mg/1 mL injection, 10 x 1 mL pre-filled syringes Clexane Safety-Lock® Sa
- Meeting Mar 2009 Recommended Antithrombotic agent no PSD
- Meeting Sep 2001 Recommended A treatment for blood clots no PSD
Access path
- TGA registered · Clexane
TGA label equal than the PBS population
- Nov 2014Recommended · restricted
- Jul 2020Recommended
Listing: Restricted → Unrestricted
- PBS listing · Unrestricted
From the public summary
6.1 The PBAC recommended the enoxaparin biosimilar (Enoxapo®) be listed on the General Schedule (Section 85) on a cost-minimisation basis under the same circumstances for which the reference product Clexane Safety-Lock® is currently PBS listed, and for the same circumstances as outlined in the July 2019 PBAC recommendation relating to the 120 mg and 150 mg strengths.PSD · Jul 2020
6.2 The PBAC advised that the listing of the 20 mg/0.2 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL and 100 mg/mL formulations of Enoxapo be based on equi-effective doses of each corresponding PBS listed formulation of Clexane Safety-Lock.PSD · Jul 2020
5.3 The Sponsor claimed that Enoxapo was non-inferior in terms of efficacy and safety compared to the comparator, Clexane Safety-Lock. The minor submission did not provide any clinical evidence in support of this claim. The sponsor provided the TGA approval letter which stated that Enoxapo had undergone an evaluation and was approved as a biosimilar medicine to Clexane.PSD · Jul 2020
5.4 The PBAC considered that the claim of non-inferior comparative effectiveness was reasonable.PSD · Jul 2020
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The PBAC considered enoxaparin (Clexane Safety-Lock®) as price equivalent to that of the currently PBS-listed enoxaparin (Clexane®) for all available strengths and indications. PBAC · 2014
Decision context
PopulationPatients requiring enoxaparin for prevention of thromboembolic disorders in orthopaedic and general surgery, prophylaxis in bedridden medical patients with acute illness, prevention of thrombosis in haemodialysis, treatment of established deep vein thrombosis, treatment of unstable angina and non-Q-wave myocardial infarction, and treatment of acute STEMI.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2020 | Recommended | Clexane Safety-Lock | — | Cost-minimisation · Cost-minimisation |
| Nov 2014 | Recommended · restricted | — | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label equal than PBS population — PBAC indication mirrors TGA label across all specified indications: surgery, bedridden patients, haemodialysis, DVT, unstable angina, and STEMI.