WarfarinCoumadin
Prophylaxis and/or treatment of venous thrombosis and its extension and pulmonary embolism; prophylaxis and/or treatment of thromboembolic complications associated with atrial fibrillation; and as an adjunct in the treatment of coronary occlusion.
Decision on record
- Meeting Nov 2016 Not recommended Unrestricted
Access path
- TGA registered · Coumadin
TGA label equal than the PBS population
- Nov 2016Not recommended
Potential safety and quality use of medicines (QUM) issues; narrow therapeutic index with risk of confusion and adverse…
From the public summary
7.1 The PBAC did not recommend the listing of Warfarin APOTEX® in the context of potential safety and QUM issues identified.PSD · Nov 2016
7.2 The PBAC considered that, due to the narrow therapeutic index of warfarin, the listing of additional brands for warfarin would significantly increase the potential risk of adverse outcomes, and that it would likely cause confusion and distress to patients, particularly because it is important that substitution does not occur between the two currently listed brands of warfarin, Coumadin® and Marevan®.PSD · Nov 2016
6.10 The minor submission did not present a formal economic analysis. However, a cost-minimisation approach was implied as Warfarin APOTEX® was priced on an interchangeable basis with Coumadin®. The statutory 16% price reduction for Coumadin® was taken into account in calculating the ex-manufacturer price for Warfarin APOTEX®, with the assumption that Warfarin APOTEX® will be the first generic brand of warfarin to be listed on the PBS.PSD · Nov 2016
6.8 The submission claimed that based on the evidence provided, Warfarin APOTEX® and Coumadin® were bioequivalent.PSD · Nov 2016
6.9 The PBAC noted that this claim was supported by the TGA assessment, which considered Warfarin APOTEX® and Coumadin® to be bioequivalent.PSD · Nov 2016
Cost-effectiveness
No formal economic analysis presented; cost-minimisation approach implied.
Decision context
PopulationPatients requiring warfarin for prophylaxis and/or treatment of venous thrombosis, pulmonary embolism, thromboembolic complications associated with atrial fibrillation, or as an adjunct in coronary occlusion treatment.
Why it was knocked back
- Potential safety and quality use of medicines (QUM) issues; narrow therapeutic index with risk of confusion and adverse outcomes; 'a' flagging would contradict risk management plan and enable brand substitution without prescriber notification; no clinical need for a third brand of warfarin; increased risk of confusion given existing two brands (Coumadin® and Marevan®) are not bioequivalent; potentially vulnerable patient population with decreasing warfarin utilisation.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Not recommended | Warfarin Coumadin® | — | RCT · Bioequivalence |
Similar precedents
Regulatory · TGA
Label equal than PBS population — PBAC indication restates the TGA label with identical clinical conditions and no additional population restrictions applied.