ApixabanApexa
Recommended CardiovascularAuthority Required
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), collectively referred to as venous thromboembolism (VTE); and prevention of recurrent venous thromboembolism.
5
Submissions
1 resub
2011–15
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Mar 2015 Recommended Deep vein thrombosis and pulmonary embolism
- Meeting Nov 2012 Not recommended Anti-thrombotic drug
- Meeting Mar 2012 Recommended Anti-thrombotic drug no PSD
- Meeting Mar 2012 Recommended Anti-thrombotic drug no PSD
- Meeting Jul 2011 Recommended Anti-thrombotic drug
Access path
- TGA registered · Apexa
- Jul 2011Recommended · restricted
vs rivaroxaban
- Nov 2012Not recommended
uncertain ICER with potential to be unacceptably high, PBAC did not accept claim of non-inferior efficacy and superior…
- Nov 2012Not recommended
uncertain ICER with potential to be unacceptably high, non-inferiority efficacy claim versus dabigatran and rivaroxaban…
- ↻ resubmittedMar 2013Recommended
- Mar 2015Recommended
Comparator changed: dose-adjusted warfarin and aspirin → rivaroxaban
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the listing of apixaban for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) on a cost-minimisation basis with rivaroxaban. The equi-effective doses are apixaban 2.5mg and 5mg twice daily to rivaroxaban 20 mg daily.PSD · Mar 2015
7.2 The PBAC considered that the apixaban restrictions should have the same criteria and conditions as rivaroxaban for VTE.PSD · Mar 2015
Economic analysis
6.17 The submission presented a cost minimisation analysis based on the non-inferiority of apixaban (2.5mg and 5mg twice daily regimens) to rivaroxaban (20mg daily) and equi-effective treatment regimens including initial titration and continuing treatment over the first 180 days of therapy. This approach was previously accepted by the PBAC in the rivaroxaban March 2013 submission and was reasonable.PSD · Mar 2015
6.18 Extended treatment was not included in the analysis. The requested apixaban price for extended therapy was derived from currently listed rivaroxaban and apixaban items adjusted for 28 day versus 30 day script durations.PSD · Mar 2015
Clinical claim
6.13 The submission claimed apixaban is non-inferior to the main comparator rivaroxaban in terms of efficacy and is superior to rivaroxaban with regard to major/clinically relevant non-major bleeding. The evaluation considered that the claim is adequately supported for acute treatment (up to 6 months) but not for extended treatment of VTE.PSD · Mar 2015
6.14 The submission claimed apixaban is non-inferior to the supplementary comparator dabigatran for the efficacy outcome, and is superior to dabigatran with regard to major or clinically relevant non-major bleeding. The evaluation considered that the 11PSD · Mar 2015
Financial management – risk sharing
6.23 The submission provided no details of risk sharing arrangements. The sponsor acknowledged that a financial management (or risk sharing) arrangement is likely to be required as a condition of listing, consistent with the current special pricing arrangements for rivaroxaban in VTE treatment and apixaban 5mg in atrial fibrillation. 13PSD · Mar 2015
6.24 The PBAC considered that apixaban may take a larger market share than rivaroxaban for the treatment of VTE. The PBAC recommended that apixaban should join the same risk sharing arrangement as rivaroxaban, for the same PBS indications, as this would mitigate any risk of additional costs to the Commonwealth.PSD · Mar 2015
Cost-effectiveness
Cost-minimisation analysis. No ICER calculated; submission based on cost-minimisation comparison to rivaroxaban.
The PBAC therefore rejected the submission on the basis that the ICER for apixaban compared to warfarin/aspirin is uncertain and has the potential to be unacceptably high, and also because the PBAC did not accept the claim that apixaban has non-inferior efficacy and superior safety compared to dabigatran and rivaroxaban. PBAC · 2013
ICER uncertain ×2ICER / price too high ×3Economic model disputed
Decision context
PopulationAdults with confirmed acute symptomatic deep vein thrombosis or pulmonary embolism for acute treatment; patients with history of acute symptomatic DVT or PE who have undergone at least 6 months therapy with apixaban for extended/continuing treatment and prevention of recurrent VTE.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2015 | Recommended | rivaroxaban | — | RCT · Recurrent VTE or VTE-related death |
| Mar 2013 | Recommended | dose-adjusted warfarin and aspirin | — | RCT · Stroke or systemic embolism |
| Nov 2012 | Not recommended | dose-adjusted warfarin and aspirin | — | RCT · stroke or systemic embolism |
| Nov 2012 | Not recommended | dose-adjusted warfarin and aspirin | — | RCT |
| Jul 2011 | Recommended · restricted | rivaroxaban | — | RCT, indirect comparison · OS, PFS, QoL, other (composite of all VTE/all-cause death, major VTE) |