Dabigatran EtexilateAKM DABIGATRAN
Prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation who are at moderate-to-high risk of developing stroke or systemic embolism, as evidenced by one or more of the following risk factors: age ≥75 years; hypertension; diabetes mellitus; heart failure or left ventricular dysfunction (ejection fraction <40%) or a history of coronary artery disease; previous stroke or transient ischaemic attack or systemic embolism.
Decisions on record
- Meeting Jul 2012 Recommended Anti-thrombotic and anti-coagulant
- Meeting Mar 2012 Recommended Anti-thrombotic drug no PSD
- Meeting Mar 2011 Recommended Anti-thrombotic and anti-coagulant
- Meeting Nov 2009 Recommended Anti-thrombotic drug no PSD
Access path
- TGA registered · AKM DABIGATRAN
TGA label narrower than the PBS population
- Mar 2011Recommended
vs adjusted-dose warfarin and aspirin
- Mar 2011Recommended
- Jul 2012Recommended · restricted
Listing: Authority Required → Authority Required (STREAMLINED)
- PBS listing · Authority Required (STREAMLINED)
From the public summary
The submission presented the same model from the March 2011 submission, but included additional components to simulate optimal warfarin treatments for a sensitivity analysis.PSD · Jul 2012
Three modelling approaches were used in the sensitivity analysis: 1. Using the estimates of subgroups formed from the a priori defined centre time in therapeutic range (cTTR) cut-offs of the RE-LY trial to populate model efficacy estimates.PSD · Jul 2012
Cost-effectiveness
The results of the economic evaluation, using total RE-LY data, produced a base case incremental cost/extra QALY over lifetime of less than $15,000. PBAC · 2012
Decision context
Populationpatients with non-valvular atrial fibrillation who are at moderate-to-high risk of developing stroke or systemic embolism
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2012 | Recommended · restricted | adjusted-dose warfarin and aspirin | $0k–15k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null |
| Mar 2011 | Recommended | adjusted-dose warfarin and aspirin | $15k | RCT · OS |
| Mar 2011 | Recommended | adjusted-dose warfarin and aspirin | $15k | RCT · Stroke/SEE |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to moderate-to-high risk patients; TGA label requires only 'at least one additional risk factor' without risk stratification.