Nebivolol HydrochlorideAPO-NEBIVOLOL
Moderate to severe heart failure in patients stabilised on conventional therapy which must include an ACE inhibitor or Angiotensin II receptor antagonist (if tolerated).
Decision on record
- Meeting Nov 2009 Recommended Heart failure
Access path
- TGA registered · APO-NEBIVOLOL
TGA label narrower than the PBS population
- Nov 2009Recommended · restricted
Comparator changed: carvedilol, bisoprolol and metoprolol → carvedilol, bisoprolol…
- Nov 2009Recommended · restricted
Comparator changed: carvedilol, bisoprolol and metoprolol → carvedilol, bisoprolol…
- PBS listing · Authority Required
Cost-effectiveness
Cost-minimisation analysis; no incremental cost-effectiveness ratio calculated.
The PBAC accepted that nebivolol is no worse in terms of efficacy and safety than its pharmacological analogues carvedilol, bisoprolol and metoprolol. PBAC · 2009
Decision context
PopulationAdults with moderate to severe heart failure stabilised on conventional therapy (including an ACE inhibitor or angiotensin II receptor antagonist if tolerated); based on the TGA indication, patients aged 70 years and older, though evidence exists for efficacy in younger patients.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2009 | Recommended · restricted | carvedilol, bisoprolol and metoprolol | — | RCT · other |
| Nov 2009 | Recommended · restricted | carvedilol, bisoprolol, metoprolol | — | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients stabilised on ACE inhibitor or ARB and specifies later-line positioning; TGA label has no such requirements.