Ivabradine Hydrochloride
Treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm, who are unable to tolerate or have a contraindication to other suitable PBS-listed drugs.
Decision on record
- Meeting Jul 2009 Not recommended Treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm who are unable to tolerate or have a contraindication to the use of beta blockers.
Access path
- Nov 2007Recommended
Comparator changed: diltiazem (non-dihydropyridine calcium channel blocker) → Diltiazem…
- Nov 2007Recommended
Comparator changed: diltiazem (non-dihydropyridine calcium channel blocker) → Diltiazem…
- Nov 2007Recommended
Comparator changed: diltiazem (non-dihydropyridine calcium channel blocker) → Diltiazem…
- Jul 2008Not recommended
incomplete evidence of comparative clinical effectiveness and safety with appropriate comparators, insufficient…
- ↻ resubmittedJul 2009Recommended
ICER dropped $75,000 → $45,000 (-40%)
- PBS listing · Authority Required (STREAMLINED)
Cost-effectiveness
Modelled economic evaluation with scenario analysis; ICER range stated in Pre-Sub-Committee Response.
The PBAC also remained concerned about the comparative toxicity of ivabradine and diltiazem, noting there are no direct comparative data on the toxicity profiles of the two drugs. Given its unique mechanism of action, ivabradine has a distinctly different toxicity profile to diltiazem and other anti-anginal agents, such that an assessment of relative toxicity concerns might best be considered through impact on quality of life. PBAC · 2008
Decision context
Populationpatients with chronic stable angina due to atherosclerotic coronary artery disease, who also have left ventricular dysfunction (LVEF ≤40%) and a resting heart rate of 70 bpm or greater
Why it was knocked back
- No evidence to directly support the restriction requested in the submission; relied on subgroup analysis of a post hoc subgroup; no evidence comparing ivabradine with perhexiline in patients refractory to all other anti-angina therapy; insufficient basis to recommend listing for either requested restriction
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2009 | Recommended | placebo | $15k–45k | RCT · Other |
| Jul 2008 | Not recommended | diltiazem and amlodipine | $15k–75k | RCT, indirect comparison |
| Nov 2007 | Recommended | diltiazem (non-dihydropyridine calcium channel blocker) | $45k–75k | RCT · Other |
| Nov 2007 | Recommended | Diltiazem (main comparator); amlodipine (minor comparator) | $45k–75k | RCT |
| Nov 2007 | Recommended | diltiazem (non-dihydropyridine calcium channel blocker) | $45k–75k | RCT |