script.reportAU
Cardiovascular

Ivabradine hydrochloride

Brand: Coralan®

PBAC's latest decision on Ivabradine hydrochloride: Not recommended (2009). Considered for 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.

PBAC outcome
Not recommended
Authority Required (STREAMLINED)
ICER (AUD/QALY)
$45k/QALY
$15k/QALY–$45k/QALY · across 3 submissions
Submissions
3
first 2007
Submissions
3
2007 → 2009

Eligible population

patients 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

Therapy area
Cardiovascular
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Other
Key trials
BEAUTIFUL, CL2-006, CL3-007, CL3-017, CL3-021, CL3-023, CL3-056, CL3-057
Comparator
placebo
Economic model
CUA
Eligible patients/year
10,000
ICER note
Modelled economic evaluation with scenario analysis; ICER range stated in Pre-Sub-Committee Response.
ICER basis
Range aggregates 3 submissions (2007–2009) — not a single base case.

Why PBAC said no

Reasons cited in the latest PSD: 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

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