PBAC's latest decision on Nicotinic acid: Not recommended (2007). Considered for use in combination with a HMG CoA reductase inhibitor (statin) in patients with dyslipidaemia with adequately controlled LDL-C and whose HDL-C levels are inadequately controlled despite monotherapy with a statin.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
2
first 2006
Submissions
2
2006 → 2007
Eligible population
patients with dyslipidaemia with adequately controlled LDL-C and whose HDL-C levels are inadequately controlled despite monotherapy with a statin
Therapy area
Cardiovascular
Line of therapy
Later-line
Evidence base
RCT, Meta-analysis
Primary endpoint
CIMT
Key trials
ARBITER 2.0, Brown et al, 2006
Comparator
placebo plus ongoing statin therapy
Economic model
Not modelled
ICER note
A modelled economic evaluation was not presented. Trial-based incremental cost estimate of less than $15,000 per cardiovascular event avoided was provided, but this is not an ICER and a full modelled evaluation was absent.
ICER (historical)
$15k/QALY–$45k/QALY in an earlier submission (2006) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Why PBAC said no
Reasons cited in the latest PSD: no statistically significant benefit demonstrated for prolonged release nicotinic acid over placebo plus statin in the key trial outcome (CIMT), uncertainty that CIMT is a validated surrogate for improved cardiovascular outcomes, uncertainty associated with the impact of raising HDL-C on cardiovascular outcomes
Submission history
Jul 2006: Not recommended · Authority Required — ICER $45k/QALY