PBAC's latest decision on Omega-3-acid ethyl esters: Not recommended (2010). Considered for Adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g. statins, antiplatelet medicinal products, beta-blockers, ACE inhibitors).
PBAC outcome
Not recommended
Restricted benefit
ICER (AUD/QALY)
$45k/QALY
Range: $15k/QALY–$45k/QALY
Submissions
1
first 2010
Submissions
1
2010 → 2010
Eligible population
patients who have had a myocardial infarction
Therapy area
Cardiovascular
Line of therapy
Second-line | Later-line
Evidence base
RCT
Primary endpoint
OS, PFS, DFS, QoL, Surrogate
Key trials
GISSI-P, OMEGA
Comparator
placebo
Economic model
CUA
Why PBAC said no
Reasons cited in the latest PSD: inadequate clinical data to establish efficacy in the proposed Australian population, highly uncertain cost-effectiveness ratio, GISSI-P trial population not representative of current Australian post-MI patients (less than 5% on statins at baseline, fewer than 50% on ACE inhibitors and/or beta-blockers), OMEGA trial results showed only statistically significant increases in non-fatal stroke and ICD-terminated VT/VF with minimal incremental benefit, uncertainty regarding whether treatment effect would apply to proposed PBS population, model sensitivity to treatment effect assumptions, potential for off-label use at high cost to PBS, unaddressed potential drug-drug interactions, increased risk of bleeding events at high doses