Omega-3-Acid Ethyl Esters
Not recommended CardiovascularRestricted benefitSecond-line | Later-line line
Adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g. statins, antiplatelet medicinal products, beta-blockers, ACE inhibitors).
1
Submissions
2010–10
On the record
$15k–45k
ICER range
1 sourced ICER · 2010
ICER stated
Cost basis
Cost-effectiveness
ICER uncertainEconomic model disputedImmature survival data
Decision context
Populationpatients who have had a myocardial infarction
Why it was knocked back
- 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
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2010 | Not recommended | placebo | $15k–45k | RCT · OS, PFS, DFS, QoL, Surrogate |