Amarin Corp Plc (AMRN)

[bogatie]

rafunrafun ICER - doubts.

Thanks for the reply. But I still have my doubts,

From the Journal of American Cardiology:
“We explored study drug adherence in patients with recurrent events. At the time of a first primary endpoint event (fatal or nonfatal), 81.3% (573/705) of icosapent ethyl and 81.8% (737/901) of placebo patients with a first primary endpoint event were receiving randomized study drug. At the time of subsequent primary endpoint events (fatal or nonfatal), 79.7% (188/236) and 79.5% (299/376) of patients with a second event, 68.1% (49/72) and 74.1% (106/143) of patients with a third event, and 68.0% (17/25) and 71.6% (48/67) of patients with a fourth event were receiving randomized study drug in the icosapent ethyl and placebo groups, respectively. Therefore, the majority of the first, second, third, and fourth events occurred while patients were on randomized study treatment. Numerical differences in study drug adherence among patients with recurrent events were not statistically significant between treatment groups.”

ICER seems to mistakenly conflate adherence and disconituation: “For icosapent ethyl, after an average follow-up of approximately two years, 18.7% of patients in the icosapent ethyl arm had discontinued treatment at the time of a first event." From the ICER Model paper.

From NEJM REDUCE-IT article (2018) "Early discontinuation from study (9.9% icosapent ethyl; 11.2% placebo) includes patients that discontinued after having a primary event (25 [0.6%] icosapent ethyl; 52 [1.3%] placebo) and prior to having an event (380 [9.3%] icosapent ethyl; 408 [10.0%] placebo)."

So I still have my original question. Study Drug adherence is not the same a discontinuation. ICER model is based on 18.7% of Vasecepa users totally discontinuing use. I think that number is inflated as during REDUCE-IT, the discontinuation rate was 9.9%.

Not taking one’s drug precisely as prescribed (adherence) is not the same as totally discontinuing its usage.

Thoughts? Again, I think the ICER model is going to give too negative an answer with this “discontinuation” rate of 18.7% built in: I think it should be 9.9%.