Amarin Corp Plc (AMRN)

[Pyrrhonian]

Also, generic Lovaza tier 3, vs Vas tier 4 (pg 37) ... we don't find Vas higher than Lovaza or generic anywhere. --Py

Did you realize that meanwhile O3 is generic it wasn't classified as T1 or T2? Furthermore it has PAR, V does not have. "Prior Authorization: Our plan requires you or your physician to get prior authorization for certain drugs. This means that you will need to get approval from our plan before you fill your prescriptions. If you don't get approval, our plan may not cover the drug.". Meanwhile it is true, V has a same Tier as gL. Furthermore, I think you could find any brand vs generic drug (for the same indication) example where brand has a higher Tier than generic. --HD

I'm not at all sure what you are arguing about. The point is if Vas was deemed *better* than Lovaza (or its generics) then it would be higher tiered than Lov. But no one seems to think so in the medical community, while all of you for some reason do. That's fine, I guess R-IT will change or cement all their minds once and for all.

And btw, they both require prior auth in that plan.

Amarin Presentations for the October 16, 2013 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee is B&W:
- the first 6,075 qualifying TG level was: median 202 / mean 220 (slide CO-70)
- "increased TG enrollment threshold to >= 200 / May 2013" (slide CO-74) - around app. 5,000
- "median TG since amendment is 230 (slide CO-74)

Okay so lots of patients with 150 - 200 TG counts and one other risk factor were randomized. Got it.

Wrt baseline EPA levels and ANCHOR or MARINE vs R-IT, do you think control in R-IT will have baseline closer to MAR or ANCH? And why? What would you guess it will be? --Py

Are you serious? I have to ask again: Do you have a clue about Amarin's studies?
- MARINE: >= 500 mg/dL and <= 2000 mg/dL, 4g mean: 680
- ANCHOR: >= 200 mg/dL and <= 500 mg/dL, 4g mean: 281.1
- REDUCE-IT: >= 150/200 mg/dL and <= 500 mg/dL, 4g mean (@6,075): 220

So, R-IT mean will be definitely 220+, but more likely (at least) 230+. So closer to ANCHOR than MARINE, which had a lowest limit equal with the highest limit in ANCHOR / R-IT ... OMG. Furthermore, TG reduction is the part of the total only, EPA / V is more than TG reduction. --HD

Lol, try to relax. My question was simple and out of curiosity and had to do with baseline EPA levels, not TG counts. But it's cool, don't worry about it.

A lot of plan puts V higher than L, as does not cover L (only gL, mostly in the same Tier - see United Health ... biggest in the US ...) --HD

It covers generic L. And there is no PBM formulary with Vas higher tiered than L or L generic. Let alone "a lot of" them.

You would immediately identify what group you were randomized to. If no change, or slight increase [to TG counts], maybe you would drop out (assuming you got mineral oil), --Py

- Acc. to the protocol: "Blinding

[0117] During the double-blind treatment/follow-up period, everyone (patients, investigators, pharmacists and other supporting staff at the Research Sites, personnel and designees of the Sponsor, study administrators and personnel at the organization(s) and vendors managing/supporting the study), with the exception of the laboratory personnel performing the analysis, will be blinded to individual results of the efficacy laboratory measurements (including lipid values). Individual results from the lipid profile may be unblinded in the event of an emergency for a patient."

Unless the patient pay for a test somewhere else (top of the free test), they do not know. Not likely ... --HD

Thanks. Where can one find this protocol?

You are saying that a patient with severe hypertriglyceridemia will never get blood work done by his/her primary care physician during the time they are on the study? Their lipids will remain blinded to them and their primary care doc? I have trouble believing that. I understand they have to go in for testing and blood draws to be part of the study at a clinical site somewhere, and won't know the results of these (and neither will the person drawing their blood), but are we naive enough to think they will go years and not know their lipids, neither them nor their primary care doc? Even though they are responsible for managing their care including continues statin use or change? I think you may be missing something here.

Jmo

GL