Don't get me wrong...A very broad label would be great...Let me explain the problem by giving you my own experience...I recently was bumped from Tier 2 where I was paying $17/a month to Tier 4 where i was paying $150/ month and intitially I thought...How could they have me on tier 4.?? Tier 4 is only for drugs that have competitive drugs for which cheaper alternatives exist...Then I had an epiphany...They (the drug plans) were only crediting Vasepa as a drug approved by the FDA for lowering trigs over 500mg/dl...and for that indication generic Lovaza would have been the cheaper alternative..The drug plans were not considering Vascepa a CVD event lowering drug..
IMO the drug plans will treat V differently after the FDA label expansion..The plans will consider Va as a drug which lowers CVD event risk . In patients that fall into the rough definition of mixed dyslipidemia on statins (or statin intolerant)...and patients that have T2DM and one or more risk factors for CVD...I believe R-I supports both these indications and do not consider this to be A "Broad " indication..There are no currently available drugs which are cheaper and proven to treat these to conditions...
I realize that Vascepa might be therapeutic in a great deal more clinical situations...Everything from DES to Herpes...and probably most other degenerative or inflammatory conditions..Unfortunately R-I did not measure the effect of EPA on these other conditions...So they do not really qualify as therapeutic targets on the label. And the drug plans may not cover them until appropriate trials are run...
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