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Biobillionair

06/09/20 2:16 PM

#279123 RE: jessellivermore #279089

JL- Brilliant insight regarding:


This may have escaped everyones' attention but it has some very significant consequences for the generics...Tier pricing is determined by the cheapest alternative and I believe generic Lovaza will be be able to undercut the generic Vascepa price..And keep in mind that even if generic V can be converted to off label R-I Vascepa..The generics have not won the right to sell the drug for the R-I indication..And if Lovaza can beat Gen Vs price then Gen V will be selling at a higher Tier (ie Tier 3 Or possibly Tier four 4)..And this real possibility could encourage the Generics to settle..as selling the drug without being able to convert to the R-I indication will not be be very profitable.


Thanks
BB/Jas
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Whalatane

06/09/20 2:40 PM

#279130 RE: jessellivermore #279089

JL there are several reasons why generic Vascepa is preferable to generic Lovaza for the Marine indication

1) no risk of elevating LDL cholesterol . As you know statins are often prescribed to combat the rise in LDL for those prescribed Lovaza for very high TG's . So Vascepa may not reduce the TG's as much as Lovaza ...but at least patients don't need to add a statin to better control their LDL ...assuming they are not already on one.

2) Fishy taste / burping of Lovaza .....some patients definitely don't like that and it's not a problem with Vascepa.

So the question for an MD ( retired ) like yourself. If you had a patient with very high TG's and who refused to add a statin to control the LDL increase associated with Lovaza ...which generic would you advocate for ?

On another topic
I've read Judge Du's decision on obviousness ...thx Montana ....and really hope there's some way that the judges can at least consider Caufman, Bhatt et al explanation of the statistical mistake that she has bought into.

Kiwi
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zz1

06/09/20 7:00 PM

#279165 RE: jessellivermore #279089

JL : The Vascepa label was revised 12/19.
The new label incorporates the R-It data AND the sentence “ The effects of Vascepa on cardiovascular morbidity and mortality in patients with severe hypertriglyceridemia has not been determined “ has now been DELETED.
The Marine indication otherwise still stands.
Other caveats in the new CV indication:
No upper threshold for TG : >= 150mg/dL,
Maximally tolerated Statin ( which could imply zero Statin) ;
No age limitations:
As Type 2 Diabetes is not specified, Diabetes in the label implies both Type 1 and 2;