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JL -- Can you direct me to the 'correct' or 'preferred' EPA/AA ratio. You probably have previously given this info -- sorry to ask you to repeat yourself. Thank you.
Retire2019:
Your question is key: "since label will be after formularies are determined, how common is it that insurance companies change their coverage mid year? "
Insurance coverage will be a big determinant of 2020 sales -- and, like you, I fear that the coming Dec approval will come too late for 2020 insurance formularies -- and will push good insurance coverage (particularly medicare plans) into 2021.
Anyone with insurance background -- please comment!!
The Medicines Company lead drug is Inclisiran:
Inclisiran basics
RNA-based therapies can interfere with mRNA (messenger RNA) to prevent the creation, within cells, of flawed proteins that cause diseases. Inclisiran is an siRNA (small interfering RNA) that mimics a gene variant that reduces PCSK9 (proprotein convertase subtilisin kexin type 9), which in turn lowers LDL-C (bad cholesterol). Clinical study results, to date, show Inclisiran lowers LDL-C and presumably the risk of cardiovascular disease. One of its best features is that it only requires twice-yearly dosing. The Medicines Company has a global license and collaboration agreement for Inclisiran from Alnylam (ALNY).
From the WSJ: Novartis AG NVS -0.06% is nearing a deal to buy cholesterol-drug maker The Medicines Co. for nearly $7 billion, in an expensive bid to expand its reach in the lucrative market for heart treatments.
From the WSJ: Novartis AG NVS -0.06% is nearing a deal to buy cholesterol-drug maker The Medicines Co. for nearly $7 billion, in an expensive bid to expand its reach in the lucrative market for heart treatments.
JL: Agree and thanks for the overview of EPA v DHA.
The study I referenced is new and seems well done. It is not a study of EPA itself - but the study does touch on EPA and it seems to validate some of the scientific beliefs expressed on our board. I don't have any position on the study itself - just bringing it to the board's attention.
https://www.mdpi.com/2072-6643/11/7/1616/htm
EPA and Prostate Cancer -- and an interesting hypothesis on inflammation. Again, the full study is at: https://www.mdpi.com/2072-6643/11/7/1616/htm
This prostate tissue chronic inflammation is an increasingly supported causal mechanism of PCa development and progression [52,53]. While w6 are pro-inflammatory, LCw3 are anti-inflammatory,mainly because of their derived metabolites [54]. These include eicosanoids, which also have anti-neoplastic properties when deriving from LCw3 [55]. A case-control study in the placebo arm of the Prostate Cancer Prevention Trial (PCPT) observed that, as expected from studies of systemic
markers of inflammation, plasma w3 were inversely associated to prostate tissue inflammation [56]. This observation supports the findings of our current study
EPA looks good in study of Prostate Cancer: "Dietary omega-3 fatty acids (?3), particularly long-chain ?3 (LC?3), have protective effects against prostate cancer (PCa) in experimental studies...In summary, this study validates in a larger cohort our previous findings suggesting that LC?3, the EPA subtype in particular, are protective against high-grade PCa."
https://www.mdpi.com/2072-6643/11/7/1616/htm
Look what insurance coverage did to Myriad on Thursday:
Shares of Myriad Genetics (NASDAQ: MYGN) rose as much as 58.4% today, after the company published a filing with the U.S. Securities and Exchange Commission (SEC) disclosing that UnitedHealthcare (NYSE: UNH) will begin covering the GeneSight Psychotropic test on the first day of October. The $2,000 genetic test is used to guide the treatment of individuals with major depressive disorder or anxiety disorders, by providing insight into which drugs they're most likely to respond to.
Today V is 'covered' by most insurance plans - but not at a favorable level. All too often, coverage is Tier 4 -- meaning a multi-hundred-dollar co-pay. Coverage differs by state and by age group (medicare versus non-medicare) and by insurance company and by employer.
What Myriad teaches us, however, is that JT should be visiting UnitedHealthcare and the other large insurers with the ICER report in-hand --- and lobbying them to make V a low-pay coverage group.
To DanFromChicago:
You are in the financial industry - so we'd be interested in your take on the GS meeting.
It was 'awkward' that JT didn't have a GS handler for his presentation. And, seemingly, there was no pick-up of AMRN coverage by GS -- so far.
Any idea what's going on???
noelan_s99:
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Cardiologymd: “No patient will pay this [a copay of >$200]”
Nolan: I do, any happy to do it until the tier improves.
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I agree, Nolan. My copay (on medicare + tier 4 (for now) drug plan) is >$200.
We may not be 'normal' patients in that we can afford the copay -- or maybe we just see the benefit more clearly than most...
CardiologyMD:
Thanks for giving us a view from a practitioner's viewpoint on insurance coverage for V.
JT seems to have a different perspective on insurance coverage. Here's what he said at the Goldman presentation:
"As a new drug, we are starting off with the already having pretty good managed-care coverage, considerable portion of our prescriptions currently are off label and the approval rate for managed-care is just a shade under 80%, little over 90% of adult lives on Medicare Part D covered by insurance predominantly tier 2, predominantly unrestricted, and about 80% of lives on commercial insurance covered by insurance. So, again predominantly tier 2, predominantly unrestricted."
For what it's worth -- I'm on Medicare with an AARP/United Healthcare for drug coverage & V is a Tier 4 drug -- so my V prescription is expensive, but I don't care.
My observation is that you (and I) still see a lot of insurance push back on V coverage. This dampens the current numbers that Sam81 provides (Thank you, Sam81, for your reports!). But it also means that the potential for increased script numbers is great -- when insurance coverage in your and my world catches up to JT's world...
DanFromChicago: What's your interpretation of the Goldman interaction?
Do you expect that GS will pick up coverage of AMRN?
Do you expect GS is pitching a merger?
What's your reaction to leaving JT on stage without any GS representative?
AVll77: Thanks for your post. Glad (and relieved) that the overall tone and content was positive. [Reminder to readers: I was only able to access the first page of the article - so my post necessarily was not a full view of what was written.]
Still think the authors muddled their characterization of V initially -- seemingly placing it as another 'fish oil' preparation. Maybe - as an Amarin investor - I'm just too sensitive here.
Again thanks for your 'full view' of the article.
Re: JACC article
Thanks BB for the reference.
I was able to view the first page of the article --- and I was very disappointed.
In my reading, the authors seemed to call V just another fish oil preparation and then seemed to say we have one positive fish oil trial result and a lot of other fish oil trials without a positive result. So their unstated but inescapable conclusion was: We'll have to wait for other confirmatory trial results before we embrace V.
Again - above is just my interpretation. Hope others (who might have had access to the full article) had a more positive reaction.
Here's some exerts: "Given the body of prior evidence showing no meaningful benefit from various fish oil preparations, the results of Reduce-It were surprising to some....Ongoing studies of related drugs may add or detract to confidence in the results. We have examples of recent, strongly positive trials being reinforced or challenged by other trials....
To Sam81:
Thanks so much for your weekly sales numbers. Much, much appreciated.
-------
I am a nobody, but here are a couple of thoughts on sales - for what it's worth:
The PR is great. It means a lot to the company and those long the stock. But how will it affect sales?
I don't think the average patient follows the FDA -- so I don't expect any immediate bump in sales due to the PR.
I do expect, however, that the Amarin drug reps will use the PR to further hit on their target MDs -- and this sales effort will be incrementally more successful. The PR is a validation of the data -- and it will be enough to convince some MDs to listen to the pitch of the sales rep -- and it will be enough to convince some MDs to begin to prescribe.
So that's my 'prediction'. Sales in 2019 already are great. The PR will have a mild positive effect - not immediately, but the PR will help build sales into the Summer and then into September (the last month before FDA approval!).
I know that Sam's numbers are what matters, but for what it's worth this is my V experience.
At my Walgreens in New Orleans, my 90-day refill has been delayed due to lack of supply. I was given 20 capsules (out of the 360 capsule 90-day supply total) and told they probably could fill my script next week.
Again - one person's experience doesn't mean anything...
H2R - There were ~17M shares short as of end of November. How do you view this short interest?