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Hi North- I hope your anesthesiologist friend tries Vascepa for her DES, I've been trying to get a friend to try this off-label for years for DES.
BB
Akanz-
how do you keep that off the market if the ITC fails to take this case
The cynic in me says the insurance company[bean-counter actuary] would rather see you dead immediately[despite losing the insurance premiums you might pay for the next 20 years], rather than bearing the cost of the psck9 for perhaps the next 20 years and continuing to raise its healthcare costs with inevitable additional expenses, reducing profit.
What do you think of the reimbursement system NVS has apparently instituted?
If the treatment works[its CAR-T for cancer] you pay. If it doesn't work[it fails], you pay nothing for the treatment or trial to see if it does work...
a refund of cost.
Chris
Looks like more buying then selling
Michael
So you are not aware that V is much more than just TG lowering? Why would you ignore its system inflammation reduction aspect?
Good ole LInus yup he certainly held onto the Vitamin C theory - May he Rest in Peace
4 mgs .... 4,000 mgs, and huge capsules.
i guess there are now 500 mg as well as 1000 mg.
I am sorry that you were made so ill by the med Personally no I dont use welchol very often I dont find it effective and as you indicated its a pain to take
Its not the med - the med does what it does
I have changed my belief that trigs play a major role in CAD I am not as convinced as I was when I started using the med in 2013 or thereabouts. I am not willing to put all my eggs in one basket that says trigs are the endall after statins in the prevention of CAD
If you have good blood work numbers your doctor (not to mention your insurance company) might not write that script or fill it for you. If you use some sort of fish oil (or even Turmeric) that might keep your Triglyceride levels to low for insurane to pay for your script. If you are able to get Vascepa it is likely much safer than what you are using now which may contain DHA, hence put you at risk for AFIB.
So you are going to give statins to statin intolerant patients really ?
Likely would be warranted if there is documented failure/intolerance to 2 high and 2 low intensity statins, failed Zetia, has been counseled and failed life style changes. If you documented all of that most insurers would approve.
So your upset that I am agreeing with you??? Ok - it made my eyes water but dried up my nose
Wow a board certified pulmonologist really ?! Yea understanding Vascepa is like three dimensional calculus its really hard
Chris, certain well-funded Public companies are seeking much the same remedy--lower drug prices--as Commissioner Gottlieb thinks the FDA should be looking into, via the anti-trust laws. PFE v. JNJ and Shire v. AGN are 2 current examples.
https://www.wsj.com/articles/shire-alleges-allergan-blocked-drug-from-medicare-contracts-1506957534
In the last-mentioned above, where Shire is seeking to compete with its own recently approved DES drug against AGN's Restasis, I wrote elsewhere:
"That is an interesting legal ploy/happening, but may prove inconsequential to many of the world population who have DES. It is a very large market potential.
... my off-label prescription for Amarin's Vascepa, initiated 4/01/2013, cured my DES within a week of 1st dose. It remains gone today, 4+ years later. Anecdotally, Vascepa has done the same for others. A talk with my wife's Johns Hopkins room-mate, a retired anaethesiologist, this past weekend revealed that Restasis did not work at all for her when tried for DES.
My cost for Vascepa, originally prescribed off-label for other purposes, is $9 per month. Neither Shire nor AGN will match that cost....and no doubt both will await results of Amarin's R-I phase 3 trial in 2018 with interest. I DO NOT KNOW WHETHER THE 30+ SECONDARY INDICATIONS OF THAT REDUCE-IT TRIAL INCLUDE DES. There is scientific literature supporting the use of EPA, icosapent ethyl, in treating DES. OTC salmon oil, or other fish oils, never worked for me and DES treatment."
In my view, innovation can trump---make technologically obsolete---many current SOCs at a much lower cost. That has happened before, it can happen again.
Parenthetically, from the WSJ:
"Cost isn’t the reason, the lawsuit says. The list prices for the drugs are comparable. A month’s supply of both Restasis and Xiidra lists for $465, according to Elsevier Inc.’s Gold Standard Drug Database. Shire says it offered substantial but unspecified discounts to compete with Allergan’s Restasis.
Babr, In the past, i've posted the significant reduction in my allergy symptoms I experienced with Vascepa. I've had other anecdotal improvements in knee pain and significant improvement in my skin and almost no indigestion, which previously was pretty regular.
Webster
Looks like my little "tweezer's top" call Friday is executing, but very little/slow. The stock is holding up a lot better than I thought it would be off of that bearish pattern. On a different subject, I checked and my insurance provider appears to have Vascepa on the approved list, so I'm going to give it a shot! I already use liquid fish oil in my green shakes every day for lunch and I'm a big believer in righteous supplementation. They've helped get me off insulin and I have good blood work numbers. I figure 4 mgs of EPA a day can't be a bad thing, right? I'm also considering getting back long $AMRN at some point, maybe soon. I still have my own internal questions as to why the FDA would allow people to patent an existing, constituent chemical part of a natural food product with a non-original process and call it a drug BUT they did and they do. Knowing that, $AMRN has created a chess game that's going to be VERY difficult for them to lose and I think I want to position myself with the likely winner of the ITC affair. Not to mention RI coming next year is likely to open up numerous avenues for profit for the firm. I like scrappy fighters and Amarin is that in spades!
UFO
Patient with known CAD stented x2 absolutely statin intolerant ldl 190 think pcsk9 woudl be warranted ?
I thought V alone would help with inflammation isolated to a specific area of the body that is experiencing symptoms like some OTC anti-inflammatory medicines.
Hilarious the sheltered world you live in . I have people that have to choose food or their meds - they choose food usually - I try to keep them in samples jumping from one med to another as best I can dependent on what I have sometimes with none sometimes generics out of walmart (if they are close to what they need) sometimes I buy it for them - at some point you will see the real world of imperfection that most have to live in.
Ralphey - Have you heard of cost/benefit analysis, number needed to treat etc.? Believe me insures care about cost effectiveness- as we all should as docs. So, yes medical organizations determine things like Quality Adjusted Life Years (usually around $50,000) to see if something is cost effective. Yes, then insurers will look at what is most cost effective to steer providers and patients towards that treatment.
So, the reason your $12K drug is likely to get denied is because it is not cost effective in the population you selected or there may be a better alternative.
Sure, I'm not naive enough to deny that insurers want to make money but we already spend 3x as much money per person than most other countries. We need some criteria to use in selecting treatments that don't brake the bank and Vascepa hopefully will be one of those- and yes insurers will pay for it if it works.
HDG ...I really don't know if these "DS" are drugs or not
Your position is that
1) These are unapproved drugs <== AMRN's position, and about everyone but you agrees with it
2) ITC will have jurisdiction <== AMRN's position
3) ITC will rule in AMRN's favor <== HDG's opinion
I start to think that inflamation is the consequence of many insults and it is a just a way of our body to protect itself . Acute or chronic inflamation are the response of our immune system trying to fight those insults. Persistent Inflamation is due one or more persistent insults (such as diabetes or dysplidemia or autoimmune disease or any other chronic disease ) and such persistent inflamation can produce several bad consequences on heart or any other organs since causing too much stress to them . EPA seems to reduce inflamation not eliminating the root cause but reducing its harmful long
term consequences also but not only for our heart
Updated Form 4's out for Thero & Kennedy
Its so entertaining listening to people talk about things they dont experience - so you really think an insurer is concerned about preventing your MI 20 years down the road vs profits today. Ahh the naivete
If thats the case then why would they ever deny me an rx for a pcsk9? I mean afterall They lower LDL and may save many lives - the $12,000 a year is a steal compared to the cost of one bypass --- yet I never got one pcsk9 approved - hmmm wonder why that noble insurance company isnt concerned about patient longevity 20 years down the line -- just cant figure it out I must be conflated
Where you live may be the reason why allergy symptoms have improved "lately" - where I live ragweed season came and went and I barely noticed it - I'm terribly allergic to ragweed pollen - had a few bad days where I had to use both Nasacort and Flonase, but otherwise I was fine. Sounds stupid, but my allergy problems this summer were caused more by failure to vacuum the house often enough than anything else - just common dust that was coming in from the big double dining room windows - the rubber gaskets that seal them decided to fail and I didn't notice it for several months - rarely go to the opposite side of the dining room table where the window is, so I didn't see the gray carpet had developed a light yellow/brown hue - ugh! You should have seen the carpet steam cleaner wastewater after I fixed the window seals and cleaned the carpet underneath them - it was frigging black!
sts-
Yes, you missed it.
As the Exhibit is redacted, we do not know too much, but:
- it was an ongoing discussion / negotiation since the beginning (February / March as the latest) of the year, since "the marketing expense payment for Q4 2016 of $[***], which Amarin invoiced Kowa on February 10, 2017" wasn't paid till mid / late Q3 2017
- the Fee % for 2017 was reduced by 200 basis point (20% -> 18%)
Best,
G
I agree low risk patients might be steered to DS
STS you obviously ignored Bfosts follow up post
Kiwi - I agree low risk patients might be steered to DS. I'm fine with that as we won't know if they would even benefit from V if RI is successful.
And you have little understanding of the economics behind the issue .
Start off by telling me how much Vascepa costs the health provider each month ...and how they cover the cost of it ?
You also ignore legitimate complaints by MD's who are often drowned in paper work trying to persuade insurances co's to cover the cost of V .
Kiwi
What brand of EPA 500 do you use.
Omega Via; Recently at the behest of the board, I did the dime store chemist cut the capsule open look/sniff/taste vs V as well as running with OVia for 5 months prior to getting a V 'script. Available @ Amazon although if you subscribe to OVia various board members like the price/freshness/handling better. I don't.
Tail payment isn't new? Guess I missed that in the original agreement - so what changed then - maybe the %'s that are blacked out?
why not steer at least the low risk primary prevention patients towards those , at no cost to your insurance co and save your $ for other drugs treating diseases that have no other options.
Why would insurers put road blocks up to a relatively cheap drug with no side effects that will prevent very expensive medical problems and steer people away from VERY expensive new drugs for unproven DS's?
I work for an insurer and our P&P committee would never do that.
Did you read that correctly Whal, because what you wrote says "Can I make claims about...disease prevention?" And the answer is "Yes...as long as the statement doesn't imply that your product can... prevent a disease." Anyone else see the problem?
STS for example ...from your link re FDA regs
Can I make claims about health promotion and disease prevention?
Yes, you may make general statements about health promotion and disease prevention as long as the statement doesn't imply that your product can diagnose, cure, mitigate, treat, or prevent a disease.
Well thats your Pharmaepa RESTORE for you ...how do you keep that off the market if the ITC fails to take this case
Kiwi
had arthritic hands for years [as did mother]...began taking V 3 years ago ....within 6 months, the pain was totally gone [i mean NO pain] and it has not returned.....go figure
Great post STS perhaps one of your best post ever!!!! I think the ITC action is notice to DS Amarin is going to aggressively protect R-I IP. Tons of R-I IP will be posted to Orange Book.
BB
Head Boiler Room doctor in charge of medical BS.
STS thx for that link .
So the DS that states that their supplement is to restore appropriate EPA levels since our modern western diet is deficient in them .....and then goes on to state in bold print
" This product is not intended to diagnose , treat , cure or prevent any disease "
...Under the Section D of what you linked ....is that DS a drug ?
Kiwi
The ITC case tho IMHO is a must win for AMRN. If they don't win and R-IT comes in showing benefit then DS companies will launch a marketing onslaught as cheap alternatives for at least those with no insurance coverage or high copays .
dml...
Sounds like a pile of BS. Big institutions trying to get more exposure and influence.
":>) JL
G- Don’t get wishy washy... Supreme Court case law supports the ITC must rule, it also supports the FDA must rule; however, this does translate to actual action. Failure to both the ITC and FDA to take appropriate corrections Amarin requested puts Amarin v. FDA “takings” claim into a winnable category of final resolution. The USA government would lose this case against Amarin.
https://supreme.justia.com/cases/federal/us/470/821/case.html
BB
For a "Dr.", you don't read real well. Tell me where in my post it says that I disagree that Vascepa doesn't do what these other people say it does. Maybe that's the problem, you have read the research on Vascepa, but you either didn't read it correctly, or you didn't understand what was written. That would explain a whole lot.
Ralphey this just tells me (and the board)how ill informed you are, FYI I am a triple boarded pulmonologist ,became interested in this drug through my own research ,because of Family history of cardiovascular disease . The more I educated myself the more intrigued I became, The issue of allergic rhinitis is a personal observation that I made, because of this I was just curious to see if anybody else had any similar experiences or suggestions/information. IIt is perfectly plausible that this medication would affect the inflammatory pathways involved in this condition. One of the most common medications for allergic rhinitis is montelukast that I have tried before,although it is effective by blocking IL6, I was not willing to stay on it long term .I would be very excited and thrilled to know that I would not need to take the nasal steroids either if vascepa worked by itself!
I may have to start to refute HD's claim that you are a real doctor.
It doesnt do all of things ?? ..... many people here say it does - are you calling them all liars ?
I just wanted to sing with the choir .....
https://newsroom.heart.org/news/the-one-brave-ideaTM-science-innovation-center-opens-in-boston-to-host-renowned-investigators-working-on-early-warning-system-to-prevent-coronary-heart-disease-and-its-consequences#.WdOvrvQIm2g.twitter
I wonder if Amarin will introduce themselves to this group.
what you know and what your behaviour portrays are two entirely different things.
you don't believe in wonder drugs nor do i.
drugs are developed in labs to mask symptoms and/or alter biomarkers.
epa is a bioactive nutrient. amarin and vascepa are merely taking advantage of what nature has given us and the diseases western diet has produced.
{no need to repeat ... you already knew this}
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