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Thanks JL. You nailed it on ACST in terms of staying away.
Many thanks!!
Thank you so much for posting this!
Can you point us to what do we have to enter in PACER to find these documents?
Thanks
From Amarin's IR:
Amarin has no indication that there was a change to UnitedHealthcare’s 2020 Commercial or Part D formulary coverages of Vascepa compared to coverage in 2019.
UHC is often slow in covering new drugs and new indications. Moreover, their commercial formularies have historically been outliers with regard to the entire category of Omega 3 products – including generic Omega 3s – which have been covered on the Non-Preferred Brand tier with a Prior Authorization requirement. And, UHC’s PA criteria for the Omega 3 category has historically restricted access to patients with Triglycerides > 500 mg/dL.
Now that Vascepa® has an FDA approved indication for CV risk reduction, we believe that UnitedHealthcare will revise their PA criteria for Vascepa to reflect the updated label. As a result, we believe that Vascepa’s access in the UnitedHealthcare Commercial business will improve during the course of 2020.
Currently, Vascepa is covered by UHC Commercial plans in the Non-Preferred Brand tier. In order to offset the higher co-payment amounts associated with such formulary coverage, Amarin continues to offer the $9 for 90-day co-pay card program to help Commercial patients minimize their out-of-pocket cost for Vascepa.
In Part D, Vascepa continues to be covered without restrictions in both the AARP and UnitedHealthcare plans. In the AARP Part D Plans, Vascepa is covered in the Non-Preferred Brand tier (as are generic Omega 3 products). In UnitedHealthcare plans, Vascepa is covered in the Preferred Brand tier for the majority of lives.
Amarin continues to engage with payers regarding their coverage of Vascepa. Within 24 hours of receiving FDA approval, Amarin communicated Vascepa’s new label to all major payers. We have meetings scheduled throughout January and February with multiple plans, including some of the largest national payers.
Hope this provides more context,
Thanks. It is baffling IR has not issued a release stating this.
Someone does have an agenda here in trying to keep the share price low and the seeking alpha releases show this......
There is so much confusion over this one issue today: see the drop in share price.
SMH
Cit says AMRN selloff unwarranted! read below.
Amarin selloff on UnitedHealth preferred list reports unwarranted, says Citi Citi analyst Joel Beatty attributes the selloff today in shares of Amarin (AMRN) to reports stating that UnitedHealth (UNH) dropped Vascepa from its preferred list for 2020. However, after comparing 2019 and 2020 documents for a few UnitedHealth plans, Beatty did not find any examples of changes in tiering or other preferential status for Vascepa. Payers likely haven't yet considered the new "game-changing" cardiovascular risk-reduction label for Vascepa that was granted in December, which leaves Vascepa with no relevant competitors, Beatty tells investors in an intraday research note. As a result, the analyst, who keeps a Neutral rating on Amarin, views today's share pullback as unwarranted. The move creates a lower entry point for those investors looking to buy the stock, says Beatty. Amarin in afternoon trading is down 6%, or $1.15, to $18.93.
Read more at:
https://thefly.com/landingPageNews.php?id=3014881
my comment: it would be great if IR can put out a release on this. SMH
Um George Haywood is far from murky. Suggest you do your research. He is one of the best biotech investors out there. He was early and right and won big on Sarepta, Martek, and XM Radio to name a few. Wall Street knows who he is.
Edelman / Perceptive Advisors has also invested in Acasti along with Haywood.
What does that tell you??
Got it. Thanks
BB--Just curious what gives you confidence that GIA is not Amarin's plan?
Appreciate any insight.
So much for this Oppenheimer analyst trying to help out ACST. It is down nearly 8% on his hit piece on AMRN.
You can't make this stuff up.
Oppenheimer analyst favors Acasti over AMRN. SMH He does not believe Acasti will need an outcome trial.
Look at the increase in Acasti in the after hour market compared to the hit to AMRN.
Congrats everyone!
Primary Label seems out the door. SMH Oh well. Hopefully stock will not sell off in AH.
Ouch. She just put the smac-kdown on Dr. Konstam
Dr. Konstam--let's pray this guy does not influence others. He has an agenda and it is clear.
It seems like he is going to vote no. He has been pessimistic from the start.
This Dr. asking this question is a problem. He is a cynic and does not believe.
Low intensity statin--hope that person asking that question does not try to derail us. He jumped out in front with his question.....SMH
Hopefully he does not sway the panel.
Thank you.
ADA Comment--can you repost their comment please?
Thanks
Thanks JL
JL--can you expound more on your comment about the market under emphasizing the importance of the one study issue?
As always appreciate your insight. Thanks
The two Anchor NO Votes the first time (Peter Wilson & Erica Brittain)--is this bad for us they are returning this time?
Perhaps they want to make up for their NO Votes last time and save face.....
AdComm Members Due Diligence
Although we don't know the final members of the panel, here is some info I've put together on the ones listed on the website. Good luck everyone and thanks for all the knowledge shared on this site.
I feel pretty good about this panel, but I'm not sure how Dr. Thomas Webber (could not find much info on him), Connie Newman (she is pro-statins), and the consumer rep will vote.
AdCom Members Due Diligence
Members: https://www.fda.gov/advisory-committees/endocrinologic-and-metabolic-drugs-advisory-committee/endocrinologic-and-metabolic-drugs-advisory-committee-roster
1. Dr. Michael Blaha
? Expertise: Caridology, Lipidology
? Favorable quotes about REDUCE-IT being a landmark study; see: https://www.nbcnews.com/health/heart-health/drug-fish-oil-cuts-risk-heart-attack-stroke-study-finds-n934701
2. Dr. Elizabeth Chrischilles
? Expertise: Pharmacoepidemiology, Comparative Effectiveness Research
? She has researched how to reduce cardiovascular disease and suggests she is open to new approaches; See: https://ahajournals.org/doi/10.1161/CIRCOUTCOMES.117.004188
? Her publications: https://icts.uiowa.edu/about-us/leadership/elizabeth-chrischilles-phd
? Research: Design and Testing of a Mobile Cardiovascular Risk Service with Patient Partners; research from integrated healthcare systems suggests that risk factors can be controlled better and treatment strategies for cardiovascular disease can be markedly improved by using a centralized cardiovascular risk service (CVRS) managed by pharmacists. The objective of this project is to develop and test a mobile app enabled pharmacist managed CVRS for disseminating and implementing evidence-based guidelines in practice.
? Research: MEDication Focused Outpatient Care for Underutilization for Secondary Prevention; to determine if a web based CVRS within diverse primary care offices can improve cardiovascular disease guideline adherence using the guideline advanced metrics; See: https://www.fammed.wisc.edu/medication-focused-outpatient-care-for-underutilization-of-secondary-prevention-med-focus/
3. Dr. James de Lemos
? Expertise: Cardiology
? Has collaborated with Dr. Budoff and Christie Ballantyne on journal articles
4. Dr. Susan Ellenberg
? Expertise: Biostatistics
? Research has focused on data monitoring committees and clinical trial designs; See: https://www.nejm.org/doi/full/10.1056/NEJMra1510066
? Given the rigor of the REDUCE-IT trial and DMC she should understand the DMC would have intervened in the trial if MO was impacting the results
? Rigorous clinical trials in public health emergencies are essential. See: https://www.ncbi.nlm.nih.gov/pubmed/29177461
5. Marvin Konstam
? Expertise: Cardiology
? Professor of Medicine at Tufts
? Completed training at Massachusetts General and Brigham and Women’s Hospitals
? Recipient of Lifetime Achievement Award from The Heart Failure Society of America
? Voted “Yes” on the EMPA-REG Outcome study that ended up being a 12-11 vote that the study provided substantial evidence to establish that empagliflozin reduces cardiovascular mortality. All practicing cardiologists on the committee voted yes; See: https://www.acc.org/latest-in-cardiology/articles/2016/06/28/17/00/fda-panel-votes-to-establish-that-diabetes-drug-reduces-cv-mortality
6. Cecilia Low Wang
? Expertise: Endocrinology, Diabetes, and Metabolism
? Faculty University of Colorado Denver School of Medicine
? Conducts clinical research on diabetes and metabolism
? Clinical interests include complications of diabetes (particularly cardiovascular disease); See: http://www.ucdenver.edu/academics/colleges/medicalschool/departments/medicine/EndocrinologyMetabolismDiabetes/faculty_staff/Pages/WangC.aspx
? Cardiovascular and Limb Outcomes In Patients with Diabetes and Peripheral Artery Disease; See: https://www.researchgate.net/publication/329672011_Cardiovascular_and_Limb_Outcomes_in_Patients_With_Diabetes_and_Peripheral_Artery_Disease_The_EUCLID_Trial
? Research on PCSK9 and the elevated residual cardiovascular risk due to inadequate lowering of LDL-C levels or non-LDL related dyslipidemia; See: https://www.ncbi.nlm.nih.gov/pubmed/29095667
? Diabetes & Cardiovascular Risk; see: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.116.022194
7. Anna McCollister-Slipp – Consumer Representative
8. Connie Newman
? Expertise: Diabetes
? Professor NYU School of Medicine
? Chair of the writing group for the AHA’s Scientific Statement on the safety of statins
? She is pro-statins; see: https://www.ncbi.nlm.nih.gov/pubmed/26318980?otool=nynyumlib&myncbishare=nynyumlib
? Authored papers with Christie Ballantyne
9. Dr. Ken Burman
? Expertise: Endocrinology, thyroid cancer
? Professor of Medicine at Georgetown
? One of the 17 yes votes who approved the LEADER trial
? Additionally, the AdCom Chairperson, Dr. Kenneth Burman, previously voted in favor of Novo Nordisk's (NVO) insulin degludec and insulin degludec/aspart when chairing a prior AdCom. Roth Capital analyst Rahimi reads this as a strong sign that he is receptive to new therapies and as a positive for Vascepa's review, she said.
Read more at:
https://thefly.com/landingPageNews.php?id=2950505
? Quote about Crestor perhaps leading to higher numbers of diabetes cases: https://uk.reuters.com/article/astrazeneca-crestor/update-2-us-panel-backs-wider-use-of-astrazenecas-crestor-idUKN1521901920091215
10. Dr. Thomas J. Webber
? Expertise: Endocrinology
? Associate Professor Duke University Medical Center
11. Dr. Jack Yanovski
? Expertise: Pediatric Endocrinology
? Focuses on growth and obesity in children
? See: https://irp.nih.gov/pi/jack-yanovski
? He has looked at obesity and cardiometabolic risks; see: https://jamanetwork.com/journals/jama/fullarticle/1774038
Excellent. Maybe send to Janet Woodcock as well.
Hi she can be contacted here:
janet.woodcock@fda.hhs.gov
Dr. Nissen--I just listened to Michael Yee's podcast. Just unreal.
Can you imagine Nissen has been trying to interfere and opine on Amarin with the FDA for the last 6 to 12 months.
SMH
You can't make this stuff up!
Hopefully the FDA realizes he is conflicted.
Eliot Brinton -- check out his post on the public docket and a draft of the slides he will present here: https://www.regulations.gov/document?D=FDA-2019-N-3936-0098
https://www.regulations.gov/document?D=FDA-2019-N-3936-0098
His post:
I am strongly in favor of FDA approval of the proposed indication for icosapent ethyl: To reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels (135 mg/dL or greater) and other risk factors for cardiovascular disease, based on the results of the REDUCE-IT cardiovascular outcomes trial.
I will not re-state the published results of that trial (well known to the EMDAC), but want to highlight a few key considerations:
1. REDUCE-IT showed an unprecedented ASCVD benefit as a statin adjunct in its:
a. %RRR,
b. absolute risk reduction/number needed to treat, and
c. degree of statistical significance
2. REDUCE-IT data are corroborated by JELIS data:
a. using an essentially identical agent (pure EPA ethyl ester)
b. in a similar population (high ASCVD risk)
c. with similar achieved plasma EPA levels
d. with a similar %RRR
Both REDUCE-IT and JELIS showed excellent tolerability and safety of pure EPA ethyl ester, which is, in turn, corroborated by mankind's favorable experience with eons of fish consumption, which bodes well long-term widespread clinical use of these fish-derived compounds.
The first attached file is a draft of the slide presentation I plan to present at the open public hearing on November 14.
The other attached files are all publications from the JELIS trial, in case the EMDAC does not otherwise have ready access to them.
Attachments (12)
James Blair's comment on the public docket is a must read. Hopefully Janet Woodcock sees it. I encourage everyone to read the letter he posted.
See below as well.
PRIVATE OFFICE
PHONE: 202-808-5500
FORMER SPECIAL.
ASSISTANT TO THE PRESIDENT
HONORABLE JAMES G.V. BLAIR
WASHINGTON, D.C. 20502
October 27, 2019
Docket No. FDA-2019-N-3936 for "Endocrinologic and Metabolic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments."
Dear Members:
On behalf of the millions of United States military veterans I extend my personal appreciation to you and
the FDA staff as you begin your reviews of the proposed expanded label for one of the most important
drugs in the 21st Century, the drug Vascepa.
Various professional medical organizations like the American Heart Association (AHA), American College
of Cardiology (ACC), American Diabetes Association (ADA), European Society of Cardiology (ESC), and the
Institute For Clinical & Economic Review (ICER) represent independent and non-partisan research
organizations and medical professionals like yourselves that have recently conducted objective
extensive evaluations or assessments of the drug Vascepa as it relates to the recent Reduce It Study and
the drug's therapeutic value in the area of cardiovascular disease including other related diseases such
as diabetes.
Both individually and collectively these highly regarded organizations have either endorsed or indicated
support for Vascepa as a recommended drug for the treatment for cardiovascular disease and many
cardiovascular related diseases like diabetes. Most recently I ICER indicated Vascepa to be a very cost
effective drug for such treatment(s).
Never before (since statins) has there been such an intense collective rigorous analysis of all clinical
data and a public dialogue with all stakeholders including professional medical organizations, the
Data Monitoring Committee, Sponsor, Amarin Corporation, and key FDA staff (including senior
leadership) over the last 6-7 years.
In lieu of the above, as a veteran and advocate for over 25 million veterans (many of whom are facing
serious cardiovascular related illnesses and diabetes) I highly support the expeditious review and
accelerated approval by the FDA of the expanded label for Vascepa.
Assuming such an approval it is further requested that the FDA Commissioner recommend to the
Secretary, Health & Human Services, Secretary of Veterans Affairs, and Secretary of the Department
of Defense that the drug Vascepa be immediately listed in all applicable formularies so that both
veterans and active duty military personnel have immediate access to this imporlant life-saving and
cost effective drug for the treatment of cardiovascular disease and diabetes.
Sincere
Hon. James G.V . Blair
Additional Personal Note: Approximately 3 years ago l was diagnosed with two aneurysms as a result of
artherioscelerosis. Approximately a year ago l was prescribed 2-4 grams of Vascepa off label to
determine if the drug would have any effect and reduce arterial plaque levels. On October 17, 2019 l
had a CTA with and without contrast of my arterial plaque levels. The results are rather eye opening
with a reduction of 15-18% in arterial plaque and reductions in the size of both aneurysms.
Such important and key information should be included as a part of your Committee's evaluation of the
drug's effectiveness in area of cardiovascular disease.
JGVB
Thanks for sharing. So you're saying the open interest on the $11 puts seems like somebody may know something ominous?
I hope this is not the case.
Although not a competitor to Vascepa it is interesting that Amgen is cutting the price of Repatha.
Amgen to Sell Cholesterol Drug for 60% Less
Than Original Price
Repatha’s initial price of more than $14,000 a year has been a deterrentto sales
Insurers have restricted coverage of Amgen’s cholesterol drug because of its price. PHOTO: ROBERT DAWSON`ASSOCIATED
PRESS
Oct. 24, 2019 3?10 pm ET
By Joseph Walker
10/24/2019 Amgen to Sell Cholesterol Drug for 60% Less Than Original Price - WSJ
https://www.wsj.com/articles/amgen-to-sell-cholesterol-drug-for-60-less-than-original-price-11571944214?mod=lead_feature_below_a_pos1 2/3
The latest move could help reduce the amount that patients pay for the drug at the pharmacy
counter, and reduce the number of patients who don’t fill their prescriptions because their
copays are too expensive.
After Repatha was approved in 2015, analysts thought it could ring up billions of dollars in
sales. But that hasn’t happened in large part because insurers have restricted coverage of the
drug because of its price. In the second quarter, Amgen reported just $91 million in sales from
Repatha.
To encourage more use, Amgen last year created a new version of Repatha priced at $5,850 a
year. Though it has a different product number code, the new version is identical to its moreexpensive
counterpart.
The company temporarily still offered the original list price option of more than $14,000, which
Amgen discounted heavily in the form of rebates. Some health plans offered only the higherpriced
Repatha, which meant patients faced bigger out-of-pocket costs.
Amgen said it kept selling the higher-priced product to allow time for insurers and pharmacy
benefit managers to adjust to the loss of rebates. In it latest announcement, the company said it
will stop selling the higher-priced version after Dec. 31.
Several pharmaceutical companies have cut the list prices of drugs in the past year in an effort
to extend to patients the discounts they were already providing to pharmacy benefit managers,
known as PBMs, which negotiate prices on behalf of insurers and employers.
Sanofi SA and Regeneron Pharmaceuticals Inc. sell a cut-rate version of their own anticholesterol
medicine Praluent—which competes with Repatha—at a 60% discount to the
original list price.
Gilead Sciences Inc. in January launched generic versions of two hepatitis C medicines priced
at discounts of 68% and 62%, respectively, to their branded counterparts. Eli Lilly & Co. said in
March that it would market a half-priced version of its diabetes medicine Humalog.
10/24/2019 Amgen to Sell Cholesterol Drug for 60% Less Than Original Price - WSJ
https://www.wsj.com/articles/amgen-to-sell-cholesterol-drug-for-60-less-than-original-price-11571944214?mod=lead_feature_below_a_pos1 3/3
The price cuts have typically been for drugs that were already being discounted heavily with
rebates. But rebates often failed to ease the direct costs shouldered by patients in Medicare
Part D and high-deductible commercial health plans that require them to pay a percentage of a
drug’s list price before rebates are applied.
About half of Medicare Part D patients taking Repatha will have copays of less than $50 per
prescription next year, Amgen said. By discontinuing the higher-priced version of the drug, the
company said it expects to increase the portion of patients with copays of $50 or less.
Some Medicare patients are required to pay as much as $370 per month for Repatha, causing
about three-quarters of patients to abandon their prescriptions, said BMO Capital Markets
analyst Do Kim in a note to clients on Thursday.
He said Amgen’s termination of the higher-priced product should increase the number of
patients paying fixed $50 copays and bring down the abandonment rate closer to the 19%
observed in commercial plans.
Write to Joseph Walker at joseph.walker@wsj.com
Thanks everyone who commented re: STAT call tomorrow! Will save my money!
Appreciate it.
Do you think Adam Feuerstein has inside intel from the FDA?
Just asking to see if it is worth spending $500 to listen to his call tomorrow.
STAT call tomorrow--what is the likelihood that Adam Feuerstein has been privy to the briefing docs or what the FDA is thinking?
I see he will be interviewing Dr Robert Rosenson from Mount Sinai who I think is working with Astra Zeneca on Epanova
see Adam's tweet encouraging Amarin bulls to join the call:
Reminder: @matthewherper and I are conducting a STAT Expert Advantage call tomorrow at 11 am EDT. Topic: $AMRN! Vascepa!!! FDA advisory panel?!?!? Details: https://t.co/PvQbgn2pC9
— Adam Feuerstein ✡️ (@adamfeuerstein) October 24, 2019
The Amaroids should join us so they can better tweet-hate us later.
Confirmatory trial--I sure hope there is no voting question about a confirmatory trial. SMH
That would be beyond ominous.
Can you attach Pacer link?
Thanks
ADCOM- Public Comments are posted.
Not sure if this was already posted on i-hub.
https://www.regulations.gov/docketBrowser?rpp=25&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-N-3936
Of course MRC posted one. SMH
Just curious as to what are your thoughts on why the FDA selected the Endocrinologic & Metabolic Committee (https://www.fda.gov/advisory-committees/human-drug-advisory-committees/endocrinologic-and-metabolic-drugs-advisory-committee) to review Vascepa and not the Cardiovascular and Renal Committee (https://www.fda.gov/advisory-committees/human-drug-advisory-committees/cardiovascular-and-renal-drugs-advisory-committee)?
Does it have to do with how broad of a label for diabetics and the other cardiovascular risk factors cited below?
The Federal Register (FR) notice for the November 14, 2019 EMDAC meeting contains FDA’s summary of
a proposed indication statement based on REDUCE-IT results for use of Vascepa® (icosapent ethyl)
capsules to reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with
elevated triglycerides levels (135 mg/dL or greater) and other risk factors for cardiovascular disease.
Language proposed by Amarin for an expanded label for Vascepa is intended to reflect the patient
population studied in REDUCE-IT and the results of REDUCE-IT, in particular:
• Reduction in five-point MACE (MI,stroke, CV death, revascularization, hospitalization for unstable
angina),
• Not a replacement for statin therapy but as an incremental and separate prescription treatment
option for patients at risk for CV events,
• CV risk identified beyond cholesterol management to include patients with elevated TG levels and
other CV risk factors,
• TG levels of >135 mg/dL specified as that is the population studied in REDUCE-IT as elevated TG
levels are a good identifier of risk (it being recognized that lowering TG levels alone are not
validated as an FDA-approved surrogate for CV risk reduction, REDUCE-IT is not designed to
validate TGs as a surrogate and the effects of Vascepa go beyond TGlowering),
• Other CV risk factors are well understood by medical professionals and further delineation ofsuch
risks in the label is likely to clutter the label, confuse patients and lead to unnecessary insurancerelated issues that we do not believe should be encouraged for a cost-effective drug like Vascepa,
and
• Emphasis in the label should be on 4 grams per day (2 grams twice daily).
Hi Bio just curious what is your basis for this $100 threshold of making it to the Board? I know you mentioned it before that the offer had to be at least $100 but just curious as to how certain are you about this that the Board won't consider something less than $100?
Thanks