Amarin Corporation PLC (AMRN) Share Price

The best thing that could ever happen to Amrn is somehow they work with major PBMs and FDA to pull back the use of Vascepa for Marine indication ( SHTG >500). Even if it means some how they end up paying a few Million $ fine. That would open up the entire US market back to AMRN.

Bought back my $15 strike July covered calls today on share weakness. I think it has a good shot at moving above $15 over the next month. Sold a few more July $10 strike puts.

What happened ?

North,
Orders of the Court: Term Year 2024 https://www.supremecourt.gov/orders/ordersofthecourt
The conference was held on 6-18. They are normally held on Friday. The above link is where the results will be published.
Sleven,

Scotusblog says decision on whether certiorari is granted or denied in Hikma v. Amarin is scheduled for conference today, and results of conference normally will be released on the Court's Order List next Monday, 7/23/2025. No sign yet whether Solicitor General will be, or has been, asked to express his views on any extant issue.

Sleven 👍️👍️

Lizzy, That's related. RMB posted the United Healthcare document that I was talking about. Read the second paragraph.
Sleven,

Sleven, see below is this what you're referring to?

When Is Icosapent Ethyl Considered Medically Unnecessary?

Severe Hypertriglyceridemia Alone:
Some insurance and pharmacy benefit managers, such as UnitedHealthcare, have determined that the use of icosapent ethyl for the treatment of severe hypertriglyceridemia (triglycerides ≥500 mg/dL) alone is not medically necessary

. In these cases, coverage is only provided for cardiovascular risk reduction in high-risk patients, not solely for lowering triglycerides in the absence of cardiovascular disease or diabetes with risk factors

.

Other Indications:
If a patient does not meet the specific criteria outlined above (e.g., does not have established cardiovascular disease or qualifying diabetes/risk factors), the medication may not be considered medically necessary and coverage may be denied

.

Clinical Use and Safety

Icosapent ethyl should only be used under a doctor’s prescription and is not intended for general use in all patients with high triglycerides

.

It may have side effects and specific contraindications, such as allergy to fish or shellfish, bleeding problems, or heart rhythm disorders

.

Conclusion

Icosapent ethyl is not categorically "medically unnecessary."
It is considered medically necessary for cardiovascular risk reduction in adults with elevated triglycerides who have established cardiovascular disease or diabetes with additional risk factors, especially as an adjunct to statin therapy
.
However, its use for severe hypertriglyceridemia alone (without cardiovascular risk factors) may be deemed medically unnecessary by some payers, and coverage may be denied in those cases.
Always consult with a healthcare provider and review specific insurance policies for the most accurate determination in individual cases.

Hard to know for sure.  I am sure some big Amarin investors may know about it, but most do not since the co has not released any info. 

Looks like the market is really excited for our formulary wins.

north
I'm Medicare, V Savings Card does not apply to Medicare patients.

Monk, Is that price with, or without, the Vascepa Savings Card?

Rmb, my GEHA plan for Medicare, part D, has morphed to CVS Health(Silver Script) Medicare Part D. It reads on the formulary status update for Vascepa:
"Covered, Unresricted, Exclusive IPE"

According to Medicare.gov 2025 Plans, Vascepa is the exclusive IPE for ~ 70% of the Medicare Part D IPE market  nationally.

My Part D provider is Wellcare and email order is through Express Scripts.
Just checked their new pricing, $80/mo for V, GV NOT AVAILABLE !

Maybe we should settle his lawsuit 🤣

Very Interesting!

https://www.biocentury.com/article/656239/amarin-merck-alum-karim-mikhail-emerges-as-possible-head-of-fda-s-cder

North, I believe the CVS letter that somebody posted a few days ago, indicated that the co-pay was a "generic pricing" co-pay. I would have to go back and find that letter to confirm (I forgot who posted it). the day we will likely learn the CVS co-pay charge for a DAW prescription for Vascepa(if we do not learn of that price earlier with downloaded discount card from Amarin)

RMB, That's it.
Sleven,

Captain, I am not able to copy it. Google (icosapent ethyl+medically unnecessary). The United Healthcare document should be in the top five results.
Sleven,

https://www.uhcprovider.com/content/dam/provider/docs/public/prior-auth/drugs-pharmacy/commercial/r-z/PA-Med-Nec-Vascepa.pdf

Can you source the UNHC public statement?

North, IIRC, you have GEHA and CVS Caremark is their PBM. Quite a number of years ago, my FEHB BCBS used to have CVS Caremark but has since gone to use a company called Prime Therapeutics as their PBM. Generic V still on that formulary unfortunately.

Let's see what happens today, beginning as early as 9:30 am at the Supreme Court and extending through July 1, the day we will likely learn the CVS co-pay charge for a DAW prescription for Vascepa(if we do not learn of that price earlier with downloaded discount card from Amarin). A few months ago, I thought it odd that my local CVS pharmacy told me that it could not tell me the price/cost of the Hikma IPE product without a written prescription for that product. I learned what the price/cost of the Dr. Reddy product was when CVS filled a 3- month prescription  for Vascepa with a 3-month supply of Dr. Reddy IPE.

Relationship between dynamic
changes in remnant cholesterol
and cardiovascular disease in
middle-aged and older Chinese: a
national cohort study
PUBLISHED 19 June 2025
https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2025.1503705/pdf

North, None of the generic labels have been changed. FDA has taken no action. The public statement from United Healthcare is that they do not view icosapent ethyl as medically necessary for the treatment of SHTG. The generic is only approved for that indication.They use that reasoning to not cover the generic. I haven't found a publicly stated reason for the CVS decision. It wouldn't surprise me if it's similar. If there is an explanation.
Sleven,

With ALL generic Vascepa now gone from CVS marketing, dispensing and selling as preferred(not just Hikma or Dr. Reddy gV products), effective July 1, 2025, that means to me that NO generic importing, making or selling organization/company(like TEVA, Apotex and others) now will have a label that resembles the once extant label that Hikma and Dr. Reddy has/had that enabled off-label selling IPE for the much larger market of CVD treatment. Have Amarin's 6 patents invalidated by Nevada District Court been restored to original life, per Hazel-Atlas?  Did FDA withdraw approval of Hikma, Dr. Reddy and other generic companies severe high triglyceride labels? Or threaten a withdrawal effective July1?

Hayward, A committee at United Healthcare has made a determination that icosapent ethyl is medically unnecessary for the treatment of SHTG. I found the document but I can't copy it. Google icosapent ethyl+medically unnecessary. There are cheaper more effective alternatives. Every time an insurance company makes this determination, it could be used as evidence of intent against those who continue to cover the generic.
Sleven,

JRoon71

Just saying the other indication is so small that if we would win ( even before an appeal ) and again IMO it is not worth the headache for big pharma to risk being dragged into court for such a low volume product , That is why CVS does not offer Generic V any more

Michael

Hayward, I agree. A judgement would obviously be fantastic. But, with appeals, this could take years. I am hoping they can find a way to begin marketing before that.

I think the new formulation is their strategy to re-capture the US market.

Also - and I have no evidence for this, other than their relationship with Novartis - I think there is a chance that they establish a marketing joint venture with BP, prior to the sale of the company. Similar to how Pfizer established a marketing JV with Warner Lambert for Lipitor, before buying them back in the late 90's.

JRoon71

IMO They need to get a major judgement against Hikma ( even with appeals ) to discourage any big insurance from selling G instead of V. This will help in a big way no big insurance company will want to list generic for sale trying to tip toe the line and get caught sub G for V for CVD indication.

Michael

The bigger question might be, at what point (or IS THERE a point) do they begin to build back a sales team in the U.S.?

If the plan is to to sell the company, then presumably the answer is 'never'. If the plan is to run the company for some time (or indefinitely), then I would think sooner rather than later.

MRM, Getting CVS back should have a fairly substantial impact.
Sleven,

I've seen some great DD the last few weeks on formulary updates. Does anyone on the board have a snapshot of the current US market for Vascepa with these latest positive changes? Have they clawed back a decent amount of the overall share from the generics?

Thanks.

Thanks DAR. I knew who the PBM's are, but I did not know UHC and Cigna ran pharmacies.

DAR, here's some additional coverage information.

https://cms.amarincorp.com/sites/default/files/documents//Formulary_Status.pdf

DAR, Optum has Vascepa at tier 2, page 16.
https://prod-o5.optum.com/content/dam/o4-dam/resources/pdfs/guides/select-standard-booklet-jan-20

jroon, and these three are the largest PBM's and make up 59% of the PBM market.

jroon, CVS, UHC and Cigna are the three largest pharmaceuticals that own PBM's. Caremark, Optum and Express Scripts.

DAR, isn't CVS the only pharmacy chain that is also a PBM? I think it's the PBM's (and insurers) that matter, not the pharmacy. Pharmacies just dispense whatever is ordered. They do not make any decisions on coverage. I think the fact that CVS has both a PBM and a pharmacy chain makes this confusing. Hope we can get more good news from other pharmacy chains.

DMC8, the CVS Caremark update makes it very clear that Vascepa only is to be dispensed. Hope we can get more good news from other pharmacy chains.

We may actually see a bump in revenues in Q2 due to stock-up orders in anticipation of the July 1 change.

https://esc365.escardio.org/ESC-Congress/sessions/16291

Captain,
https://www.uhc.com/medicare/alphadog/AAUT25HM0255400_000
United Healthcare doesn't cover the generic. Unless I missed it. Their PBM is Optim Rx. They do cover the generic. I assume that is a result of the lawsuit against Health Net.
Sleven,

WIDESPRED LIPOPROTEIN ALTERATIONS IN A REDUCE-IT LIKE POPULATION: THE ICOSAPENT ETHYL (IPE)-NMR AVATAR STUDY.
https://www.sciencedirect.com/science/article/abs/pii/S0939475325003539

Remember that Amarin derives revenue from wholesale distribution and not from the Rx.

“Be sure your pharmacy has an adequate supply of this brand product effective July 1, 2025, to ensure continuity of care for plan members.”

"This update applies to "ALL NETWORK PHARMACIES"

ok who's the a''h'l' who printed a 1 sh trade at 13.09 15 minutes ago?! FFS couldn't resist.🤣

JR. I think Aetna insurance is now covering Leqvio for this who have had an MI , have LDL cholesterol over 100 mg/dl and are statin intolerant .
Novartis has run several trials with Leqvivo (Inclisiran ) and is also apparently selling it into private hospitals in China .
They have this Bill and Fill system . MD orders the Leqvivo and administers in his /her office twice a year and then bills the insurance Co plus a small ad on for the in office service .
Anthos has a real break thru to reduce bleeding especially for A Fib patients .
Now if NVS were to do a small joint trial with AMRN in Germany ...that could move the needle .
Kiwi

Yup, pretty much all of them. And we wonder why our healthcare and our medications are so expensive. 😒 Most countries have figured that out