Amarin Corp PLC (AMRN) Options

https://docs.publicnow.com/viewDoc?filename=183729%5CEXT%5CF47C2B2E7D96EFE4A0A492560322F8304DE50EE1_2418EAD75412C51C041563AD95C2D3CCAC961B1A.PDF

If only it were the practioners that were paying for it.  

$AMRN Although OMACOR, also known as LOVAZA in the US has been on the formulary since May 2003 and is no longer reimbursable (as of April 2016), it still holds the majority market share over VAZKEPA®. However, that share has been eroding ever since VAZKEPA® entered the market.
The Table in this illustration shows two things:

1. The overall OMG-3 market is growing (refer to the upper graph).
2. That expansion is due to the increase in VAZKEPA® Scripts (Lower Graph)

In a little over two years VAZKEPA® has gone from zero market share to 42% while OMACOR’s share stands at 58% in October. OMACOR’s total caps are frozen at around 430k. I wonder how much longer it will take for practitioners to finally figure out that paying out of pocket for a drug that does not work is pretty stupid. It’s the EPA Stupid!

Read the DMC post today re: 12/19 Italy reimbursement link

Denisk, I got the impression that it was 180EU to Amarin, and the difference (to 239) is the allowable markup that pharmacies are allowed for their own costs and profit.

Maybe I am reading it wrong.

RMB, don't really know that. 

I get the impression that each region has their own overall budget that they have to stick to (not a per-drug limit). But I sort of doubt they would cut off scripts in any way if they exceed their budget.

At worse, they would re-negotiate when the contract is up, but I don't really know that process. There's definitely information online about it, I just haven't dug that deep yet.

I think the biggest hurdle was getting AIFA approval, and now hopefully France is next, possibly in 2025, then China in 2026, and hopefully all the other countries currently approved start selling scripts ASAP.

rmb, I agree. With 35 reps on the road they need to ramp sales quickly to cover their expense. Of course from Capt's numbers the scripts continue to grow in other countries so that will help for the immediate Italy ramp in rev.
2025 should be interesting.
Continued Eu Rev ramp
France, China and ROW
Advancement of Hikma case with new legal lead
5 months to maintain Nasdaq listing
BB ?
AG?
New product for US market?

GLTA

https://www.navlindaily.com/article/24340/italy-reclassifies-reimburses-amarin-s-vazkepa

Someone here earlier today likened the situation there with that of Spain's. I know they have 35 people already to go to try to drum up sales. It would be nice if we got an uptake there close to that seen in Spain.

Do they keep an ongoing tally of the cost of the scripts and do they stop reimbursing if they reach this predetermined budget limit?

Number sleven, thanks for this find. Good news for V in Italy from what I see.

deleted

Sleven, based on what I read, they would use the AIFA-approved script criteria to establish an estimated population, which translates to an estimated total national cost.

So they look at the estimated population of 250K people, take a % that they estimate will have scripts written (say it's 10%), and then apply the monthly reimbursement rate (EU 170).

Then they divide that up among the regions.

So all told, let's say they project 25,000 scripts to be written, that would be 25,000 x 170 x 12 = EU 51M

Then that 51M gets allocated among the regions, based on population.

At least that's what I took from the various sources I read.

Couldn't even hold a fraction of a penny gain at the close?!?!?!

I used to think that being separated from almost all the countries in the world by 2 great oceans was so good.  For a long time it was good in terms of protection from invasion.  On the other hand if we were in the middle somewhere surrounded by dozens of countries ( like Europe) we would have more easily seen how other countries do it and not tolerate the ridiculous healthcare system we have.  

I don't post any bids. I asked others to post them if they see unusual large bids. I did put a bid in at .48 I guess it filled. The nonsense contimues.

There is apparently 2 rates of VAT in Italy for Pharmaceutical products 10% and 22%.
So if the reimbursement is 280.57 euros , that would translate to either $239 (22%) or $265 (10%) net, better than the $180 figure that was previously mentioned
I don't know exactly which rate would apply for Vaskepa.

https://marosavat.com/manual/vat/italy/#:~:text=Standard%20rate%3A%2022%25,Super%2Dreduced%20rate%3A%204%25
Does that seems right?

Bullrunner2 Proliberty It seems each time you post these bids , the price of AMRN stock is going down.

https://www.navlindaily.com/article/24340/italy-reclassifies-reimburses-amarin-s-vazkepa
Sleven,

Talshu, I think you answered my question. If I understand your response. The strict reimbursement criteria identified nationally is irrelevant. (Obese, Tg over 200, LDL under 70). Again if I understand correctly. Is that just for budget calculation?
Thanks.
Sleven,

I don’t understand your question.
Each region gets its portion of the national health budget ; and then decides how it wants to spend it.

Talshu, Does that mean we could see an expansion in patient coverage regionally?
Sleven,

Number eleven,
Italy is similar to Spain where the National Healthcare System – Sistema Nacional de Salud – makes the decision regarding reimbursement. Yet, this decision will in turn have to be approved by the 17 regional Autonomous Communities (and 2 Autonomous cities) comprising the country, and which have their own executive and judicial powers to decide how spending on healthcare is made in their individual region.

Please keep posting the large bids if seen. I don't follow the live streamer currently.

Per Jroon every subdivision in Italy has to approve Vazkepa! 🤣🤣🤣🤣🤣

Seven, yes, you're correct. My script is under the Part D plan. I'm on the phone with them now, and for 2025, V will be covered, but it is still tier 3. The formulary I read online was probably for another plan. It's so confusing.

Sarissa is loading up the boat. Its denner time.

Yes, there seems to be an endless supply of formularies that CVS Caremark pushes out. I checked out a few online and the vast majority do not cover Vascepa at all, but the Medicare plans usually do.

Found this on one of their websites explaining how they operate:

An effective formulary strategy is the foundation of cost containment. Our approach prioritizes coverage for clinically appropriate, cost-effective medications for members while ensuring low net cost for our clients. And as of January 1, 2025, we’re improving access further – without impacting client financials – with more inclusions to our Standard Control Formulary than last year. Hyperinflation management – removing drugs with hyperinflated prices from our formularies, that have readily available, clinically appropriate, and cost-effective alternatives – is embedded within our managed template formularies to prevent wasteful spend. In a constantly evolving pharmaceutical environment, biosimilars represent one of the biggest opportunities for reducing drug costs for payors and patients. Up to eight biosimilars for Stelara® are expected to launch in 2025, representing a significant cost reduction opportunity.

With each new entrant, we will evaluate it consistently within our formulary process, with a review of clinical, economic, and market factors, to ensure we get to the optimal outcome for our clients.

https://business.caremark.com/insights/2024/2025-cvs-caremark-formulary-updates.html

Lizzy, CVS has multiple formulary plans. Same for the other big players. I noticed that Vascepa was listed more often on Medicare/Medicaid plans.
Sleven,

Sleven, the formulary for CVS Caremark shows Vascepa at tier 2. In 2024, it was tier 3. I found the below on page 30 of their formulary. Why the discrepancy?

SOAJ 140mg/ml
2 NM PA
VASCEPA CAPS .5gm, 1gm 2
VYTORIN TAB 10-10MG
QL (30 tabs / 30 days)
3 QL
VYTORIN TAB 10-20MG
QL (30 tabs / 30 days)
3 QL
VYTORIN TAB 10-40MG
QL (30 tabs / 30 days)
3 QL
VYTORIN TAB 10-80MG
QL (30 tabs / 30 days)
3 QL
WELCHOL PACK 3.75gm;
TABS 625mg
3
ZETIA TABS 10mg 3
BETA-BLOCKER/DIURETIC

proliberty, someone is walking up the stock price, I see a $.49 bid now for 112,100. I hope it's real

Bid for 200k shares at $0.48 as of 11:45am on Dec 20th.

Short stop?

Perhaps the aggressive hiring mode that is occurring now in Italy speaks to the regional structure of the country. I remember once hearing that even different modes of government can be locally elected throughout the country.

Odd take. I was just doing a little research on the comments posted by TCI and Sleven.

And why would questions about Italy suggest that I work for a generic company? If anyone uses info gathered from anonymous posters on an internet board to make investment decisions, that would be strange.

Good questions Sleven. 

Ah, got it. Yeah, that doesn't really address that. It looks like pricing can vary a bit by region (I assume it would only be lower). I can't find anything on adjusting patient population, but based on everything I've read so far, it would seem illogical for a region to EXPAND the patient population. Everything seems to point to regions contracting what they are willing to pay for, versus the AIFA approval.

Yes, in Italy, individual regions can choose different reimbursement rates for drugs compared to the national rates set by AIFA (Agenzia Italiana del Farmaco), meaning that even if a drug is approved for reimbursement at a certain price at the national level, each region can decide to reimburse it at a slightly different rate based on their own local considerations; this can lead to variations in patient access to medications across the country depending on where they live.
Potential challenges:
This system can create complexities for pharmaceutical companies navigating market access in Italy, as they may need to negotiate different pricing agreements with each region.
Currently, only three regions (Val d’Aosta, Calabria, Liguria) and the autonomous province of Trento adopt the National PHT without any local adaptation.

JCLOWN already soft bashing this morning. Wonder which generic drug company he works for.

JRoon, I saw your post. It doesn't resolve the questions I have. Can the regional authority embrace a larger patient population? Can they choose a different reimbursement price? I have no idea. It is all a bit unclear to me.
Sleven,

Yeah, sort of seems that way. Makes it real tough to commit resources there if you don't know what regional inclusion will look like. But my guess is that maybe the local pharma experts have a better sense for how this goes than what you read online. Bit of a head-scratcher, though.

1.29m shares BID @46.5cts?

.

See my previous post

Canada # 2

JRoon, I hope you find something definitive. I haven't been able to.
Sleven,

Well this sounds like quite the laborious process...

while most drugs are generally eligible for reimbursement in Italy through the national health service, the specific drugs covered and reimbursement levels can vary depending on the region, meaning not all drugs are reimbursed equally across all regions in Italy; each region has its own process for evaluating and including drugs on their reimbursement list, sometimes leading to disparities in access.
Regional variations:
Although AIFA sets the initial reimbursement status, individual regions can further decide which drugs to include on their local reimbursement lists and at what level of coverage.
This seems to explain it pretty explicitly:
Reimbursement for drugs is often a barrier to market access; is this true in Italy today?
Yes, absolutely. The challenge is that the there are two reimbursement processes in Italy – national reimbursement as part of AIFA’s approval, and the inclusion of new medicines in the regional list of drugs. So, a company can successfully go through the process of evaluation and approval with AIFA, including agreement for reimbursement at a specific price. But then you have to get market access at a regional level, which is not only a new battle but also a more complicated one. Italy has 20 regions, and most have their own approach. Plus, the regions each go through their own process of evaluating a drug. This decision is misguided because the AIFA evaluation is extremely thorough, looking at three points: unmet medical needs, added therapeutic value, and quality of clinical trial data. This is a unique approach – many other HTAs do not look at data quality in-depth. So the regional evaluation is pointless, and only serves to delay patient access to the drug. The AIFA evaluation takes 12 – 15 months, and then the regional process can take up to 15 months. So sometimes, it could be up to 30 months before a drug can reach the market, depending on the region.

TCI1, I remember that. The patient population restrictions in the Italian national reimbursement, was concerning to me. Now I'm not sure what to think.
Sleven,

It appears from the documents I read that each region has the final say on if their region will reimburse, very similar to Canadian provinces.

Why there is a national reimbursement system (AIFA) is a little confusing. My assumption is that maybe AIFA does the price negotiation on behalf of the country, and then each region decides of they want to reimburse at that price.

I am going to do a little more digging to see if I can get more clarity.

On previous earnings calls both Holt & Berg said Italy was somewhere in between UK and Spain in terms of roll out, so quicker than UK but not as fast as Spain.

JRoon, I really don't know what to make of this. Who has the final say?
Sleven,