Amarin Corp PLC (AMRN) Quote

Kiwi, Thanks. I have read that information before. It's useful but vague.
Sleven,

Whats on the table in PBM negotiations ?


Drug rebates: PBMs negotiate rebates with drug manufacturers, often for expensive brand-name and specialty drugs. These rebates can serve as a tool to promote the use of certain expensive drugs in exchange for lower costs or preferred placement on formularies.

Formulary placement: Drug manufacturers may offer rebates or other incentives to get their drugs placed in favorable positions on PBMs' formularies (lists of preferred drugs). This can impact which drugs are more easily accessible to patients.

Market share: Manufacturers may offer better deals to PBMs in exchange for increased market share for their drugs.

Clinical programs: Some negotiations may involve implementing clinical programs that encourage doctors to prescribe certain drugs.

Pricing structures: PBMs can use various pricing models, including "spread pricing" where they charge payers more than they reimburse pharmacies for drugs.

Generic vs. brand-name drugs: PBMs may negotiate for increased use of generic drugs to lower overall costs, or in some cases, may be incentivized to favor brand-name drugs due to rebate structures.

Prior authorization and step therapy: Negotiations may involve implementing or adjusting these cost-control measures for certain drugs.

Out-of-pocket costs for patients: Negotiations can impact copays and other cost-sharing structures for patients.

Overall net costs: While rebates are a major focus, the ultimate goal should be to achieve the lowest net cost for payers and patients, though this isn't always the case in practice.

Transparency: There's often a lack of transparency in these negotiations, making it difficult for employers and other payers to fully understand the terms and compare plans effectively.
It's important to note that the dynamics of these negotiations can sometimes create misaligned incentives, where actions that increase rebates or PBM profits may not always result in the lowest overall costs for payers or patients.

Kiwi

AMRN new 52 week low

Amarin would need to have some indication of legal progress (well beyond CAFC giving them back their day in court) before any injunction is to be considered. Long ways down the road, and so far, not something Amarin is publicly calling for.

Some sort of injunction Rose would be a beautiful thing..... we'd jump to $10 on that news.

I have never seen a formulary that states ‘we will drug ABC only from XYZ manufacturer. Maybe this is communicated to the pharmacy when filling the script - as to which manufacturer’s drug is permitted but I have never seen that. If a person, for instance has say Aetna insurance with CVS Caremark PBM there are still a myriad of pharmacies that the insured can bring their script to be filled. Odds would say that there would be various manufacturers of the drug from which the various pharmacies would fill the script. Like I said I have received GV from multiple different manufacturers. Only time will tell if I still will continue to see that variety. There must be a reason Amazon is holding off introducing an AG (other than the one we have heard about worrying that it could impact negotiations in the EU or ROW) so it could be that you are absolutely correct about the fact that an AG would be useless. Time will tell. There have been posts here with links to stories about how successful other drug companies have been with their AGs so I find this an intriguing question. Best scenario, though, would be to gain some legal advantage and some sort of injunction against the Generics opening up the US market again for us.

I also heard from CNBC Squawk Box this morning that neither of the presidential candidates want FTC to have this much power to go after companies and Lina Khan's days are numbered. These corporations know how to handle and cover up the findings. What a sad state we are in.

SO much hope, so much pain, so little insight. The Fat lady is beginning to sing. Momma makin that pink sheet pudding. 57 pennies and yet its a great stock to buy !! ANOTHER BUYING OPPORTUNITY RIGHT !!

JRoon, I don't know enough about that to have an opinion. I'm not sure what's on the table during a PBM negotiation.
Sleven,

Ah, got it. Ok.

It would still seem that Amarin is at a disadvantage due to their size and lack of multiple medications to negotiate with.

JRoon, The pharmacy benefit managers control the formularies. They are the ones who decide what drugs will and won't be covered by the majority of insurance plans. PBM agreements are at the center of the fight for the US market.
Sleven,

I also wonder if it is a demand issue. Amarin ceased all sales and marketing efforts a few years ago, so there is little demand for branded Vascepa in the U.S. Generics do not market (that I am aware of), so outside of docs adopting Vascepa based on their exposure at conferences, even PBM deals don't move the needle tremendously. And at the same time, insurers have to be willing to reimburse. Even if PBM's cut deals with Amarin for branded V, if insurers don't put them in the formulary, it just sits on shelves at CVS (Walgreens, Rite-Aid, etc.).

It seems that the challenge for Amarin goes much wider and deeper than simply cutting a deal with PBM's.

This is where it would be helpful to understand what/if Sarissa has a real plan for the U.S. market. Because I don't really see one.

JRoon, I agree. Until recently Amarin had managed to maintain an exclusive arrangement with CVS. I/we don't know how they did that. This leads me to believe that we can compete with the generic companies. Pharmacy benefit managers are cutthroat. We still have other PBM agreements that are intact. It's possible that we could regain our exclusive contract in the next negotiation cycle.
Sleven,

Yeah, originally the "idea" of PBM's was a good one - be the "expert" between the pharmacy and the drug supplier. Negotiate prices, bring prices down, etc.

It was not unlike the origins of health insurance and HMO's. But, like them, profit motive got in the way of a good thing, and they constantly find ways to chip away at the "savings" they are providing.

One point of interest, however, is that PBM's actually will sometimes mark generic drugs higher than branded drugs, and manage the cost and profits through a rebate system.

It all seems very shady.

I think one of the biggest challenges that Amarin faces with PBM's and insurers is that they are a "one-trick pony". They are small, and provide only one drug.

RMB,
https://www.techtarget.com/healthcarepayers/feature/How-Payers-and-Pharmacy-Benefit-Managers-Work-Together-to-Lower-Costs#:~:text=PBMs%20negotiate%20drug%20prices%20with,price%20and%20receiving%20a%20rebate.
This is quick worthwhile read.
Sleven,

I understand that CVS has joined Express Scripts in its Missouri law suit against the FTC.

Last night, CBS “60 Minutes”(Stahl, I think) interviewed FTC chair Khan for about 20 minutes, asking questions about food and prescription drug inflated prices/costs that consumers have experienced and cannot afford to pay. Those consumers apparently did w/o the prescribed medication and substituted something else that didn’t necessarily work like the prescribed medicine. Video was shown of 2 persons—DOJ’s Kanter and FTC’s Khan—sitting together and discussing their respective law enforcement problems. Both want fair and effective competition.

I haven’t repeated a search of Kanter’s and Khan’s speeches or appearances to see if the above can be retrieved. A CBS podcast of above might be available.

See Louisiana Senator Cassidy (a doctor) on CNBC-TV discussing PBMs, about 7:50 a.m. this morning

North, Pharmacy benefit managers are under some scrutiny at the moment. They control the prescription drug trade in our country. It is debatable if they actually benefit the consumer in any way. I'll see what I can find concerning how they negotiate with "manufacturers". I'm not sure what I'll find. These organizations are immensely powerful. I would imagine that they make the major South American drug distributors jealous.
Sleven,

RMB, I don't have access to a signed contract between CVS and a generic manufacturer. I would be surprised if anyone could find that. It is possible that multiple generic companies could have engaged in a form of collective bargaining. That is beyond the scope of my knowledge. My point still stands. A PBM will provide the product that offers them the best profit. I am speaking simply about a complex financial system. Just calling our product a generic isn't going to provide CVS with a financial incentive.
Sleven,

north40000, thanks for your posts, and specifically this one related to CVS. And, I am especially impressed with your willingness to stand up for V and to pay the ~$1000 for approved V instead of accepting an AG. Then, per RMB's follow-up response that CVS offers various AG's and not V for the CVD, it seems to me there is a legal issue of direct infringement that could / should be brought against CVS Caremark. I am with you 100% and if you and marjac want to fight that fight, I again will support through a go fund me account. Amarin needs to get off their collective butts and do something but as experienced in the past have done very little on the legal front to preserve their only drug.
Thanks again for all you do for this board.

Does the following remind Blue voters of a Sarissa proxy-war promise?

Financial Times

NHS lunches 'suscription' scheme for antibiotics with Pharma sector.

Drugmakers will Receive flat fies for new medicines in push to avoide overuse.

By Ian Johnston in London August 12 2024


The NHS will agree subscription-style deals with drugmakers for antibiotics, as the UK seeks to encourage the development of new medicines and curb antimicrobial resistance caused by their overuse.

The NHS on Monday said it would negotiate fixed fees to pharmaceutical companies of up to £20mn a year per drug, working alongside the National Institute for Health and Care Excellence, the health spending watchdog.

The first-of-its-kind scheme was designed to “break the link between the payments companies receive and the number of antibiotics prescribed, removing incentives for overuse”, the NHS said.

The health service issued tenders for the subscription contracts on Monday, with an estimated total value for the programme worth up to £1.9bn over 16 years. The plans will apply across all four nations of the UK.

David Glover, NHS assistant director of medicines analysis, said the plans were “a major step forward in making sure it is financially viable for pharmaceutical companies to develop next-generation antimicrobial drugs to keep the spectre of drug-resistant superbugs at bay”.

Developing new antibiotics has historically been an unattractive investment for pharmaceutical groups because novel treatments must be used sparingly to avoid exacerbating antimicrobial resistance (AMR) — when organisms causing infection evolve to survive drugs.

This has contributed to a dearth of new treatments, with no new classes of antibiotics discovered since the 1980s.

Without the development of new drug classes, drug-resistant infections could kill 10mn people globally a year by 2050, according to a UK government-commissioned report in 2016. Some 1.3mn deaths were attributed to AMR in 2019.

The global cost in lost GDP could amount to $1tn-$3.4tn a year by 2030, according to World Bank estimates.

Regulators are taking steps to incentivise investment. Drugmakers that make new classes of antibiotics would earn “vouchers” under an EU proposal, where they would be offered longer regulatory exclusivity for other drugs in their portfolio.

Companies could use these vouchers to market their drugs for longer without facing competition or sell the vouchers to rivals.
Health minister Karin Smyth said the UK was “leading the way” in the development of new antibiotics. She added that antimicrobial resistance was “not a challenge we can tackle on our own” and that the government would seek an “ambitious agreement at the UN general assembly next month for co-ordinated action”.

The UK’s subscription scheme comes after a 2022 pilot phase between the NHS and Pfizer and Shionogi, the US and Japanese drugmakers, for their sepsis and pneumonia medicines.

Huw Tippett, chief executive of Shionogi Europe, said the new scheme was “the kind of sustainable solution we need to tackle the very serious and urgent issue of antimicrobial resistance”.

The maximum annual payment the UK will make per drug is £20mn over no more than 16 years, with spending decisions controlled by the Nice watchdog.

The UK will prioritise products that treat infections caused by pathogens identified as “critical” by the World Health Organization, including so-called Gram-negative bacteria, which are among the leading drug-resistance threats.
However, the £20mn maximum sum could remain unattractive compared with the billions of pounds in sales that drugmakers hope to earn from leading assets in their portfolios.

Paul Catchpole, head of value and access policy at the Association of the British Pharmaceutical Industry, a trade body, said the plans to offer a “guaranteed return on investment” were a “positive step?.?.?.?to ensure the availability of effective antibiotics for future generations”.

https://on.ft.com/4gAR2on

Sleven, if everything is as you say, then of course it would seem there would be no benefit to an AG. But my experience seems to run counter to what you have laid out. I have been with federal BCBS for many years. I was on brand V from before R-I results. CVS Caremark has been the PBM. Once GV was introduced my BCBS covered both brand V and GV. A couple of times the pharmacy tried to switch me to GV but quickly gave me brand V when I hollered. At some point (I think Jan 23?) BCBS through the CVS Caremark formulary stopped covering brand V. Since then I have been forced to take GV. But I can’t say that happened because they made a deal with one Generic company, as I have received GV from at least 3, if not 4 different manufacturers. So when you say that CVS has dropped brand V from their formulary are you sure it is because they made a deal with one and only one Generic company? If it turns out that CVS Caremark is covering a variety of Generic Vs, and not just one GV then an AG might still be of some value. Do you have information that CVS made a deal with only one GV manufacturer?

I will respond to the issue you raise, sleven. I had paid $9-15 co-pay, with GEHA insurance, for a 3-month prescription for Brand Vascepa, prescription on file with my local CVS, for many years prior to 7/01/2024. As of that date, Brand Vascepa was not on the formulary at CVS with my GEHA insurance at that price; I was informed by a joint GEHA/Caremark letter that, as of 7/01/2024, I would have to pay full, uninsured price for a 3-month supply of Brand Vascepa. GEHA had apparently lost a competitive bid to supply CVS with any Brand Vascepa to Express Scripts(?). I have not obtained any other insurance, having been with GEHA since ~1961 when I entered U.S. government employment. I paid ~$1000 to fill that prescription for Brand Vascepa at CVS earlier this month, even with a coupon furnished by GoodRX.

I will not accept so-called generic Vascepa to fill that prescription for substantially the reasons expressed in that recent Fed. Cir. opinion—Hikma’s product has not been shown to be therapeutically equivalent to Brand Vascepa, nor has FDA approved any ANDA or sANDA filed by Hikma for its product to be used to treat or reduce risk from CVDs.

I do intend to investigate whether I can obtain a prescribed Brand Vascepa from PFE’s newly established consumer pharmacy— “any” prescription drug, and at what price.

Meantime, I am going to explore any interest DOJ or FTC may have in investigating Brand and/or generic Vascepa, false advertising issues that may be present re “generic Vascepa” being offered for sale and actually sold, or other deceptive, collusive practices that may have occurred that permit so-called generic Vascepa to be in any of Amarin’s market for Brand Vascepa in the first place.

zman_DC has not posted anything I have seen lately. Anyone else see a post from him in September or August? Or know what has happened to him?

Enjoy the tacos.

Meowza, If they enroll that study I'll be happy to participate. I haven't had good cocaine since 85.
Sleven,

North, That is an entirely different issue.
Sleven,

# sleven: Might have to ask Zip whether the “authorized generic” he is referring to is the emulsified low dose form of Vascepa that I believe is patented ‘til ~ 2040. Change of Brand name of that product might be useful; whether it would be a generic of any kind is another matter.

Zip, The product that Amarin is selling is icosapent ethyl. Brand or generic doesn't change the cost. If Amarin wants to compete with the generic companies for the US market they need to cut a better deal with the pharmacy benefit managers. They don't care what we call our product.
Sleven,

RMB, I am certainly no authority on pharmacy benefit managers. I have little more than a general understanding of the prescription drug market machine. "Pharmacy benefit managers negotiate drug prices with manufacturers and pharmacies to help lower prescription drug costs for health plans." That is the simple Disney land explanation of what a PBM does. For the sake of this discussion let's use that and not go deep into the shady shit they actually do.
CVS Care Mark recently negotiated a deal with one of our generic competitors. Hypothetically let's say it was Teva. Brand Vascepa has been removed from all related formularies, and replaced with GV. The product that is going to be supplied by the manufacturer who negotiated the deal. If in this example Teva struck the deal with CVS, that PBM is not going to be supplying the generic manufactured by Hikma. This is the reason that it would not benefit Amarin to release an authorized generic. When we offered CVS the best deal they sold only our product. The game we are currently playing is all about pricing. Recently one of the people on this board said that the code B4G appeared on a CVS related formulary. The most common reason I could find for this was a supply shortage by the generic manufacturer. This fight for control of the US market is far from over.
Sleven,

An AG at lower prices than brand Vascepa could indeed benefit Amarin...

-Lower prices favor more approvals for payments from National health services, including in Europe and China
-Larger volumes of API favor lower costs to Amarin for acquiring API from wholesalers.
- Larger volumes of sales worldwide for an Vascepa AG give Amarin a competitive edge over other generic Vascepas

RMB, Enjoy the vacation.
Sleven,

As I said, my knowledge in this matter could stand to be improved, but I assume an AG could compete against GV in the category of generics. Now we have sales of brand V declining and Generics gaining market share. If a PBM or insurance co stops covering brand V then at least an AG could still be viable in that situation and take some of the generics scripts in that coverage scenario. Anyway I will sooner or later read any responses but am currently on a Panama Canal cruise so won’t be posting too often for a while. Getting off the ship now in Puerto Vallarta.

RMB, How would an authorized generic do anything that would effect the current US market situation?
Sleven,

Thanks for posting. Well if it weren’t for the Generics and morons still prescribing L and GL (other than for VHTG), the future would look bright for Amarin. I am sure I am not knowledgeable enough about the dynamics of the situation, but absent a quick legal victory (wiping the Generics from the scene) I wonder if an AG is about the only way to take advantage of the projected growth

https://www.researchnester.com/reports/omega-3-prescription-drugs-market/6461

Yes, thank you. That's what I meant.

MA52TA, It's not off label. Vazkepa is approved for sale. It's just not reimbursed.
Sleven,

Vazkepa is already sold in ITALY off label. I don't think there will be a "launch".

“We are getting approval from Italy?” I thought Laurent wasn’t sure? Isn’t the jury still out?

Study, just wanted to say I likewise appreciate the DD you post (especially appreciate the discussion details you posted on the NICE UK pricing meeting back in 2022).

I do agree we really can't afford another rejection from Italy. Look forward to getting this behind us so we can focus on France/Germany.

Laurent. Thx for keeping us up to date on this process.
Kiwi

N7. thx for the update
Kiwi

We are getting approval from Italy this time. I don't anticipate it moving the share price substantially however since it's all about revenue and cash preservation at this point. We had to make some compromises with Italy (I know cost was one of the compromises but don't know what the other compromises were). I don't know what the determined price was. I need a better sleuth than my poor, limited skills to find that out for us. We are between a rock and a hard place and our hands were tied. We couldn't afford another delay. We've got to get boots on the ground and Vaskepa into the hands of the Italian people with government HC coverage ASAP. Clocks ticking and not on our side. France is still a long way away and Germany is nothing more than a distant dream at this time. At least we've got Italy finally. It will be interesting to see timelines from management for roll out when they get offical announcement of approval from government. I think your time frame for next Friday is spot on. Thanks for all your due diligence for the shareholders. I've learned a ton from you and appreciated.

I think we'll see a pdf posted on the AIFA website upcoming friday 9/27. We'll either see something like "Opinion expressed" or "Subject postponed". If "Opinion expressed" then I think that means it's up to Amarin to PR whether it's a yes or no, but we won't know beforehand.

Kiwi, Don't know about Italy. Was an AIFA meeting this week.. Vazkepa was on the agenda.
Sleven,

N7. where are we in this process in Italy ?...as a reminder ...in the EU and other parts of the world, the dates are written day / mth / yr vs in the US mth /day / yr
Kiwi

Further proof that it’s NOT “just” about TG reduction:

We know from PROMINENT, STRENGTH and from REDUCE-IT EPA Mediation Analysis (https://esc365.escardio.org/presentation/265872)

That TG reduction is not the main driver for residual risk. In this new JACC study (hot off the press), and co-authored by Deepak Bhatt:

“Triglyceride Levels, Alirocumab Treatment, and Cardiovascular Outcomes After an Acute Coronary Syndrome” https://www.jacc.org/doi/full/10.1016/j.jacc.2024.06.035

They sought to examine relations between triglyceride levels and the effect of alirocumab vs placebo on cardiovascular outcomes using prespecified and post hoc analyses of the ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial.

They concluded “that baseline triglycerides was associated with cardiovascular risk. However, the reduction in triglycerides with alirocumab did not contribute to its clinical benefit.”

It’s interesting to point out that fenofibrate and EPANOVA both significantly raised LDL-c and ApoB levels while alirocumab and IPE did not!
Hummm?

JRoon71
Thanks for the detailed perspective for UK !!

Looks like we need about “5 more UKs” ($20M in 2026) during the next 2 years to get back to cash flow positive ?

5 possibilities - Spain? China? Italy? ROW? New “deep discount exclusive deals with US PBM”?

Okay thanks N7. On another topic, I work at a Nuke Plant. These are “Baseload” Units, run 24/7 for 18 months. Without our country’s Nuclear Fleet, we would be in serious trouble.
With the coming of AI, there will be increased demand for electricity to run these Data Centers. Microsoft is apparently working a deal with Three Mile Island to purchase all the power produced at the station. Electric Utilities are a great investment going forward. Not only will you get a dividend, but you’ll get share price appreciation. Artificial intelligence (AI) is also the coming thing.
Here’s hoping that Amarin secures Italy. If they can do that, then France would follow suit. Can someone explain to me why Bempedoic acid + Ezetimibe has such a high acceptance rate? GLTA

Nuke,, We just received our preliminary HTA assessment in Ireland. Now we need to respond. This was a different drug going through the process. You can see that there is a fairly quick back and forth toward the end.
Sleven,