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Oneragman
Here is my opinion:
KM knows the true potential of Vascepa. He also knows it will take at least two years to generate significant revenue in Europe (having been screwed over by Germany which was supposed to finance EU expansion). He and the Board feel confident they can limit expenses and maintain enough revenue to make it until Europe is cash flow positive. They are prepared to wait two years for the money to start coming in. KM and the Board probably suspect Denner is too impatient and wants to flip the company for some quick cash at a discount going hat in hand to Pfizer, Merck, Novartis etc begging for any bid at all to allow him out ASAP because he is sitting on a huge loss. $4 now vs wait 2-3 years for $10. KM and the Board brought in an M&A specialist to assure investors they are open to being BOUGHT - but not SOLD at a discount.
If a proxy fight develops, the board will advocate patience with a greater pay out over letting Denner sell the company for peanuts ASAP.
MY OPINION, based on my personal financial plan, is that I would rather wait another 2 years for $10 then let Denner sell for $4 next year. I will probably vote with the Board’s picks. Amarin is counting on convincing enough funds to give them more time to allow the full potential to be reached. I think they have a good chance of getting their candidate elected. Besides, 1 or 2 Board members aligned with Denner won’t be enough to control an 8 member Board with an established “Strategic Plan”. Motions are carried with a majority vote, 6-2 still wins.
I absolutely understand how many investors sitting on big losses just want this nightmare to be over. Sell now for whatever they can get and move on. Being an investor since pre adcom days, Amarin has taught me patience. I’m extremely grateful Lars is on his way out the door! The new guy seems to have a good CV. The woman- not so impressed.
Let’s see if they managed to reduce API purchases and conserved cash at the Q3 report.
Kiwi
I also suggest yogurt. Part of the benefit is that people are also less likely to tilt their head back swallowing a spoonful of yogurt with pills like Vascepa in the yogurt
Supporting the theory that V could be beneficial for Alzheimer’s
(Article 1 message: V stimulates production of lipoxin A4)
Title:
Resolvin E1 regulates interleukin-23, interferon-? and lipoxin A4 to promote resolution of allergic airway inflammation
Oliver Haworth, Manuela Cernadas, [...], and Bruce D Levy
https://drive.google.com/file/d/1auICOblPby2qWs1QxWTXOYWVqmppM9UA/view?usp=drivesdk
Abstract
Interleukin-23 (IL-23) is integral to the pathogenesis of chronic inflammation. Resolution of acute inflammation is an active process mediated by specific signals and mediators, such as resolvin E1 (RvE1). Here, we provide the first evidence that RvE1, in nanogram quantities, promotes resolution of inflammatory airway responses in part by directly suppressing IL-23 and IL-6 production in the lung. Also contributing to the pro-resolving effects of RvE1 treatment were increased concentrations of interferon-? in the lungs of RvE1-treated animals. These findings point to a pivotal role of IL-23 and IL-6—which promote survival and differentiation of TH-17 cells—in maintaining inflammation, and uncover an RvE1-initiated resolution program for allergic airway responses.
From the article:
“RvE1 treatment led to a significant decrease in LTB4 (Fig. 4j). Of interest, endogenous concentrations of the counter-regulatory eicosanoid mediator lipoxin A4 (LXA4) increased from peak inflammation (day 18; 64.1 ± 12.9 pg/ml) to resolution (day 21; 183.7 ± 31.3 pg/ml). RvE1 administration led to further significant increases in LXA4 concentrations on protocol day 21 (330.00 ± 55.5 pg/ml (Fig. 4k). No significant differences in concentrations of the lipid mediator prostaglandin D2{derived from DHA} (954.1 ± 34.0 (vehicle) versus 943.5 ± 24.5 pg/ml (RvE1)) were noted. Together, these findings uncover a “fingerprint” of selective mediator regulation by RvE1, and suggest that TH-17 cells and LTB4 may promote maintenance of inflammation in a manner distinct from the pathogenic roles played by TH2 cells and CysLTs in the initiation of allergic inflammatory responses.”
(Article 2 message: decreases in lipoxin A4 linked to Alzheimer’s)
Title:
Age-linked suppression of lipoxin A4 associates with cognitive deficits in mice and humans
https://flip.it/s_Ehie Age-linked suppression of lipoxin A4 associates with cognitive deficits in mice and humans
Fabricio A. Pamplona, Gabriela Vitória, …Fernanda Tovar-Moll Show authors
Translational Psychiatry volume 12, Article number: 439 (2022) Cite this article
Metrics details
Abstract
Age increases the risk for cognitive impairment and is the single major risk factor for Alzheimer’s disease (AD), the most prevalent form of dementia in the elderly. The pathophysiological processes triggered by aging that render the brain vulnerable to dementia involve, at least in part, changes in inflammatory mediators. Here we show that lipoxin A4 (LXA4), a lipid mediator of inflammation resolution known to stimulate endocannabinoid signaling in the brain, is reduced in the aging central nervous system. We demonstrate that genetic suppression of 5-lipoxygenase (5-LOX), the enzyme mediating LXA4 synthesis, promotes learning impairment in mice. Conversely, administration of exogenous LXA4 attenuated cytokine production and memory loss induced by inflammation in mice. We further show that cerebrospinal fluid LXA4 is reduced in patients with dementia and positively associated with cognitive performance, brain-derived neurotrophic factor (BDNF), and AD-linked amyloid-ß. Our findings suggest that reduced LXA4 levels may lead to vulnerability to age-related cognitive disorders and that promoting LXA4 signaling may comprise an effective strategy to prevent early cognitive decline in AD.
Zip
I don’t think one capsule per day would do any good. If she can swallow one capsule, she can swallow 4, one at a time.
I really wanted to just tell her to use a different orifice.
Rose
Absolutely!
But the biggest mistake people make is that they tilt their head back when they go to swallow pills. The throat is designed with a 90° angle so when you tilt your head back it narrows the throat and makes it hard to swallow.
CBB
I missed happy hour so this is about the direct message.
First, the 500mg caps are not available in Canada. Second, I don’t give up that easy. I know the Pts daughter and I had her talk some sense into her mother (and apply a significant amount of guilt). She has since returned to fill the Rx and give it a try. I will keep an eye out for when she refills to make sure she sticks with it or I will rat her out to her daughter that mom isn’t doing what she needs to do to be around for her grandchildren.
Zip
Had a Pt last week: just had an MI with emergency 3x CABG age 65. I recommended V and showed her the 40% reduction in MI data. She had just had a near death experience. I showed her the capsules and her response was “no way am I taking those 4 huge capsules”. I just walked away. People are idiots
NS
I see no reason why it couldn’t.
NS
No Lovaza in Canada either. No Omega 3 competition at all.
After 2 1/2 years on the market, their weekly sales are just hitting 1000, almost entirely private insurance.
https://drive.google.com/file/d/1FuKWonJa9mpy1EnFyb6EWrpJNz88UAgX/view?usp=drivesdk
Rose
I doubt they will have inventory they have to write off. I believe they have created a new category called long-term inventory, which hopefully is API in long-term storage, protecting it from spoilage (maybe using large storage containers of pure IPE oil at very low temperatures).
NS
Realistically, it will be at least 2-3 years before the EU generates enough sales to make a dent in the current MASSIVE inventory levels, even longer before Amarin will need to start buying substantial API.
Kiwi
“expect a poster at AHA like the PREPARE -IT data U were so excited about
Remember that ?”
PREPARE-IT was a late breaking CT, not a poster presentation and PREPARE-IT showed a 22% reduction in hospitalizations BUT it was under powered because they anticipated a 30% hospitalization rate but only had 8%. The trial was “trending positive” but the p of 0.18 meant it was automatically rejected by the medical community.
As for MITIGATE, I hope it is successful and Kaiser jumps on it to aggressively keep their customers out of the hospital but I will be shocked (and apologetic) if they do.
I used to live in the utopian world of believing people and companies would do the right thing for the right reason but life, experience, Amarin, judge Du and guys like Nissen, Raf and many others brought me down to the real world where self interest, greed, ambition, and the “me first and me only” attitude means that what should happen isn’t what necessarily does happen.
As JL used to say, “V will sell itself” or “it will be like Pepsi”. It should have. It isn’t.
Kiwi
Insurance companies (and government payers) are too focused on making their budget THIS QUARTER. The people “controlling” drug costs are not in the same department as the “inpatient cost controllers”. The drug budget is not going to get an increase in funding now because the guys in the inpatient department are excited about cost savings in 3-5 years. The guys making these budget decisions are hoping they will be promoted and moved on by the time the consequences arrive.
Put simply: they are too short sighted to incorporate the big picture.
Swg_tdr
“Question, would a prevention and long term oriented "state" health organization-- say speculatively of NZ, Australia, or China -- adopt V?”
China is very “preventative medicine” oriented and their CCS adopted V into their PREVENTATIVE Cardiovascular guidelines over a year ago (maybe 2). I think it will grow much quicker there than other countries BUT it needs to first be accepted by their payers which typically happens 2 years after launch and for which they expect at least a 50% discount (due to volume). A domestic gV will probably launch almost immediately and will probably be given a financial advantage over Edding but hopefully volume and raw material allow Edding into the sandbox.
Oz and New Zealand will probably be similar to Canada where government payers have tried to put up barriers to slow the growth but ounce approved and covered I would expect a faster uptake than US.
Kiwi
“MITIGATE is a Kaiser run trial .
U understand that … correct ?
So if their own trial shows benefit in their own patients …. U expect them to ignore it ? “
Yes. Without question.
Mrmainstreet
I think KM’s approach to locking in insurance companies was the right way to go, and probably the only choice he had. If he tried to just compete openly by offering a lower price it would have been a race to the bottom, as they say. 2 years after the launch of a generic the market share that Amarin maintains is impressive. The limited supply of raw material is what made the negotiations possible. The bleeding appears to have slowed, dare I say stopped, but cash flow prevents Amarin from aggressively promoting and growing sales, especially if the generics get 55% of any sale’s generated.
If they can minimize further purchases of IPE (inventory levels are already so high they have 3-4 years worth of stock) then they will have enough cash to launch EU and wait the 1-2 years for sales to start getting significant revenue.
Bottom line: I’m impressed KM was able to get 45% of insurance contracts.
Kiwi
“So if there was any clinically significant risk reduction in Kaisers MITIGATE Covid portion … they should be acting , and we should know .. fairly soon”
R-IT had great data with an extremely strong p value to back up the existing JELIS trial data (plus CHERRY & EVAPORATE). Kaiser didn’t run out and prescribe V to all their Pts that fit the profile.
The recent “Any MI” data at ESC showed a clear and strong correlation between serum EPA levels and MI risk reduction when analyzing the on treatment Pt arm (no MO involved). 40% reduction in MI risk for Pts on V! 40% REDUCTION for f’s sake. Kaiser isn’t rushing out to get their high risk MI Pts on V. There is about a 1% chance (I’m feeling generous) that any strong MITIGATE data will get an insurance company to aggressively encourage V use. It’s just not going to happen. Insurance companies don’t think that way.
Tatsumaki
I’ve read through your prior posts and I have to say I agree with pretty much everything you’ve posted. My interpretation/summary of your posting history:
1) Amarin’s biggest obstacle is that they are asking doctors to prescribe V without giving them a clear MOA nor a measurable biomarker. Eg: Jardiance is flying off the shelves because docs & Pts understand “the drug opens the kidneys and you piss out your sugar” and you can check your BG and SEE it’s effects as well as lab tests showing a meaningful decrease in HgA1C. With V docs & Pts have to go 100% on faith of a single CVOT. If not for the adcom disaster and betrayal by the FDA “Lower your TG’s without raising your LDL” would have been the sales pitch that worked to take over the Lovaza market first then reinforce V with R-it. “Trust me, your less likely to have an MI in five years” - meh (I tell my Pts this with child like enthusiasm in my voice and 9 out of 10 pts just stare back at me with no reaction).
2) insurance companies decide which drug you take and insurance does not want to cover V. Insurance co’s paying in advance in the hopes a more expensive catastrophic event won’t happen in the future is the EXACT OPPOSITE of the fundamental business plan of the insurance industry- they want the client to PAY THEM in advance in the hope of being protected in the event an expensive catastrophic event happens 5 years down the line. Keep in mind many people shop around and change insurers every year so why pay for preventative medicine when the client will likely be with another insurance company when/if an event happens.
3) it’s now all about serum EPA levels, which you think is a bad thing if I understand your old posts. Here I agree that they were forced to take this approach (nothing else to claim/promote) but I disagree that it leaves them open to DS competition at lower prices. People want what their insurance will cover and insurance will not cover DS. Doctors may think any product that gets the EPA level up is an option (especially Pts with no insurance or where prescription Omega3’s aren’t covered) but they will always prefer to go with a clinically proven safe and effective Rx.
4) exclusivity is irrelevant, we have had CVD regulatory exclusivity since Dec 2019 and it hasn’t had ANY relevance since April 2020 with DU’s decision. Regulatory exclusivity and patents have absolutely no influence on V vs gV being dispensed.
5) V 2.0 or statin combo: neither have any advantage nor will they get WS’s attention unless they will be less expensive than gV while maintaining a good margin.
6) another positive clinical trial won’t impress WS, although it will help convince doctors and price negotiations, but a negative or neutral trial will kill the company. RESPECT has a modest upside but a huge downside.
Hope I have correctly interpreted your posts. I see there have been some posts that question your motives so I thought I would point out that you are not alone in your views.
V works. Unfortunately nobody cares.
Laurent
This larger transcript from the interview reaffirms my original interpretation that Amarin will be presenting their own data. My hopes are back up that it may be the AA:EPA ratio data needed to reinforce positive RESPECT data.
“We are going to have new data submitted at AHA to ensure that we keep supporting the evidence behind VASCEPA."
Laurent
Thanks for digging out the transcript. I think my interpretation was wrong, he never says or suggests that Amarin had submissions to AHA, just that there are submissions. He quite likely was referring to RESPECT and possibly MITIGATE. There is still the possibility Amarin could have the ratio data but if they don’t my faith in KM will take a serious hit.
Thanks Laurent!
At the last HCW presentation KM mentioned that Amarin was hoping to have a presentation at AHA as a late breaking CT IIRC. A presentation on the AA:EPA ratio data in R-IT would be the dream.
When I had the opportunity to talk to Dr Bhatt in the summer of 2021 I asked him specifically if there was an analysis of the AA:EPA ratio from R-IT since the paper I wrote was based on that ratio. He replied “there is no plan to do such an analysis at this time.” I am sure they have the data. An omega 3 drug being investigated would certainly run the standard Omega panel which includes levels and ratios of EPA, DHA, AA, total omega3, total omega6 etc. They had to know RESPECT (focused on AA:EPA as a primary endpoint) was well timed to present at AHA and only a completely incompetent management (so this will make or break my view on KM and Amarin) would pass on a chance to tag team the RESPECT data (completely independent trial) with their own data.
Ralphey
Yes, the US pays more but you also get access to these live saving medications years before anyone else. Eg: V available since 2012 in US, 2020 in Canada and 2022 in Europe. That has a value to it as well
JRoon71
The first year of Pfizer selling V was under the identical conditions HLS had the prior year. Not upward inflection between year one (only HLS) and year 2 (HLS plus twice as many Pfizer).
Zmanindc
I will take the Canadian system over the US any day of the week. V has been on the market in the US since 2012 and it is still very hard to get V covered by insurance. We may have to fill in a form that can take 4-6 days for approval but that is something new and annoying here where it is common in the US to the point Ralphey doesn’t even prescribe it anymore, and he believes V works. Also, the Canadian government requires private plans to cover approved medications so 95% of private plans have been covering V for the past 2 years. What percentage of US private plans cover V?
The US healthcare system is an international joke, run by profit driven companies, and it has very little to do with litigation problems. Canada and the EU view healthcare as a human right, not a privilege of the rich like the US. Our system is far from perfect but light years ahead of the US.
The accountants at your insurance company dictate which drugs you get, what lab tests you can have, which hospital you can go to even which pharmacy as well as which brand of drug you are allowed. In Canada everyone always knows they can see a doctor, go to a hospital, get any required test, go to the pharmacy of their choice - all (except the pharmacy for 24-65 yr old) free.
Thanks for reminding me how insignificant the new Exceptional Access Program form is in the big picture and reminding me how great my healthcare system is, I was allowing myself to get frustrated by something that is trivial compared to my southern neighbours.
(I’m not bashing the US, just honestly grateful we don’t have a similar system)
Zmanindc/Kiwi,
I have presented to both GP’s and cardiologists. I’ve met with the regional manager for Pfizer and VP for HLS. I am very familiar with their marketing plans, strategies and territories. Pfizer is trying their best. Neither HLS or Pfizer can get in the door of doctors offices because most are still working from home 4 out of 5 days.
A note about reimbursement: Quebec requires proof of TG over 250 and Ontario has a specially developed “Exceptional Access Program” form that has to be filled out with proof of fasting TG over 150 within the past 3 months. This form is unheard of for any other drug. They don’t even require a form like this for a PCSK9. Government payers are terrified that V is going to be over prescribed and have created new barriers I’ve never seen before. This is only as of August so it doesn’t explain the absence of ANY incline in sales curve.
It’s just frustrating
CBB (and everyone else, but especially CBB)
Look at the HLS sales graph:
https://drive.google.com/file/d/1FuKWonJa9mpy1EnFyb6EWrpJNz88UAgX/view?usp=drivesdk
Question to everyone who has been criticizing $AMRN reps and Amarin’s ability to sell V and who keep saying BP is needed to get sales going: looking at this chart, can you tell where the great and mighty Pfizer joined HLS with their experienced cardiovascular sales force twice the size of the existing HLS newly hired reps?
Pfizer reps began actively promoting V in the Canadian market in Sept 2021. ABSOLUTELY NO CHANGE IN THE SLOPE
It looks as if Pfizer has had absolutely no effect on sales. But, but, but CBB HOW CAN THIS BE??????? You have said over 100 times that Amarin needs to be bought by BP , especially Pfizer, to get sales going. Is it possible every single post you have ever made (because every single one whines for BP to buy Amarin) has been wrong?
I have learned over the past 2.5 years since V approval in Canada (launch Feb 2020, with inclusion in the Canadian Cardiovascular Society treatment guidelines for Dyslipidemia in March of 2021) how INCREDIBLY HARD it is to get a doctor to try something new, no matter how much data you give them, no matter how tiny the p value and no matter how miner the potential side effects. They seem to stick with what they learned in medical school and just coast along afterwards. If it came on the market after they graduated then they are too scared to use it.
Number sleven
My apologies for crediting Dogn for your great find, you both do amazing DD and I was too lazy to verify the source.
Couldbebetter
I made a few edits to help Nissen understand the ESC graph
https://drive.google.com/file/d/1LC2DUel6JgdPBy8DLKhBtcHo-tS0TE5b/view?usp=drivesdk
Kiwi
Did you not see the graph for serum EPA vs MI risk reduction I posted recently from ESC presentation?
https://drive.google.com/file/d/1tExSMHgFlP1MC7qkhc-RfoDYAQ7R7GHo/view?usp=drivesdk
Very clearly shows that WITHIN THE EPA ARM (so no mineral oil, no inflammatory biomarker differences, everything is the same except the serum EPA levels) there is a very clear reduction in MI risk with increasing serum EPA levels. I’m not sure even Nissen could find an alternative theory to explain these results.
The German government used ezetimibe in spite of it being an obviously flawed comparator because that is what payers do to try and get a better price. KM called the NICE bluff and didn’t drop the price significantly and NICE caved and approved. KM packing up and leaving Germany was his clear message he can’t and won’t drop the price in Germany. The arbitration committee sees this regularly (as shown in the excellent find by dogn https://www.globallegalinsights.com/practice-areas/pricing-and-reimbursement-laws-and-regulations/germany ) and has the power and independence to offer a reasonable price (although 90% of the time it is lower than the rest of EU but that is expected as they are the biggest market). We may not need to reapply or resubmit for approval, the Nov 18 decision could come back with something both sides can live with (just like the UK).
Dogn
Thanks
Capt (and all)
I’ve put the chart on Twitter so if you want to help spread the word go to:
Here is a great graph showing the correlation between serum EPA levels and MI risk reduction. In treatment arm clear risk reduction as EPA levels increased pic.twitter.com/iXkcPPhJmk
— Mark Brady (@MarkBrady2014) September 7, 2022
Dogn
Is Epadel once daily going to be prescription or is it OTC (non prescription) in Japan like the twice daily form and therefore no reimbursement?
Interesting new slide I came across showing reduction in MI correlated to serum EPA levels:
relationship between MI reduction and achieved EPA levels in the IPE treated group
https://drive.google.com/file/d/1tExSMHgFlP1MC7qkhc-RfoDYAQ7R7GHo/view?usp=drivesdk
IF MO was the cause in increased events in the placebo arm then there wouldn’t be a direct correlation between IPE level and reduction in MI’s.
NS
Excellent find!
There were many interesting points discussed, mostly showing how the government engages in unfair price negotiations, but this was of particular interest: “Determination of low-cost comparators.
Further critical comments refer to the insufficient distinction between the G-BA assessment process on the one hand and the reimbursement price negotiation process on the other. As the price negotiations are based, in practice, on the price of the respective comparator (bottom-up approach), the determination of the suitable comparator in the G-BA assessment process is of utmost importance. It is argued by the pharmaceutical industry that the selection of suitable comparators by the G-BA has
been biased in a number of cases because of the selection of a generic "low-cost comparator', even though alternative, more innovative and thus more expensive
comparators would have been more appropriate (EZETIMIBE!!!). It should be noted that, based on 2020 data, the price pressure of low-cost comparators is so strong that almost 90% of the reimbursement prices negotiated or determined by arbitration are below the average price of the same drugs in comparable European countries, and around 60% are even below their lowest prices.”
The fact the UK and Sweden have agreed to reasonable prices make it likely that V will be included in that 60% that are below their lowest price. That could still turn out to be $160 USD.
I did not see it stated explicitly in the document but it did appear to me that the arbitration committee is quite used to seeing the false comparator ploy and is able to alter that decision. This is very good news. I was afraid they were bound by the prior committee’s decision.
Without knowing what is really going on in the negotiations but having read much of this document I believe KM made the right choice by announcing Amarin is pulling out of Germany. He made it clear that Amarin is serious and will not give their product away for cheap because of government bullying. Whether this plan works to positively influence the arbitration committee or not, it’s worth the $4M write off as a negotiation strategy. If they get a reasonable offer they could be back up and selling in a very short time.
NICE threw everything they could at Amarin and KM didn’t blink and, IMO, came out the winner. EU negotiations is what he was originally hired for and I trust his decisions after the results he got with NICE.
Excellent DD, thanks for sharing!
NS
Definition of suspend
transitive verb
1 : to debar temporarily especially from a privilege, office, or function
suspend a student from school
2a : to cause to stop temporarily
suspend bus service
b : to set aside or make temporarily inoperative
suspend the rules
3 : to defer to a later time on specified conditions
suspend sentence
4 : to hold in an undetermined or undecided state awaiting further information
The PR previously implied a temporary change. The current PR is clearly a final decision.
As long as the comparator drug is ezetimibe there is no path forward and they have no choice but to abandon Germany. Positive results from RESPECT (and possibly MITIGATE) will allow them to reapply and I would expect that second application to be equally resisted by the Germany government as they try and drive the price down (multiple rounds, false accusations, clowns brought in to cast doubt etc).
It’s always about the money with insurance companies or government payers. I believe V will be approved for secondary prevention, but it will likely be another 6-12 months IMO.
NS
BID is the Latin shorthand for “twice daily”, used when writing prescriptions
Dogn
I have a theory: maybe “long term inventory” which is over $200M is unencapsulated IPE which is being kept in cold storage 1) so that it could be used to produce the new emulsified V2 2) used to produce V for China (IIRC during a cc MK said China product could not be manufactured prior to approval) 3) just trying to delay spoilage.
This study is from 2012 and it looks at the EPA:AA ratio in Pts undergoing PCI or CABG in Japan (ie: no MO)
https://www.jstage.jst.go.jp/article/circj/76/2/76_CJ-11-0941/_pdf/-char/ja
Table 5. MACE vs. EPA/AA Ratio
MACE
34/142 (23.9) in the low EPA/AA group
18/142 (12.7) in the high EPA/AA group
P value 0.0096
Higher EPA/AA ratio (>0.4037)
HR (95%CI), P value
0.52 (0.27–0.99), 0.048
0.51 (0.26–0.98), 0.043
0.49 (0.25–0.94), 0.033
I haven’t fully reviewed the trial but this appears is encouraging for RESPECT which is specifically looking at EPA/AA ratios.
Rose
There isn’t any new information this weekend, just further analysis of existing data from R-IT.
North
As Laurent posted on the 18th:
“Germany has always been very tough ever since the 2010 AMNOG act, and today's outcome was not a surprise to me. From everything I've read, German negotiators were by statute not allowed to reimburse higher than the "appropriate comparative therapy" which was set to ezetimibe at 45€ a month (this is all because the GBA gave a no benefit added assessment earlier this year). “
I think the road forward is blocked as long as they have the designation of “no added benefit” (which is absurd) and Amarin knows it and that is why they had no choice but to pack up and leave. Resubmitting after RESPECT is their only option unless arbitration allows for changing that designation.