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Do we know when Germany pricing will be public knowledge? I would think it has to be relatively soon if they plan to launch there by end of 3Q?
Thanks for the reply and hope you are right! We need a catalyst and a favorable ruling there would definitely help our beaten down PPS.
Does anyone know when we can anticipate a ruling on Teva/GSK? I know arguments were back in Feb.
Has anyone reached out to any analysts to see if they are aware of these insurance changes?
It would be interesting to hear their position on this. I can try contacting them myself as well.
Excellent post. Does anyone know why this (insurers dropping gV) isn’t being discussed in the media or being mentioned by a single analyst?
Thanks Marjac, always appreciate your expertise and willingness to answer questions.
Agree w/ the logic there. Does anyone know if the case can be remanded “on the briefs”?
I wouldn’t think so, but just curious.
DM (and others), what do you think a fair pre decision PPS value is? ~$9?
We ran up to $8+ back in April, so I would have to think $9 (or higher) is a safe bet as the decision approaches. And I don’t think $10 is out of the question.
Thank you marjac. Always appreciate reading your insights.
Marjac, can you opine on the potential of August oral arguments?
This seems quick, but I notice Aug 6/7 are still wide open and the Aug schedule was just revised today w/ still nothing booked for those two days (Thurs/Fri of that first Aug week).
I asked this question broadly earlier, but didn’t receive any input. I think this would be a helpful development as it accelerates our appeal timeline significantly. Would greatly appreciate your insights if you have a chance.
Burn
August Oral Arguments?
I’ve seen some discussion on this, but not a ton. How do people feel about our prospects of getting on the August calendar? I think this would accelerate our timeline significantly and perhaps put the SP back on the upward trajectory we’ve all been waiting for.
As a few have pointed out, Aug 6/7 (Thurs/Fri) remain completely open for scheduling.
Burn
New comment from Markman today. Interesting read, sorry if this was posted already:
In response to some of the comments below:
Amarin has challenged Judge Du's "weighing" of the secondary considerations. Amarin has separately challenged the secondary considerations that Judge Du found did not weigh in favor of nonobviousness (eg., praise, skepticism, unexpected benefits.) Thus, the Court could take up either one of these challenges, or both. One is not dependent upon the other. Technically, as discussed above in the post, there is a pathway to reversal where the Court determines that "weighing" the secondary considerations was legal error, and reverses without considering any challenges to the secondary considerations. But there is also another pathway where, if the Court determines that "weighing" the secondary considerations was, in fact, legal error, that will invite the Court to weigh all the evidence for and against obviousness de novo. At that point, the Court might reasonably reconsider the weight of the prima facie case, the weight of the secondary considerations found in favor of obviousness (commercial success and long-felt need), but also the weight of those secondary considerations found by Judge Du not to be in favor of non-obviousness (praise, skepticism, etc.) Thus, does the “weighing” of the secondary considerations argument potentially act as a mechanism for the Court to reconsider praise, skepticism and praise? Yes, potentially. The oral arguments may provide insight into how far the Court is inclined to go down this path.
If the Court reaches the point where it is weighing, de novo, the prima facie case against the secondary considerations, I would not say that it is purely subjective, but it is nonetheless an exercise in which reasonable judges, reasonable experts, and reasonable people (eg., jurors) can disagree. That is inherent in the process.
If Amarin loses the appeal, the likelihood of refiling these patents to more adequately claim a second patient population would be extremely remote. The priority date would be 2020, rather than 2008, and Amarin would have to overcome a host of prior art published since 2008, which would make this very difficult. The patents that Amarin has covering this drug, which could warrant an injunction, are listed in the Orange Book. A fair presumption is that Amarin has already asserted the best patents that it has to block Hikma and Dr. Reddy’s, at least with respect to the Marine indication.
Amen to that. Guy just likes to run his mouth and offers zero value of any kind.
It’s as close to zero as it can be. And I could care less what you think of me.
A regulatory professional of 20 years. There is zero chance the marketing application is declined by EMA.
Anyone w/ regulatory domain knowledge would agree.
I can confirm what others have said: EU approval is a lock.
It is the same RI indication, but I believe they are seeking an even wider label in EU. Trigs > 135
Well said. Hope nobody listened to him.
Thank you for sharing. Just an observation regarding:
“There are 11.3M individuals in the EU with elevated triglycerides levels above 150mg/dL”
Amarin is seeking cutoff at 135 in their EU filing, so if they receive this, it would obviously increase the population further, boosting peak sales projections. If Amarin is seeking this, they must feel they have a good chance of it being granted.
Burn
Thanks HDG, always appreciate your insights. You are right that the regulatory review process is not as straightforward in EU w/ the various clock stops for questions, etc. But your projections look spot on to me.
Do you think Amarin intentionally delayed the EU submission to defer having to make a decision on an EU partner (and also to maximize their value to a potential buyer?).
Inflection point for determining EU strategy
JT has commented a few times that the company has not yet been forced to make a decision on partnering in EU. But now that the EU marketing application has been submitted, the clock is ticking IMO.
So two questions:
1) A partner or buyout is needed to commercialize V in EU. GIA is not an option. So does anyone have any thoughts on a possible time frame where/when a decision would need to be made? I’m thinking within next 3-6 months, but that’s just a guess.
2) Did Amarin intentionally delay the EU submission by 9 months in order to buy more time/defer this decision? In the meantime they also gained FDA approval, which essentially derisks the EU submission, as EU will most certainly follow FDA’s lead and approve V.
Would be curious to hear others thoughts. Happy holidays everyone.
-BS/OY
I caught that too. Deferring a decision on an EU partner continues to optimize value to any potential buyer.
It now makes a lot of sense why they delayed the EU submission 9 months from the US one...
Agreed. It’s just not feasible for commercialization activities. They will partner in EU or be bought out.
Yep. Either by 11/11 or 11/25 according to the latest timetable on the EMA website.
EU MAA submission timelines
The EMA timetable currently shows 11/11 and 11/25 as the only remaining 2019 submission deadlines for initial MAA. So we should expect the EU submission by one of those two dates.
This assumes Amarin intends to hit their EU submission target of “late 2019” and EMA doesn’t add an additional deadline in December.
Yeah something sure seems rotten about all this. I’d like to hear Yee’s response here.
Cleveland Clinic’s Nissen denies any communication with FDA about Amarin’s Vascepa
Drama, thy name is Amarin (AMRN).
If you want to get a rise out of investors who have been following Amarin, the maker of the fish-oil-derived heart drug Vascepa, try mentioning the name of Cleveland Clinic cardiologist Dr. Steven Nissen.
That’s what Jefferies analyst Michael Yee did in a “tidbit” that came 12 minutes and 30 seconds into his podcast for investors, saying Nissen “has been writing correspondence with the FDA over the past six to 12 months.” Yee said that he had tried to use the Freedom of Information Act to get Nissen’s emails, but that they would not be coming any time soon. He said he didn’t know what Nissen might want, but noted that Nissen is the lead investigator for a large study of a competing product, AstraZeneca’s Epanova.
Yee also said that he likes Nissen a lot, but that Nissen is “quite a controversial guy.” The link to the podcast was quickly shared by investors in Amarin on Twitter.
Nissen, reached for comment, called the remarks “complete nonsense.” He said that he has had no recent communication with the FDA about Vascepa, about Epanova, or about related issues. Nor has he talked about the drug with any of the experts who will serve on an expert panel about the Vascepa’s use in two weeks.
“I mean, literally, when I say no, I’m not playing games with you,” Nissen said. “I mean no, no, no. There’s been no conversation that anybody could ever interpret under any circumstances as representing a discussion about Vascepa, end of story, period.”
For some Amarin investors on Twitter, the mention of Nissen’s name was enough to generate some heat. “This is highly unethical and improper!” wrote user @JohnCapello. “Nissen should use Adcom comments like everyone else and be clear about his affiliation with [AstraZeneca].”
The reaction shows the tension ahead of the Nov. 14 FDA advisory committee meeting, which will help determine whether Amarin can market Vascepa to a much larger group of patients. A study released a year ago showed the drug reduced the risk of heart attack, stroke, and cardiovascular death compared to a placebo.
Nissen’s history, both with the drug industry as a whole and with Amarin, helps explain the high emotions. He first gained national attention for being outspoken about the cardiovascular risks of Merck’s Vioxx, before that drug was withdrawn from the market. In 2007, he raised concerns that Avandia, a diabetes drug made by GlaxoSmithKline (GSK), might increase the risk of heart attacks. Sales of the drug, the best-selling diabetes pill at the time, plummeted to virtually nothing.
In 2013, the FDA declined to approve a broad use of Vascepa, citing the need for more data. At the time, Nissen said he “strongly opposed” the broader approval. “Unfortunately, the prior fish oil products did not conduct any outcome trials, leaving the medical community with many questions, but no answers,” Nissen wrote at the time. “We should not make the same mistake a second time.”
Now those data are available. But Nissen has been among those who has raised another concern. The Amarin study used mineral oil as a placebo, and blood test results thought to be heart unhealthy, like LDL and CRP, went up in the placebo group. Could this have exaggerated the positive results? Nissen has made that argument. His study, for AstraZeneca (AZN), uses corn oil as a placebo.
That’s the concern Yee was implying Nissen might have been communicating to the FDA. Amarin had initially indicated an advisory panel might not be necessary. When it was scheduled on Aug. 8, shares nosedived. But Nissen insists he has not been talking to the FDA about Vascepa at all.
Yee did not respond to an email explaining Nissen’s position.
Apparently results of accelerated assessment decisions are not contained in the highlights. I thought they were personally, but was mistaken.
It will be in the minutes. Minutes come out in 6 weeks. Or Amarin could disclose it. But many times companies don’t disclose this, one way or another.
Very soon. End of this week or early next at latest.
Because in EU/EMA you apply for accelerated assessment in advance of the submission. It’s different than US.
Re: Accelerated assessment in EU
Just to be clear, Amarin hasn’t received this yet. Not from what I can see.
That excerpt was from the agenda for CHMP week and it’s being discussed as a topic this week by CHMP. Fingers crossed we get it. It’s more difficult to get in EU than US, or so I’ve been told.
LBL, this article wasn’t written by me. I was simply sharing w/ the board as it required registration.
Amarin Vascepa Label Extension: Bigger Population May Pose Issues For Payors Despite Favorable Value Assessment By ICER
Amarin’s triglyceride-lowering therapy Vascepa has a very favorable cost assessment from the Institute for Clinical & Economic Review (ICER) for its current labeled use, but the product is still raising payer concerns about a large bump in cost from more users if a pending cardiovascular outcomes claim wins FDA approval.
Payers at a September 26 ICER meeting on the new indication for Vascepa (icosapent ethyl) expressed concern about the budget impact of taking a product with a favorable value into a much broader population, and once again raised the argument that prices should be reduced when efficacy is demonstrated for broader use.
The ICER meeting had been timed to coincide with FDA’s priority review deadline to act on the Vascepa label expansion based on the REDUCE-IT trial. However, the agency has decided to take the supplemental application to an advisory committee and pushed the decision back to December. (See our Aug. 29 note, Advisory Committee Tracker: Back-To-School Agenda Starts With Peanut Allergy Review; Amarin REDUCE-IT Review Is Unexpected Addition.)
The good news for Amarin during the ICER review is that payors still appear to view the product as likely to see a substantial uptake in use from the REDUCE-IT data – so much so that they invoked comparisons to the budget pains experienced after the introduction of Sovaldi for hepatitis C.
That may not seem like an immediately obvious comparison, given the dramatic difference in price points (Sovaldi famously was launched at a list price of $1,000 per pill, while Vascepa currently costs about $1,600 for a full year of treatment) and treatment paradigm (Sovaldi is a short-term curative therapy while Vascepa is a chronic lifetime treatment).
However, payors see a similarity in the potential to transform an existing line-item from relatively small patient numbers to a sudden, significant increase. In that context, they are concerned that even at a price point that is well within current value-based targets, the budget impact may be overwhelming.
A similar dynamic was at play during ICER’s review of the PCSK9 LDL-lowering therapies. ICER initially estimated a value-based price well below the launch prices for the drugs – and then lowered the estimate after favorable outcomes data was gathered. (See our Sept. 13, 2017 note, ICER and the VA: Amgen’s Repatha FOURIER Outcomes Trial Will Indicate Impact of Recent Agreement.)
In that class, however, payors' forecast of budgetary implosions did not come to pass – nor did manufacturers’ hopes for blockbuster sales figures.
ICER’s estimates suggest that Vascepa is currently priced at least 75% below a theoretical cost-effective maximum price. But the group still believes that a further price reduction might be warranted if the REDUCE-IT data is added to the label.
ICER’s cost-effectiveness analysis for Vascepa concludes that the product could be priced between $6,300-$9,200 per year to achieve commonly cited cost-effectiveness thresholds of between $100,000 and $150,000 per Quality-Adjusted Life Year gained for its initial target population for patients with severe, very high triglyceride levels above 500 mg/dL. The product’s current estimated annual net price of $1,625 (as noted in a recent ICER report) is significantly lower than the value-based price benchmark range WAC at $3,699.
At the September 26 meeting, ICER President Steve Pearson referred to a “general instinct” that a label extension to a broader population should give rise to “some consideration” for “a lower price.”
UPMC Health Plan Senior Medical Director Bernie Good, who also spoke on behalf of the Department of Veterans Affairs, agreed with that premise. He was one of the speakers to raise the comparison to Sovaldi and the other new hepatitis C products in terms of the impact on the VA.
“When the drugs for hepatitis C came out, it blew up the pharmacy budget,” Good said. The “spectacular” effects of the products led the VA to negotiate with manufacturers for a lower price. “We bargained as hard as we could, and it was bare knuckle negotiations. We got the price down to the best price among any developed country, far less than Canada, then treated as many patients as we could.”
Vascepa was approved in 2012 as an adjunct to diet to treat severe hypertriglyceridemia (550 mg/dL or above). The REDUCE-IT supplement is for cardiovascular risk reduction in patients with triglycerides above 133 mg/dL.
“I don't sense that we're looking at Vascepa in the VA or at UPMC Health Plan as being a $100 million a year drug” for those programs, he said. “I just don't see it, but what will have to happen is if it gets the label and VA all of a sudden sees this huge uptake, they're going to need to step back quickly, meet with Amarin, say ‘what the heck do we do about this,’ and try to come up with some amicable” agreement. “I would hope that, being a good a partner, if the drug is doing extremely well and you're selling, maybe the price would come down to make it easier.”
ICER’s Pearson specifically made note of Amarin’s own estimates of the potential target population for Vascepa. He quoted Amarin CEO John Thero as estimating that the new indication could encompass up to 40 million patients annually.
In that context, a relatively low per patient price still leads to huge spending. “That's $40 billion a year, each year, if half of the eligible patients that your CEO is targeting take this drug at that price,” Pearson pointed out.
Pearson asked Amarin SVP and Chief Medical Officer Craig Granowitz: “Is that a price that you think the health system can afford? Should afford? Is that something that you guys think about, the budget impact as it gets scaled up?”
Granowitz replied that the issues around budget impact are “largely going to be outside the realm of what a pharmaceutical company is going to decide.”
“These are payer decisions,” he said. “Whether that is the government or whether that is a commercial payer with their customers, what we've tried to do, and what your analysis shows, [is] that we have been responsible. We have generated a product that delivers high efficacy, a good risk-benefit, and is cost effective under the scenarios that you tested. I think that is being the responsible player that society expects of the pharmaceutical industry.”
Granowitz also noted the company’s commitment to “responsible pricing.” The Amarin CEO, he pointed out, “has made a number of statements regarding our commitment to responsible pricing and maintaining access."
Granowitz further noted that the company has experience with most large payors. Vascepa has “been available on the marketplace for a number of years, and we are contracted with most of the major payers already” the Amarin exec said, “Certainly those contracts have terms and conditions associated with them.”
He emphasized the company’s commitment to making the product broadly available. “There is a strong commitment of the company to make the product as broadly available as possible and to continue to be a partner in our responsible pricing to ensure access to the medication. I don't think we've been unambiguous as a company regarding those values and commitments, and I think our actions have followed the statements that we've been making in that regard.”
The effects could be acutely impactful for a program like the VA which has little budget flexibility. “In a system like the VA, it's a fixed budget. If the VA spends $150 million a year on Vascepa, it doesn't just get added to the annual budget. It has to come from something else. Maybe it's a good tradeoff, but maybe it's not,” Good said.
Payers at the ICER meeting expressed concern about the potential approval of a CV claim for Vascepa leading to a drop in statin use that could undercut real world benefits of the therapy. That may preview a potential discussion point during the upcoming FDA advisory committee review.
The REDUCE-IT protocol required that all patients take statins during treatment with Vascepa. However, UPMC Health Plan’s Good remarked that “a lot of patients don’t like statins” and compliance may drop in the real-world setting.
“Payers will be very interested in looking to see how this product is being used. Is it being given to statin intolerant patients to start with? I suspect we will see a fair amount of that,” Good said. “Will we see statin compliance and medication adherence drop? I suspect that we will. Maybe it's okay, maybe it works without the statin, but maybe it doesn't.”
IngenioRx Clinical Pharmacist Kayla Leeser remarked that the PBM’s coverage policy would try to ensure statin use but may also include criteria for use in statin intolerant patients. (IngenioRx is Anthem’s in-house PBM.)
“Our coverage policy, which would be evidence based, would include the criteria for the patient population in the clinical trial,” she said. “So, we would ensure statin use and maybe consider an out for those patients who truly are statin intolerant.”
Payers at the meeting also discussed ICER’s analysis of a year-old CV outcomes claim for Janssen’s Xarelto (rivaroxaban) in patients with peripheral and coronary artery diseases. As with Vascepa, it was a case of a drug with a price that falls well below the potential maximum cost-effective price benchmark.
Xarelto, originally approved for prevention of deep vein thrombosis, pulmonary embolism and management of atrial fibrillation, received an additional approval in October 2018 for use with aspirin to prevent major cardiovascular events in patients with PAD or CAD.
ICER concluded that Xarelto could be priced between $5,200 and $7,600 per year to achieve commonly cited cost-effectiveness thresholds of between $100,000 and $150,000 per Quality-Adjusted Life Year gained. The product’s current estimated annual net price, as noted in the report is significantly lower than the value-based price benchmark range at $2,215 per year (WAC $5,457).
ICER concluded that use of the product with aspirin provided high certainty of a “small-to-substantial net health benefit” when compared to aspirin alone to reduce the risk of CV events in patients with stable CVD—but noted that insufficient evidence remains for comparing the product to dual antiplatelet therapy (DAPT).
The report identifies an “indirect comparison of the risk of major adverse cardiovascular events in patients with a recent MI” which suggested that “DAPT may provide a similar cardioprotective benefit to” Xarelto with aspirin. In the comparative network meta-analysis, ICER compared the risk of cardiovascular death, stroke, or MI in patients with stable CVD between Xarelto + aspirin, ticagrelor + aspirin, clopidogrel + aspirin, and aspirin alone.
Panelists at the meeting noted this as an opportunity for further research to compare Xarelto to DAPT. Massachusetts General’s Jason Wasfy noted that while it is currently standard practice to prescribe DAPT following a myocardial infarction in patients at higher risk of recurrent thrombotic events, he would like to see more research on whether Xarelto could serve as a comparative or secondary treatment following treatment with DAPT.
“There is a yawning gap in comparative clinical effectiveness…about the role of rivaroxaban low dose as a substitute for dual antiplatelet therapy in these patients,” Wasfy stated. “There is no clear answer for us as clinicians, and as such, a lot of us use DAPT in these circumstances. I suspect that until that question is evaluated through either observational research or hopefully a clinical trial, I don't see a big role for low dose rivaroxaban.”
UPMC’s Good agreed that more evidence is needed and that payers have not yet addressed comparing the therapies, but he said he foresees a situation where patients take DAPT for twelve months following placement of a stent and perhaps transition to low-dose Xarelto.
“I don't know that either of the systems I've worked in have specifically addressed this,” he observed. “There are some health systems that say stop dual antiplatelet therapy at 12 months and so I think a logical thing might be to then switch them [to rivaroxaban]. Whether that's better than continuing on dual antiplatelet therapy, or starting off with [rivaroxaban], I don't know, but I think most patients are going to get dual antiplatelet therapy after procedure, or after an admission or myocardial infarction.”
BB - my previous post was a response to your post 218100 regarding the generics case.
Amarin agreed to share correspondence regarding “approval” of sNDA. To me, that narrows things a bit, in terms of what Amarin will share. Basically the approval or rejection letter is how I interpreted it.
Therefore I don’t believe this should/would be inclusive of every piece of correspondence w/ FDA broadly regarding the sNDA review and I think that’s the argument being made by Amarin.
Thanks for posting the case info. Fascinating to read through it. The request to see the entire sNDA seemed kind of bizarre. Even if they ended up narrowing it to “only” two modules.
BB, it's hard to believe FDA has not articulated the reasons here, but that's the same read I am getting too.
In most cases, the sponsor should/would be aware (at least at a high level) of why the delay/AdCom. It's unusual for sure, and I think that's reflected in the (lately) sagging PPS.
OY
HDG, good to hear from you. I agree, no major amendment filed before Aug 8, but what has happened since? And is one planned? That's really the question I want answered.
I wish they would be more forthcoming, but unfortunately, as you can see, they are not commenting at the moment.
OY
sNDA amendment question to IR
Hi all,
I recently posed the following question to IR, as it's something I've been wondering about, and a clear answer would be very insightful. Unfortunately they weren't able to give me any concrete info, but I wanted to share regardless, just to let folks know what I heard back.
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Hi Elisabeth,
Hope you are well. I had a quick question regarding the sNDA. Can you confirm if Amarin has filed a major amendment to the R-IT sNDA, or if one is planned?
There seems to be a lot of confusion on this topic, so if you are able to provide some clarity, I think that would be very helpful.
Thanks in advance!
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Hi Eric- I have no comment on this. So sorry that I cannot provide more information. I know people are looking to get more clarity but I have nothing that I can provide.
Many thanks,
Elisabeth