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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?
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
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
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,
Any word on Italy reimbursement? TIA
N7; What is the gist of this article? The other thing that amazes me is where do these drug companies come up with these names? Dang, so many drugs, the naming of which must be “mind boggling?”
Cocaine is great for weight loss, but probably doesn't help your risk of having a cardiovascular event...
https://www.ncpe.ie/fenfluramine-fintepla-for-lennox-gastaut-syndrome-hta-id-23051/
This provides a timeline for moving forward in the HTA process.
Sleven,
and if we don't get Italy on board and make some progress over the pond, there really isn't much to sell to BP. To me, we are in crunch time.
One of NVO’s P2b weight-loss clinical trials is being treated as a failed trial today; NVO share price declined ~ $7.4; VKTX shares are + @ $70.47.
Yes.....I'm a bit soured on trials as you can imagine....... when you have great comprehensive trial like Reduce-It which validates a trial like Jellis and you struggle to get market acceptance by the healthcare industry, it just shows how flawed the system is. Money talks. Do what Big Pharma wants or they stop funding your research or sponsoring your weekend symposiums. If you can't beat them, you have to sell to them.
Ram, and actually for them, safety is probably the bigger concern (thus the trials), where Vascepa really only has one (very small) potential side-effect of afib.
Kiwi, I would say these studies were provided to the world by Captain Obvious. Why would we even need 1 double blind placebo controlled study showing a drug engineered for weight loss would also be associated with reduced risk of cardiovascular events and diabetes?
Should we have a double blind placebo controlled study showing jumping from an airplane without a parachute is associated with higher mortality rates?
And here's a list of the double blinded placebo controlled trials run on GLP-1 drugs
LOL! Ram, that's pretty funny, but true.
What's sad is that Vascepa is almost like that - beneficial for almost everyone (most populations have Omega3 deficiencies), and has a safety profile close to water.
This is why the FDA and drug claims crack me up....... of course a weight loss drug if it works can say "Reducing the risk of major cardiovascular events in patients with type 2 diabetes and established cardiovascular disease".........
That's like me coming up with a pill that contains either air or water and claiming "Reducing the risk of major cardiovascular events in patients with type 2 diabetes and established cardiovascular disease if taken while on a whole food diet with moderate exercise" In addition, my pill would have an incredible safety profile across all populations inclusive of Male's, Females, and all Genders in between.
I will set up a go fund me page and and am open to all investors. Bitcoin accepted.
Re GLP's approval for heart health in the US
That's a great question. I don't really know the answer. The unfortunate part is that Vascepa (and EPA in general) is so good for most people's health with such a great risk profile, but the challenge is getting the world to accept that (and pay for it).
Our world is all about the "quick fix" in healthcare.
It’s been reported that drug manufacturers commonly get about 70% of the Actual NHS price in the UK.
Will the approval of GLPs in Europe for heart health and eventual approval in US impact Vascepa sales?
Capt what kind of revenue do you estimate this represents?
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