In case the members here in Advanced Prostate Cancer forum didn't get the message,
Patient advocates on Tuesday blasted the Biden administration's refusal to compel the manufacturer of a lifesaving prostate cancer drug developed completely with public funds to lower its nearly $190,000 annual price tag.
In 2021, prostate cancer patient Eric Sawyer petitioned U.S. Health and Human Services (HHS) Secretary Xavier Becerra to grant march-in rights—under which the government can grant patent licenses to companies other than a drug's manufacturer—for enzalutamide, which is sold under the brand name Xtandi by Pfizer and Japanese pharmaceutical giant Astellas.
The drug's development was 100% taxpayer-funded. Yet a one-year supply of Xtandi currently costs $189,800 in the United States, or up to five times more than its price in other countries.
HHS' National Institutes of Health (NIH) said Tuesday that it "does not believe that use of the march-in authority would be an effective means of lowering the price of the drug."
"What the Biden administration is saying is that charging U.S. residents three to six times more than any other high-income country is reasonable."
The agency added that it "will pursue a whole-of-government approach informed by public input to ensure the use of march-in authority is consistent with the policy and objective of the Bayh-Dole Act," a reference to legislation meant to promote the commercialization and public availability of government-funded inventions.
James Love, director of the Washington, D.C.-based advocacy group Knowledge Ecology International, called the administration's rejection "appalling."
"What the Biden administration is saying is that charging U.S. residents three to six times more than any other high-income country is reasonable," he wrote.
U.S. Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-Vt.) said in a statement that he is "extremely disappointed that the Biden administration denied a petition by prostate cancer patients to substantially reduce the price of Xtandi."
"This is a drug that was invented with taxpayer dollars by scientists at UCLA and can be purchased in Canada for one-fifth the U.S. price," Sanders added. "The Japanese drugmaker Astellas, which made $1 billion in profits in 2021, has raised the price of this drug by more than 75%... How many prostate cancer patients will die because they cannot afford this unacceptable price?"
Rep. Lloyd Doggett (D-Texas), the ranking member of the House Ways and Means Health Subcommittee, said in a statement:
Today's decision is a blow to prostate cancer patients, their families, and taxpayers. Developed with U.S. taxpayer research dollars, Xtandi costs American patients $180,000 a year—as much as six times as much as patients in other countries. This excessive price gouging cost taxpayers $2 billion to cover Medicare beneficiaries' treatment in 2020 alone. The Biden administration has missed yet another opportunity to do something meaningful to lower prescription drug costs and protect taxpayer investments.
The administration's position "protects monopolists over taxpayers and patients, despite clear statutory authority and reasonableness to intervene," Doggett added. "This decision effectively rubber-stamps continued Big Pharma abuse."
In a move that Public Citizen president Robert Weissman called "pathetic," HHS and the Department of Commerce announced Tuesday that they would "pursue a whole-of-government approach to review... march-in authority as laid out in the Bayh-Dole Act" by forming an interagency working group.
The group "will develop a framework for implementation of the march-in provision that clearly articulates guiding criteria and processes for making determinations where different factors, including price, may be a consideration in agencies' assessments."
In a statement, Becerra said that the administration is "committed to increasing access to healthcare and lowering costs."
"March-in authority is a powerful tool designed to ensure that the benefits of the American taxpayers' investment in research and development are reasonably accessible to the public," he added. "We look forward to updates from the Bayh-Dole Interagency Working Group, and at my direction, HHS will review the findings, engage the public, and better define how HHS could effectively utilize our authority moving forward."
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Magnus1964
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Thanks for this Mag... I wasn't aware of this and likely many more aren't either... Being enlightened of the injustices against us all is the first step in (hopefully) stopping them....As an Xtandi user, this is concerning to me... 👍
Thanks for making us aware. I'm not on Xtandi, but still feel the injustice that the pharma industry supported by the elected officials is causing us all our lives and suffering.
Magnus, those us who live in Canada just shake our heads in amazement. I have been on Xtandi (enzalutamide) for over five years (2017-2022). Only recently did I switch to Zytiga (abiraterone) as part of a clinical trial. My oncologist at our local cancer agency gave me the choice five years ago and I chose Xtandi. During the time I took this drug, I would receive a three month prescription from my medical oncologist and the pharmacy in the cancer agency would then supply the drug. The cost to me? Nothing, nada, zilch. The United States is the only developed country in the world without a medical plan for its citizens.
That’s great news being Canadian , My MO put me last month on Xtandi but I never knew this is so much expensive as I did no paid a dime, my group plan paid 70% and rest Government,
Do you know what the government is paying for this medicine? My only concern is what I pay not the cost before that. My Nubeqa is $14,000 but my cost is $20.00 per month.
Sorry, No idea. Our health care system is paid for by individual provincial governments with subsidies from the federal government. All citizens and residents of Canada pay taxes into the health care program and we all have provincial Care Cards which you are obliged to show when you receive a medical service.
I feel comfortable saying the government pays the high price.Might be less than in the US but still high. Your taxes cover the costs but you can be delayed on treatments or medicines.... Right?
That has never been my experience. Prescriptions arrive like clockwork and I have had every type of scan you can name: PET scans, CT scans, MRIs, Nuclear Bone Scans. PSA tests and blood work every month.
Magnus a big thanks to you for bringing such a glaring example of exploitation to our attention. Even if taxpayers did not fund the research and discovery of Xtandi, it is still outrageous that after all these years Americans are being charged so exorbitantly for Xtandi. Taxpayers may not have fully funded the development and manufacturing of Xtandi, however Pfizer and co benefitted from the publicly funded infrastructure including scholarly research at UCLA in course of the research and development of Xtandi. As a current user of Xtandi, I am disappointed that the government failed to step in to stop such a naked exploitation. Thanks again Magnus, you rock!
My MO wants to start xtandi. I have insurance but can i mail order out of the usa?
Yes, it takes billions to bring a drug to market. That was put into place so some upstart in a garage doesn't come up with a cheaper better drug and put them out business.
Regulations are put into place to benefit the large corporations. If you don't think big pharma rules over the NIH, CDC and FDA, you are dreaming.
Many regulations are "put in place" to protect the end user. Sanitation, documentation, proof of concept for example. Years of money spent in hopes of a medicine that works with few side effects. Studies and documents. Patients on product are not easy or cheap either.I agree that requlations can be onerous and add to costs that ultimately need recovering. I also agree that some companies gouge on prices. And will state that the government could have from the start negotiated on prices but didn't.
Thanks for this information. Here in the states Xtandi may be available for little to no cost to patients with and without insurance through specialty pharmacies via Astellas Pharmaceutical. Here is a link to the Xtandi website bit.ly/40vFyJX , US residents can also call 1‑855‑898‑2634 for more information.
We are two retired people. They asked us for our SS paperwork and then DECLINED us due to income. We live in a small city in Kansas... not rolling in $$.
1. Apply for Medicare extra help first, 2. get denied then go over to Xtandi to reapply for assistance. Your MO should be able to help you with the process. There are also other organizations in the states that may provide grants . (i.e. PAN, Healthwell and others)
No Magnus regular Medicare. (this was for the "Extra Help" application only. Part D covers part of the cost, we applied for assistance with the copays.
Have you tried contacting xtandi (1‑855‑898‑2634), or the Patient Access Network? You doctor is the one that will have to fill out the paperwork. You need to talk to your doctor.
Yes, exactly Magnus, my post was for those seeking financial assistance. My MO and the facilities pharmacy, took care of most of the applications and obtained assistance for most of 2023. Prior to being on Medicare (and with no health insurance) we worked directly with Astellas (Xtandi) and a specialty pharmacy and obtained Xtandi at no cost 🙏
On medicare with prescription coverage with Aetna. Got first round of Xtandi in the mail yesterday from the specialty pharmacy and out of pocket it cost us $3,200.00 for a 30 day supply.
That's exactly the same scenario I just got. Have Medicare A&B Part F Aetna amd Humana 3226.01 a month. My total income last year with my SS was 26,590
Many states have prescription drug coverage plans, Free, that help greatly. In NY State it's is called EPIC. What state are you in? Also you might consider a Medicare plan that includes prescription coverage to begin with. Medicare Part D alone stinks.
I just did a search on PA drug assistance plans. The max income for eligibility for a married couple is $41,500. Are they serious. You have to be below the poverty line.
I came here to post the same. When I thought Xtandi was in my future I immediately applied and got a $0 copay card for it from the manufacturer (commercial insurance is a requirement for that program).
I ended up on NUBEQA, but also obtained a $0 copay card from Bayer under a similar program.
Another "specialty medication" I use to take (not for cancer), same story.
All three were extremely easy to apply for and were instantly approved. You get a credit card or 2nd insurance card to cover whatever you copay is. There is an annual limit, but even with $250 copays I've never come close to the annual $0 limit.
I’m on Zytiga not Xtandi (which failed me in month 3 & 4.
Are there reasons why guys wouldnt buy Xtandi in Canada? I grew up in Detroit, and Windsor was a quick 20 min thru the tunnel under the Detroit River, or over the Ambassador Bridge. Mike
Here another happy recipient of free Xtandi in the Netherlands, been using it for 5 years now at zero cost. Of course we pay for health insurance, let’s see… about 1500 dollars per year with 385 deductible. How I love our ,what you call, socialist system . At least everyone has a chance to use these meds regardless of their financial position.
Canadians and Americans are like cousins, moreover Canada is not a socialist country. What you may find outrageous is that sometimes big pharma manufactures drugs cheaply in Canada, sell them there cheaply, but exports the same drug to the US and price then outrageously high. Try and take it easy warrior; I think we should direct our efforts towards finding relieve from higher prices in our common fight against this deadly beast.
Thanks Magnus. I really appreciate you bringing this to our attention. Like many, I was taken aback by the exorbitant price of Xtandi when it was prescribed for me in combination with Lupron. I was as shocked as well to learn that U.S. taxpayers had funded the UCLA research that produced the discoveries that led to the development of Xtandi by California biotech Medivation and Japanese drugmaker Astellas . Yet today Xtandi is sold in the U.S for 3-6 times the price as in other highly developed countries. (Pfizer acquired Medivation for $14 billion in 2016 after initial FDA approvals were obtained, so now shares in the profits of its partnership with Astellas.)
For anyone interested in learning more, the full text of Tuesday’s NIH decision and also of an administrative appeal to HHS that the three prostate cancer patient petitioners filed yesterday with Secretary Becerra have been posted to the website of Knowlege Ecology International, the not-for-profit intellectual property rights organization.
Xtandi has a wonderful patient assistance program that is not very difficult to qualify for. I have a reasonable income and haven’t paid for Xtandi in years.
We were just turned down this week from them. We do not have a "high level of income". I've heard they have lowered the income threshold making it more difficult to qualify.
Has anyone experienced or known anyone in the U.S. that was unable to obtain Xtandi because they didn’t have the money? Has anyone out there paid $192,000 for this drug? Do you think Medicare pays the list price? I guess I’m having a little trouble identifying what is the real problem here. Call me selfish but I am looking for the next “Xtandi” to keep me alive and I don’t want some socialist politicians screwing that up. (They have such a great track record!). I am not saying the drug pricing system is perfect but without real healthy profits for the drug companies development of new cutting edge treatments will dry up.
You make a very good point. However, In this case the R&D was funded by us, not by the Pharm Companies, and they'll always defend their pricing with the cost of R&D defense. And that just doesn't apply here. I'm with you on the "Socialist" part of your comment. In fact, I don't want a socialist near ANYTHING here in America. They destroy everything and undermine our morals and values by elevating Government over God.
The CMS website shows that during 2021 Medicare paid $163,928.80 for a 12-month course of Xtandi at 160 mg/day ($112.28 for each 40 mg capsule). Total Medicare expenditures for Xtandi in 2021 were $2,411,262,130. By comparison, the May 2021 price in Japan where Astellas is headquartered was $21.64 per 40 mg capsule, less than one-fifth the U.S. price.
Thanks for that, it’s good information. It’s a very unfair system that American patients and taxpayers have to pay so much more than other countries for their RX’s. I hope some smart people can construct a market based drug development approach that’s more equitable. I am fortunate to have pretty good insurance but I would pay any price to buy Xtandi because it has given me 2 years of pretty good life . Thank you Pfizer!
Thanks Rolphs. Xtandi (enzalutamide) is a very good drug and I’m delighted to hear that it’s working well for you and hope it gives you many more years of good life.
Personally, I’d give the lions share of credit for enzalutamide to the two UCLA researchers who, supported by U.S. taxpayer funded grants, discovered the three synthetic elements that UCLA patented as enzalutimide and licensed to Medivation. (Medivation in turn granted Japanese drugmaker Astellas global rights to the drug and a 50 percent interest in U.S. distribution rights. Medivation and Astellas obtained FDA approvals in 2012 and commercialized Xtandi.) For their efforts, UCLA and the research team received over a billion dollars. Pfizer only appeared on the scene in 2016 when it acquired Medivation for $14 billion. In announcing the deal, Pfizer Chairman & CEO declared, “The proposed acquisition of Medivation is expected to immediately accelerate revenue growth and drive overall earnings potential for Pfizer.” And so it has. Sales for Xtandi have totaled $25 billion with the majority from U. S. cancer patients and their insurers. Medicare alone has paid out$10 billion for Xtandi!
The reason cancer patients in the U.S. pay 3-6 times more for Xtandi than cancer patients in other wealthy countries is because our Government has failed to enforce the U.S. patents granted for taxpayer funded discoveries which require products resulting from such discoveries be “made available to the public on reasonable terms” or enacted other meaningful consumer protections.
Pfizer and Astellas are well aware of this void and exploited it to the fullest.
You know a lot more than I do about this subject. I totally agree the U.S. should enforce the “made available to the public on reasonable terms “ provisions of this agreement. I suppose it keeps high paid lawyers busy considering the stakes. Thanks for the background on this!
Just one more of many examples of America failing to live up to its potential to be a great nation for its citizens. “The business of America IS business,” as was noted over a century ago.
The healthcare system in the US is "for-profit" regardless of anyone's politics. What do people expect in terms of drug pricing when the guiding principal is market economics?
I agree with you Ed. I just wish businesses cared about the welfare of the citizenry, even a little bit. Not going to happen and I understand that. My business case professor stated: "Businesses have two goals and only two: 1) shareholder value and 2) executive compensation." True then and true now.
I agree. I think it's kind of rediculous to hear the same people who bitch about "socialism" and how we need to have have a "privatized" heathcare system also complain when the market-driven system they adore wants to make whatever the market will bear. This is how capitalism works, sorry Can't have it both ways.
I did pharmaceutical research for a few years. They will squeeze every penny they can. They justify it by saying alternative treatments would have cost more and they're saving money in the long run. But it's nothing more than legalized price gouging.
It's funny, if you or I go to somehwere that just had a hurricane and try to sell water for $20 a gallon we'll be accused of and prosecuted for price gouging.
On behalf of the people in the Netherlands using Xtandi , thanks for your warm and generous feelings towards our little Kingdom. With the nations in Scandinavia among the happiest people in the world. I wonder why ?Maybe because even though we pay a lot of taxes ,we get a lot in return? Where we don’t have to worry when get prostate cancer if we can afford the treatments? Now let’s hope somebody is willing to collect those pills falling from the packaging machine and send them across the ocean to our socialist paradise . Have a nice day too !
Yeah, it does effectively control and ration healthcare by the exorbitant pricing and insurance models.
Rich people can get whatever they want whenever, the middle class it’s a bit more difficult and sometimes unaffordable, the working poor are just screwed.
Thank you for the update Magnus. I'm still riding with Xtandi 5 year out. Given the current relationship our government has with big pharma, I'm not suprised.
When I needed to start Zytiga (Abiraterone Acetate) a year and a half ago, I found out my co-pay through my BlueCross Medicare Advantage plan would be at least $10,000 per year. However - lucky me - I'm one of the shrinking number of Americans these days who is a military veteran and am eligible for health care through the VA. Even though I get my primary cancer care outside of the VA system I am able to get my Abiraterone for free from the VA oncology pharmacy. BTW- unlike Medicare, the VA can negotiate drug prices - go figure
But even if I had to get it outside of the VA I was shocked to find the range of prices for the same drug from different sources. If I switched to a different Medicare Advantage plan, my annual co-pay for Abiraterone would be only $2,000 instead of the 10,000 at BC/BS.
The April 2022 edition of Consumer Reports had an article about prescription prices through online pharmacies. Out of curiosity I checked the price of Abiraterone (1,000 mg per day) at the pharmacies listed in the CR article if I bought it directly WITHOUT using insurance. Some didn't carry it. But of those who did, I found I could buy it directly at an annual cost ranging from $1,356 to $3,672 -- all much, much cheaper than just my co-pay if I got it through my so-called "insurance." And bear in mind these online pharmacies (Costoco, Wegmans, etc.) make money at these prices, as do the drug manufacturers.
How is it possible that a patient can buy a drug directly from an online pharmacy for just a couple of thousand dollars, when medical insurance companies and their customers have to pay hugely inflated list prices?
When I started getting my free prescriptions from the VA I asked if I needed to pick it up - me thinking the VA would be paying $10,000 or more for each month's prescription and wouldn't want it dropped on my front porch. They said no, they will just mail it. The reason I now know is because the VA doesn't pay anything close to the list price or even close to the patient co-pay through typical insurance plans.
I've been on Xtandi since August. Since I am still working and have health insurance through my employer the cost is not an issue. Normally there would be a co-pay, but with the drug's manufacturers patient assistance program the out of pocket cost is $0. Note there are no income tests, the only requirement is that you have commercial insurance coverage - meaning...you are not on medicare. I'll be retiring this July so that is when cost does become an issue for me - as it already is for many on this board.
.Two things on the horizon "should" help those on medicare. Per one of the provisions of the 2022 anti inflation act, the phase four catastrophic coverage charge of 5% goes away in 2024 and then in 2025 an annual out pocket cap of $2,000/year goes into effect. Effectively this means that the most you'll pay for drugs with traditional medicare, with a drug supplement is about $3,000/yr in 2024 and $2,000/yr in 2025 and beyond.
But notice that I said "should" help. Republicans have been threatening to repeal this aspect of the 2022 anti inflation bill ever since it passed. I've voted Republican more often than not over the years but this issue will certainly influence my future votes as I transition to medicare.
What this has to do with inflation is beyond me, and is one of the problems in DC. Not saying this part is bad, I've always thought there should be some kind of catastrophic help. But if the government is going to tell drug companies what they can sell for means they'll make it up somewhere else.
Well...I've been a CPA for 42 years, and previously work as a finance manager for pharmaceutical company so I think I understand the issues pretty well. While it's absolutely true that pharma deserves to make substantial profits in order to fuel R&D and because very few drugs that come through the pipeline actually make it to market. The question is how much is enough...and I know from being in the industry that a lot of money is spent on lobbying politicians to make sure that question is never asked.
The US is one only two countries that allow drug companies to advertise products on TV, Magazines and newspapers. And man do they ever spend the money on those ads. They are the major sponsors for the media and the press. Maybe we should ban the advertising of drugs, after all the doctors should be making the decisions on what drugs we are prescribed. Bonus, the drug companies wouldn't be spending all that money on advertising. So the drugs could be cheaper.
In politics and in drug development it pays to "follow the money." When the U.S. government needed a vaccine for Covid they realized it would take 8-10 years to develop and approve one with conventional methods. Instead they gave billions taxpayer dollars to Pfizer and Moderna (among others) in a crash R&D effort that gave us miracle vaccines in less than a year. These drug companies made exorbitant profits off these vaccines but also saved millions of lives. A percentage of these same profits at these companies are now being plowed back into new R&D, based on accelerated RNA technology, to target cancer . This has promise to lead to vaccines that treat/cure the PCa beast. (Look at the Moderna website to see the exciting possibilities.)
Thank you for posting! Is a criminal Enterprise when profiteering is at a level that causes the vomit reflex!!!
I know for "insurance" purposes, my monthly prescription cost is somewhere around $36k... Nubeqa & Lynparza, and that's not counting the Degarelix shot and labs, etc... Forget my copay mind you but the amount billed and what insurance settles on isn't the same of course. Yes, it takes billions to move a mountain, but I'm not sure why those mountains are only located in the U.S.! Lol
Hey Cool, I like a healthy dialogue on these complex issues with no rancor and hopefully a little humor….Most of the new breakthrough drugs come out of the U.S. (and not in Europe) for a reason. A lot of other developed country’s governments force negotiations with drug companies on price so no surprise they find greener pastures. In some sense other nations get a “free ride” on U.S. R&D after the medicines are approved. If drug companies know that their profits will be capped, they will think twice before investing millions of dollars developing a product for a reduced payout many years later or maybe not at all. I agree it’s not a good business model but there’s “no free lunch. “ If you want innovative, life saving drugs to continue to come out someone has to pay up (at least until the patent runs out).
I'm sorry and maybe I'm reading my your reply wrong, but do you think you're educating me on something? Lol
Shall we talk about how the FDA totally disregards studies done in other countries, like completely! That forces the research to be done again here... Or shall we discuss how the FDA is "Self" funded and how that intricate "paradigm" might, just might, be hugely problematic as well. We could then talk about how doctors, through the influence of licensure are reluctant to give patients prescriptions for the purpose of international pharmacy fills... Why? What do they care where I get my meds? Especially if it's not a controlled narcotic, but a legal life saving drug. I'm not talking about insurance coverage either where they take the pooled $ and still generate a profit while denying patients access to care, etc. I could go on... And I sound like a negative nancy, but I'm not. I understand what's going on, but that doesn't mean I have to agree with it, I don't! We don't have socialized medicine here, it is a business, and that's all we need to know. Once profit is attached, then things change, and not always for the better. Like I said, I'm good! But my heart aches every time I read about someone having difficulty obtaining care, a drug, treatment, etc., let alone because of "cost"... It shouldn't be!
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