Biden administration unveils first 10 drugs subject to Medicare price negotiations

[BumRushDaShow]

Source: CNBC

The Biden administration on Tuesday unveiled the first 10 prescription drugs that will be subject to price negotiations between manufacturers and Medicare, kicking off a controversial process that aims to make costly medications more affordable for older Americans.

President Joe Biden’s Inflation Reduction Act, which passed in a party-line vote last year, gave Medicare the power to directly hash out drug prices with manufacturers for the first time in the federal program’s nearly 60-year history. The agreed-upon prices for the first round of drugs are scheduled to go into effect in 2026.

The Medicare negotiations are the centerpiece of the Biden administration’s efforts to rein in the rising cost of medications in the U.S. Some Democrats in Congress and consumer advocates have long pushed for the change, as many seniors around the country struggle to afford care.

But the pharmaceutical industry views the process as a threat to its revenue growth, profits and drug innovation. Drugmakers like Merck
and Johnson & Johnson and their supporters aim to derail the negotiations, filing at least eight lawsuits in recent months seeking to declare the policy unconstitutional.

Read more: https://www.cnbc.com/2023/08/29/10-drugs-to-face-medicare-price-negotiations-see-the-list.html

---

The 10 are -

Eliquis, made by Bristol-Myers Squibb, is used to prevent blood clotting to reduce the risk of stroke.

Jardiance, made by Boehringer Ingelheim, is used to lower blood sugar for people type 2 diabetes.

Xarelto, made by Johnson & Johnson, is used to prevent blood clotting to reduce the risk of stroke.

Januvia, made by Merck, is used to lower blood sugar for people with type 2 diabetes.

Farxiga, made by AstraZeneca, is used to treat type 2 diabetes.

Entresto, made by Novartis, is used to treat certain types of heart failure.

Enbrel, made by Amgen, is used to treat rheumatoid arthritis.

Imbruvica, made by AbbVie, is used to treat different types of blood cancers.

Stelara, made by Janssen, is used to treat Crohn's disease.

Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill, insulins made by Novo Nordisk.

Article updated.

Original article/headline -

Biden administration unveils first 10 drugs subject to Medicare price negotiations as it moves to cut costs

The Biden administration on Tuesday unveiled the first 10 prescription drugs that will be subject to price negotiations between manufacturers and Medicare, kicking off a controversial process that aims to make costly medications more affordable for older Americans.

President Joe Biden's Inflation Reduction Act, which passed in a party-line vote last year, gave Medicare the power to directly hash out drug prices with manufacturers for the first time in the federal program's nearly 60-year history. The agreed-upon prices for the first round of drugs are scheduled to go into effect in 2026.

The Medicare negotiations are the centerpiece of the Biden administration's efforts to rein in the rising cost of medications in the U.S. Some Democrats in Congress and consumer advocates have long pushed for the change, as many seniors around the country struggle to afford care.

But the pharmaceutical industry views the process as a threat to its revenue growth, profits and drug innovation. Drugmakers like Merck
and Johnson & Johnson and their supporters aim to derail the negotiations, filing at least eight lawsuits in recent months seeking to declare it unconstitutional.

[lkinwi]

3. Wow!

This makes a world of difference for many with type 2 diabetes. My donut hole may not be quite so expensive!

[lkinwi]

4. Thank you President Biden! ❤️

[onetexan]

43. THIS!!☝️

I'm hoping they w also include my arthritis med Rinvoq. Crazy expensive per pill.

[PatSeg]

5. Amazing, so many recent presidents

have paid lip service to these issues, but President Biden is actually doing something. The competence of this White House is astonishing.

[NCjack]

6. Listen to the drug companies crying! Maybe they can cover their

profit losses by reducing their advertising costs.

[ancianita]

14. +1

[CousinIT]

52. I'm old enough to remember when Big Pharma could not advertise their drugs

on television. Those ads just didn't exist. We need to go back to that.

[LibinMo]

56. Doctors couldn't either

That sort of thing seemed like Quackery.

[sinkingfeeling]

7. Interesting that those are ones most advertised with

flashy, expensive TV ads. Good picks, Joe.

[BumRushDaShow]

9. I was just thinking that

especially the singing/dancing Jardiance ad that I see on MSNBC continually!

(and I have seen at least 2 other variations of that)



And OMG I just found this that SNL did -

[ancianita]

16. God I hate that ad, and have put all MSNBC ads on mute for years... thanks, Joe!

The capital of Big Pharma should be made to tighten its profit belt. These one-minute ads are ridiculous.

[xocetaceans]

24. Pharma should not be allowed to advertise. Most adverstising is on some level misinformation. ...

... The use of any medication and/or the demand for any medication should not be based on anything other than the medication's safety and efficacy. That is best judged by medical professionals. The average person on the street "doing his or her own research" while being mostly fully unable to understand medicine leads to things like the anti-vax movement. That the anti-vax movement has as much of a foothold as it currently does will affect this society in the next pandemic even worse than it currently has--one which will almost certainly occur but possibly with a more serious pathogen.

I agree with your statements/sentiments to the extent that I won't even watch cable any longer with its seeming dependency on Pharma's money. Reading online with Firefox and an ad-blocker seems to work to screen out most advertising thankfully.

[ancianita]

26. Agree. They shouldn't be in 'product promotion' to increase public pressure on their doctors.

They're like the junk food ad industry. There's nothing "health" or "care" about Big Pharma.

[xocetaceans]

29. I would generally agree when one discusses their sales divisions. If one were discussing the ...

... scientific side of things or Pharma's ability consistently to mass produce safe and effective pharmaceuticals, I would say something different. Their ability to do large scale production well is what justifies their existence in that they solve that particular problem. Advertising contributes nothing to that, though, and misinformation contributes nothing to that, but only damages the whole idea of public health.

Anyway, I wish I knew more about these fields, but I don't, so I'll have to trust medical professionals (that's a vast swath of people in different roles in the practice of medicine and all of its related sciences).

I am glad that the Biden Administration is making progress on these issues, but it is frustratingly slow.

[ancianita]

32. Agree. And the fact that corps have standing to sue the govt. is a travesty.

Big Corps has encroached on the courts since the 1800's and now has an outsized control of them. It's frustratingly slow because of all the 'standing' and due process they shouldn't have to begin with.

We're a country of "law in commerce," and so suits are to be expected. The courts sold out equal protection for humans against corporations a couple of centuries ago. Let's hope all the cases get resolved within a year so Americans finally get the benefits of this administration's decisions.

More on the Merck suit:
https://nypost.com/2023/06/06/merck-sues-us-government-to-halt-medicare-drug-price-negotiation/

[xocetaceans]

34. Those are also some interesting points. I cannot argue anything about law or standing, etc.

Thanks for that article. I had not read such a further analysis earlier in the year.

As you stated, hopefully all the cases will be resolved quickly, but the idea that this might eventually go to the Supreme Court does not inspire either hope or comfort. Nevertheless, I'll hope along with you.

[ancianita]

35. Well...

the Merck suit was just filed yesterday or today. The ruling on its claims of unconstitutionality by the government will probably set ruling precedent for the rest of the suits. Which could hasten the lower pricing sooner.

[xocetaceans]

38. I think the Merck suit has been ongoing for a while (since 6/6/23), but I have not really looked.

Here is a site that I just found while looking for updates on the anti-IRA suits that Pharma has filed. You might also find it interesting as it seems to follow all the litigation against the IRA:

O'NEILL INSTITUTE--Healthcare Litigation Tracker

ISSUE
Inflation Reduction Act

Enacted in 2022, the Inflation Reduction Act (IRA) includes major provisions to make health coverage more affordable and lower prescription drug costs. The IRA extends the availability of enhanced premium tax credits for Affordable Care Act Marketplace coverage through 2025. It empowers Medicare to negotiate the price of certain single-source, high-priced drugs. The IRA also requires drug manufacturers to pay rebates to the government if their price hikes of Medicare drugs exceed the inflation rate. Further, the IRA restructures the Medicare Part D benefit to limit patients’ out-of-pocket costs.

...

Bristol Myers Squibb Co. v. Becerra et al.

...

Merck v. Becerra et al.

...

https://litigationtracker.law.georgetown.edu/issues/inflation-reduction-act/

[ancianita]

39. You're right. I stand corrected. More than one have sued, and I mistook the article date for the

suit filing date.

Welp, gotta say it's interesting that the Biden administration makes this announcement about price negotiations while these litigations proceed. I don't know how that can affect the plaintiffs' suits. They seem to comprise half that list.

[ancianita]

54. This bugs me most.

Advertising contributes nothing to that, though, and misinformation contributes nothing to that, but only damages the whole idea of public health.

These two problems are among the many reasons that I'm another who distrusts Big Pharma -- public health shifting into a commodity. More proof of corporate insurgency that slows the efficacy of the nation's government.

[ExWhoDoesntCare]

50. WTbloodyF?

They're greedy gougers, yes. but plenty about "big pharma" is indeed health care. The medications they make do work, and save tens of millions of lives, every single year. They certainly work far better than delusional woo alternative rubbish ever has--or ever will.

You know what experts who know what they're talking about call alternative medicine that works?

MEDICINE.

Any claim that "big pharma's" products aren't about health care is downright deplorable. MAGAt-level deplorable.

That's how wrong it is.

[dalton99a]

23. +1

[Novara]

8. I'm surprised epi-pens aren't on the list

Seems that would be a good one to have as well.

[sinkingfeeling]

10. Several states have capped prices of epipens.

[Novara]

25. Good

[BumRushDaShow]

13. This is just the first 10 announced

and they will continue to go through a list of drugs and add more.

I believe epipens are mostly covered for anyone that has Medicare Part D. They did supposedly cap the cost a few years ago for Medicaid recipients - https://www.cms.gov/newsroom/press-releases/cms-administrator-epipen-agreement-protects-medicaid-integrity-saves-hundreds-millions-dollars

[IronLionZion]

44. Epipens have some unique issues complicating things

there needs to be more generic options available and for schools to not require only the brand name. Their monopoly power needs to be diminished through competition. There are alternatives but many state and local laws require the brand name.

Since schools and children are a major consumer block, Medicare's negotiating power is very limited.

[CousinIT]

11. Big Pharma makes much of their exorbitant profits in the US by gouging consumers here

So they're squealing like stuck pigs. They don't need that massive profit for 'research'. They get gov't grants for that and private ones too. They spend trillions on advertising and the rest on fat CxO salaries. That doesn't help patients/consumers. It only helps Big Pharma.

NOWHERE ELSE IN THE WORLD does Big Pharma charge as much for prescription meds as it does in the US. This is a major contributor to the fact that the US has the highest healthcare costs in the developed world, while also having the lowest or one of the lowest life expectancy.

Expensive cost of prescription drugs is also part of what drives health insurance rates up and helps suck Medicare dry. Who pays? WE DO. Every person in the US pays. And more than anyone, the elderly, sick and injured pay by being unable to afford the damn insurance or the damn prescription drugs or costly procedures.

What a fuckin RACKET. What Biden has done here is just a very small first step in mitigating some of this shit. But there is a WHOLE LOT more to be done to fix America's WEALTHcare problem. Because we don't have HEALTHcare here. We have WEALTHcare. And it's about time that was abolished. NOT Medicare. WEALTHcare. Abolish WEALTHcare and we'll all be much better off.

[ancianita]

17. EXACTLY.

[24601]

40. My reform would be that companies may develop, import or sell a drug in the US if, and only if, US

customers pay a price no higher than in any other country.

[CousinIT]

51. +1 n/t

[Elessar Zappa]

45. We need a system like Canada's.

Or like Britain’s NHS back when it was actually working.

[4lbs]

49. Yup. It is a main reason why the same drug is very cheap elsewhere.

The drug companies can gouge the US consumer and "we" mostly can do little but
take it up the butt.

[Bayard]

12. Excellent!

Joe gets things done.



MSNBC just showed another poll where a big % are still saying President Biden is too old to run again. Its just unbelievable, with all that he's accomplished in 4 years.

[kacekwl]

15. That's great but why the

Fu#k do we have to wait until 2026 ? My wife and I have had to stop taking drugs because the cost is crazy high. Once you're in the donut hole it's ridiculous. But certainly the poor pharmaceutical industry needs time to rake in as much money as possible while paying for commercials and paying lawyers and Congress billions. I don't get it.

[BumRushDaShow]

18. Because they have to give time for *the actual negotiations*

and then have CMS and pharmacies update their systems among other things. That is how Congress wrote the provision into the law.

They expect some will balk and go to court as well.

[xocetaceans]

27. I'm virtually certain that you've already seen the following, but just in case ...

Merck sues US government to halt Medicare drug price negotiation
By Michael Erman
June 6, 20233:35 PM CDT | Updated 3 months ago


NEW YORK, June 6 (Reuters) - Merck & Co (MRK.N) sued the U.S. government on Tuesday, seeking to halt the Medicare drug price negotiation program contained in the Inflation Reduction Act (IRA), which it argues violates the Fifth and First Amendments to the U.S. Constitution.

This is the first attempt by a drugmaker to challenge the law, which the pharmaceutical industry says will result in a loss of profits that will force them to pull back on developing groundbreaking new treatments.

Americans pay more for prescription medicines than any other country. The Biden administration's drug pricing reform aims to save $25 billion annually by 2031 through price negotiations for drugs paid for by Medicare, the government health plan for those age 65 and over.

The lawsuit, filed in U.S. District Court for the District of Columbia, argues that under the law, drugmakers would be forced to negotiate prices for drugs at below market rates.

...

https://www.reuters.com/business/healthcare-pharmaceuticals/merck-sues-us-government-halt-medicare-drug-price-negotiation-2023-06-06/

[BumRushDaShow]

28. Yup

They are going to fight it to the end.

The U.S. pays the difference that allows a lower cost for drugs around the rest of the world, where they put their foot down and cap prices, but not here.

[appleannie1]

19. I take Xarelto daily.

I have had pulmonary embolisms a number of times so it is necessary to stop my blood from clotting. I am fortunate in that I am able to get the drug through a Pennsylvania drug program. The proceeds from our lottery goes completely toward senior citizen programs in this state and keeping drugs affordable for seniors is part of that. I am able to get the prescription for about 1/10the of the actual cost. It is still the most expensive drug that I take. So if you are ever in Pennsylvania be sure to buy a scratch off ticket or lottery ticket. You would be helping seniors to stay alive and could win a little in the process.

[BumRushDaShow]

21. ...

Ewwww....


!!!!!!!!!!

[lonely bird]

20. Good

I take three of the drugs listed.

[dalton99a]

22. Kick

[lees1975]

30. Three medications on that list are recommended by my doctors

and the cost at the pharmacy was incredibly high, ridiculously so. It's robbery. The profit margins for drug companies are unacceptably high, especially on these drugs, on which they capitalize on health concerns and fears.

So knock those prices down. Thank you, President Biden, this is what makes you so much more of a real President than the pretender who occupied the office before you got there.

[JohnnyRingo]

31. I take Eliquis. This is what it costs on Medicare.

It got so bad the social worker at dialysis did the legwork to get it from the company for free because I proved can't afford it, a program they have to have if they want to be qualified for Medicare. (I had to send in taxes and income statements)

This is for one month during the Medicare gap. For three months it costs about $200 a month, then it goes to my deductible phase where I pay full price again. There is no generic equivalent

[img][/img]

[LetMyPeopleVote]

33. Biden Administration is announcing the first 10 Medicare Part D drugs selected for price negotiation

Link to tweet

[republianmushroom]

36. I like it

[dlk]

37. All of the drugs on this list are extremely expensive

And pharmaceutical companies generally omit Medicare recipients from their patient care programs to help reduce drug costs. Of course, big pharma is addicted to their price gouging and will continue to do anything to maintain their sky high profits. The ability to negotiate Medicare drug prices is long overdue. Thank you President Biden!

[IowaGuy]

41. I don't know anything about any of the drugs other than Jardiance....

It is so expensive because there are no generics competing with it. Even though some are ready to go, they are prohibited by the FDA to putting them on the market for a couple of years. After this protection runs out in a year or two (Boehringer has pushed for extensions in the past and probably still is pushing), the price of it was likely going to drop precipitously anyway.

I wonder how many of these other medications are in the same boat and are on the verge of losing their monopoly anyway.

[BumRushDaShow]

42. "they are prohibited by the FDA to putting them on the market for a couple of years"

It's FDA following Patent law and statutes related to it in the FD&C Act - https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity#What_is_the_difference_between_patents_a

Summary of that from the FDA FAQ (from that link)-

Orange Book Frequently Asked Questions

1. What is the difference between patents and exclusivity?
Patents and exclusivity work in a similar fashion but are distinct from one another and governed by different statutes. Patents are a property right granted by the United States Patent and Trademark Office anytime during the development of a drug and can encompass a wide range of claims. Exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug or of certain supplements. A new drug application (NDA) or abbreviated new drug application (ANDA) holder is eligible for exclusivity if statutory requirements are met. See 21 C.F.R. 314.108, 316.31, 316.34 and sections 505A, 505E, and 505(j)(5)(B)(iv) of the FD&C Act. Periods of exclusivity and patent terms may or may not run concurrently. Exclusivity was designed to promote a balance between new drug innovation and greater public access to drugs that result from generic drug competition.


2. How long is a patent term?
Patent terms are set by statute. Currently, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States. Many other factors can affect the duration of a patent.


3. How long does an exclusivity period last?
It depends on what type of exclusivity is at issue.

Orphan Drug Exclusivity (ODE) – 7 years

New Chemical Entity Exclusivity (NCE) – 5 years

Generating Antibiotic Incentives Now (GAIN) Exclusivity– 5 years added to certain exclusivities

New Clinical Investigation Exclusivity – 3 years

Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity

Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only)

Competitive Generic Therapy (CGT) - 180 days (this exclusivity is for ANDAs only)

See 21 C.F.R. 314.108, 316.31, 316.34 and sections 505A, 505E, 505(j)(5)(B)(iv), and Section 505(j)(5)(B)(v) of the FD&C Act.

(snip)

More: https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity#What_is_the_difference_between_patents_a

On average it's about 17 years from when they decide to go with a patented entity, and then get it to the finished product stage, and on the market. The faster they can get it approved, the longer it can be sold without competition before the patent expires. What normally happens is once a company finds an active ingredient and decides to patent it, it often takes time to go through researching how to formulate it, then test dosage forms and amounts through animal and clinical trials, and finally get approval of their NDA (New Drug Application). If they run into problems getting a finished product on the market, that might mean that they do only have a few years left on the patent before someone else can use it.

What happens too is that the biggest pharma companies may have generic firms in their corporate portfolios so they often have those firms submit an ANDA (Abbreviated New Drug Application) for a lesser cost "generic" version of the original (but will still pocket the $$$ even though they are the innovator firm).

[jmowreader]

46. Prices of these 10 drugs for one month at Walgreens...

Eliquis: $601.15
Jardiance: $579.01
Xarelto: $567.57 with Free GoodRX Coupon
Januvia: $572.46 with coupon
Farxiga: $552.07
Entresto: $714.37
Enbrel: $7283.00
Imbruvica: "this is a limited distribution drug and is generally not available in a pharmacy" Drugs.com reports this sells for $13,546 per month
Stelara: This one is complex. You start out with an IV infusion in a doctor's office, and Cthulhu only knows what that costs. Then there is a maintenance injection every two months, which costs $26,452.
Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill, insulins made by Novo Nordisk...the Fiasp pens are $584, the vials of either one are $300, the pens are $584.47.

This makes you wonder: if Boehringer Ingelheim wasn't paying a woman to dance around in an ugly yellow dress talking about how wonderful Jardiance is and wasn't paying television stations around the country to air the spot, how much would this "little pill with a big story to tell" cost?

[oldsoftie]

47. Now tell everyone we've been subsidizing every OTHER country who negotiates!

The US paying FAR higher prices because WE never did.
THIS is a big deal & it needs to be a big campaign issue. Not just "we're saving you money", but the nuts & bolts too

[4lbs]

48. My mother was prescribed Eliquis some years ago.

At the time, the cost was around $800 USD per monthly prescription. That was for 30 tablets for someone with no health insurance, and paying full price.

However, because my parents were both on MediCare (they were retired in their 80s at the time), and had additional health insurance to cover the "gaps", the co-pay was only $10 per month.

Nevertheless, had they not had this extra insurance, the cost would have been hundreds of dollars per month. Pretty much offsetting the monthly cost of the extra health insurance, just on this one drug alone.

Since Eliquis is a brand name, and relatively new (compared to say, aspirin, ibuprofen, or acetaminophen), there is no cheaper generic version available. It's name-brand price or you are SOL.

However, she turned out to be allergic to anything blood-thinner related, and the Eliquis caused her to have nosebleeds and really didn't help all that much. She stopped taking it after 5 days, and the nosebleeds stopped within 24 hours of that.

Hopefully this will at least drop the price from hundreds of dollars per month for regular MediCare to maybe $50 per month, or something reasonable.

[electric_blue68]

53. Seems like a BFD(!). I'm for single payer, but in the meantime Thanks, President Biden!

I don't need any of these, and hope I never have to but Yay for all the people that need them!

[Yo_Mama_Been_Loggin]

55. K & R