FDA allows automatic 'generic' swap for brand-name insulin

[Eugene]

Source: Associated Press

U.S. regulators took action Wednesday that will make it easier to get a cheaper, near-copy of a brand-name insulin at the drugstore.

Doctors now have to specifically prescribe what’s called a biosimilar or OK substituting it for a more expensive brand-name insulin.

Wednesday’s move by the Food and Drug Administration will allow pharmacists to automatically substitute the cheaper version, just as they do with generic pills for other kinds of drugs.

It’s the FDA’s first approval of an “interchangeable” biosimilar, a near-copy of an injected biologic medicine that’s manufactured inside living cells. It could save diabetics and health plans millions of dollars annually and encourage other drugmakers to create more biosimilar medicines. Health data firm IQVIA projects U.S. savings from increasing use of biosimilars from 2020 through 2024 will top $100 billion.

-snip-

By LINDA A. JOHNSON
an hour ago


Read more: https://apnews.com/article/business-science-health-8c698faa57d55ce73bc7422cfd22ca89

[BumRushDaShow]

1. That's going to make a big difference for folks

What often happens nowadays with "generics" is that the progenitor might own a smaller company and they end up having that company make the generic (allowing them to still take in the $$$).

[Igel]

2. It's been a significant and unstated part of the outrage for the last few years.

I take l-thyroxine daily. My doc always checks the "substitute generic" as a matter of course.

$12/month, and that's after the last price increase (or change in what insurance paid for, makes me no difference).

Once I went to pick up a month's supply and after what the insurance paid my portion was something like $480. The matter was cleared up quickly. Now, there have been changes in l-thyroxine generic. Mostly because a few years ago the FDA decreed that all manufacturers of generic l-thyroxine must ensure that the bioavailability of their various products must come within a few percentage points of the FDA standards so they're essentially interchangeable at a given dose level.

Same with insulin. You hear reports of people paying hundreds of dollars a month and what's happened is that the doc's prescribed the greatest and latest version, brand-name. Maybe it's in a nifty injector. Perhaps it's super-duper time release. Emulsified by elves at the North Pole. Able to be stored at room temperature, because so few of us have refrigerators these days. Slightly different formulation, with 0.2% NaCl instead of 0.15% NaCl. Something that makes it yet again or still under patent protection, and therefore expensive.

It's like a $99 microwave suddenly costing $1200 because there's a "warm up coffee" button that's never been on a microwave oven before. Usually we got along fine with the previous formulation (or gadget), we don't need the new version that yanks the price up 19x.

It was the same thing with the epipen outcry years maybe 5 ago. "But it costs 3 cents to manufacture the active ingredient." Yeah, and 5 cents to manufacture the nifty new patented delivery device. Pointless number, like saying how much the flour and eggs and salt and water cost when figuring out how much a loaf of bread should cost. Or, if you're a landscape maintenance person, how much the gasoline costs: "Dude, $50 for mowing the yard--but the gas only cost $1!" But since the delivery mechanism is new, and patented, it's expensive. Don't like the new nifty device, do what my high school nurses did--buy a different model for a few % of the more expensive dealy's price.

[BumRushDaShow]

5. "what's happened is that the doc's prescribed the greatest and latest version"

That's because the pharma companies court hospitals, physicians and other medical personnel using their sales reps, and give them "free samples" and other goodies and "incentives" for prescribing their latest products...

[Sapient Donkey]

7. Is l-thyroxine and levothyroxine the same thing?

How did it that end up being $480? Even at times when I didn't have insurance I don't think the price was ever more than $20/mo. Which is pretty bad considering there is way it costs anything near that to produce 30 pills.

I just did a search to see if l-thyroxine and levothyroxine are the same, and I found a bunch of other brand names for it. I thought Synthroid was the brand name and then they had generics. Now, I am guessing what's what you were talking about with new minor differences that bring up the prices, aye?

[mopinko]

3. i had an rx for a generic drug for my lungs

the generic of advair. but the rx plan insisted on the name brand. i transferred pharmacies, and now cant get a generic w/o a new rx. manager basically over-wrote docs orders.

i talked to insurer, and they told me that when a generic comes out, the name brand maker will cut deal w the pharma admins to keep the name brand.

trouble is, i lost my rx insurance. i have to either get a new rx, which means a trip to the doc, cough up the name brand price or, i dunno, not breathe.

[cstanleytech]

8. Shouldn't the new pharmacy be able to get a copy of

all your prescriptions from the old pharmacy.

[Jilly_in_VA]

9. You have to make a formal request

to the new pharmacy and then they call the old pharmacy. If there is anything that doesn't have a refill on it, it won't transfer. I have just been through this TWICE in the last 4 months and I am so mad I'm about to spit nails. What a FUBAR nightmare.

First my old pharmacy, which was basically a mom-and-pop that I loved, closed with only a 3 week warning. They transferred all their customers to the local Walgreens. I started noticing that suddenly the prices of my meds jumped...so I did some research and found that Walgreens, unlike my previous pharmacy, wasn't "preferred" by my Part D drug plan. My only nearby alternative was Walmart, but I don't deal with Walmart pharmacies because of prior experience with them as a nurse. So I changed to a CVS down in town. I gave them a printed list of all my meds and allergies and was told they would enter everything. I had NOTHING but trouble from them. First of all I was not told that a certain med is considered a "controlled substance" so it did not transfer, so when I went to pick it up it wasn't there and I had to call the refill in to my former pharmacy and go get it there, where it of course cost more. Then there was rudeness from techs on the phone, things not being ready when they were supposed to be, and the final straw was this week when I went to pick up refills of Rxs that I had called in and being told that they had no record of those on my profile and no record of me calling them in. I knew I had refills on both so that was their error. I totally let them have it and walked out, went to Kroger which is on my "preferred" list and where I'd done some dealing with GoodRx, and had them call CVS for my transfer. Then I notified my doctor's office, and wonder of wonders, everything was ready later that day.

My head hurts just telling the story!

[mopinko]

11. i got stuck w walgreens, who i despise.

the store near me is the worst. but it turned out i didnt actually have to use them, so i went back to cvs.
i talked to them, and they said they couldnt fix it. only 1 refill left anyway,
wasnt my regular doc, and frankly not someone i want to see again, but...

and people wonder why m4a makes steam come put pf my ears.

[mzmolly]

4. It's about time!

[lark]

6. I really hope this helps our Type 1 friend.

His insulin is so extremely expensive, it's criminal.

[Jilly_in_VA]

10. This is great

I hope it helps my cousin's husband. He's a Type I also.

Now watch Big Pharma companies try to pull their "shortage" stunt. We've seen it before.