FYI for anyone who isn't familiar with the wacky US insurance situation: Nobody in the US actually pays $800 for the drug. That's the "list price" for insurance companies to pay. Even insurance companies don't pay that price because they negotiate their own rates with the drug companies, which are lower.

Then the drug companies come in and offer a "savings card" which you apply at the pharmacy like another layer of insurance. I searched and Miebo has one too: https://miebo.blsavingscard.com/ You'd have to read all the fine print, but it reveals that the actual cash-pay price is $225 (still high, obviously) and they have a co-pay assistance program that reduces your copay to $0 to incentivize you to get your insurance billed for this drug. So a lot of people who take this drug in the US actually pay $0 because they sign up for this card.

The FDA is partially to blame for this situation: They required a complete New Drug Application before they would let anyone bring it to market, even though it's over the counter in other countries.

The cost of performing a New Drug Application starts in the mid hundreds of millions of dollars range and can extend into the billions for some drugs.

So nobody could feasibly introduce it to the market here without investing $500 million or more up front. At that price, your only viable option is to stick a big price tag on it and try to milk that money back from insurers.

> FYI for anyone who isn't familiar with the wacky US insurance situation: Nobody in the US actually pays $800 for the drug. That's the "list price" for insurance companies to pay. Even insurance companies don't pay that price because they negotiate their own rates with the drug companies, which are lower.

This isn't really true on obamacare/ACA plans, even the high-end ones like gold PPOs. The formularies are much worse than employer-based plans. Insurers are required to cover one drug in each therapeutic category, but its usually an older generic. Most brand name drugs like this one have really bad coverage or not at all, which means the insurer won't even negotiate with the pharmacy to lower the drug.

Yes you can use coupons, sometimes, but the pharmacy can't always process them and the manufacture is always change the conditions and expiring them. I got one for my glaucoma drops directly from my eye doctor, and it was expired immediately when I tried to use it. I have paid $650 (for a 3 month supply, the full retail cost) for my drops when the coupon didn't work, and I couldn't get them any other way - I can't interrupt the med or else my eyes get damaged. So that falsifies your "nobody" assertion.

These "savings cards" have a maximum annual benefit applied to them so for those on insurance that do not cover those expensive medications or who are self-paying use up the benefits before year end and do in fact eventually pay full sticker price.

I think that might be worse than just having the high price. Such a kafka-esque systems just to get medicine.

> FYI for anyone who isn't familiar with the wacky US insurance situation: Nobody in the US actually pays $800 for the drug. That's the "list price" for insurance companies to pay. Even insurance companies don't pay that price because they negotiate their own rates with the drug companies, which are lower.

Sure, we do not pay $800 at the pharmacy when we go to pick up the prescription, but every cent the insurance company pays, we are paying by proxie with added admin costs.

This varies wildly by medication; and makes a ton of assumptions that all happen to benefit the drug company's position/parrots their PR.

For example, my partner needs $100/pill medication, which also had a "savings card." That card only lasts for 12-months or 8-pills (whichever comes first). Then it is $100/pill. After insurance (High Deductible), we pay out of pocket $100/pill up until $3200. Insurance discount: 0%.

So the cash price and the insurance price are identical, except the insurance price counts towards deductible. UK price of the same medication? £10/pill, and that isn't via the NHS, that is full-price private (NHS could be as low as FREE, depending on several factors).

what about the poor people? the ones that can't really afford insurance. i've heard multiple times that epipen prices are crazy expensive and that's a really basic drug.

> The FDA is partially to blame for this situation: ...

> The cost of performing a New Drug Application starts in the mid hundreds of millions of dollars range and can extend into the billions for some drugs.

> So nobody could feasibly introduce it to the market here without investing $500 million or more up front. At that price, your only viable option is to stick a big price tag on it and try to milk that money back from insurers.

It's interesting that you seem so passionate about this because you're totally incorrect. The cost of a NDA for a novel prescription drug requiring clinical data (the most expensive application) is ~$4.5mil. In fact, the estimated TOTAL revenue to the FDA from ALL PD application fees in FY 2025 is ~$1.3billion (or, just under 300 novel prescription drugs). So, obviously, FDA fees can't be as much as you're claiming.

What you're actually describing is the total cost of the entire drug development pipeline (research, design, lab costs, chemical costs, application costs, marketing costs, etc.) to develop a brand new, novel drug. And it's only ~$200m, increasing to $500m if you include dead ends / failures in the process, and ~$900m if you include both failures and capital costs--yep, that's right the capital costs alone are almost as much as the entire rest of the drug development pipeline.

See: https://jamanetwork.com/journals/jamanetworkopen/fullarticle...

And that's for novel Prescription Drugs.

> They required a complete New Drug Application before they would let anyone bring it to market, even though it's over the counter in other countries.

No. In that case they would pay the FDA OMUFA fees, not the FDA PDUFA fees, which are ten to fifty times cheaper than the PDUFA fees.

The real question is: how much does the drug cost, independent of who pays for it?

I know people who have paid list prices for drugs because their insurance wouldn’t cover them.

> So a lot of people who take this drug in the US actually pay $0 because they sign up for this card.

They do not pay $0 because the insurance company raises the rates for all of their customers to cover the cost of all the red tape and time spent negotiating with drug companies over their bullshit. The insurance companies aren't eating those costs, they're profiting from them and it's us who end up footing the bill. By the time you factor in the unnecessary time, staff, record keeping, etc. the actual cost for the $20 drug will be even more than the $800 sticker price.

No matter how our crooked system twists things to make it look otherwise they always make you pay. One way or another.

Not true. No one pays up front, our previous pay for those prices.

All that handwaving and apology but yet

>the actual cash-pay price is $225

So still 11x the price, plus whatever the prescription costs.

Unforgiveable.