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Comment by reacweb | Hacker News Reader

IMHO, calling it cheap is very exaggerated. It is already expensive at $109.99 compared to the simplicity of the product and the low cost of production and research. At $600, it was insane.

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In Belgium they cost about 40 euros (and of course is covered by health care). I can't imagine the manufacturing cost to be much higher, even taking into account the way higher standards for medical equipment. The epinephrine itself is dirt cheap.

Sounded like $109 was for a 2-pack. Is that Belgian price maybe a single?

Ah, right, that makes sense. About the same price then.

The quality control must be very strict. I'm sure that's what makes the price difference.

You surely can't be arguing that they shouldn't be selling a cheaper version?

And at this rate it only takes a couple more iterations of competition until the thing is almost free.

Excellent, I say.

This is probably CVS partnering in paying for an expansion in manufacturing capacity (or promising to make some payments if they don't meet some sales goals) and is really a drop from $150 (the previous price point of generic Adrenaclick). I wouldn't count on further drops in price, at least not without other generics coming to market.

"Other generics coming to market" is what I meant by "a couple more iterations of competition".

It is still almost twice the price of a 2009 epipen.

Not on a net cost basis.

Low cost of production is one thing, but don't discount the liability insurance baked into the price of every unit sold

Is your assertion that liability insurance only became either required or suddenly much more expensive in 2007 and that it was coincidental that Mylan bought the rights to the injectors the same year the price started going up?

Do you have a good article discussing the liability claims that manufacturers of epinephrine auto-injectors have faced?

Do you know how much it costs to produce the device and meet all the likely regulations? I would have thought this is to only break even. It's more a marketing move to be the good side in the story and get more business from ethical followers.

Given the $600 of the original, I'd say $109 is cheap.

EpiPens are medical devices, not drugs, so the regulatory approval process is significantly different. Whereas drugs usually take around 15 years and about a billion dollars to develop and approve, medical devices can take as little as 3 years and $25 million. For example, the entire approval process for the Revo MRI-conditional pacemaker was less than two years [1] (although companies enter an active dialog with regulators long before submitting the application).

The prescription you get for adrenaline is actually for the autoinjector mechanism, which is significantly cheaper to develop and test than a pacemaker, so I'd bet the numbers are at most 5 years/$50 million.

[1] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma....

That's not quite accurate. It's a device/drug combination. The manufacturer still has to produce the drug under GMP conditions and get an aNDA approved for the drug portion.

One could argue it's more expensive than just a medical device.

I was oversimplifying, but yes the manufacturer still has to prove that their drug is equivalent to the gold standard for therapeutic uses and that they have sufficient quality control. How much it costs depends on the complexity of the drug and who does it. An experienced generic drug manufacturer will have everything in place for patient selection, investigators on their payroll, and expertise in designing protocols for the marketing application. Since we're talking about adrenaline, not some complex drug cocktail, I think the device portion would make up the majority of the cost (life and death emeregency device + has to work in the field without a medical professional tends to be pricey).

Are they not allowed to buy the epinephrine they use?

It's cheap and widely available (US retail prices seem to be on the order of $1 per dose. Retail.).

Even if they buy the epinephrine they use, they still need to validate the purity, do a sterile fill of the device, track stability in the device, etc.

It's not like they could buy a 100 kg of epinephrine, dissolve it up and just fill syringes with it.

That's anchoring bias. It wasn't $600 2 years ago

What was the cost 2 years ago? I believed it was $350 for two. So $109 is still cheaper than the price before.

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