We've been dealing with this exact issue with Flovent for my son.
Amusingly our insurance's captive/preferred pharmacy wants to mail us the generic for $40 + 25 S+H instead of us buying it locally for $150. Except that they can't climate control the shipment and it's 20F over the rated temp of the inhaler here today, in the shade. So their in house pharmacist allowed an override.
You'd think, America being billed as the land of the free, some politician might free Americans to order stuff from abroad as long as it's safe as in regulated by some competent body like the EU, Canada etc.?
It's fascinating isn't it? You'd never suspect that people are smuggling drugs out of prison, but the inhalers weren't the only thing either.
I'm not sure it's ever been looked in to, but having seen it first hand, I can tell you there's a whole hustle for people on the inside trying to get prescribed expensive drugs in order to supplement their meager existences.
This is a really good summary. It is mentioned by worth reiterating that evergreening does not prevent generic competition of the origional formulation or configuration. I think it is a bit of a misnomer to refer to these as patent lifetime extensions.
Having spend decades work with pharma companies, I agree that one of the main issues is missaligned incentives between patients and PBMs/health plans.
Bad patents are hard to quantify but a big part of picture. Should the patent office rejected Flovent + HFA as obvious? Another example would be Novarits patents on VEGF in silicone syringes. Litigating a global patent fight with Pharma companies with billions at stake is a huge barrier. The best way to prevent this IMO is more disgression in initial patent issue.
I think the other issue is that generics have such bad margins that it's hard to convince anyone to manufacturer them in the best of cases, so if anything happens to make a generic too hard to sell they'll just give up.
Combining that with PBMs being allowed to choose a preferred manufacturer for a generic or even preferring the (more expensive for the patient) brand, and refusing to offer the same coverage for a generic and you get less access to generics than there should be.
Honestly, PBMs should have to contribute at least the same amount of money to any version of a drug. If it's genuinely more expensive for them, the patient would still have to pay more. If it's not, it's none of their business.
Can you explain your last thought? I dont quite follow.
I do think a lot of the rot is in the PBM layer, and the country would benefit from an attempt to eliminate it, reduce their influence, and move away from the formulary.
Insurance should dictate what is covered, NDC exclusions should be banned, and rebates should be discouraged.
Ideally manufacturers sell for a list price, and insurance decides what is an acceptable balance of cost to subscriber satisfaction.
PBMs would go back to handling the papwerwork, or better yet be replaced by an open standard protocol
Original author here:
Yeah a lot of the evergreening techniques (chiral switch, etc.) don't prevent anyone from getting the original, though of course doctors may try to switch you. The inhaler thing is double bad because of the CFC ban.
I didn't dig into the details of the fluticasone HFA switch, but my impression is that while it's obvious to replace the propellant, apparently you do need to do some engineering (e.g., on the nozzle) to make it work right. I don't know enough about what they actually had to do to know if the patent should have been granted or not.
the fix here is create a system where patents can be taken away for excessive profits. if your manufacturing cost is $10 a pack and you sell it for $500 after you already paid off development you deserve to lose it.
That is a lot more pie in the sky than tightening origional patent review. You would have to throw out 200 years of patent law and face several constitutional challenges.
A more moderate response would be for government programs like medicare and medicaid to simply refuse buy products with such a high markup. This is called purchasing controls and practiced by many European countries.
Because in the US, for a human being able to afford anything related to health is a business and not a right like other countries. You don't need to write a post for that.
We've been dealing with this exact issue with Flovent for my son.
Amusingly our insurance's captive/preferred pharmacy wants to mail us the generic for $40 + 25 S+H instead of us buying it locally for $150. Except that they can't climate control the shipment and it's 20F over the rated temp of the inhaler here today, in the shade. So their in house pharmacist allowed an override.
Still a royal PITA.
You'd think, America being billed as the land of the free, some politician might free Americans to order stuff from abroad as long as it's safe as in regulated by some competent body like the EU, Canada etc.?
I once encountered a small scale smuggling operation in which prisoners were smuggling their inhalers out of a prison to sell on the street.
The prisoners were receiving as much as $10 per inhaler, funded by a family on the outside that couldn't afford the inhalers at pharmacy prices.
That's amazing. A lot of people import them from Canada, but this is much more interesting.
It's fascinating isn't it? You'd never suspect that people are smuggling drugs out of prison, but the inhalers weren't the only thing either.
I'm not sure it's ever been looked in to, but having seen it first hand, I can tell you there's a whole hustle for people on the inside trying to get prescribed expensive drugs in order to supplement their meager existences.
Hey! Long time no see! Nice car! How did you get so much money?
Drug deala
??? Fentanyl ???
Nah. Beclomethasone
This is a really good summary. It is mentioned by worth reiterating that evergreening does not prevent generic competition of the origional formulation or configuration. I think it is a bit of a misnomer to refer to these as patent lifetime extensions.
Having spend decades work with pharma companies, I agree that one of the main issues is missaligned incentives between patients and PBMs/health plans.
Bad patents are hard to quantify but a big part of picture. Should the patent office rejected Flovent + HFA as obvious? Another example would be Novarits patents on VEGF in silicone syringes. Litigating a global patent fight with Pharma companies with billions at stake is a huge barrier. The best way to prevent this IMO is more disgression in initial patent issue.
I think the other issue is that generics have such bad margins that it's hard to convince anyone to manufacturer them in the best of cases, so if anything happens to make a generic too hard to sell they'll just give up.
Combining that with PBMs being allowed to choose a preferred manufacturer for a generic or even preferring the (more expensive for the patient) brand, and refusing to offer the same coverage for a generic and you get less access to generics than there should be.
Honestly, PBMs should have to contribute at least the same amount of money to any version of a drug. If it's genuinely more expensive for them, the patient would still have to pay more. If it's not, it's none of their business.
Can you explain your last thought? I dont quite follow.
I do think a lot of the rot is in the PBM layer, and the country would benefit from an attempt to eliminate it, reduce their influence, and move away from the formulary.
Insurance should dictate what is covered, NDC exclusions should be banned, and rebates should be discouraged.
Ideally manufacturers sell for a list price, and insurance decides what is an acceptable balance of cost to subscriber satisfaction.
PBMs would go back to handling the papwerwork, or better yet be replaced by an open standard protocol
Original author here: Yeah a lot of the evergreening techniques (chiral switch, etc.) don't prevent anyone from getting the original, though of course doctors may try to switch you. The inhaler thing is double bad because of the CFC ban.
I didn't dig into the details of the fluticasone HFA switch, but my impression is that while it's obvious to replace the propellant, apparently you do need to do some engineering (e.g., on the nozzle) to make it work right. I don't know enough about what they actually had to do to know if the patent should have been granted or not.
the fix here is create a system where patents can be taken away for excessive profits. if your manufacturing cost is $10 a pack and you sell it for $500 after you already paid off development you deserve to lose it.
That is a lot more pie in the sky than tightening origional patent review. You would have to throw out 200 years of patent law and face several constitutional challenges.
A more moderate response would be for government programs like medicare and medicaid to simply refuse buy products with such a high markup. This is called purchasing controls and practiced by many European countries.
Just for comparison, a standard 200-dose inhaler is USD 5 here, https://terrywhitechemmart.com.au/shop/product/asmol-inhaler.... I assume the "salbutamol" is the same as albutamol in TFA.
For any Fox News fans reading this: That's "socialism" for you :-).
Because in the US, for a human being able to afford anything related to health is a business and not a right like other countries. You don't need to write a post for that.