4 ms·

Is it really $10-15k each additional patient year requires or it's more of "total cost was this much, we divide it by number of patients". Where do this money g

Is it really $10-15k each additional patient year requires or it's more of "total cost was this much, we divide it by number of patients". Where do this money go to? Fx, with these covid trials, 40000 people in pfizer trial, half a year cost would be $200-300 mln. People presumably weren't paid for this. Of course there's some work by doctors that needs to be paid for, but that can't be this large amount. Also, does this all assume USA standards of pricing? Because in rest of the world healthcare is much cheaper. I just think big pharma are fundamentally ok with huge cost for trials and are not motivated to decrease it/make it more efficient, since they're ok with their pie being larger. They will just shift costs to healthcare system and will be happy with larger profit.

refurb 6y ago
Ha! You think big pharma likes spending that kind of money on trials? I’ve been a part of those negotiations with the FDA. It costs that much because the company says “we believe a 6 month trial is sufficient to prove both safety and efficacy” and the FDA says “if you want it approved, you need to collect 2 years of data”. Now, $10-15k per patient-year is for a typical therapeutic. And that is an average across global trial sites, not just the US. It’s not much money. You go a 15 min doctors appointment and your insurance is billed $150. Now imagine going 1 per week and having multiple tests run each time. Or having to stay in the hospital for a day when the drug is administered. You can burn through $1,000 per month pretty damn quickly.
- aquadrop 6y ago
  I don't see a reason they would be really against it. FDA says it to everyone, so all companies in same condition. And they can shift cost to healthcare system and have larger revenue. They probably don't mind their pie as a whole being larger, because having revenue of 50 billions and profit of 10 billions is better than revenue of 5 and profit of 1, even though proportionally it's the same. All big pharma companies are massively profitable, fx Novartis net income in 2017 $17.8bln on $50.4bln revenue. Pfizer's $14bln operating income on $53.6bln revenue in 2018. And it's year after year. They really don't seem to suffer from those high costs trials. Also, Pfizer reports only $8bln on R&D in same 2018. I'm sure there' a lot of inefficiencies in those trials, same as it turned out vaccine could be created in year instead of a decade. (btw, previous large scale epidemic of swine flu was largely profitable for pharma companies). They just don't have incentive to reduce the inefficiencies. You're telling it's not just US but then you cite high healthcare costs (retail vs large scale trial, definitely can be cheaper at scale), which is much cheaper outside of US. I would be very interested in reading numbers of detailed case study of creation of some real world vaccine/drug.
  - refurb 6y ago
    They probably don't mind their pie as a whole being larger, because having revenue of 50 billions and profit of 10 billions is better than revenue of 5 and profit of 1, even though proportionally it's the same It doesn't work this way. Pricing of pharmaceuticals is independent of the cost of development. Nobody will pay $200 per Covid vaccine dose just because the cost to develop it went up 10x. Every extra dollar spent on development, is one less dollar of profit. That's why some drugs never make it to market - the cost to bring them to market and the low price means they'll never be profitable.
    - aquadrop 6y ago
      Even if it doesn't happen for each and every drug, that can easily be the trend on average. And it probably already happened with covid vaccines. Moderna comes out and says it will cost ~$30 per shot. Why not 3? And for others drugs, when price goes into thousands and don't have much competition that easily can be the case.
msabalau 6y ago
I'm a volunteer for this vaccine, in the first month I have three in-patients visits, involving two inoculations, 6 blood draws, 2 Covid tests, and three nasal absorption tests. My first visit lasted a little over three hours including a very comprehensive medical history and physical exam, and time taken to ensure that I was giving truely informed consent. I interacted with three medical professionals on the first visit, sometimes in the exam room, and sometimes via phone from the exam room to protect each other from long in person indoor exposure. Like any medical visit this year, a considerable amount of PPE was used. I was given an app use daily to record my health, and a digital thermometer so that all subjects are using the same calibrated equipment. Having reported a headache two days in a row in the app, there was a remote phone call follow up by a research clinician, in addition to the planned check in phone calls that I haven't mentioned. They do pay me a very modest ammount, so I've bought myself a couple of ebooks after paying for big city parking near the research clinic. They need to pay for that office space. Before I entered the study I needed to interact with recruiters, to qualify that it was safe enough for me to participate and to ensure that they were getting people from a variety of backgrounds. They needed to be ready to respond if I had a severe adverse reaction to the the trial vaccine. There is an entirely separate independent review board that I can go to with questions. In the event that I had Covid symptoms, there is an entirely separate set of assessments, visits and samples taken. Given the amount of work being done by this and other research labs hired Astrazeneca, and comparing this to quotes I've received for a very modest UX usability studies, it's hard to see see this an sort of money grab.

refurb 6y ago

Ha! You think big pharma likes spending that kind of money on trials? I’ve been a part of those negotiations with the FDA. It costs that much because the company says “we believe a 6 month trial is sufficient to prove both safety and efficacy” and the FDA says “if you want it approved, you need to collect 2 years of data”. Now, $10-15k per patient-year is for a typical therapeutic. And that is an average across global trial sites, not just the US. It’s not much money. You go a 15 min doctors appointment and your insurance is billed $150. Now imagine going 1 per week and having multiple tests run each time. Or having to stay in the hospital for a day when the drug is administered. You can burn through $1,000 per month pretty damn quickly.

aquadrop 6y ago
I don't see a reason they would be really against it. FDA says it to everyone, so all companies in same condition. And they can shift cost to healthcare system and have larger revenue. They probably don't mind their pie as a whole being larger, because having revenue of 50 billions and profit of 10 billions is better than revenue of 5 and profit of 1, even though proportionally it's the same. All big pharma companies are massively profitable, fx Novartis net income in 2017 $17.8bln on $50.4bln revenue. Pfizer's $14bln operating income on $53.6bln revenue in 2018. And it's year after year. They really don't seem to suffer from those high costs trials. Also, Pfizer reports only $8bln on R&D in same 2018. I'm sure there' a lot of inefficiencies in those trials, same as it turned out vaccine could be created in year instead of a decade. (btw, previous large scale epidemic of swine flu was largely profitable for pharma companies). They just don't have incentive to reduce the inefficiencies. You're telling it's not just US but then you cite high healthcare costs (retail vs large scale trial, definitely can be cheaper at scale), which is much cheaper outside of US. I would be very interested in reading numbers of detailed case study of creation of some real world vaccine/drug.
- refurb 6y ago
  They probably don't mind their pie as a whole being larger, because having revenue of 50 billions and profit of 10 billions is better than revenue of 5 and profit of 1, even though proportionally it's the same It doesn't work this way. Pricing of pharmaceuticals is independent of the cost of development. Nobody will pay $200 per Covid vaccine dose just because the cost to develop it went up 10x. Every extra dollar spent on development, is one less dollar of profit. That's why some drugs never make it to market - the cost to bring them to market and the low price means they'll never be profitable.
  - aquadrop 6y ago
    Even if it doesn't happen for each and every drug, that can easily be the trend on average. And it probably already happened with covid vaccines. Moderna comes out and says it will cost ~$30 per shot. Why not 3? And for others drugs, when price goes into thousands and don't have much competition that easily can be the case.

msabalau 6y ago

I'm a volunteer for this vaccine, in the first month I have three in-patients visits, involving two inoculations, 6 blood draws, 2 Covid tests, and three nasal absorption tests. My first visit lasted a little over three hours including a very comprehensive medical history and physical exam, and time taken to ensure that I was giving truely informed consent. I interacted with three medical professionals on the first visit, sometimes in the exam room, and sometimes via phone from the exam room to protect each other from long in person indoor exposure. Like any medical visit this year, a considerable amount of PPE was used. I was given an app use daily to record my health, and a digital thermometer so that all subjects are using the same calibrated equipment. Having reported a headache two days in a row in the app, there was a remote phone call follow up by a research clinician, in addition to the planned check in phone calls that I haven't mentioned. They do pay me a very modest ammount, so I've bought myself a couple of ebooks after paying for big city parking near the research clinic. They need to pay for that office space. Before I entered the study I needed to interact with recruiters, to qualify that it was safe enough for me to participate and to ensure that they were getting people from a variety of backgrounds. They needed to be ready to respond if I had a severe adverse reaction to the the trial vaccine. There is an entirely separate independent review board that I can go to with questions. In the event that I had Covid symptoms, there is an entirely separate set of assessments, visits and samples taken. Given the amount of work being done by this and other research labs hired Astrazeneca, and comparing this to quotes I've received for a very modest UX usability studies, it's hard to see see this an sort of money grab.