4 ms·

Genuinely curious - why do these drugs cost so much? Can we make it cheaper? I know there’s a lot of hit & miss and that the cost of the drug also covers the mi

by pgt 6y ago

Genuinely curious - why do these drugs cost so much? Can we make it cheaper? I know there’s a lot of hit & miss and that the cost of the drug also covers the misses, but it feels like we should be able to do this for millions, not billions.

ryanmercer 6y ago
https://www.pcisynthesis.com/want-to-know-why-early-drug-development-costs-so-much/ https://www.pcisynthesis.com/want-to-know-why-early-drug-dev... and http://sitn.hms.harvard.edu/flash/2020/modern-drug-discovery-why-is-the-drug-development-pipeline-full-of-expensive-failures/ http://sitn.hms.harvard.edu/flash/2020/modern-drug-discovery... are decent reads. Mostly it's the complexity of the compounds involved, the supply chain, and regulatory costs.
- s1artibartfast 6y ago
  And the the time value of money. see my sibling post.
s1artibartfast 6y ago
It has to do with the time value of money and long development timelines. Here is a great blog post from a scientist trying to find investors for drug to cure his wife's terminal disease.[1] >it takes a hundred dollars of drug revenue 17 years from now to motivate someone to invest one dollar today. No wonder drugs are expensive. That is a 10,000% return on investment required to break even. http://www.cureffi.org/2019/04/29/financial-modeling-in-rare-disease http://www.cureffi.org/2019/04/29/financial-modeling-in-rare...
- deleted 6y ago
  [deleted]
akiselev 6y ago
It genuinely takes a massive amount of labor using mostly highly paid professionals like doctors, nurses, and research scientists. Even before any trials start, the support materials for a premarketing application for a drug are usually in the thousands of pages and include clinical trial protocols that describe minutiae like how blood samples will be drawn so data is comparable between hospitals. Then you have to find participating hospitals, PIs, and patients which means lots of negotiation and patient screenings and TV/radio/web advertising. Then you have to manufacture the drugs in small to medium quantities. Then you have to actually run the trials which means paying a lot of people and most if not all of their medical care related to the clinical trial. Phase I trials, for example, are usually carried out under constant medical supervision and push the dosage as high as they can until 50% of the cohort will no longer tolerate it. That alone is usually thousands or tens of thousands per day per patient. By the time you get to phase III where you have hundreds to thousands of patients, you're shelling out up to $1k per patient for the incentive and $100-1k per checkup for the length of the trial. A 1k person phase III can easily cost tens of millions in labor just to administer the drug and collect samples once a month for a year. Data provenance and normalization is important so a not insignificant chunk of this time is largely unavoidable paperwork.
- swanson 6y ago
  And getting FDA approval is not the finish line. It's just the start of the roll-out. Now employ teams of reps to get the drug covered by every commercial insurance company and all Medicare/Medicaid parties so that patients have access to this life-saving treatment, get policies and authorization forms and billing codes created and implemented. Do outreach to make sure doctors and patients even know that a drug has been approved and how it compares to existing options.

by pgt 6y ago

ryanmercer 6y ago

https://www.pcisynthesis.com/want-to-know-why-early-drug-development-costs-so-much/ https://www.pcisynthesis.com/want-to-know-why-early-drug-dev... and http://sitn.hms.harvard.edu/flash/2020/modern-drug-discovery-why-is-the-drug-development-pipeline-full-of-expensive-failures/ http://sitn.hms.harvard.edu/flash/2020/modern-drug-discovery... are decent reads. Mostly it's the complexity of the compounds involved, the supply chain, and regulatory costs.

s1artibartfast 6y ago
And the the time value of money. see my sibling post.

s1artibartfast 6y ago

It has to do with the time value of money and long development timelines. Here is a great blog post from a scientist trying to find investors for drug to cure his wife's terminal disease.[1] >it takes a hundred dollars of drug revenue 17 years from now to motivate someone to invest one dollar today. No wonder drugs are expensive. That is a 10,000% return on investment required to break even. http://www.cureffi.org/2019/04/29/financial-modeling-in-rare-disease http://www.cureffi.org/2019/04/29/financial-modeling-in-rare...

deleted 6y ago
[deleted]

akiselev 6y ago

It genuinely takes a massive amount of labor using mostly highly paid professionals like doctors, nurses, and research scientists. Even before any trials start, the support materials for a premarketing application for a drug are usually in the thousands of pages and include clinical trial protocols that describe minutiae like how blood samples will be drawn so data is comparable between hospitals. Then you have to find participating hospitals, PIs, and patients which means lots of negotiation and patient screenings and TV/radio/web advertising. Then you have to manufacture the drugs in small to medium quantities. Then you have to actually run the trials which means paying a lot of people and most if not all of their medical care related to the clinical trial. Phase I trials, for example, are usually carried out under constant medical supervision and push the dosage as high as they can until 50% of the cohort will no longer tolerate it. That alone is usually thousands or tens of thousands per day per patient. By the time you get to phase III where you have hundreds to thousands of patients, you're shelling out up to $1k per patient for the incentive and $100-1k per checkup for the length of the trial. A 1k person phase III can easily cost tens of millions in labor just to administer the drug and collect samples once a month for a year. Data provenance and normalization is important so a not insignificant chunk of this time is largely unavoidable paperwork.

swanson 6y ago
And getting FDA approval is not the finish line. It's just the start of the roll-out. Now employ teams of reps to get the drug covered by every commercial insurance company and all Medicare/Medicaid parties so that patients have access to this life-saving treatment, get policies and authorization forms and billing codes created and implemented. Do outreach to make sure doctors and patients even know that a drug has been approved and how it compares to existing options.