The FDA only judges the medical evidence. That is complex enough.
Adding pricing to it's concerns would make what is already a nightmare process even worse.
Adding pricing to it's concerns would make what is already a nightmare process even worse.
TBH, I believe that is a huge root cause problem with our health care system. We need to stop pretending that money is infinite, and measure the cost against the benefit (in this case, little or none) when deciding whether Medicare/insurance companies should pay for a treatment.
Perhaps this shouldn't be the responsibility of the FDA, but SOMEWHERE there should exist a process that says, "OK, this drug increases lifespan on average by 1 week, but costs $10,000 a month in treatment, sorry we're not going to cover it."
What you’re saying seems sensible, but my cynicism…
The MHRA decides which drugs are safe and effective and for which diagnoses.
Then NICE decides which of those drugs are available on the public health system (NHS) by evaluating £/quality-adjusted life year. I don’t see why Medicare should be any different.
If it’s not available on the public health system you can still pay for it yourself or via private insurance provided it’s licensed by the MHRA.
And, it's especially the case that for certain individuals (this page also made the top of HN today, https://www.goodrx.com/blog/most-expensive-drugs-period/) that drug costs are a gargantuan, total-lifetime-salary kind of expenditure.
> NHE grew 4.6% to $3.8 trillion in 2019, or $11,582 per person, and accounted for 17.7% of Gross Domestic Product (GDP).
> Prescription drug spending increased 5.7% to $369.7 billion in 2019, faster than the 3.8% growth in 2018.
So that is around 10%. Still a pretty high amount of money.
[0] https://www.cms.gov/Research-Statistics-Data-and-Systems/Sta...