[tomsto]

This is how it works in the U.K.

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.