4 ms·
Normal procedure for the FDA is to approve only effective drugs, not just drugs that are safe but might not actually work. If on a whim they've decided to chang
by streptomycin 5y ago
Normal procedure for the FDA is to approve only effective drugs, not just drugs that are safe but might not actually work. If on a whim they've decided to change that, Medicare needs to be updated to be more skeptical of FDA-approved drugs.
Unfortunately, our government is not very good at things like passing laws, so likely it will be quite some time before Medicare is adjusted. Very clever exploitation of an opportunity to basically steal billions of dollars from the public. I can't even be that mad, it's such an evil genius plan. Nicely done, Biogen.
- refurb 5y agoNo. This is an intentional accelerated approval. Approved based “likelihood of clinical benefit based on bio marker changes”. The FDA is NOT saying it definitely works, it’s saying there is enough data to give early access.
- lotsofpulp 5y agoExactly. CMS is free to declare it insufficiently effective to be worth paying for.
- refurb 5y agoCMS can do a “Coverage Determination” as they often do and either not cover it at all (unlikely) or severely limit it’s use (likely) potentially to patients who agree to be a part of a registry where outcomes are collected.