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Tuesday, December 26, 2023 12:43:42 PM
Then under that 21st Century Cures Act getting off-label insurance coverage and Medicare coverage now should be very easy. Just a little RWE justifying, small studies.
Expansion of the label formally can also be justified with RWE now, though you’d probably do more formalized trials also, to provide practitioners with compelling evidence to make your treatment a new SOC for those other label expanded uses. You’d probably do both, get approval for patients to get it, but also have a trial for the importance of establishing a strong benefit and publishing.
There are many more ways to make a drug available broadly to more patients than there was in the past and that includes with proper allowance and justification for medical coverage so that patients can afford such treatments.
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