Sunday, February 25, 2024 1:28:23 AM
QALY. If one has a confounded value endpoint, you can win the battle but lose the war, even if the original survival endpoint is significant or strongly trending if QALY is based on it instead of ECA comparison. To obtain reasonable reimbursement, one must unconfound to the most legitimate extent possible. Otherwise, you might get stat. sig., but you can’t get sufficient reimbursement, which would be bad for patients, investors, management and scientific progress.
Right now, reimbursement, calculated from the ECA comparison, will be sufficient.
Right now they don’t want to re-confound by establishing a distorted value calculation by reintroducing the confounded comparison prior to QALY valuation for reimbursement.
To me, it’s all pretty straight forward, and it takes NWBO discipline to keep the horse in front of the cart in this situation, but science and regulatory economics demands it.
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