JAMA Internal Medicine · 2021 · 43 citations · 18 references
This cohort study found that, although the pCODR takes into account the magnitude of clinical benefit, only half of the cancer drugs that received a positive recommendation had evidence of improved OS and the survival gains were usually modest. These results suggest that, although the pCODR helps filter out some cancer drugs with low quality of evidence and low magnitude of benefit, cancer drugs without meaningful patient benefit continue to enter the Canadian market; these findings are important for making reimbursement policy decisions globally.
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ESMO-Magnitude of Clinical Benefit Scale version 1.1
Nathan I. Cherny, Urania Dafni, Jan Bogaerts et al. · Annals of Oncology · 2017 · 625 citations · Full text
FDA Approval and Regulation of Pharmaceuticals, 1983-2018
Jonathan J. Darrow, Jerry Avorn, Aaron S. Kesselheim · JAMA · 2020 · 336 citations