Approval and Coverage of Cancer Drugs in England, Canada, and the US
Ce dossier présente deux études, l'une évaluant la couverture en Angleterre de 87 indications d'anticancéreux autorisés par la "US Food and Drug Administration" entre 1992 et 2017 via une procédure accélérée, l'autre évaluant le bénéfice clinique des anticancéreux soumis aux décisions de remboursement au Canada
For approval of cancer drugs, the US Food and Drug Administration (FDA) is tolerant of uncertainty and prioritizes speed over other factors. Most drug approvals are based on surrogate markers, such as tumor shrinkage in a fraction of patients (response rate) or delayed tumor growth (progression-free survival). These surrogates use arbitrary percentage cutoffs and are not optimized to ensure that a drug can improve the length or quality of life.After a cancer drug is approved, insurance coverage usually follows. As cancer drugs are a protected class of medications that typically require coverage of all drugs that are approved within a therapeutic area, Medicare reimburses for cancer drugs approved by the FDA without price negotiation. Approval by the FDA often results in billions earned by a drug company.