Costs and benefits of early access to new cancer drugs through the US Food and Drug Administration's accelerated approval pathway: retrospective observational study and economic evaluation.

Abstract

To evaluate the survival gains and additional Medicare spending associated with early access to new cancer drugs granted accelerated approval by the US Food and Drug Administration (FDA), compared with access to cancer drugs following completion of confirmatory trials. Retrospective observational study and economic evaluation. US Medicare programme, which provides health insurance for adults aged 65 years and older. Medicare beneficiaries who received new cancer drug indications from the time of