Assessment of the Quality of the Clinical Evidence in Submissions to the Australian Pharmaceutical Benefits Advisory Committee: Fit for Purpose?

Background: Assessments of the comparative clinical (and cost) effectiveness of new medicines are increasingly being used to inform decisions on their reimbursement. Assessments of added clinical benefit are invariably based on evidence generated to support registration.

Objective: Our objective was to identify and characterize significant problems relating to the quality of the clinical evidence in submissions to the Australian Pharmaceutical Benefits Advisory Committee (PBAC) seeking subsidy on the Pharmaceutical Benefits Scheme and thus determine whether the evidence presented to the committee was "fit for purpose.