Analysis of sponsor hearings on health technology assessment decision making

Abstract

Objective. The aim of this study was to get a better understanding of the frequency of Pharmaceutical Benefits Advisory Committee (PBAC) hearings, the factors that influence a sponsor s decision to proceed with a hearing and to assess the impact hearings may have had on PBAC decision making. Methods. All public summary documents (PSDs) from March 2014 to November 2016 PBAC meetings, obtained from the Pharmaceutical Benefits Scheme (PBS) website, were examined to identify major submissions for which sponsor hearings were conducted. Each PSD was analysed to determine the topics discussed at the sponsor hearing and the usefulness of a sponsor hearing from the PBAC s perspective. Results. During the study period there were 472 PSDs. 74 sponsor hearings (28% of major submissions) were conducted during the study period. A clinician external to the sponsor presented at the majority of the hearings (78%) and accordingly, the main topics presented related to clinical positioning/use and clinical benefit/use. Conclusion. The PBAC considered approximately 45% of sponsor hearings to be informative or moderately informative whereas 18% were classed as uninformative.