Analysis of sponsor hearings on health technology assessment decision making.

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. What is known about the topic? Although the sponsors of medicines being considered by the Pharmaceutical Benefits Advisory Committee (PBAC) for public subsidy have been able to give a 10 min presentation to the Committee at the time of decision making for several years, it is unknown whether these hearings are beneficial. What does this paper add? We present what is believed to be the results of the first analysis of PBAC sponsor hearings. What are the implications for practitioners? All stakeholders should consider the findings of our research and associated recommendations to ensure that future sponsor hearings enhance PBAC decision making and promote good public health policy.