Factors associated with Pharmaceutical Benefits Advisory Committee decisions for listing medicines for diabetes and its associated complications.

Abstract

Objective To retrospectively analyse the key factors associated with listing decisions by the Pharmaceutical Benefits Advisory Committee (PBAC) for medicines for diabetes and its complications on the Pharmaceutical Benefits Scheme. Methods The clinical and economic evidence were retrieved from public summary documents (PSD) of all major submissions between July 2005 and March 2020. A multivariate binary logit regression analysis was conducted to assess the relationship between the categorical explanatory variables and PBAC recommendations. Results We identified a total of 211 PSD of which 118 (56%) were recommended for listing. Clinical and economic uncertainty were significantly and inversely associated with the PBAC recommendation. Submissions with high clinical and economic uncertainty were less likely to be recommended. Conclusion Our findings will enhance the understanding of medical professionals, pharmaceutical companies, and other stakeholders about the rationale of PBAC reimbursement decisions for these medicines and assist prospective applicant sponsor companies in preparing their submissions.