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

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. What is known about the topic? Most studies on Pharmaceutical Benefits Advisory Committee (PBAC) decisions focused mainly on the cost-effectiveness, while some assessed only the financial impact of medicines. A few PBAC studies analysed the reimbursement decisions for medicines targeting specific disease groups, e.g. oncology, orphan disease, and multiple sclerosis. What does this paper add? This study presents an in-depth retrospective analysis of the PBAC decisions for listing medicines related to diabetes and its complications on the Pharmaceutical Benefits Scheme and contributes to the existing evidence-based knowledge of health technology assessment. What are the implications for practitioners? 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. [ABSTRACT FROM AUTHOR]