Factors affecting PBAC outcomes of medicines for diabetes and its comorbid conditions

Background: The Australians access subsidised prescription medicines for diabetes and its comorbid conditions, which include cardiovascular diseases (CVD), obesity, chronic kidney diseases (CKD), and diabetes-related eye diseases through the Pharmaceutical Benefits Scheme (PBS).

Aim: To retrospectively analyse the factors associated with the Pharmaceutical Benefits Advisory Committee (PBAC) recommendations for listing medicines for diabetes and its comorbid conditions on the Pharmaceutical Benefits Scheme (PBS).

Methods: Public Summary Documents (PSD) of all major submissions considered by the PBAC between July 2005 and March 2020 were reviewed. A wide range of factors related to the clinical and economic evidence presented in the PSDs was extracted. A multivariate logit regression analysis was performed to identify the factors associated with the PBAC recommendation.

Results: A total of 211 PSDs were identified and reviewed. The overall recommendation rate was 56% (118/211). Clinical uncertainty, annual PBS net cost estimate, and economic uncertainty were significant factors associated with the PBAC recommendation. Submissions with high clinical uncertainty, annual PBS net cost estimate of less than or equal A$10 million, and high economic uncertainty were less likely to be recommended for PBS listing.

Conclusion: The outcomes of this research are beneficial for the Australian patients, medical practitioners, pharmaceutical companies, and policymakers. Further research should explore the reimbursement decisions for medicines for diabetes and its comorbid conditions of health technology assessment (HTA) agencies in similar countries to enable cross-country comparison of the factors affecting the reimbursement decisions.