OBJECTIVES: To investigate the key determinants of the Pharmaceutical Benefits Advisory Committee’s (PBAC) deferred decisions and to determine the number of submissions necessary for a positive recommendation.

METHODS: All Public Summary Documents from 07/2005 to 07/2020 with deferred outcomes were identified, categorized based on the deferred decision reason, and then quantitatively analyzed.

RESULTS: A total of 201 deferred decisions were identified. PBAC deferred the majority of their decisions due to economic factors (57% [115/201]), with clinical factors only driving the decision in 7% (14/201) of cases. The remaining decisions were deferred due to pending TGA approval (12% [24/201]), issues with the patient population under review (1% [3/201]), a change in the treatment criteria (1% [2/201]), and other factors such as products meeting the criteria for a post-market review or the Life Saving Drugs Program (21% [43/201]).

The most common economic reasons for deferred decisions were: a higher ICER than the comparator (34% [39/115]), model-based issues (27% [31/115]), insufficient economic data (13% [15/115]), insufficient or incorrect financial and usage estimates (11% [13/115]), higher product costs (13% [15/115]), and the use of an inaccurate patient population in the economic model (2% [2/115]). Of the decisions deferred due to clinical factors, limitations included the evidence base (57% [8/14]) and an inappropriate comparator (43% [6/14]).

Seventy-two percent (145/201) of deferred applications were given a positive recommendation after the relevant data was submitted in subsequent submissions. A positive decision was achieved after a second submission in 57% of cases, 25% after a third, 16% after a fourth, 1% after a sixth, and 2% after an eighth submission.

CONCLUSION: With the submission of reasonable data in subsequent applications, most products manage to achieve a positive recommendation by PBAC.