This national retrospective study described trends in dispensing of pancreatic enzyme replacement therapy (PERT) in Australia and assessed whether the introduction of a 60-day dispensing policy was associated with changes in supply at the Pharmaceutical Benefits Scheme (PBS) level. The analysis also considered the context of documented medicine shortages and market changes that could influence utilisation.
Researchers used publicly available PBS dispensing data covering February 2014 through October 2025. Population denominators for calculation of monthly dispensing rates per 100,000 population were drawn from Australian Bureau of Statistics estimates. Medicine shortage periods, including sustained shortages in 2025, were identified using the Therapeutic Goods Administration (TGA) shortage database.
The study examined dispensings of pancreatic enzyme extract products across registered strengths available on the PBS. Analyses specifically assessed the 5000 U, 10,000 U, 25,000 U, and 35,000 U strengths. Notable market events documented in the dataset included the discontinuation of a 40,000 U strength from November 2020 and the introduction of a 35,000 U strength in July 2021.
Interrupted time-series methods were applied to compare dispensing before and after implementation of 60-day dispensing. The pre-policy period was defined as July 2021 to August 2023, and the post-policy period as October 2023 to October 2025. Analyses produced estimates of immediate (level) changes and trend differences for each strength.
Overall dispensing of PERT increased over the study interval. The reported rate rose from 33 dispensings per 100,000 population per month in February 2014 to 85 dispensings per 100,000 population per month by October 2025, representing a 160% increase. The authors interpreted this growth as reflecting increasing clinical need for PERT in Australia.
Dispensing patterns varied by strength in response to market changes. Following the July 2021 introduction of the 35,000 U strength, its share of total dispensings increased. Conversely, dispensings of the discontinued 40,000 U product declined from November 2020. These shifts indicate that product availability and market entries/exits affected utilisation across strengths.
Interrupted time-series analyses identified a statistically significant immediate change in dispensing only for the 5000 U strength associated with the policy introduction. For the 25,000 U and 35,000 U strengths, statistically significant changes were detected after introduction of the policy, but the authors emphasised that the absolute differences in dispensings per 100,000 population per month were minimal. No substantial or sustained destabilisation of PBS-level PERT dispensing was attributed to the 60-day dispensing policy overall.
The study noted that medicine shortages, including sustained shortages identified in 2025 via the TGA database, influenced utilisation patterns across strengths. The authors highlighted the influence of single-brand reliance in the market and documented formulation changes (such as discontinuation and new-strength introductions) as contributors to shifting dispensing distribution among strengths.
PERT use in Australia increased between 2014 and 2025, consistent with rising clinical need. While market events and shortages affected utilisation patterns across strengths, the implementation of 60-day dispensing was not associated with meaningful changes in national PBS dispensing of PERT. The study recommends ongoing monitoring of PERT supply and utilisation given the sector’s reliance on a single-brand therapy and the occurrence of sustained shortages.
The abstract reports methods, time frames, key findings, and conclusions from the PBS and TGA datasets. Detailed numerical outputs, model coefficients, confidence intervals, or further subgroup analyses were not provided in the abstract and therefore are not reported here.