Department of Health’s capacity crisis raises red flags for patient access to essential medicines

Pharma News: The Department of Health and Aged Care is facing a significant challenge in managing the influx of Pharmaceutical Benefits Advisory Committee (PBAC) submissions from the pharmaceutical industry. Recent notifications reveal that companies plan to advance over 50 major submissions for the upcoming March 2025 PBAC meeting.

“This is an unprecedented number and exceeds both the current capacity of the contracted Health Technology Assessment (HTA) workforce for evaluation and the number the PBAC can consider in one meeting.

“The Department does not control the number of submissions brought forward by sponsoring pharmaceutical companies, and on very rare occasions – a handful in the past 10 years – the number has exceeded evaluation capacity,” the Department of Health stated.

In response to this overwhelming demand, the Department has reached out to both existing and additional providers of HTA evaluation services. Unfortunately, there is insufficient capacity available to evaluate all submissions in time for the March meeting, necessitating the postponement of some submissions to a later date.

This predicament is particularly striking in light of the recent HTA review report and the lack of clarity regarding implementation timelines or funding commitments from the Department, especially with an election on the horizon.

The medicines industry has been advocating for ambitious targets to expedite patient access, suggesting a 60-day timeframe for PBS listing following ARTG registration for all submissions. However, the HTA Review report proposes timelines for the government that, while improved, still fall short of the industry’s optimistic aspirations. It calls for over 90% of medicines demonstrating superiority to be listed on the PBS within 6 to 12 months of ARTG registration.

The PBAC’s decision to defer some submissions to a later meeting will have potential implications for patients, clinicians, and sponsors.

In determining which submissions would be included in the March 2025 agenda, the PBAC employed its “clinical judgment and experience”. According to the organisations, a “patient-centred approach considered: clinical need, high added therapeutic value and the nature of the condition”.

Submissions deferred from March 2025 are set to be reviewed at the PBAC’s July 2025 meeting, contingent on the submission volume and capacity at that time. In light of these developments, Medicines Australia has requested an urgent meeting with the Department of Health, with a statement on the discussions expected today.

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