Department of Health data reveals slower pace in PBS listing despite ongoing reforms

Pharma News: The Department of Health has published the latest report on the Pharmaceutical Benefits Scheme (PBS) process improvements. Backed by the Joint Oversight Committee, the report is part of the objectives set forth in the Strategic Agreement (2022-27) between Medicines Australia and the Commonwealth Government, aimed at enhancing the efficiency, transparency, and timeliness of PBS listing procedures.

In the fiscal year from July 1, 2022, to June 30, 2023, the average time from PBAC minutes to PBS listing was 124.7 days (approximately 4.1 months) for applicants who submitted their notice of intent for pricing form in week 4 and their pricing offer package in week 5. This marks a notable increase compared to the previous 2021-2022 period, where the average duration was 101.8 days (approximately 3.4 months).

For all other applicants, the duration from PBAC minutes to PBS listing averaged 176.2 days (approximately 5.8 months) in the 2022-2023 period, representing a noticeable increase from the previous year’s average of 143.3 days (approximately 4.8 months). Additionally, in the current reporting period, less number of initial submissions were recommended first time (49%) compared to the previous reporting period (56%).

Importantly, Medicines Australia defines the patient access gap differently; from when an innovative health technology (including medicines, biotherapeutics and vaccines) is registered with the Therapeutic Goods Administration (TGA) to when it becomes available to patients on the PBS.

Australia’s registration to reimbursement timeframe compares poorly with other countries, such as Japan (102 days), Germany (136 days) and the UK (156 days). The most recent analysis of Department of Health data indicates this timeframe has blown out to 25 months, meaning Australian patients are waiting months longer for new medicines to become available on the PBS.

Liz de Somer, CEO of Medicines Australia, told Health Industry Hub, “Having robust metrics is key to ensuring the Australian Health Technology Assessment (HTA) system is operating at its most efficient, thereby delivering new and innovative medicines to Australian patients via the PBS in the earliest possible timeframe.

“Medicines Australia believes that, while the original set of metrics has been informative, it is time to consider their evolution and expansion, and how learnings from the metrics report can be used to educate and make the PBAC and post-PBAC processes more efficient.”

She added, “This will be especially important in the context of reforms that are implemented following the HTA Review, and it will be crucial to define and report on access metrics in a way that is straightforward for stakeholders to interpret, especially patients.”

In its inquiry, the House of Representatives Standing Committee on Health, Aged Care and Sport, heard from several submitters that the main cause of delay in funding new medicines was the multiple submissions that were required before a positive recommendation could be made by PBAC. Stakeholders also noted that the submission and valuation process was being used for pricing and commercial negotiation purposes with companies seeking higher prices in first submissions before having to lower prices in subsequent submissions.

Eli Lilly sought the views of 100 Australian medical specialists on issues relating to medicines access. The response was clear – not one of the specialists surveyed considered the current average timeframe between registration and reimbursement acceptable.

The New Frontier Report made a number of recommendations around the need to measure outcomes. Among other things, it recommended that the Department of Health publish data annually on application processing times and positive recommendation rates for the Pharmaceutical Benefits Advisory Committee (PBAC) and benchmarked against other nations with advanced HTA processes.

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