Federal Health Minister succumbs to pressure, commits to extra meeting to clear PBAC backlog

Pharma News: The Minister for Health and Aged Care, Mark Butler MP, has confirmed that the Pharmaceutical Benefits Advisory Committee (PBAC) will add an extra meeting in 2025 to tackle the growing backlog of submissions. This decision comes amid mounting pressure from the pharmaceutical industry, Shadow Health Minister Senator Anne Ruston, and advocacy groups.

In discussions spanning the past ten days, Medicines Australia has urgently engaged with the Government, warning of significant consequences if 45 PBAC submissions – originally set for review in March – were postponed.

Minister Butler responded, highlighting the government’s measures to address the issue, saying “Since being notified of the situation, the Albanese Government has increased capacity to ensure all submissions are evaluated and considered by May 2025.

“At the March 2025 meeting, the PBAC will consider the submissions most likely to benefit patients and improve the standard of care in Australia.”

Minister Butler also emphasised the importance of future readiness, noting, “There is a huge pipeline of new medicines and treatments coming, and that is why our Government undertook the Health Technology Assessment Review. The HTA Review will improve access to new health technologies and medicines and make the HTA processes simpler and easier for consumers, clinicians, and industry.”

Yet, the implementation of the HTA Review report recommendations was dubbed “complex and costly” by Adjunct Professor Debora Picone, Chair of the HTA Review Reference Committee.

Medicines Australia CEO Liz de Somer expressed relief at the government’s decision but criticised the situation’s handling.

“Minister Butler has made the right call. An additional meeting is required so patients can access the latest innovative medicines as soon as possible,” she said. “Proper consultation could have circumvented the need to involve the Minister and alarm patients who are waiting for access to lifesaving and life-changing medicines.

UCB Australia also welcomed the announcement by Minister Butler, with Selina Clifford, General Manager UCB Australia, saying “Our immediate concern is for patients who have been waiting for many years for effective treatment options.

“Our shared objective with government is to fulfil our obligations to patients and the community more widely. If the Pharmaceutical Benefits Scheme, on which the whole Australian community depends, is under resourced and cannot fulfil its obligations to provide timely and equitable access to medicines, we risk reducing trust in the system.”

De Somer further commented, “It is disappointing patients and industry were put in this situation without effective consultation. Australians already wait an average of 466 days from the time a medicine is approved by the TGA to when it is made available on the PBS, far longer than in comparable countries. Patients should not have to wait even longer because of a meeting schedule.

“It is patients – taxpayers – who are impacted the most when PBS decisions are delayed. The HTA Review has demonstrated Australians do not receive timely access to new medicines. This does not need to be exacerbated by PBAC deferring consideration of new medicines in 2025.”

Looking forward, Medicines Australia is calling for systemic reforms to ensure the issue does not recur. Their recommendations include:

• Streamlining administrative processes following positive PBAC recommendations to prevent further delays.
• Expanding the PBAC’s panel of medicine evaluators to increase capacity for handling complex submissions.
• Scheduling more PBAC meetings annually to manage the growing volume and complexity of new medicines.
• Pursuing HTA reform to accommodate innovative medicines, reduce the need for resubmissions, and speed up decision-making.

Despite these developments, uncertainty looms over the HTA Review’s implementation timeline and the Department of Health’s funding commitments, particularly with a federal election on the horizon.

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