Medicines Australia statement in response to PBAC submission deferrals

25 October 2024: Medicines Australia met with senior representatives from the Department of Health and Aged Care yesterday to discuss concerns held by Members following the Government’s decision to defer consideration of a significant number of PBAC Submissions from the March 2025 meeting.

Industry’s concerns include:

-Lack of consultation on the process for prioritisation
-Lack of ability for sponsors to object to the prioritisation or make a case to preference submissions 
-Scepticism about the PBAC’s claim that it can only assess 32 submissions. 
-Implications and flow-on consequences for co-dependent submissions; particularly those that have already been scheduled for MSAC consideration.
-The negative signal this sends to sponsors about Australia as a first launch country. 
-The capacity of evaluation units and how the broader HTA evaluator community is utilised.
-Alternative options to avoid delaying submissions by a full cycle.

Medicines Australia CEO Liz de Somer said the meeting was productive.

“We understand the PBAC determined to accept 32 submissions that are a mix of category1&2 and resubmissions that require a full economic evaluation and propose to defer 24 (major) category 1&2 and 21 (minor) category 3&4 submissions.”

“It is essential industry and Government work collaboratively on this matter, given the significant impact it will have on patient access to critical medicines as well as significant business planning consequences.

“Most importantly, we need to ensure that every possible option is explored to enable the submissions to be evaluated prior to July and not create ongoing delays to access for patients throughout 2025,” said Ms de Somer.

It was agreed the Department will:

-Jointly explore with Medicines Australia all possible solutions to speed up evaluations and PBAC consideration of submissions at the March and July 2025 PBAC meetings.
-Explore an ongoing evaluation process and the use of an intracycle meeting to reduce the number of submissions that need to go to the July meeting.  
-Provide Medicines Australia with the criteria used by the PBAC to make its triaging decisions and the deliberative process undertaken.
-Consistent with past practice, listing will continue to occur during the caretake period, subject to an agreement between the Government Opposition ahead of an election being called.

Medicines Australia and the Department agreed to continue to work to ensure this situation is not repeated and actions that will be taken are:

-A review of evaluators currently on the Department’s panel to ensure there is capacity to deal with peak submission periods. 
-A review the criteria for the appointment of evaluators so that evaluators that do work with industry are not automatically disqualified from being appointed to the Government panel if other conflict of interest strategies can be developed and effectively implemented. 
-A review of the PBAC and sub-committees’ capacity and schedule of meetings to deal with evaluations and assessment of submissions going forward and to enable intracycle meetings to substantively evaluate and assess submissions. 
-Genuine consultation with Medicines Australia prior to members being notified should this situation occur again. 

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Media enquiries to Kate McKeown, Senior Manager Communications and Media – kate.mckeown@medicinesaustralia.com.au or 0408 775 288.