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AMWG Streamlined Pathways Subgroup

Page last updated: 30 March 2021

Scope:

The Streamlined Pathways Subgroup will address the tasks identified in section 10.3 “PBS processes” of the Strategic Agreement between Medicines Australia and the Commonwealth of Australia, specifically:

  • Development of a revised pathways framework, for approval by the Minister.
  • Doubling of access for sponsors to early advice.
  • Reducing time from PBAC recommendation to listing by an average of 2 months.
  • Targeting a 50% reduction in the number of resubmissions to the PBAC.

The Streamlined Pathways Subgroup will link into the Combined AMWG and GMWG PBS Transparency and Efficiencies Subgroup.

Activities may include:

  • Secure resources to construct an independent consultancy to undertake, with advice from the Group on:
    • Development of an agreed list of principles and assumptions.
    • Develop draft framework documents that align with the principles and procedures to be followed in implementing the above processes and objectives.
    • Using existing process maps - identify and agree on areas where efficiencies could be made, and where resources are needed.
    • Identify decision criteria for categorising submissions associated with different resource needs into distinct submission pathways.
    • Identify resource needs associated with each submission pathway.
    • Develop a fit for purpose process for submissions in each of these pathways, inclusive of a process for triaging applications (if needed), tailored consultation, evaluation and post-recommendation processes.
    • Validate draft framework by applying criteria for each submission pathway to a prior PBAC meeting agenda and analysing the potential duration of evaluations, number of resubmissions, and time until listing as a result of applying the new pathways framework.
    • Consultation with stakeholders throughout each of the above activities.
    • Engagement with PBAC and other Committees as identified in discussions.

Meeting Communiques