AMWG Streamlined Pathways Subgroup

Page last updated: 9 July 2019

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:

  • Revised pathways framework, incorporating a Managed Access Program framework to Minister for Health by July 2018.
  • Doubling access for sponsors for early advice (by July 2018).
  • 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.

Potential initiatives will need to be developed into a work plan for consideration by the Access to Medicines Working Group and to be presented to the Minister for Health by July 2018.

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