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The Australian Managed Entry Scheme: Are We Getting it Right?

Haitham W Tuffaha1,2, Paul A Scuffham3,4

  • 1Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, Australia. haitham.tuffaha@griffith.edu.au.

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The Australian managed entry scheme (MES) aimed to improve drug access and evidence quality but was rarely established. Most drugs were listed after price reductions, highlighting the need for careful consideration of MES feasibility and stakeholder engagement.

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Area of Science:

  • Health policy research
  • Pharmaceutical economics
  • Evidence-based medicine

Background:

  • Introduced in 2010, the Australian managed entry scheme (MES) aimed to enhance patient access to subsidized drugs and improve evidence quality for decision-makers.
  • The Pharmaceutical Benefits Scheme (PBS) is central to Australia's subsidized drug access framework.
  • Uncertainty in survival benefit was a key challenge for drug reimbursement decisions.

Purpose of the Study:

  • To critically review the Australian managed entry scheme (MES) experience from 2010 to 2017.
  • To analyze the rationale, implementation conditions, and policy outcomes of MES agreements.
  • To evaluate the effectiveness of MES in improving access to subsidized medicines.

Main Methods:

  • Comprehensive review of Pharmaceutical Benefits Advisory Committee (PBAC) online documents (January 2010 - July 2017).
  • Systematic extraction of information on MES agreements, including rationale, conditions, and outcomes.
  • Analysis of 11 drugs where MES was considered, focusing on antineoplastic agents and evidence uncertainty.

Main Results:

  • MES was considered for 11 drugs, predominantly antineoplastic agents (75%), with survival benefit uncertainty being a major factor.
  • MES was not established for 8 out of 11 drugs (73%), often after price reductions by sponsors.
  • Three MES agreements were successfully established and concluded, with data submitted within agreed timeframes.

Conclusions:

  • The Australian MES experience indicates a low establishment rate, with price negotiation often preceding listing.
  • Careful consideration of MES feasibility and value, alongside transparent stakeholder engagement, is crucial for successful implementation.
  • Clear, balanced, and transparent conditions are essential to meet diverse stakeholder expectations within MES frameworks.