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Managed entry agreements for pharmaceuticals in Australia.

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  • 1Quality Use of Medicines and Pharmacy Research Centre, Sansom Institute, School of Pharmacy and Medical Sciences, University of South Australia, GPO Box 2471, Adelaide SA 5001, Australia.

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Australia utilizes managed entry agreements for new medicine funding, primarily through pricing arrangements. Health outcome-based agreements are less common, with only one population-level example implemented.

Keywords:
Coverage with evidence developmentManaged entry agreementMedicine subsidizationPharmaceutical policy

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Area of Science:

  • Health economics
  • Pharmaceutical policy
  • Health services research

Background:

  • Managed entry agreements (MEAs) are crucial for national medicine coverage in Australia.
  • These agreements include non-outcome based pricing arrangements and health outcome-based agreements.
  • As of February 2013, 71 special pricing arrangements were in place, with 26 for hospital-restricted medicines.

Purpose of the Study:

  • To analyze the landscape of managed entry agreements for medicine funding in Australia.
  • To differentiate between non-outcome based and health outcome-based agreement structures.
  • To examine the implementation and potential of different MEA types, including randomized controlled trial (RCT)-based schemes.

Main Methods:

  • Review of existing managed entry agreements in Australia.
  • Categorization of agreements into non-outcome based (pricing/volume rebates) and outcome-based (individual/population level).
  • Analysis of policy documents, including a 2010 memorandum of understanding regarding MEAs.

Main Results:

  • A significant number of non-outcome based agreements exist, primarily pricing arrangements.
  • Individual-level outcome-based agreements focus on continuation rules and documented patient benefit.
  • Population-level outcome-based agreements are rare, with only one implemented for bosentan.

Conclusions:

  • Australia employs various managed entry agreements to facilitate medicine access.
  • Non-outcome based agreements are prevalent, while outcome-based models, especially at the population level, are less common.
  • Future funding recommendations suggest a need for further evidence development, potentially including RCT-based entry schemes.