In Australia, managed entry agreements (MEAs) have been operating for a many years, primarily in the form of non-outcomes based price-volume agreements and dose-capping schemes. The 2010 memorandum of understanding between the Australian Government and Medicines Australia introduced the possibility for industry to request consideration of a ‘Managed Entry Scheme’, whereby the PBAC may recommend PBS coverage of a proposed drug at a price justified by the existing evidence, pending submission of more conclusive evidence of cost-effectiveness to support a higher price. The supporting framework states that an MEA would be considered where there is a high clinical need for the drug in the requested indication, and new clinical data would resolve the uncertainties relating to the extent or value of the clinical effect that would otherwise prevent an initial positive recommendation.
In this session, two industry speakers will discuss the evolution of MEAs in Australia and overseas, the practicalities of their implementation, and first-hand experience in setting up outcomes-based schemes. The potential impact of recent TGA reforms for accelerated and conditional registrations on the need and requirements for MEAs and reimbursement will also be discussed.
Chairperson: Adam Gordois, Director, Health Economics, Covance