Australian managed entry scheme: a new manageable process for the reimbursement of new medicines?

The global prescription medicines industry argues that it needs high prices for new medicines to meet ever-increasing development costs. While many payers are prepared to pay high prices if they represent good value for money, they first need to feel assured that the value for money estimates are robust. Insofar as new medicines enter the market with limited and uncertain data relating to their performance in normal clinical practice, the value for money case for some medicines may well be driven largely by assumptions than by empirical evidence. The concern to manufacturers is that payers respond to this uncertainty by listing the product at a lower price (which may not satisfy the producer) or not listing the product until more evidence is available (which may not satisfy clinicians and patients). Is there a solution that will satisfy all key stakeholders? Will clinicians and patients continue to have timely access to new medicines and will payers have sustainable reimbursement systems? Will the industry continue to be rewarded with high prices for new medicines so long as they represent good value for money? In 2011, the Australian Government introduced a managed entry scheme whereby the Pharmaceutical Benefits Advisory Committee will recommend the listing of a new medicine at a price justified by the existing evidence, pending the availability of more conclusive evidence of cost-effectiveness to support its continued listing at a higher price. This commentary examines the Australian Government's managed entry scheme and issues that are likely to arise from its implementation.