The Australian managed entry scheme: are we getting it right?

In 2010, the Australian Government introduced the managed entry scheme (MES) to improve patient access to subsidised drugs on the Pharmaceutical Benefits Scheme and enhance the quality of evidence provided to decision makers. The aim of this paper was to critically review the Australian MES experience. We performed a comprehensive review of publicly available Pharmaceutical Benefits Advisory Committee online documents from January 2010 to July 2017. Relevant information on each MES agreement was systematically extracted, including its rationale, the conditions that guided its implementation and its policy outcomes. We identified 11 drugs where an MES was considered. Most of the identified drugs (75%) were antineoplastic agents and the main uncertainty was the overall survival benefit. More than half of the MES proposals were made by sponsors and most of the schemes were considered after previous rejected/deferred submissions for reimbursement. An MES was not established in 8 of 11 drugs (73%) despite the high evidence uncertainty. Nevertheless, six of these eight drugs were listed after the sponsors reduced their prices. Three MESs were established and implemented by Deeds of Agreement. The three cases were concluded and the required data were submitted within the agreed time frames. The need for feasibility and value of an MES should be carefully considered by stakeholders before embarking on such an agreement. It is essential to engage major stakeholders, including patient representatives, in this process. The conditions governing MESs should be clear, transparent and balanced to address the expectations of various stakeholders