Managed entry agreements for pharmaceuticals in Australia.

In Australia, a number of managed entry agreements have been developed to enable national coverage of new medicines. Non-outcome based agreements are usually pricing arrangements that involve price or volume rebate agreements. In February 2013, there were at least 71 special pricing arrangements in place, including 26 for medicines restricted to use in hospitals. Health outcome based agreements can be made at the individual or population level. At the individual level, there were 28 medicines funded subject to continuation rules involving documentation of adequate benefit within the individual; some of these medicines also had price agreements in place. At the population level, only one outcome-based agreement has been implemented so far, for bosentan, a medicine marketed for pulmonary hypertension. In May 2010, a memorandum of understanding signed between the Australian Government and Medicines Australia, the peak pharmaceutical industry organisation, included the possibility for industry to request consideration of a 'Managed Entry Scheme' as part of the funding submission process for medicines with high clinical needs. It includes the possibility of a randomised controlled trial (RCT)-based entry scheme. Although this form of managed entry has yet not been trialed in Australia, several 2012/2013 funding recommendations included requests by the decision making committee for further evidence development.