Ferrario, A., and Kanavos, P. (2015). Management of uncertainty and high prices for new medicines: a comparative analysis of the use of market entry agreements administered in Belgium, England, the Netherlands and Sweden. ploughshare. Sci. Med. 124, 39-47. doi: 10.1016/j.socscimed.2014.11.003 In Australia, a number of managed entry agreements have been developed to allow national coverage of new drugs. Non-results-oriented agreements are generally price agreements with discount agreements on prices or volumes. As of February 2013, there were at least 71 special price regimes, including 26 for drugs that were limited to use in hospitals. On the basis of health outcomes, agreements can be reached at the individual or population level. At the individual level, 28 drugs have been funded, subject to continuity rules, which include documentation of appropriate benefits within the individual; Some of these drugs also had price agreements.
At the population level, only a results-based agreement has been implemented for bosentan, a drug marketed for pulmonary hypertension. In May 2010, an agreement was signed between the Australian government and Medicines Australia, the leading pharmaceutical industry organization, to ask the industry to request a review of an “entry manage regime” as part of the funding process for high-demand clinical drugs. It provides for the possibility of a randomized controlled study (RCT) on an entry-level basis. Although this form of registration managed in Australia has not yet been tested, several funding recommendations for 2012/2013 have been submitted by the decision-making committee for further data development. Results: Of all pairs of drug indications (MIPs) recommended to be included in the list, one third of MEAs have been implemented. Our study of 87 mep had 170 MEA. The government`s Expert Committee on Health Technologies (HTA) recommended MEAS for 90 per cent of UNEP`s 87. In total, 81 per cent of MEAS were simple financial arrangements: the majority were discounts (32 per cent) or repayment caps (43 per cent). Results-based MEAs were the least common (5%). 92% of MEAS were implemented and exploited by legal agreements. About half of the PM were identified on the basis of accepted de minimis rights.
49% of the drugs belonged to the ATC-L group. In Australia, managed entry agreements cover new drugs. Keywords: cancer, entry agreements, risk sharing, pauwels refund, K.