Managed Entry Agreements Australia
Entry-level managed agreements are agreements between companies and health care recipients that cover new drugs while facing uncertainty about their financial impact or performance. Financial agreements are used in at least two-thirds of OECD and EU member states. Many of these countries also use results-related agreements, which subordinate coverage, business payments or discounts paid by companies to product performance, but these MEAs are less common. With the help of the European Commission, the OECD has reviewed the experience of countries that have adopted performance measures to date to identify best practices and opportunities to use these agreements in the future. Note: This taxonomy is based solely on the structure of the agreements. All types of agreements mentioned above may exist not only between companies and health organizations, but also between companies and other types of institutions that constitute a health system, including government agencies or national authorities responsible for making coverage or pricing decisions and/or evaluating health technologies (HTA), regional health authorities, health care providers, etc. In particular, for products used in hospitals, MEAs may be available between companies and hospitals. Source: authors of the study based on Carlson (2010), Ferrario and Kanavos (2013) and Gerkens et al. (2017). In Australia, a number of controlled access 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. Keywords: Entry-level agreements; Results-based agreements Performance agreements Pharmaceutical policy. Once the managed entry system, in which RCT data is used as evidence, is in effect, it is anticipated that the use of other types of evidence for the purposes of an administrative admission system will be considered the second stage of the overall project. Over the next 12 months, the Access to Medicines Working Group (AMWG) is expected to continue methodological work to develop the second phase of this project. The introduction of the Access System Management Provision is part of the growing cooperation between the Pharmaceutical Advisory Committee for Benefits (PBAC) and the Australian Department of Health and Aging with the pharmaceutical industry to improve the quality and strength of evidence provided to decision makers in claims. Competitors An application that attempts to identify another drug that treats the same disease as a drug already listed as part of an entry system administered may have the potential to alter the magnitude of future clinical needs, but not the QALY obtained.