JB and SG were employed by the health authorities at the time of writing and CS is employed by F. Hoffmann La Roche. However, the content of the document and the conclusions are those of each author and cannot be understood as reflecting the content of the organization that employs them. The authors explain that the research was funded by the Innovative Arzneimittel initiative 2 Joint Undertaking under Grant Agreement 115890. This joint venture is supported by the European Union`s Horizon 2020 research and innovation programme and EFPIA. So far, an agreement on health outcomes has been implemented. The cost of hospital treatment has increased rapidly in Finland. In 2017, medaffcon conducted a survey to understand what methods other than flat-rate rebates are used to facilitate access to hospital care. The survey focused on entry-level manague agreements, which provide access to patented drugs made over the past two years (2015-2017).
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. We have defined a manague entry agreement as an agreement between a manufacturer and a payer/supplier that allows access to health technology under certain conditions (Figure 2).2). We examined the scientific and grey literature on administered registration agreements (Figure 3) using a pyramidal approach to identify publications that (a) report on stakeholder experience with different types of entry agreements under management, b) describe different types of entry agreements under management or (c) the pros and cons of their use. The resulting documents were used to develop semi-structured issues for interviews with key stakeholders: manufacturers (also market authorization holders), payers and HTA agencies.
At the same time, we sent a questionnaire to European payers and HTA agencies asking for the status of products that were granted conditional marketing authorisation or approved in exceptional circumstances in 2006-2016. Given that no adaptive products were introduced (mid-2016), we felt that this subset of marketing authorizations was the best way to reflect the introduction of a product requiring additional evidence. During the interviews, manufacturers indicated that they were routinely invited by the EMA to collect additional data on TCR, safety studies or patient registries as part of conditional marketing authorizations.