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. Given that adaptive pathways include the use of conditional marketing authorization, this finding has a significant impact on the introduction of adaptive products and merits further analysis. It raises the question of the extent to which products previously licensed with conditional marketing authorizations would meet the criteria for selecting adaptive pathways. It is also possible that not all conditionally authorized products automatically have the characteristics that would make it suitable for a results-based agreement. Payers and manufacturers may also have different ideas about the type of product that would be an appropriate candidate for a results-based agreement. In the context of publicly funded health systems in Europe, the availability and capacity of manufacturers, payers and health technology assessment agencies (HTAs) is a prerequisite for the proper functioning of your system.
This has caused hesitation, especially in HTA bodies and paying agencies, as many fear having to pay for poorly tested but expensive treatments (Ermisch et al., 2016). At the same time, manufacturers are not clear as to how HTA positions and payers will evaluate the first data package for products in adaptive channels, and therefore there are uncertainties about possible price entry and management models. According to the EMA definition, the adaptive approach is a scientific approach to drug development, which aims to facilitate patients` access to promising drugs that sustainably address needs not met by a prospective approach.