– Financial agreements are easier to implement, but miss the opportunity to use evidence generated after approval. A possible agreement could combine financial components with a hovering, taking into account the results of new discoveries from TTS, observational studies, registries or electronic medical records; Confidentiality of performance-based MEA information versus interest in such informationNumbre from countries where information is not confidential and where there is interest in such information from other countries, based on interviews with experts from 12 OECD countries (1) using PERFORMANCE-based MEAs… Managed Membership Treaty.- Published: Information is easily accessible in the public domain (z.B. on the Internet). – Unpublished: The information is not publicly available, but is not confidential and may be shared with third parties upon request.1. Australia, Belgium, the Czech Republic, Estonia, France, Hungary, Italy, Korea, Lithuania, the Netherlands, Sweden, the United Kingdom (England only) – information about Australia only relates to ad hoc agreements. Information for England relates only to access to employment agreements (31 agreements under the Cancer Prevention Fund and 4 for other OECD-controlled disease areas) that are publicly available; Not to other patient access systems. Source: Author of the study based on interviews with OECD experts. 3IMI ADAPT SMART workshop – Introduced managed in the context of adaptive trails (London, 5 July 2016) Brief workshop report. available on adaptsmart.eu/wp-content/uploads/2016/02/ADAPT-SMART-Managed-entry-short-WS-report.pdf – The complexity of results-based accounting agreements could be mitigated by the use of existing data infrastructure to avoid long periods of study and the use of simple outcome measures (e.g. B interruption time, hospitalization), which can be followed more easily in clinical practice; Discussions at the ADAPT-SMART3 workshop found that, in addition to technical, medical and political factors, a lack of trust between payers and manufacturers could be one of the main obstacles to the wider use of results-based agreements.
Payers and HTA posts indicated that they still see very high prices for new products without much differentiation in terms of value added, while manufacturers indicated that payers appeared to be more concerned about the budget implications and were not willing to consider more complex agreements4. We believe that an adaptive pathway could be an appropriate environment to solve some of these confidence problems: (i) products for adaptive pathways should have a reasonable expectation of considerable added value5, i.e., a questionable product value would not be a problem, (ii) early dialogue takes place years before products are put on the market that could facilitate the development of viable payment models when stakeholders largely agree that these products are needed, and (iii) Adaptive Pathways products would be closely monitored in the market, and ways could be explored to facilitate regulatory and ATA surveillance, for example through the EMA6 registration initiative.