Managed Entry Agreement Definition

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 – Unpublished: The information is not publicly available, but is not confidential and may be shared with third parties upon request.1.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. It is considered that adaptive route products would be more dependent on observational studies that would replace Phase III studies. However, in practice, conditional marketing authorization is generally granted, with a legal obligation to conduct confirming clinical trials rather than relying exclusively on observational studies. Banzi et al. (2015) reviewed all 24 conditional marketing authorizations between 2006 and 2014 and documented the study projects that served as the basis for the approval and specific obligations required by regulators (Banzi et al., 2015). Conditional marketing authorizations are generally issued on the basis of a single-arm Phase II study; b) a single-arm Phase II study and a Phase III-RCT (ongoing or completed); (c) intermediate data from a Phase III RCT; or (d) double-blind phase III RCT.

In addition, the type of study to which the manufacturer was required to convert conditional marketing authorization into a full marketing authorization for 22 out of 24 products was an RCT; as a general rule, either a Phase III RCT, the final analysis of a Phase III RCT, or a long-term follow-up of a Phase III RCT (Banzi et al., 2015). As the EMA has repeatedly stated, that marketing licensing standards will not change under adaptive channels7, rct evidence is the standard for statutory obligations under conditional marketing authorizations and not for compliance studies. However, interviews have shown that, despite current regulatory data developments, this evidence has generally not been used by payers or HTA entities to enter into results-based agreements for these types of products.