Real-World Evidence and Managed Entry Agreements
Introduction: Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources such as Electronic Health Records (EHRs), data from product and disease Registries, patient generated data, etc. Real-World Evidence (RWE)...
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| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
AboutScience Srl
2025-07-01
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| Series: | Global & Regional Health Technology Assessment |
| Subjects: | |
| Online Access: | https://journals.aboutscience.eu/index.php/grhta/article/view/3563 |
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| Summary: | Introduction: Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care
routinely collected from a variety of sources such as Electronic Health Records (EHRs), data from product and
disease Registries, patient generated data, etc.
Real-World Evidence (RWE) is the clinical evidence about the usage and potential benefits and/or risks of a medical
product derived from the analysis of Real-World Data.
This document illustrates the results of a discussion of a multi-disciplinary expert Panel on the role of RWE with
specific regard to both the post-marketing (re)evaluation of the benefit-risk profile of drugs in the real-world
setting and the management of uncertainty about efficacy and safety at the time of their marketing, through
Managed Entry Agreements (MEAs).
Method: The debate took place during the 7th edition of the Seminari di Mogliano Veneto, attended by experts
working in different organizations.
Results: The experts have emphasized the need (i) to introduce outcome-based MEA for drugs with high uncertainty
in outcomes and a high impact on spending, (ii) to evaluate the opportunity to define any secondary
objectives in order to be able to carry out additional evaluations when establishing a new Registry, and (iii) to use
other data sources through linkage and interoperability of the information systems involved (e.g., administrative
databases, disease Registries).
The Panel also agreed on a general need to define guidelines at national level on how to generate RWE to support
the various regulatory processes including evaluation for the purposes of applying MEA and price renegotiation.
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| ISSN: | 2284-2403 2283-5733 |