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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| Language: | English |
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AboutScience Srl
2025-07-01
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| Series: | Global & Regional Health Technology Assessment |
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| Online Access: | https://journals.aboutscience.eu/index.php/grhta/article/view/3563 |
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| author | Silvia Adami Cosetta Bianchi Elisa Crovato Gianluca Trifirò |
| author_facet | Silvia Adami Cosetta Bianchi Elisa Crovato Gianluca Trifirò |
| author_sort | Silvia Adami |
| collection | DOAJ |
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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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| format | Article |
| id | doaj-art-ba57e2ac7ef1423282d30bd4f09f7f8a |
| institution | Kabale University |
| issn | 2284-2403 2283-5733 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | AboutScience Srl |
| record_format | Article |
| series | Global & Regional Health Technology Assessment |
| spelling | doaj-art-ba57e2ac7ef1423282d30bd4f09f7f8a2025-08-20T03:50:16ZengAboutScience SrlGlobal & Regional Health Technology Assessment2284-24032283-57332025-07-0112110.33393/grhta.2025.3563Real-World Evidence and Managed Entry AgreementsSilvia Adami0Cosetta Bianchi1Elisa Crovato2Gianluca Trifirò3Direzione Farmaceutico-Protesica-Dispositivi Medici, Regione del Veneto - ItalyDephaforum s.r.l., Milano - ItalyMarket Access Chiesi, Parma - ItalyDipartimento di Diagnostica e Sanità Pubblica, Università degli Studi di Verona, Verona - Italy 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. https://journals.aboutscience.eu/index.php/grhta/article/view/3563Managed Entry AgreementsReal-World DataReal-World EvidenceRegistry |
| spellingShingle | Silvia Adami Cosetta Bianchi Elisa Crovato Gianluca Trifirò Real-World Evidence and Managed Entry Agreements Global & Regional Health Technology Assessment Managed Entry Agreements Real-World Data Real-World Evidence Registry |
| title | Real-World Evidence and Managed Entry Agreements |
| title_full | Real-World Evidence and Managed Entry Agreements |
| title_fullStr | Real-World Evidence and Managed Entry Agreements |
| title_full_unstemmed | Real-World Evidence and Managed Entry Agreements |
| title_short | Real-World Evidence and Managed Entry Agreements |
| title_sort | real world evidence and managed entry agreements |
| topic | Managed Entry Agreements Real-World Data Real-World Evidence Registry |
| url | https://journals.aboutscience.eu/index.php/grhta/article/view/3563 |
| work_keys_str_mv | AT silviaadami realworldevidenceandmanagedentryagreements AT cosettabianchi realworldevidenceandmanagedentryagreements AT elisacrovato realworldevidenceandmanagedentryagreements AT gianlucatrifiro realworldevidenceandmanagedentryagreements |