Real-World Evidence e Managed Entry Agreements

Abstract

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.

FIGURA 1 -

Il panorama delle banche dati sanitarie (2).

FIGURA 2 -

Tassonomia dei Managed Entry Agreements (5).