Executive Summary
A technical workshop is planned for later this year to identify common “use cases” for real-world evidence that are important to the European Medicines Agency, health technology assessment bodies and payers. 
Source: AlamyANALYSIS OF RWD DATABASES CAN PROVIDE VALUABLE INFORMATION TO SUPPORT REGULATORY AND REIMBURSEMENT DECISIONS
The European Medicines Agency is working with representatives of EU health technology assessment (HTA) bodies and payers to identify situations where the use of real-world evidence (RWE) might be of interest to all three of them to support their respective decision-making functions.
Once RWE “use cases” that are common to the regulators, HTA bodies and payers are identified, the plan is to launch pilot studies on the topic later this year and in 2023. “In this context, a technical workshop with HTA bodies and payers is planned in Q3 2022,” the EMA told the Pink Sheet.
The pilot studies will be delivered via the EU initiative that involves integrating various real-world databases in the region into a single, secure network, called the Data Analysis and Real World Interrogation Network (DARWIN EU). (Also see “DARWIN EU: The Go-To Place For Real World Data” – Pink Sheet, 1 Mar, 2022.)
DARWIN EU is being set up by the EMA and the EU Heads of Medicines Agencies, with support from the European Commission, to help deliver timely and reliable RWE from across Europe on the use, safety and effectiveness of medicines. While DARWIN EU will primarily be used by regulators in the EU medicines regulatory network to support medicines evaluation, it can also provide HTA bodies and payers with RWE to inform their assessments.
Initial discussions on HTA and payer RWE use cases took place at DARWIN EU advisory board meetings in November 2021 and February 2022, during which a “significant overlap” was noted with the use cases identified by the European medicines regulatory network, the EMA said. This prompted discussions to agree on use cases for which RWE was important to all three stakeholders.
Last month, the EMA published the minutes of the February 2022 advisory board meeting, where Wim Goettsch, representative for the EU Payers Association, said that payers’ preferred use cases for RWE were for ultra-orphan drugs, advanced therapies, oncology agnostic treatments, for products with limited information after marketing, treatments targeting small patient groups and products with high uncertainty, high price and high heterogeneity.
The disease areas where the use of real-world data is considered by payers include hemophilia, beta-thalassemia, spinal muscular atrophy, metachromatic leukodystrophy and oncology agnostic treatments, the minutes state.
Source: https://pink.pharmaintelligence.informa.com/PS146408/EMA-HTA-Bodies–Payers-Explore-Common-Ground-On-Use-Of-RWE