RWE4Decisions outlines stakeholder actions needed to advance real-world evidence to support HTA and payer decisions

RWE4Decisions is seeking feedback on a set of draft actions recommended for various stakeholder groups to develop the use of real-world evidence (RWE) to inform healthcare decisions made by health technology assessment (HTA) bodies and payers.

Building on previous work, RWE4Decisions has announced the launch of a public consultation for their latest publication entitled, “Draft Actions for Stakeholders to Generate Better Real-World Evidence for HTA/payers.” This initiative aims to evaluate policy and system developments from the past 5 years and provide recommendations to stakeholder groups on how to support HTA/payers in utilizing robust RWE to inform decision-making. Actions are proposed for six stakeholder groups: national and collaborative HTA bodies/payers, pharmaceutical industry, clinical teams, patient groups, disease registry holders and real-world data (RWD) analytics groups.

RWE4Decisions is a ‘HTA/payer-led learning network facilitating multi-stakeholder dialogues on issues related to the use of robust RWE in healthcare systems, particularly in HTA/payer decisions about highly innovative medicines, where clinical evidence is often immature and prices are high.’ The draft actions were initially developed from focus group discussions with each stakeholder group, focusing on the progress and remaining challenges related to a previous set of stakeholder actions published in 2020. Subsequently, all actions were discussed and refined by expert facilitators from each stakeholder group during a multidisciplinary roundtable meeting and a public webinar organized by RWE4Decisions.

The proposed actions recommend collaborative and systematic measures for six stakeholder groups to enhance the generation, analysis, and interpretation of RWD to produce high-quality RWE for HTA and payer decision-making. Several actions address emerging policy issues across Europe; for example, one action calls for collaborative HTA/payer groups, such as Beneluxa, to, “develop a joint voice on issues to feed into policy and system developments like the [European Health Data Space] EHDS and DARWIN EU.” Similarly, payer groups are urged to, “engage in RWD initiatives, such as IHI projects, regulatory and HTA-led activities, and policy developments like the EHDS.” Clinical teams are encouraged to, “engage in developments related to the EHDS to support public and political awareness of the value of secondary use of health data.” Patient groups should, “seek to influence the implementation of the EHDS and understand its implications for national data collection systems, particularly to ensure patients have access to their own data.”

The pharmaceutical industry is encouraged to, “engage and support the operationalization of the EU Regulation on Health Technology Assessment (HTAR) to highlight the need for RWE in the first two tranches of joint clinical assessments (JCAs) and promote the development of clear guidance on assessing RWE in the EU HTA context.” This action extends to RWD/analytics groups, who are recommended to, “build an RWE analytics knowledge base and support RWE assessment and generation within HTA bodies, linking to new policy initiatives such as the HTAR.”

Organizations are invited to submit their responses to the proposed draft actions by July 15, 2024.