Public Consultation: Stakeholder Actions

In 2020, RWE4Decisions published a paper on the actions that stakeholder groups could undertake to support the use of robust real-world evidence in HTA/Payer decisions about highly innovative technologies. This concerned HTA/Payers, pharmaceutical industry, clinicians, patient groups, disease registry holders, and real-world data (RWD) analytics groups. In view of the changes which have occurred since its writing, a review of this publication is necessary. Based on focus group discussions with each stakeholder group and two multidisciplinary meetings, we have developed a series of new draft actions. These actions are now issued for public consultation, with responses sought from organisations.

Working within the principles of collaboration and transparency, each stakeholder can undertake actions to support the use of real-world evidence in Payer/HTA decisions about highly innovative technologies.

We invite organisations to participate in the public consultation on the Draft Stakeholder Actions, which will be open until the 28th of June 2024.

Click here to access the public consultation

See the Revision Timeline

Download the Paper Published in 2020

Real-world Evidence to Support Payer/HTA Decisions about Highly Innovative Technologies in the EU – Actions for stakeholders
Paper

Real-world Evidence to Support Payer/HTA Decisions about Highly Innovative Technologies in the EU – Actions for stakeholders

September 2020
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This paper goes beyond strategic intent to consider actions that regulators, HTA bodies, Payers, clinicians and patients could take to improve the use of real-world data to inform their decision. Case studies of recent Payer/HTA assessments about highly innovative technologies showed that there was a lack of clarity about the Payer/HTA questions that could be answered by RWD and how the quality of real-world evidence (RWE) could be assessed. For each stakeholder group, recommended actions to support the generation, analysis and interpretation of RWD to inform decision-making were developed.
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