Session (CTI)

Issue: As healthcare systems face growing pressure to allocate scarce resources to innovative health technologies, real-world evidence (RWE) is increasingly considered to support access decisions. However, the use of RWE to inform reassessment and potential decommissioning of existing health technologies is less established. Is RWE robust enough to justify withdrawal, reimbursement restrictions on specific patient populations, and what evidence is required within a transparent and ethical governance framework? The session will discuss key uncertainties around using RWE to reassess the value of health technologies and inform potential decommissioning, including pre-specified reassessment criteria, analytic standards, funding, governance, independent review of data generation, and safeguards to manage bias and conflicts of interest when manufacturer-sponsored analyses may influence reimbursement restrictions. Overview: This panel will debate whether and how real-world evidence should influence reimbursement reassessment and decommissioning decisions. Julie De Almeida will open by framing the debate using examples including NICE's use of the SACT dataset in oncology reassessment and the CanREValue framework. Prof. Durand-Zaleski will provide an HTA perspective, discussing how RWE could trigger reassessment and decommissioning decisions by identifying low-value prescribing, limited effectiveness in routine practice, safety concerns, inappropriate use, or subgroups where reimbursement is no longer justified. From an industry perspective, Dr. Balp will highlight challenges of using observational data to support decommissioning decisions, including the potential impact on patients already treated, incentives for evidence generation, and implications for innovative therapies. A key question is who should fund RWE that may result in decommissioning or reimbursement restrictions? Prof. Jönsson will provide an independent academic perspective, challenging both viewpoints and asking whether there should be pre-specified reassessment criteria at initial coverage making RWE critical across the lifecycle of a health technology.