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New report on relevance of transversal budget impact analysis by KCE in Belgium
In late June 2023, the Belgian Health Care Knowledge Center (KCE) published a report on transversal budget impact analysis. The budget impact analysis (BIA) is required to obtain reimbursement for implants and invasive medical devices. BIA should be submitted as part of the application to the National Institute for Health and Disability Insurance (INAMI-RIZIV) commission for reimbursement of implants and invasive medical devices (CTIIMH-CRIDMI). In that context, BIA is used to estimate the financial consequences of reimbursing the implant or medical device. The “transversal” approach means that consequences are considered for all payers in the healthcare system.
BIAs are currently mainly based on randomized controlled trials (RCT) results. The aim of the study was to evaluate how real-world data from Belgian national databases could be used to obtain more precise cross-sectional BIAs. Currently, manufacturers have only limited access to the information contained in these datasets.
KCE concluded in the report that real-world data could provide valuable additional information for BIAs, for example, about the expected number of patients or the cost of the device, hospitalization, and subsequent medical follow-up. However, the industry should continue to collect a certain amount of evidence through RCTs that cannot be obtained from real-world data sources.
Furthermore, KCE made recommendations for industry and other stakeholders regarding BIA and for Belgian authorities regarding improving access and quality of real-world data.
See the full details in French here.
This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Contact us to get a free, three-month, no-obligation trial.