This study mapped off-label oncology drug use in The Netherlands and the Dutch framework for reimbursing it. Indication-drug pairs were classed from European Medicines Agency authorisations and European Society for Medical Oncology guidelines. As of January 2025, 331 of 930 (35.6%) reimbursable pairs were off-label, 90.3% involving high-cost drugs and 67.1% chemotherapy. In 2023, off-label use made up 24.4% of high-cost prescriptions but 2.3% (€30.3 million of €1.3 billion) of spending. Targeted therapies took 67.7% of off-label costs, and the framework reimbursed treatments meeting clinical-benefit thresholds. Evidence was reviewed only for selected treatments, and its strength varied for rarer indications.
Why it is interesting: It puts national figures on how far cancer treatment runs beyond its licensed indications. Frequently used off-label treatments had strong evidence, while evidence for rarer indications varied.
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