The Danish Medicines Council (Medicinrådet) has commissioned two real-world evidence pilots to test whether outcomes achieved after national recommendation match the clinical assumptions used in the original assessment. The work forms part of a wider programme to make systematic post-launch evidence collection a more usable part of Danish hospital-medicine access.
The Danish Alliance for Real-World Evidence (DARE) will analyse pembrolizumab plus chemotherapy in patients with non-squamous non-small-cell lung cancer with PD-L1 expression below 1% and no ALK translocation or activating EGFR mutation. The second pilot covers sacituzumab govitecan in unresectable or metastatic triple-negative breast cancer.
The Council identifies a recurring evidence problem. Trial populations can differ from patients treated in Denmark, while study comparators may represent weaker treatment than current Danish practice. Real-world follow-up will examine whether effectiveness, safety and use after recommendation support the original assessment of benefit relative to cost.
The Council has been able to issue time-limited conditional recommendations since 2022 while additional evidence is collected. Its subsequent experience found these arrangements difficult to establish, partly because they require lower prices during the evidence-generation period, companies face uncertainty over the position after temporary access ends, and clinical follow-up lacks consistent infrastructure.
The pilots therefore have a wider methodological purpose. The Council wants to develop a reusable framework for post-launch data collection and analysis across new treatments. Its Real-World Data Partnership runs from 2025 to 2028 and receives DKK6 million annually during 2026–2028 through Cancer Plan V.
A workable follow-up model could allow the Council to accept greater uncertainty in selected initial assessments while linking access more systematically to subsequent evidence and reassessment.
Source: Danish Medicines Council
Link: Medicinrådet samarbejder med DARE om real-world data (Danish Medicines Council collaborates with DARE on real-world data)
Date: 3 July 2026
Source: Danish Medicines Council
Link: Medicinrådets arbejde med real-world data er i gang (Danish Medicines Council’s work on real-world data is under way)
Date: 4 March 2026
