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Medicinrådet launches real-world data pilots in oncology

Real-world follow-up is moving to the forefront of oncology decision-making in Denmark.

Medicinrådet has initiated work (as part of Kræftplan V) to develop and test models for collecting and using real-world data (RWD) to assess cancer treatments’ effectiveness, safety, and use after implementation.

The council notes that decisions on whether new medicines can be used as potential standard treatment in Denmark are increasingly made on very limited data, a challenge expected to grow alongside rising medicine costs.

A steering group with broad representation from healthcare system actors has been established, and pilot projects will be used to iteratively develop and adjust RWD models and processes in Danish clinical practice.

First two RWD pilot cases:

  • Pembrolizumab + chemotherapy in non-squamous NSCLC with PD-L1 <1%, without ALK translocation or activating EGFR mutation.
  • Sacituzumab govitecan in unresectable or metastatic triple-negative breast cancer.

Medicinrådet also plans to tender analytical support for the pilots in spring 2026 via the EU Official Journal. Read more at https://medicinraadet.dk/nyheder/2026/medicinradets-arbejde-med-real-world-data-er-i-gang

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