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Breaking: Denmark speeds up access to PD-(L)1 immunotherapies

Cancer patients get faster access to certain PD-(L)1 immunotherapies in Denmark.

Inspired by the NT-Council in Swden, The Danish Medicines Council has adopted a new, simplified process for PD-(L)1 inhibitors in locally advanced inoperable or metastatic cancer, meaning many patients can start treatment within 10 days after marketing authorisation.

Key facts from the announcement:

  • The prior individual assessment (fast-track) process typically took around 14 weeks.

  • Under the new model, new PD-(L)1 drugs and eligible indication extensions are combined into a common, general recommendation for the whole class (instead of case-by-case review).

  • (Neo)adjuvant and perioperative indications are still assessed via Medicinrådet’s 14-week process.

  • The simplified model applies when the PD-(L)1 inhibitor is used as monotherapy or with non-patent-protected medicines, and when one-year drug costs are in line with others in the class (accepted annual price threshold).

The model takes effect 1 June and will be evaluated after one year.

Having developed an extensive number of applications following the 14-week process, NHTA will follow this closely and it will be interesting to see the impact this change will generate (timelines, patient impact, budget impact, competition, etc.)

Read more at https://medicinraadet.dk/nyheder/2026/kraeftpatienter-far-hurtigere-adgang-til-ny-immunterapi

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