Mogamulizumab is now recommended as standard treatment for two rare cutaneous lymphomas.
This is a big step, illustrating the increased importance of local RWE in the DMC assessment process. Using RWD from Danish patients to address the gaps and concerns flagged by the DMC in the initial assessment has changed a negative recommendation to a positive recommendation to a the importance of leveraging local RWE.
Danish Medicines Council has recommended mogamulizumab (Poteligeo) for adults with Sézary syndrome or advanced mycosis fungoides, both subtypes of cutaneous T-cell lymphoma.
The council estimates that around six patients per year will be eligible for treatment.
This decision reverses the council’s 2021 conclusion, when mogamulizumab was not recommended as standard treatment. The company returned with a new application including new ITC based on Danish registry data and a lower price.
Key points:
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The treatment may extend survival and help address severe skin itching, which can substantially reduce quality of life.
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The assessment is based on an indirect comparison with Danish registry data.
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There is substantial uncertainty about the size of the survival benefit.
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The council will examine options to follow treatment effectiveness through real-world data.
Reach out to Andreas Bentsen, ab@nhta.com or Asger Lindvig, al@nhta.com if you wish to know more about how to turn local RWE into positive HTA decisions.
Read more at https://medicinraadet.dk/nyheder/2026/medicinradet-anbefaler-ny-behandling-mod-to-sjaeldne-former-for-lymfekraeft
