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Mogamulizumab for previously treated mycosis fungoides and Sézary syndrome

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1 Recommendations

1.1 Mogamulizumab is not recommended, within its marketing authorisation, for treating mycosis fungoides or Sézary syndrome in adults who have had at least 1 previous systemic treatment.

1.2 This recommendation is not intended to affect treatment with mogamulizumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Standard care for mycosis fungoides or Sézary syndrome in people who have had at least 1 previous systemic treatment includes methotrexate, bexarotene, interferon and chemotherapy.

The clinical trial evidence is very uncertain because mogamulizumab is compared with vorinostat, a treatment that is not used or licensed in the UK. Also, many people switch treatments and there are a lot of differences among the trial population. This means it is unclear how well mogamulizumab works.

Mogamulizumab does not meet NICE's criteria to be considered a life-extending treatment at the end of life. The most likely cost-effectiveness estimate is much higher than what NICE normally considers an acceptable use of NHS resources. So mogamulizumab cannot be recommended for routine use in the NHS.

Collecting further data is unlikely to address the clinical uncertainty because of the limitations in the trial design. So mogamulizumab cannot be recommended for use within the Cancer Drugs Fund.