1.1 Mogamulizumab is recommended, within its marketing authorisation, as an option for treating Sézary syndrome in adults who have had at least 1 systemic treatment. It is recommended only if the company provides mogamulizumab according to the commercial arrangement.
1.2 Mogamulizumab is recommended as an option for treating mycosis fungoides in adults, only if:
their condition is stage 2B or above and
they have had at least 2 systemic treatments and
the company provides mogamulizumab according to the commercial arrangement.
1.3 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.
Standard care for previously treated mycosis fungoides or Sézary syndrome includes brentuximab vedotin, methotrexate, bexarotene, peginterferon and chemotherapy.
Mogamulizumab is licensed for treating mycosis fungoides and Sézary syndrome in adults who have had at least 1 systemic treatment. The company has positioned it for Sézary syndrome after 1 or more systemic treatments but only for advanced mycosis fungoides after 2 or more systemic treatments. This is because there are limited treatment options for this population.
Mogamulizumab has not been directly compared with standard care used in the NHS. It has only been directly compared with vorinostat, which is not available in the UK. Indirectly comparing mogamulizumab with evidence from people having standard care in the NHS suggests that people are likely to live longer with mogamulizumab. The evidence from this indirect comparison is uncertain because all the different factors that affect clinical outcomes may not have been considered. But it is unlikely that the evidence can be improved so the uncertainty is considered acceptable.
Mogamulizumab does not meet NICE's criteria to be considered a life-extending treatment at the end of life. Also, there is uncertainty about the cost-effectiveness evidence, but the cost-effectiveness estimates are likely to be within what NICE normally considers an acceptable use of NHS resources. So, mogamulizumab is recommended.