NICE is not recommending NHS funding for Kyowa Kirin's Poteligeo (mogamulizumab) as a treatment for mycosis fungoides or Sézary syndrome for adults who have had at least one previous systemic treatment.
In preliminary guidelines, the Institute said clinical trial evidence is 'very uncertain' because mogamulizumab is compared with vorinostat, a treatment that is not used or licensed in the UK, where standard care for mycosis fungoides or Sézary syndrome in people who have had a least one previous systemic treatment includes methotrexate, bexarotene, interferon and chemotherapy.
Also, many people switch treatments and there are a lot of differences among the trial population, so it is unclear how well mogamulizumab works, NICE said.
The Institute also noted that the drug mogamulizumab does not meet NICE’s criteria to be considered a life-extending treatment at the end of life.
As such, the most likely cost-effectiveness estimate is much higher than what NICE normally considers an acceptable use of NHS resources, and collecting further data is 'unlikely to address the clinical uncertainty because of the limitations in the trial design', it concluded.
Poteligeo (mogamulizumab) is a humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), approved in Europe in November 2018 for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
In a Phase III trial, the immunotherapy showed significantly superior progression-free survival (PFS) than vorinostat, with data showing a median of 7.7 months versus to 3.1 months, respectively.