The National Institute for Health and Care Excellence (NICE) has published positive guidance, in the form of a Final Appraisal Determination (FAD), confirming that POTELIGEO (mogamulizumab) is recommended as a treatment option for adults in England and Wales with the ultra-rare blood cancers mycosis fungoides (MF) and Sézary syndrome (SS), two forms of cutaneous T-cell lymphoma (CTCL). The treatment is approved for use after two prior systemic treatments for adults living with MF and after one prior systemic therapy for adults living with SS.
The FAD comes following a successful appeal lodged by Kyowa Kirin, Lymphoma Action, Leukaemia Care, and the UK Cutaneous Lymphoma Group (UKCLG) in response to a previous appraisal by NICE, published on 4 March 2021, that concluded POTELIGEO would not be made available on the NHS in England and Wales.
All parties involved in lodging the appeal welcome the new, positive decision by NICE as it represents a distinctive step forward in addressing the high unmet clinical needs of those living with MF and SS. This decision also marks another milestone in the availability of POTELIGEO across the United Kingdom, following the acceptance of POTELIGEO by the Scottish Medicines Consortium (SMC) for adults living with MF and SS in Scotland on 7 June 2021.
Richard Johnson, Northern Cluster General Manager, responsible for the UK at Kyowa Kirin, said: “This is a momentous day for those living with MF and SS in the UK. By issuing positive guidance for POTELIGEO, NICE has helped ensure that those with MF and SS who have few systemic treatment options available to them are now able to access an innovative therapy. This decision is also testament to the dedication, commitment and long-term efforts of the broader CTCL community in advocating for a wider range of treatment options in the UK for those living with conditions like MF and SS.”
Ropinder Gill, Chief Executive at Lymphoma Action, commented: “We’re really grateful and delighted with this decision. Mogamulizumab can have a life changing impact for those people affected by cutaneous T-cell lymphoma, a form of the rare condition skin lymphoma. They have limited treatment options – this is a great outcome for them. We were privileged to be part of the process alongside others, and to represent the patient voice with our patient advocate Stan.”
Prof Julia Scarisbrick, consultant dermatologist and head of the Cutaneous Lymphoma Service within the Rare Diseases Centre at University Hospital Birmingham, added: “Adults living with CTCL have significant unmet clinical need and a lack of treatment options available to them. There has been a real need to address this for a long time and particularly so for those at the advanced stages of the disease, who have a poorer prognosis and impaired health related quality of life.4 With NICE’s decision, adults with MF and SS across the whole UK now have an effective, well tolerated therapy shown to improve quality of life available to them that can provide a welcome alternative to those who need it.”