mogamulizumab (Poteligeo)

Following a full submission assessed under the orphan medicine process:

mogamulizumab (Poteligeo®) is accepted for restricted use within NHSScotland.

Indication under review: treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

SMC restriction: for the treatment of patients with advanced MF or SS (stage ≥IIB MF and all SS) following at least one prior systemic therapy, who are clinically ineligible for or refractory to treatment with brentuximab vedotin.
In an open-label phase III study, mogamulizumab, compared with a histone deacetylase (HDAC) inhibitor, was associated with a significant improvement in progression-free survival.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.