The UK’s National Institute for Health and Care Excellence (NICE) has not recommended Kyowa Kirin’s Poteligeo for the treatment of adults living with rare blood cancers in its final appraisal document (FAD).

Poteligeo (mogamulizumab) is a treatment for adults living with the rare blood cancers mycosis fungoides (MF) and Sézary syndrome (SS), two subtypes of cutaneous T-cell lymphoma (CTCL), who have received at least one prior systemic therapy.

In its FAD, NICE said that clinical trial evidence for Poteligeo is ‘very uncertain’ as the drug was compared with vorinostat, a treatment that is not used or licensed in the UK.

In addition, Poteligeo did not meet NICE’s criteria to be considered a life-extending treatment at the end of life.

The most likely cost-effectiveness estimates are much higher than what NICE usually deems an acceptable use of NHS resources, according to the FAD.

NICE also said that it could not recommend the treatment for use within the Cancer Drugs Fund (CDF), as collecting further data would be ‘unlikely’ to address the clinical uncertainty due to the limitations in the trial design.

In response to NICE’s decision, Richard Johnson, northern cluster general manager, responsible for the UK at Kyowa Kirin said: “We are disappointed that, despite feedback from the patient and clinical community together with extensive evidence provided, the appraisal committee’s decision is negative.”

“We fully support the recently published UK Rare Disease Framework and specifically priority 4 on ‘improving access to specialist care, treatments and drugs’. This is critically important given that many people with rare diseases, including those with CTCL, face challenges to access safe, high quality care and treatments,” he added.