Cost regulators for NHS treatments in England and Wales say they are currently minded not to recommend Takeda’s Adcetris on the NHS for relapsed or refractory systemic anaplastic large cell lymphoma (ALCL), a cancer of the lymphatic system.

The National Institute for Health and Care Excellence has requested a revised probabilistic cost-effectiveness analysis from the company which should include additional modelling of both progression-free survival and overall survival for chemotherapy, and full exploration of the parametric models for progression-free and overall survival for both Adcetris (brentuximab vedotin) and chemotherapy .

This is because while data from a single arm study (SG035-0004) in 58 patients suggest the drug is clinically effective based on response rates, there was uncertainty over the extent of progression-free survival and overall survival because median progression-free survival and overall survival were not reached, and also regarding the unadjusted indirect comparison with chemotherapy, the current standard of care.

Until new analyses are presented, Adcetris cannot be recommended as a cost-effective use of NHS resources in this setting, the Institute said.

The drug has been available to patients in England through the Cancer Drugs Fund since April 2013 for relapsed or refractory systemic anaplastic large cell lymphoma.

NICE recently published final guidance recommending routine use of the drug on the NHS as an option for treating CD30‑positive Hodgkin lymphoma in various settings.

Adcetris is an antibody-drug conjugate attached by an enzyme-cleavable linker to a potent chemotherapeutic agent, monomethyl auristatin E.