The National Institute for Health and Care Excellence (NICE) has rejected NHS funding for an intravenous formulation of GlaxoSmithKline's Benlysta (belimumab) as an add-on therapy for certain patients with active autoantibody-positive systemic lupus.

The preliminary decision, outlined in an appraisal consultation document, relates to use of the drug in people aged five years and older when there is a high degree of disease activity (for example, positive anti-double-stranded DNA, low complement) and despite standard therapy, as per its marketing authorisation.

According to NICE, while clinical trial evidence suggests that after a year of treatment Benlysta plus standard therapy reduces disease activity more than standard therapy alone, “the results are uncertain because the trials were short”.

Also, it noted that the long-term benefit of Benlysta compared with standard therapy or rituximab is unknown, as long-term extension studies did not have comparator arms.

Cost-effectiveness estimates are also uncertain, and are most likely higher than what is normally considers an acceptable use of NHS resources, the Institute said.

The consultation is open until June 25 for comments.