The National Institute for Health and Care Excellence (NICE) has recommended Eli Lilly’s Taltz for the treatment of active ankylosing spondylitis (axSpA).
The final appraisal document has specifically cleared Taltz (ixekizumab) for use in axSpA that is not controlled well enough with conventional therapy, or for active non-radiographic axial spondyloarthritis with objective signs of inflammation that is poorly controlled with nonsteroidal anti-inflammatory drugs (NSAIDs).
NICE has only recommended Taltz where tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough, and if Lilly provides the drug according to the commercial arrangement.
The main clinical trial evidence used to support the recommendation came from three placebo-controlled randomised clinical trials in patients who had an inadequate response or intolerance to NSAIDs.
This included the COAST-V, COAST-W and COAST-X studies, which were designed to assess the efficacy and safety of both radiographic and non-radiographic axSpA.
In these studies, Taltz demonstrated significant reductions of the signs and symptoms of axSpA, as assessed by the proportion of patients achieving the primary endpoint of Assessment of Spondyloarthritis International Society (ASAS) 40 at week 16 compared with placebo.
NICE also determined that the cost-effectiveness estimates for Taltz compared with conventional therapy, using direct evidence from the COAST trials, were within the range that the watchdog normally considers to be a cost effective use of NHS resources.
“Many patients living with axSpA suffer from chronic back pain and associated functional disability, which has a detrimental impact on their quality of life. We’re very pleased that NICE is recommending Taltz as a new treatment option,” said Jyun Yan Yang, senior medical director Lilly, UK and Northern Europe.