The UK’s National Institute for Health and Care Excellence (NICE) has rejected Bristol Myers Squibb’s (BMS) Zeposia (ozanimod) for the treatment of relapsing/remitting multiple sclerosis (RRMS).
In an appraisal consultation document, NICE said that although there is evidence that Zeposia can reduce the number relapses and brain lesions compared to interferon beta-1a, the drug’s effect on disability progression is unclear.
NICE also said that the cost-effectiveness estimates for Zeposia were uncertain due to the ‘limitations’ In the clinical effectiveness evidence, adding that they ‘are above what NICE normally considers an acceptable use of NHS resources’.
Last May, Zeposia was cleared by the European Medicines Agency for the treatment of RRMS and also gained an approval from the US Food and Drug Administration (FDA) last year.
“It’s frustrating NICE has made a decision not to recommend Zeposia as a treatment for relapsing multiple sclerosis (MS). While there are a range of treatments for this form of the condition, oral options are limited, and people could benefit enormously from a new, more convenient alternative,” said Sarah Rawlings, director of Research and External Affairs at the MS Society.
“NICE’s decision isn’t final, and we are urging them and the manufacturer to review the evidence and consider what’s best for those living with MS.
“Zeposia would be the only oral first-line treatment for some people with relapsing MS, and we are hopeful both sides will act on the significance of this,” she added.