The National Institute for Health and Care Excellence (NICE) does not recommend Zeposia (ozanimod) be available at low or no cost through the National Health Service (NHS) to treat adults with active relapsing-remitting multiple sclerosis (RRMS) living in England and Wales.
In a recent draft recommendation, NICE stated that data from two clinical trials — the Phase 3 SUNBEAM (NCT02294058) and the Phase 3 portion of RADIANCE (NCT02047734) — showed Zeposia was superior to Avonex (interferon beta-1a, by Biogen) at reducing the frequency of MS relapses, as well as the number of brain MRI lesions in RRMS patients.
However, no statistically significant differences were observed between the two treatments regarding their ability to halt disability progression.
Due to the lack of evidence on disability worsening with Zeposia’s use, NICE argued the medication cannot be considered a cost-effective treatment at this point, and its inclusion and availability through the NHS — a publicly funded healthcare system — is not warranted.
NICE requested that Celgene — Zeposia’s manufacturer, now a subsidiary of Bristol Myers Squibb — provide additional evidence and a more detailed analysis of clinical trial data regarding the therapy’s effects on disability progression.
NICE’s opinion came as a disappointment to the MS Trust, a U.K. nonprofit organization that has taken part in Zeposia’s appraisal. It plans to send a formal reply to the U.K. health agency.
Comments and suggestions regarding this recommendation can be made through NICE’s website until Feb. 12 at 5 p.m. local time. NICE’s appraisal committee will then meet to re-evaluate all the evidence, review comments submitted, and draw up a final appraisal document.
RRMS patients already being treated with Zeposia and payment arrangements in place are not affected by this guidance, NICE noted. Treatment may continue until “they and their NHS clinician consider it appropriate to stop.”
Zeposia, an oral treatment, is approved in the U.S. and Europe to treat adults with active RRMS. The therapy works by preventing overactive immune cells that attack the brain and spinal cord in people with MS from leaving lymph nodes. It does so by blocking the activity of selective sphingosine 1-phosphate (S1P) receptors, which are found on the surface of certain types of immune cells and are responsible for guiding them out of lymph nodes.
Zeposia is also being investigated as a potential treatment for ulcerative colitis and Crohn’s disease, two inflammatory diseases that affect the gastrointestinal tract.
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