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Ozanimod for treating relapsing–remitting multiple sclerosis

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1 Recommendations

1.1 Ozanimod is not recommended, within its marketing authorisation, for treating relapsing–remitting multiple sclerosis in adults with clinical or imaging features of active disease.

1.2 This recommendation is not intended to affect treatment with ozanimod that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Disease-modifying treatments for relapsing–remitting multiple sclerosis include alemtuzumab, beta interferons, cladribine, dimethyl fumarate, fingolimod, glatiramer acetate, natalizumab, ocrelizumab and teriflunomide. Treatments aim to reduce the number of relapses, slow the progression of disability and maintain or improve quality of life.

Clinical trial evidence shows that ozanimod reduces the number of relapses and brain lesions compared with interferon beta‑1a. However, ozanimod's effect on the progression of disability is unclear. It is uncertain how effective ozanimod is compared with other treatments because there is no evidence directly comparing them.

The cost-effectiveness estimates are uncertain because of limitations in the clinical effectiveness evidence and are above what NICE normally considers an acceptable use of NHS resources. Therefore, ozanimod is not recommended.