1 Recommendations

1.1 Ofatumumab is recommended as an option for treating relapsing–remitting multiple sclerosis in adults with active disease defined by clinical or imaging features. This is only if the company provides ofatumumab according to the commercial arrangement.

1.2 This recommendation is not intended to affect treatment with ofatumumab 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

NHS treatments for relapsing–remitting multiple sclerosis include alemtuzumab, beta interferons, cladribine, dimethyl fumarate, fingolimod, glatiramer acetate, natalizumab, ocrelizumab and teriflunomide.

Clinical trial evidence shows that, in people with relapsing–remitting multiple sclerosis, ofatumumab reduces the number of relapses and slows disease progression when compared with teriflunomide. There is no evidence directly comparing ofatumumab with the other treatments listed. But indirect comparisons suggest that ofatumumab reduces the number of relapses and slows disability progression compared with beta interferons, cladribine, dimethyl fumarate, fingolimod, glatiramer acetate and teriflunomide. They also suggest it is as effective as alemtuzumab, natalizumab and ocrelizumab.

The most likely cost-effectiveness estimates suggest ofatumumab is cost effective and an acceptable use of NHS resources, so it is recommended.