1 Recommendations

1 Recommendations

1.1 Ocrelizumab is recommended as an option for treating relapsing–remitting multiple sclerosis in adults with active disease defined by clinical or imaging features, only if:

  • alemtuzumab is contraindicated or otherwise unsuitable and

  • the company provides ocrelizumab according to the commercial arrangement.

1.2 This recommendation is not intended to affect treatment with ocrelizumab 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

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

Clinical trial results show that ocrelizumab reduces the number of relapses and slows disability progression compared with interferon beta‑1a for people with relapsing–remitting multiple sclerosis. There is no evidence directly comparing ocrelizumab with other treatments. Indirect analyses suggest that ocrelizumab reduces the number of relapses compared with interferon beta‑1b, glatiramer acetate, dimethyl fumarate, fingolimod and teriflunomide, and is as effective as alemtuzumab and natalizumab. These analyses suggest that ocrelizumab slows disease progression in the total relapsing–remitting multiple sclerosis population compared with some treatments but not others. Also, it is uncertain whether ocrelizumab slows disease progression in the subgroups of highly active and rapidly evolving severe disease.

The most plausible cost-effectiveness estimates for ocrelizumab compared with most relevant comparators are in the range that NICE normally considers an acceptable use of NHS resources. However, because it is more costly than alemtuzumab, ocrelizumab can only be recommended as an option for treating relapsing–remitting multiple sclerosis in adults with active disease defined by clinical or imaging features if alemtuzumab is contraindicated or otherwise unsuitable.

  • National Institute for Health and Care Excellence (NICE)