NICE ‘no’ for Roche’s Ocrevus

The Institute’s appraisal relates to the drug’s use for treating relapsing forms of multiple sclerosis in adults with active disease defined by clinical or imaging features.

While clinical trial results show that Ocrevus (ocrelizumab) reduces the number of relapses and slows disability progression compared with interferon beta-1a, there is no evidence directly comparing the drug with other available treatments, the NICE said.

While indirect analyses suggest that Ocrevus cuts the number of relapses compared with interferon beta-1b, glatiramer acetate, dimethyl fumarate, fingolimod and teriflunomide, and is as effective as alemtuzumab and natalizumab, it is uncertain whether it slows disease progression compared with other treatments, particularly in the subgroups of highly active disease and rapidly evolving severe disease, it added.

The committee concluded that the most plausible cost-effectiveness estimates for the drug, even when taking into account the discounted price agreed in the confidential patient access scheme, was too high to be considered an acceptable use of NHS resources.

Ocrevus is first-in-class, humanised monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and nerve cell damage, which can lead to disability in people with MS.

The drug was approved by European regulators in January for relapsing multiple sclerosis (RMS) and early primary progressive multiple sclerosis (PPMS).

Clinical trial data showed that it significantly cut the annualised relapse rate by 46.4 percent at 96 weeks compared with interferon beta-1a treatment in patients with RMS, while for patients with PPMS, it led to a 24 percent reduction in the risk of 12-week confirmed disability progression compared with placebo.

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