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New HTA Decisions in England
May 2021
Drug name
KESIMPTA® (ofatumumab)
Company
Novartis
Decision date
20/04/2021
Therapeutic area
Neurological conditions
Therapeutic sub area
Multiple sclerosis
Decision
Recommended
Indication
Treating relapsing–remitting multiple sclerosis in adults with active disease defined by clinical or imaging feature.
Decision Detail
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.
Summary
Two phase 3 randomised controlled trials (ASCLEPIOS I and ASCLEPIOS II) provided the main evidence for clinical effectiveness. 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 committee considered the impact of the various assumptions on the ICER. The committee noted that the ICERs it was using for decision making included commercial arrangements for ofatumumab and each comparator drug. These ICERs are confidential and the exact values cannot be reported here but were within what NICE considers a cost-effective use of NHS resources. The committee noted that, with the exception of waning of treatment effect, changes to each assumption had a minor impact on the base-case ICER. The committee concluded that it could recommend ofatumumab as an additional treatment option for relapsing–remitting multiple sclerosis.