Cladribine is recommended as an option for treating active relapsing forms of multiple sclerosis in adults, only:
if they have active relapsing–remitting multiple sclerosis, and
when high-efficacy disease-modifying therapies would be offered.
This recommendation is not intended to affect treatment with cladribine 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 healthcare professional consider it appropriate to stop.
Why the committee made these recommendations
This technology appraisal evaluates cladribine only for active relapsing–remitting multiple sclerosis. This does not include everyone it is licensed for.
High-efficacy disease-modifying therapies for active relapsing–remitting multiple sclerosis include ocrelizumab and ofatumumab. The aim of treatment is to reduce the number of relapses, slow the progression of disability, and maintain or improve quality of life.
Clinical trial evidence shows that cladribine reduces relapses and increases the time until disability progresses compared with placebo. Indirect comparisons suggest that the relapse rate with cladribine is similar to that of ocrelizumab and ofatumumab.
When compared with ocrelizumab and ofatumumab, the most likely cost-effectiveness estimate for cladribine is within the range that NICE considers an acceptable use of NHS resources. So, cladribine is recommended for people with active relapsing–remitting multiple sclerosis when high-efficacy disease-modifying therapies would be offered.