1 Recommendations

1 Recommendations

1.1 Cladribine tablets are recommended as an option for treating highly active multiple sclerosis in adults, only if the person has:

  • rapidly evolving severe relapsing–remitting multiple sclerosis, that is, at least 2 relapses in the previous year and at least 1 T1 gadolinium-enhancing lesion at baseline MRI or

  • relapsing–remitting multiple sclerosis that has responded inadequately to treatment with disease-modifying therapy, defined as 1 relapse in the previous year and MRI evidence of disease activity.

1.2 This recommendation is not intended to affect treatment with cladribine tablets 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

Highly active relapsing–remitting multiple sclerosis is currently treated with alemtuzumab, daclizumab, fingolimod or natalizumab. This appraisal focused on 2 subgroups of people with highly active relapsing–remitting multiple sclerosis, that is, those with rapidly evolving severe disease and those with suboptimally treated relapsing–remitting multiple sclerosis.

Clinical trial results show that cladribine tablets (hereafter referred to as cladribine) reduce relapses and slow the progression of disability compared with placebo for people with relapsing–remitting multiple sclerosis. The effectiveness of cladribine for treating rapidly evolving severe or suboptimally treated relapsing–remitting multiple sclerosis is not proven, but it is likely to be more effective than placebo.

Based on indirect analyses, there is not enough evidence to determine whether cladribine is more or less effective than other treatments for people with rapidly evolving severe and suboptimally treated multiple sclerosis. Because of this, the committee also considered a scenario in which cladribine and its comparators are assumed to be equally effective.

Cladribine is less costly than other treatments and needs less frequent dosing and monitoring. It is cost effective compared with all other treatments and can therefore be recommended for rapidly evolving severe and suboptimally treated relapsing–remitting multiple sclerosis (that is, disease that has responded inadequately to disease-modifying therapy).

  • National Institute for Health and Care Excellence (NICE)