1.1 Cladribine is 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 with at least:
2 relapses in the previous year and
1 T1 gadolinium-enhancing lesion at baseline MRI or a significant increase in T2‑lesion load compared with a previous 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 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, fingolimod or natalizumab. This appraisal focuses 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 (disease that has responded inadequately to disease-modifying therapy).
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, cladribine and alternative treatments are considered equally effective for this appraisal.
The MRI criteria used by clinicians to define rapidly evolving severe relapsing–remitting multiple sclerosis have changed over time. In addition to the presence of T1 gadolinium-enhancing lesions at baseline, clinicians may now identify patients with rapidly evolving severe relapsing–remitting multiple sclerosis by a significant increase in T2‑lesion load compared with a previous MRI.
Cladribine is less costly than other treatments and needs less frequent dosing and monitoring. It is cost effective compared with all other treatments, so can be recommended for rapidly evolving severe and suboptimally treated relapsing–remitting multiple sclerosis.