Browse Conditions Browse Medicines

NICE recommendation: Cladribine for treating relapsing–remitting multiple sclerosis

Mavenclad, Leustat and Litak, for Multiple sclerosis from Merck Serono, Lipomed and Janssen-Cilag

The National Institute for Health and Care Excellence (NICE) have published their recommendations for the use of cladribine 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.
This means that patients in England and Wales can be treated with cladribine for this condition if their doctor thinks it is appropriate.

For more information see the full article.

Why NICE 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.

© NICE [2019]

Cladribine for treating relapsing-remitting multiple sclerosis. Technology appraisal guidance [TA616]. Published date: 19 December 2019
Available from: See Link below. All rights reserved. Subject to Notice of rights
NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

The information provided by NICE was accurate at the time this article was issued.


NICE recommendation: Cladribine for treating relapsing–remitting multiple sclerosis

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


Disclaimer: This site is designed to offer information for general educational purposes only. The health information furnished on this site and the interactive responses are not intended to be professional advice and are not intended to replace personal consultation with a qualified physician, pharmacist, or other healthcare professional. We cannot provide individual medical advice. You must always seek the advice of a professional for questions related to a disease, disease symptoms, and appropriate therapeutic treatments.


About condition About Mavenclad About Leustat About Litak