Evidence-based recommendations on alemtuzumab (Lemtrada) for treating relapsing–remitting multiple sclerosis in adults.

  April 2019: The European Medicines Agency’s pharmacovigilance risk assessment committee have started a review of alemtuzumab.

The committee advised that during the review, alemtuzumab should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least 2 disease-modifying therapies, or when other disease-modifying therapies cannot be used. Patients having treatment with alemtuzumab and who are benefitting from it may continue treatment in consultation with their doctor.

In addition to the restriction, the committee has recommended an update of the product information for alemtuzumab to inform patients and healthcare professionals about cases of:

  • immune-mediated conditions, including autoimmune hepatitis (with damage to the liver) and overactivation of the immune system
  • problems with the heart and blood vessels occurring within 1–3 days of having alemtuzumab
  • severe neutropenia.

Healthcare professionals should consider stopping treatment in patients who develop signs of these conditions and patients should immediately seek medical help if they experience symptoms.

Any enquiries from NHS organisations about the changes in the summary of product characteristics should be directed to UK-medicalinformation@sanofi.com or telephone 08453 727101.

Is this guidance up to date?

Next review: The guidance on this technology will be considered for review when the European Medicines Agency concludes its review into the safety of alemtuzumab. The guidance executive will decide whether the technology should be reviewed based on information gathered by NICE, and in consultation with consultees and commentators. 

Guidance development process

How we develop NICE technology appraisal guidance

Your responsibility

The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.

Commissioners and/or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.

Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

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