Evidence-based recommendations on daclizumab (Zinbryta) for relapsing–remitting multiple sclerosis in adults.
Following safety concerns, the European Medicines Agency (EMA) has provisionally restricted daclizumab use to people with highly active relapsing multiple sclerosis that has not responded to other treatments, and to people with rapidly evolving relapsing disease who cannot have certain other medicines. These restrictions apply while a review of the safety of daclizumab on the liver is ongoing (see the EMA website for details of the decision). It represents a more restricted indication than that originally appraised in NICE technology appraisal guidance 441. In addition, people with liver injury must not be given daclizumab. Starting treatment with daclizumab is not recommended for people with autoimmune diseases other than multiple sclerosis, and caution should be used when giving daclizumab together with medicines that can damage the liver. Doctors should continue to monitor the liver function of people having daclizumab, and closely watch them for signs and symptoms of liver injury.
The wording of recommendation 1.1 in NICE technology appraisal guidance 441 has not been amended at this stage. However, it should be noted that part of the population for whom NICE recommends daclizumab – specifically, people with active relapsing–remitting multiple sclerosis previously treated with disease-modifying therapy whose disease is not ‘highly active’ – will no longer be eligible for treatment because of the EMA’s provisional restrictions. NICE will review the recommendations on daclizumab and amend them if appropriate when the EMA concludes its review.
Guidance development process
Next review: April 2020
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.
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.