Evidence-based recommendations on fingolimod (Gilenya) for highly active relapsing-remitting multiple sclerosis.
July 2019: Fingolimod is contraindicated during pregnancy and in women of childbearing potential not using contraception. See the European Medicines Agency’s advice on fingolimod.
NICE has been asked to clarify whether the recommendation for the use of fingolimod extends to people with relapsing remitting multiple sclerosis who are currently receiving treatment with glatiramer acetate, and who experience an unchanged or increased relapse rate or ongoing severe relapses compared with the previous year. NICE understands that this query refers to the note included in the ‘Posology and method of administration’ section of the summary of product characteristics for fingolimod that states that ‘patients can switch directly from beta interferon or glatiramer acetate to fingolimod provided there are no signs of relevant treatment–related abnormalities’. In line with the referral received from the Department of Health, NICE appraised fingolimod with reference to the therapeutic indication specified in the marketing authorisation; that is ‘Patients with high disease activity despite treatment with a beta-interferon’. The manufacturer provided no submission for the other population in the marketing authorisation. Considering that NICE cannot produce guidance for a medicine outside of the licensed indication included in the marketing authorisation, the recommendation for the use fingolimod does not extend to people currently receiving glatiramer acetate.
Is this guidance up to date?
Next review: This guidance will be reviewed if there is new evidence that is likely to change the recommendations.
There is a simple discount patient access scheme for fingolimod. Contact Commercial.Team@novartis.com. or 01276 698717 for details.
Guidance development process
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.