Amendment of the conditional inclusion of the medicine Fingolimod (Gilenya®) for the treatment of relapsing remitting multiple sclerosis (RRMS)

Zorginstituut Nederland carried out an assessment in relation to extending the specific conditions for the medicinal  product fingolimod (Gilenya®). There is an extension in the existing indication of Gilenya capsule 0.5 mg  for pediatric patients 10 years or older with highly active relapsing remitting multiple sclerosis (RRMS). And therefore this means a request tochange the specific conditions for reimbursement of fingolimod (Gilenya®). Fingolimod 0.5 mg is currently included on List 1A of the GVS only for adults with the indication RRMS. The new strength, 0.25 mg, is only intended for use in pediatric patients with RRMS.

Registered indication

Up till November 2018, fingolimod was indicated as a single disease-modifying therapy for highly active relapsing remitting multiple sclerosis in the following groups of adults patients:

  • Patients with very active disease despite a full and adequate course of treatment with at least one disease-modifying drug;


  • Patients with rapidly evolving, severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in one year and with 1 or more gadolinium-enhancing lesions on brain MRI or a significant increase in the T2 lesion load as compared to a previous recent MRI.

In November 2018, the European Medicines Agency (EMA) approved an extension in the existing indication. The current indication for fingolimod was extended to include pediatric patients aged 10 years and older with the same indication as adults. The marketing authorisation holder is also asking for reimbursement for the 0.25 mg capsule.

Zorginstituut's advice

Fingolimod 0.5 mg has already been included on List 1A, under conditional inclusion, for adults with RRMS. Based on the above considerations, we advise the Minister to alter the condition for fingolimod, by adding pediatric patients, as indicated below; fingolimod 0.25 mg can be added to this. Altering this specific condition will be accompanied by additional costs.
As cladribine is not registered for pediatric patients, no research is taking place involving children and because we do not expect such research to start in the near future,  we advise the Minister not to alter the condition for reimbursement of cladribine, with which fingolimod is clustered.

Extension in the specific condition for fingolimod 0.25 mg and 0.5 mg for children with RRMS.

Fingolimod condition

Only for an insured person aged 10 years or older with highly active relapsing-remitting multiple sclerosis (RRMS) who did not respond to treatment with at least one disease-modifying drug that is registered for the treatment of MS.

This report is a summary of recommendations by Zorginstituut Nederland. The original text is in Dutch.