NHS England published a clinical commissioning policy on disease-modifying therapies for patients with multiple sclerosis in April 2013.
In accordance with NICE guidance, this recommends the use of fingolimod in the treatment of highly active relapsing-remitting MS in adults, only if:
• They have an unchanged or increased relapse rate or ongoing severe relapses compared with the previous year despite treatment with beta interferon*, and• The manufacturer provides fingolimod with the discount agreed as part of the patient access scheme.
*Of note, NICE only considered the evidence for its use in patients with high disease activity despite treatment with a beta-interferon, as this was the therapeutic indication specified in the marketing authorisation at the time. The guidance does not include its use in patients who have received other disease-modifying therapies (as per the updated indication).
The commissioning policy also outlines the following stopping criteria:
• No reduction in frequency or severity of relapses compared with pre-treatment phase following a minimum 3 month period of fingolimod treatment• Unacceptable adverse effects of the drug• The patient is pregnant, breast feeding or attempting conception• Development of secondary progressive disease causing inability to walk for more than 6 months