Fingolimod for the treatment of highly active relapsing–remitting multiple sclerosis

Fingolimod (Gilenya, Novartis Pharmaceuticals UK) is a sphingosine-1-phosphate receptor modulator that prevents lymphocytes from crossing the blood–brain barrier and causing damage to nerve cells in the brain and spinal cord. Fingolimod has a marketing authorisation as a single disease-modifying therapy in highly active relapsing–remitting multiple sclerosis for the following groups:

• Adults with high disease activity despite treatment with a beta interferon. These patients may be defined as 'those who have failed to respond to a full and adequate course (normally at least 1 year of treatment) of beta-interferon. Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial magnetic resonance imaging (MRI) or at least 1 gadolinium-enhancing lesion. A "non-responder" could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year'.

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

The most common adverse reactions to treatment with fingolimod include influenza virus infections, headaches, diarrhoea and elevated liver enzyme activity. The summary of product characteristics (SPC) states that 'macular oedema with or without visual symptoms has been reported in 0.4% of patients treated with fingolimod 0.5 mg, occurring predominantly in the first 3 to 4 months of therapy. An ophthalmological evaluation is therefore recommended at 3 to 4 months after treatment initiation'. For full details of adverse reactions and contraindications, see the SPC.

Fingolimod is given as a 0.5 mg oral dose once daily. The SPC states that 'patients can switch directly from beta interferon or glatiramer acetate to fingolimod provided there are no signs of relevant treatment-related abnormalities'. The list price of fingolimod is £1,470 for 28 capsules (excluding VAT; MIMS July 2011), which is equivalent to an annual cost of approximately £19,169 per person. The manufacturer of fingolimod has agreed a patient access scheme with the Department of Health, in which a discount on the list price of fingolimod is offered. The size of the discount is commercial-in-confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.