NICE recommends first ever pill-based medicine for people with Multiple Sclerosis

The healthcare guidance body, NICE, has recommended that the NHS offer, the first ever pill-based medicine fingolimod, for patients with highly active relapsing-remitting Multiple Sclerosis.

Professor Carole Longson, director of the Health Technology Evaluation Centre at NICE (National Institute for Health and Clinical Excellence) said: “Our committee concluded that fingolimod is a valuable new therapy for highly active relapsing-remitting multiple sclerosis.

"We are pleased to recommend fingolimod as a treatment option for the specific patient population for whom it has been demonstrated to be cost effective, providing Novartis applies its proposed discount.”

She added: “Multiple sclerosis can be a disabling condition and so we hope that this novel treatment will help to reduce relapses for these people.”

Relapsing-remitting multiple sclerosis (RRMS), is estimated to affect around 27,500 people in England and Wales, and is characterised by periods when symptoms worsen and then improve.

Treatments to manage relapses are generally administered by injection, whereas fingolimod is administered orally.

NICE has specifically recommended fingolimod for adults who have an unchanged or increased relapse rate or ongoing severe relapses compared to the previous year, despite taking beta interferons.

People with RRMS, who are currently receiving fingolimod but whose disease does not meet these criteria, should be able to continue treatment until they and their doctors consider it appropriate to stop.

The positive recommendation from NICE will only apply if the manufacturer, Novartis, provides the drug at a confidential discounted price, as proposed in its patient access scheme.

NICE had previously refused to approve fingolimod for NHS use in England and Wales on the grounds of cost-effectiveness and the therapy is not currently approved for use in Scotland.

Nick Rijke, director of Policy & Research at the MS Society, said: “We are delighted; this decision signifies a major step forward in the treatment of this devastating condition.

“Gilenya has been found to be highly effective in trials and taking a daily tablet will come as welcome relief from frequent, often unpleasant, injections."

However he said: "We’re deeply disappointed by the SMC’s decision in Scotland – and urge them to reconsider.”

In Multiple Sclerosis, white blood cells (called lymphocytes) attack the coating of the nerve cells which help messages from the brain travel to the rest of the body.

As these cells are damaged, people experience symptoms such as numbness and tingling, blurred vision, mobility and balance problems, and muscle weakness and tightness.

Fingolimod works by preventing the lymphocytes from attacking nerve cells in the brain and spinal cord. This is why it is called a ‘modifying’ medication.

The recommended dosage for fingolimod is 0.5mg once a day. The list price for 28 capsules is £1,470. This is equivalent to an annual cost of approximately £19,196 per person (without the patient access scheme).

Patient Access Schemes can be proposed by pharmaceutical companies during the development of NICE's technology appraisals in order to make drugs more affordable for the NHS.

Manufacturers agree these directly with the Department of Health. Novartis has requested that the size of its proposed discount for fingolimod remains confidential.