Novartis receives preliminary NICE recommendation for Gilenya

Novartis' multiple sclerosis therapy Gilenya (fingolimod) has won a provisional recommendation from the National Institute for Health and Clinical Excellence (NICE).

Final draft guidance from the UK regulator has outlined plans to endorse the therapy as a means of reducing relapse rates among patients with highly active relapsing-remitting multiple sclerosis.

It is the first pill-based medicine to demonstrate this capability, with the new recommendation representing an alteration of NICE's previous stance, thanks to the provision of relevant new information and analysis by Novartis.

If approved, Gilenya would be specifically recommended for patients affected by unchanged or increased relapse rates or ongoing severe relapses compared to the previous year, despite taking drugs such as beta interferons.

Professor Carole Longson, director of the health technology evaluation centre at NICE, said: "The analyses show that … treatment with fingolimod will be a cost-effective option for the NHS in this group of people with multiple sclerosis, if Novartis provides the drug at a discounted price."

Last month, the company received European approval for its anticancer agent Glivec in a new specification as a treatment for post-surgical adult patients with KIT-positive gastrointestinal stromal tumours.