Sanofi's Aubagio backed by NICE

Sanofi's oral multiple sclerosis (MS) therapy Aubagio should be reimbursed by the NHS in England and Wales, according to new guidance.

The National Institute for Health and Care Excellence (NICE) issued final draft guidance ahead of the weekend suggesting Aubagio (teriflunomide) was cost-effective for adults with relapsing-remitting MS, overturning a negative decision on the drug in September.

The agency had asked for more several clarifications on the evidence submitted by Sanofi in support of Aubagio, which was approved by European regulators for the treatment of MS in August, and it has emerged that the pharma company has also agreed to an undisclosed discount on its price. Aubagio has an annual reference cost of £13,529 (about €16,000) per patient in the UK.

"At the first draft stage the committee decided that there was not enough information to recommend [Aubagio], but as the manufacturer was able to provide updated evidence and analysis during the consultation period, the committee was able to make draft recommendations for the use of the drug," commented Carole Longson, director of NICE's Health Technology Evaluation Centre.

The positive decision was a relief to Sanofi after another of its MS drugs - injectable drug Lemtrada (alemtuzumab) - was turned down by NICE in draft guidance last week. Once again the agency asked for clarifications on the evidence submitted by the pharma company.

Publication of negative draft guidance - followed by a reversal on consultation with the drug sponsor - has become something of a theme for MS drugs, and also occurred with Novartis' oral therapy Gilenya (fingolimod) which was ultimately endorsed in May 2012.

Analysts have suggested that the new generation of oral MS therapies will come to dominate the market in the coming years, with Biogen Idec's recently-approved Tecfidera (dimethyl fumarate) leading the market ahead of Gilenya and Aubagio.