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NICE backs reimbursement of Sanofi's MS drug Lemtrada

Final guidance opens doors for use on NHS in England and Wales
National Institute for Health and Care Excellence NICE logo

The UK's National Institute for Health and Care Excellence (NICE) has given a green light to reimbursement of Sanofi's Lemtrada therapy for multiple sclerosis (MS) on the NHS.

Final guidance published this week concludes that Lemtrada (alemtuzumab) is cost-effective for adults with active, relapsing-remitting MS and so should be reimbursed when prescribed to patients in England and Wales.

Lemtrada - originally developed by Sanofi's Genzyme unit - was approved by the European Commission last September, but a preliminary report from NICE in December indicated that the agency required more data on the cost-effectiveness of Lemtrada compared to other disease-modifying treatments before it could reach a decision.

The drug received an initial positive opinion from NICE at the start of April, and the decision was subject to an appeal and comment period that has now ended.

Lemtrada is given as an intravenous infusion in two annual treatment courses and has the same active ingredient as Campath, a drug sold to treat chronic lymphocytic leukaemia, though at a much lower dose. Lemtrada was launched in the UK in May 2014.

"We are pleased that NICE has recommended Lemtrada as being both clinically effective and cost effective for people with relapsing remitting MS," said Genzyme's president and chief executive David Meeker.

"There are approximately 100,000 people in the UK diagnosed with the disease and Lemtrada can be a potentially transformative treatment for appropriate patients," he added.

The NHS now has three months to put the necessary measures in place to be able to provide the treatment, meaning that come September, local hospitals have a legal obligation to provide the treatment to patients deemed eligible.

Nick Rijke, director for policy and research at the MS Society, said that NICE's approval of Lemtrada "is a major step forward in the treatment of people with multiple sclerosis."

"This drug has taken decades to develop, and while it's not without risk, it's proven to be a highly effective medicine for people with relapsing remitting MS," he added.

Lemtrada was first introduced in Germany in October - bringing in sales of €2m in the fourth quarter rising to €5m in the first three months of this year - and has also been approved in Canada,
Australia, Mexico and Brazil.

In the US, the FDA turned down Genzyme's application for Lemtrada last year on the grounds that it needed further evidence of safety, but the company has said it expects to resubmit the drug for FDA review sometime in the second quarter of this year.

Article by
Phil Taylor

28th May 2014

From: Sales



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