NICE issues draft OK for Genzyme’s Lemtrada in RRMS

by | 6th Apr 2014 | News

In final draft guidance, the National Institute for Health and Care Excellence (NICE) is recommending the use of Genzyme’s Lemtrada (alemtuzumab) in the treatment of relapsing-remitting multiple sclerosis (MS).

In final draft guidance, the National Institute for Health and Care Excellence (NICE) is recommending the use of Genzyme’s Lemtrada (alemtuzumab) in the treatment of relapsing-remitting multiple sclerosis (MS).

The Institute said it was “very pleased” to be able to make this recommendation, which follows the provision by the manufacturer of further evidence, as requested by the independent appraisal committee.

Currently-available treatments for relapsing-remitting MS are either oral daily tablets or injections which are given several times a week and can have unpleasant side effects. Lemtrada is taken intravenously once a year for two years, the first course being administered for five consecutive days and the second for three consecutive days, allowing patients to lead their lives without treatment for the rest of the time.

The drug does have some possible side effects associated with it which, according to clinical specialists, are manageable, and it has a shorter time period, compared with most available treatments, during which it is not recommended that a person gets pregnant, says NICE.

The final draft guidance is now out for consultation until April 22, and NICE will then issue its final guidance in June. NICE recommendations are normally enforceable three months from the data of publication, so neurologists should be able to prescribe Lemtrada from October, comments the MS Trust, which has welcomed the news that the drug should become an option for anyone with active relapsing-remitting MS.

It will allow people “the opportunity to choose a disease-modifying treatment that gives them the best balance between risks and benefits, in consultation with their neurologist and MS nurse,” said Amy Bowen, director of service development at the MS Trust.

The decision was also welcomed as “terrific news” by Michelle Mitchell, chief executive of the MS Society.

“Lemtrada has been shown to be highly effective in clinical trials and while it isn’t without risks, and it isn’t right for everyone, it has the potential to dramatically change the course of MS progression for those eligible for the treatment,” she said.

Lemtrada’s indicative price is £7,045 per 12mg vial, which equates to £56,360 for the full course of treatment. While its price has not yet been confirmed, the Department of Health has “exceptionally” agreed for this indicative price to be used for the purpose of this appraisal, says NICE, which also points out that actual costs may vary in different settings because of negotiated procurement discounts.

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