UK’s NICE says “yes” to Genzyme’s MS drug Lemtrada(04/04/14)

In final draft guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has recommended the use of French drug major Sanofi (Euronext: SAN) subsidiary Genzyme’s multiple sclerosis drug Lemtrada (alemtuzumab).

The NICE is appraising alemtuzumab as a treatment for adults with relapsing–remitting multiple sclerosis, a chronic and disabling neurological condition that, as it progresses, can have a substantial negative impact on a person’s quality of life.

Currently available treatments for this type of MS are either oral daily tablets or injections given several times each week and can have unpleasant side effects. The NICE pointed out. Alemtuzumab is taken intravenously once a year for two years. The first course is administered for five consecutive days, and the second course is administered for three consecutive days, 12 months later allowing those with the condition to lead their lives without treatment for the rest of the time. Alemtuzumab does have some possible side effects associated with it which, according to clinical specialists, are manageable. Compared with most available treatments, alemtuzumab has a shorter time period during which it is not recommended that a person gets pregnant. This could be seen as advantageous for patients who are planning to have a baby.

Carole Longson, NICE Health Technology Evaluation Centre director, said: “We are very pleased to be able to recommend alemtuzumab for adults with relapsing-remitting multiple sclerosis. Following a request for more information by our independent Appraisal Committee, the manufacturer was able to provide further evidence, which has led to this positive recommendation.”

Until the NICE issues final guidance, National Health Service bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.

Pricing to be confirmed

The indicative price of alemtuzumab is £7,045 ($9,722) per 12 mg vial, which equates to £56,360 for the full course of treatment consisting of five daily consecutive 12mg doses in year one, followed by three daily consecutive 12mg doses 12 months later in year twp. The price of alemtuzumab has not yet been confirmed by the Department of Health. However, the Department has exceptionally agreed for this indicative price to be used for the purpose of this appraisal. Costs may vary in different settings because of negotiated procurement discounts.

Last year, when issuing draft guidance (The Pharma Letter December 5, 2013), Prof Longson said: “When reviewing the evidence for alemtuzumab, the Appraisal Committee concluded that there were still questions to be answered. This is why we have requested more details from the manufacturer; to ensure that we have the information the Appraisal Committee needs to reach their conclusions.”

Source: www.thepharmaletter.com (04/04/14)