The National Institute for Health and Care Excellence (NICE) has issued final guidance recommending that Lemtrada should be reimbursed on the NHS, as an option for treating adults with active RRMS, within its marketing authorisation.[i] Lemtrada has been shown to significantly reduce annualised relapse rates in both treatment-naïve and treatment-experienced adult patients with active RRMS versus an active comparator. [ii],[iii]
Lemtrada, a humanised monoclonal antibody therapy, is the first MS therapy to demonstrate superior reduction in the risk of disability accumulation in treatment-experienced people, when compared to subcutaneous interferon beta 1a (SC IFNB-1a).3 "We are delighted that after many years in development, Lemtrada is now available on the NHS. Treatments which have the potential to improve the lives of those living with MS should be available to all who might benefit. Lemtrada offers an important additional treatment option which will be welcomed by the MS community," said Amy Bowen, Director of Service Development at the MS Trust. Unlike other MS treatments currently available, Lemtrada is administered in two short treatment courses, one year apart.[iv]
Lemtrada is the second of Genzyme's treatments for MS to receive approval for use from NICE and become available on the NHS.1 Lemtrada has been in clinical development for MS for more than 10 years and the development programme involved more than 1,500 patients.
"We are thrilled by today's news that NICE has approved Lemtrada for NHS use for people with RRMS. At Genzyme, we put patients at the heart of everything we do and this final milestone brings a treatment option to people with MS that could really reshape the management of their condition. We are also immensely proud of our association with Lemtrada as a home-grown product, developed and pioneered in Cambridge by a team of UK scientists. This reminds us of the UK's position at the forefront of science-led medicine, the importance of industry collaboration which brings global expertise in clinical development and our joint commitment to MS patients," commented Brendan Martin, General Manager for Genzyme UK and Ireland.
Approximately 100,000 people in the UK have MS and about 2,500 people are newly diagnosed with it each year.[v] Eighty-five percent of people with MS are initially diagnosed with RRMS, and people with RRMS experience approximately one or two relapses per year.[vi], [vii] Around half of all relapses may leave people with lingering problems, and symptoms may worsen over time.
About Lemtrada (alemtuzumab)
Lemtrada is a humanised monoclonal antibody therapy which selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has transient impact on other immune cells. The reduction in the level of circulating T and B cells by alemtuzumab and subsequent repopulation may reduce the potential for relapse, which ultimately delays disease progression. Patients treated with Lemtrada had fewer relapses compared to patients treated with a beta-interferon injected multiple times per week, and treatment experienced patients were less likely to experience worsening of their disability. Lemtrada is administered in two short treatment courses. The first treatment course includes one infusion per day for five days (course one). A year later a second course is administered one infusion per day for three days (course two). Lemtrada had been in clinical development for MS for more than 10 years and is supported by an extensive multicentre, multi-country clinical programme. Lemtrada was developed as part of research at the University of Cambridge and more than 1,500 patients received Lemtrada treatment course as part of these clinical trials.
EU Indication and Usage
Lemtrada is indicated in the European Union for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease defined by clinical or imaging features.[viii] Genzyme have introduced a risk management plan to ensure that Lemtrada is used as safely as possible. Based on this plan, safety information has been included in the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet for Lemtrada, including the appropriate precautions to be followed by healthcare professionals and patients.
For full prescribing information about Lemtrada, the Summary of Product Characteristics can be found here, which includes the data that has supported the license indication: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003718/WC500150521.pdf