Frimley, 19 April 2011: The first oral treatment for multiple sclerosis (MS) has been given the green light by UK regulators and is now available in the UK. Fingolimod (2) 0.5 mg (Gilenya™) has been authorised for people with highly active relapsing remitting multiple sclerosis (RRMS) who have failed to respond to an interferon (injection), or for those with rapidly evolving severe disease.(1) Fingolimod provides a new treatment option for patients failing on injections but whose disease is not severe enough for infusion therapy. Patients on an interferon need to have had one or more relapses within the last year to be eligible for treatment with fingolimod.(1)
Dr Eli Silber, Consultant Neurologist who leads an MS service for South London based at King’s College Hospital explains, “This has the potential to be one of the most significant advances since the first line therapies arrived over a decade ago. Fingolimod is not just the first oral treatment, which is an innovation in itself, but provides a new option for people with more active disease.” He continued, “An oral treatment that cuts relapse rates by half is good news because for patients living with the uncertainty of MS, one relapse is one relapse too many.”
MS is an autoimmune condition affecting 100,000 people in the UK, whereby a person’s immune system attacks their own brain and spinal cord.(3) The damage caused can make it difficult for messages to travel from the brain to various areas of the body, resulting in a variety of symptoms including difficulty walking, fatigue, blurred vision or loss of sight, bowel and bladder incontinence and can also lead to lifelong disability.(4)
The cost of managing multiple sclerosis includes the cost of treating relapses (relapses requiring hospitalisation are estimated to cost the NHS £3,034 per episode),(5) the price of disease modifying therapies and any associated administration costs of each drug.
Currently, patients who fail on an interferon but who are not right for infusion therapy have limited treatment options. This gap in treatment is because the National Institute of Clinical Excellence (NICE) stipulates that people with RRMS who continue to experience relapses on an injection are not eligible for second line infusion therapy, unless their disease is classified as rapidly evolving and severe (TA127).(6)
Fingolimod is available to appropriate patients in the UK from today and neurologists can apply now for treatment reimbursement via individual funding requests. NICE is currently reviewing fingolimod and will issue draft guidance in July 2011.
1. Gilenya Summary of Product Characteristics. 2011 http://www.medicines.org.uk/EMC/medicine/24443/SPC/Gilenya+0.5mg+hard+capsules Last accessed 11 April 2011
2. Cohen JA et al. Oral Fingolimod vs. intramuscular interferon in relapsing multiple sclerosis. N Eng J Med 2010, 362 (5) 405-415
3. http://www.mstrust.org.uk/information/publications/msexplained/ Last accessed 1 April 2011
4. http://www.nice.org.uk/nicemedia/live/12170/50871/50871.pdf Last accessed 1 April 2011
5. Department of Health. NHS payment by results 2011-12 national tariff information. 23 March 2011. Available at: http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_125398.xls last accessed 4 April 2011
6. http://www.nice.org.uk/nicemedia/live/11822/36136/36136.pdf Last accessed 1 April 2011
7. http://guidance.nice.org.uk/TA/Wave20/71 Last accessed 1 April 2011
8. Kappos L et al. Placebo-controlled study of oral fingolimod in relapsing multiple sclerosis. N Eng J Med 2010, 362 (5) 387-401
9. Novartis data on file
10. O’Connor P et al. Oral fingolimod (FTY720) in MS. Two-year results of a phase II extension study. Neurology. 2009, 72; 73-79
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Last updated on: 19/04/2011
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