The first pill to treat MS could be banned for use by NHS patients because it’s ‘too expensive’.
The once-a-day pill fingolimod cuts by half the relapses that can lead to people being increasingly disabled, and experts hoped it would replace injections and hospital infusions for thousands of sufferers.
Until now, many people with Multiple Sclerosis have had to self inject at least weekly or travel to hospital for infusions.
But the NHS rationing body, the National Institute for Health and Clinical Excellence (Nice), says it is not value for money despite criticism over how it reached its verdict.
The MS Society said sufferers would be better off living almost anywhere else in Europe because access to new treatments is so poor in the UK – it is ranked 13th out of 14 countries in terms of getting advanced care.
The charity and the drug manufacturer Novartis plan to appeal the provisional Nice decision.
MS is the most common disabling neurological condition, affecting almost 100,000 Britons – 50 young people are diagnosed each week.
It involves damage to myelin, a protective sheath surrounding nerve fibres of the central nervous system which means the body’s immune system attacks itself.
Symptoms range from mild, occasional illness involving numbness, muscle weakness and eye problems to rapid and severe deterioration, resulting in serious disability.
Dr Eli Silber, consultant neurologist who leads an MS service for South London based at King’s College Hospital said ‘This is disappointing and I hope Nice will review its draft decision.
‘The computer models used to determine cost effectiveness don’t take into account the significant amount of money that would be spent on patients at the end of life with severe disability, when there isn’t much we can do.
‘MS often affects young people, with families and work, and this decision denies them the opportunity to have the risk of disability reduced at a much earlier stage.’
Experts believe the drug, which is the first oral treatment, has the potential to be one of the most significant advances for a decade.
Trial results in the New England Journal of Medicine last year show fingolimod, also known as Gilenya, cuts relapse rates and holds back progression of the disease.
Patients treated with fingolimod had a 50 per cent cut in disabling relapses compared with commonly used injections of beta interferon.
The chances of progressing to a worse form of the disease were cut by about a third, without significant side effects.
The new drug appears to dampen the immune response that causes nerve damage in multiple sclerosis.
The £19,000 annual cost of the drug compares with the £21,000 annual cost of hospital infusions using Tysabri, but is more expensive than interferon injections ranging from £6,000 – £8,000 a year.
However, MS specialists say the drug could make overall savings for the NHS, because fewer patients would need hospital treatment costing £3,000 a time after relapse and disability is lessened.
Controversy already surrounds the availability of beta interferon and other disease modifying drugs.
Despite a ‘risk sharing’ scheme brought in seven years ago under which drug manufacturers agree to bear the cost if an individual course of treatment fails, access to the drugs is still ‘patchy’, according to the MS Society, with many patients still being denied them.
Simon Gillespie, Chief Executive of the MS Society, said ‘This is disappointing news for people with MS and it will leave some people with no effective treatment option.
‘Access to MS treatments in the UK is very poor – in fact people with MS would be better off living almost anywhere else in Europe, and this decision will only deepen that inequality.
‘We’re concerned at how this decision has been reached and now strongly encourage Nice and Novartis to work together to look at how the treatment can be better re-considered and evaluated.’
Professor Carole Longson, director of the Health technology evaluation centre at Nice said ‘While it’s important that people with multiple sclerosis have treatment options, Nice has to ensure that the NHS provides treatments that bring benefits that are value for money.
‘Unfortunately our independent committee wasn’t given sufficient evidence to show that fingolimod could reduce relapses considerably better than the other treatments currently being used.
‘Based on the available clinical evidence and economic analysis, our independent committee concluded that fingolimod would not be effective good use of NHS resources.’