First pill for treating MS sufferers is also turned down

THE Scottish Medicines Consortium (SMC) yesterday rejected recommending the prescribing of the first oral pill for sufferers of multiple sclerosis in Scotland.

The SMC said that, while the manufacturers of Fingolimod, had provided evidence about it helping to reduce relapse rates, they had not compared it with another drug commonly used in Scotland.

It added that evidence showed that starting treatment with Fingolimod could cause a short-term decrease in heart rate and swelling of the centre of the retina inside the eye, and that about half the patients developed infections. The SMC concluded that it did not consider the drug to be “value for money” for the NHS in Scotland.

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Novartis launched Fingolimod in the UK in April 2011, but the National Institute for Health and Clinical Excellence (NICE) recommended in December that Fingolimod was not a cost effective treatment for the NHS in England and Wales to provide.

Fingolimod works by acting on certain types of white blood cells (lymphocytes) which are involved in the immune attack that characterises MS, which results in the destruction of myelin, the substance covering and protecting nerves in the central nervous system.

It effectively reduces the number of lymphocytes circulating in the blood, resulting in reduced immune attack on nerve cells in the brain and spinal cord.

In addition, there is evidence that Fingolimod may have a direct effect on nerve cell damage and enhance re-myelination

In March last year, the European Medicines Agency (EMA) approved Fingolimod as a second-line treatment to be used if people continue to have relapses or if their relapse rate has increased despite a year’s treatment with one of the first line drugs.

It can also be used with people with rapidly evolving severe relapsing remitting MS – two or more relapses a year.

Scotland has one of the highest rates of MS in the world, with 10,500 diagnosed cases. The debilitating disease attacks the central nervous system, with current treatment consisting of intermuscular injections or infusion therapy.

Last night, Dr Belinda Weller, a consultant neurologist who took part in clinical trials, said: “Today’s decision is very disappointing, as we’ve waited a long time for the first pill to treat this disabling condition effectively.”

Novartis has asked the SMC for further clarification.