MS pill drug firm blamed for ‘evidence failure’

The MS Society urged the National Institute for Health and Clinical Excellence (Nice) and drug firm Novartis to work together so Gilenya (also called fingolimod) can be re-appraised.

In draft guidance which is subject to consultation, Nice rejected the drug because of “uncertainties” over its effectiveness, a lack of appropriate data and concerns over cost-effectiveness.

It said it was unclear how much the drug would help the specific group of people for whom it was licensed – adults with relapsing-remitting multiple sclerosis (RRMS) who experienced at least one relapse a year despite being treated with beta interferon drugs.

Another group of patients suitable for the drug were those with rapidly evolving severe RRMS, who experience two or more disabling relapses regardless of their treatment.

Nice said Novartis had submitted data mainly looking at a subgroup of patients with the former type of MS.

Novartis also only submitted data comparing Gilenya with a placebo and with a type of beta interferon not believed to be widely prescribed on the NHS, according to Nice.

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.”

MS Society chief executive Simon Gillespie 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.

About 100,000 people in the UK have MS, a disease that has traditionally been treated with injectable drugs