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NICE still set against Novartis’ MS drug Gilenya

Pharma company fails to sway the UK watchdog with a patient access scheme for its oral multiple sclerosis treatment

NICE has again rejected Novartis' multiple sclerosis treatment Gilenya (fingolimod) for use on the NHS.

The cost-effectiveness body's second draft guidance upholds its initial negative decision that the drug is not cost-effective enough as a treatment for highly active relapsing remitting multiple sclerosis (RRMS).

This is despite a proposed patient access scheme from Novartis that would see the pharma company cover part of the drug's costs to offer a discount price for the NHS.

Sir Andrew Dillon, CEO of NICE, said: “While Novartis submitted evidence that shows fingolimod can reduce relapses, our independent committee has not been convinced that it is a cost effective treatment option for the NHS, even with the proposed patient access scheme.”

Gilenya has an annual cost of treatment is £19,196 per patient, when prescribed at the recommended dosage of 0.5mg once a day, but NICE said it did not provide enough clinical benefits when compared to treatments such as Biogen's Tysabri (natalizumab), which costs £14,730 per patient per year

Details of Novartis' patient access scheme remain confidential, but NICE said the most plausible incremental cost effectiveness ratio was £40,000 per quality of life year (QALY) gain. NICE generally considers a treatment cost-effective if this figure is below £30,000.

Novartis disputed the decision, claiming the cost per QALY was pushed above the threshold due to NICE's recommendation for use of best supportive care in combination with the treatment.  When supportive care is removed from the care model, the cost per QALY for Gilenya comes under £30,000, the company said.

Gilenya (fingolimod) is the first oral treatment for multiple sclerosis to come to market in Europe following its approval by regulators in March.

Dr Jayne Spink, director of policy and research at UK charity the MS Society, said: “This is incredibly disheartening news for people with MS and it will leave some people with no effective treatment option. We would like to see Gilenya freely available to all those that could benefit and remain hopeful that this will happen.”

NICE will consult on its draft guidance until January 5, with final guidance expected in April 2012.

2nd December 2011

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