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NICE reverses draft guidance and backs Novartis’ Gilenya

New data sees MS drug recommended for use within NHS in final draft guidance

Novartis' multiple sclerosis drug Gilenya (fingolimod) has been recommended by the UK's National Institute for Health and Clinical Excellence (NICE) in final draft guidance that overturns its previous negative recommendation.

The cost-effectiveness body has now said the oral drug should be available in a sub-group of adult patients with highly active relapsing-remitting multiple sclerosis (RRMS) following an analysis of new data provided by Novartis.

The recommendation still limits use of the drug to RRMS patients who have an unchanged or increased relapse rate or ongoing severe relapses compared to the previous year, despite them taking other drugs such as beta interferons. Nevertheless it is now set to become the first oral MS medicine to have NICE backing for use on the NHS in England and Wales.

Novartis previously suffered knock-backs in two previous draft guidance documents from NICE that declined to recommend Gilenya after deeming it not deemed cost-effective enough compared to previous treatments.

This was a despite a patient access scheme proposed by Novartis that would see the pharma firm cover part of the drug's costs.

But NICE was swayed by fresh data from the phase III FREEDOMS and TRANSFORMS trials that showed the drug would be an effective use of NHS resources, if Novartis offered the drug at the proposed reduced rate.

Professor Carole Longson, director of the Health Technology Evaluation Centre at NICE, said: “Following new information provided during the consultation, the analyses show that for these people, treatment with fingolimod will be a cost effective option for the NHS in this group of people with multiple sclerosis, if Novartis provides the drug at a discounted price, as proposed in its patient access scheme.”

The decision comes as Novartis awaits results from a safety review of the drug carried out by the European Medicines Agency (EMA) following 11 deaths among patients taking the drug.

Despite this, NICE's guidance was backed by patient organisations, include the MS Society.

The organisation's director of policy and research, Nick Rijke, said: “We are delighted - this decision signifies a major step forward in the treatment of MS. Gilenya has been found to be highly effective in trials and taking a daily tablet will come as welcome relief from frequent, often unpleasant, injections.”

However, Rijke said he was disappointed that the Scottish Medicines Consortium, which regulates what drugs are available for use in the NHS in Scotland, failed to recommend Gilenya in guidance issues earlier this week.

“[W]e're deeply disappointed by the SMC's decision in Scotland – and urge them to reconsider,” said Rijke.

The SMC took issue with “weaknesses in the economic case” presented by Novartis, which it said meant Gilenya was not considered to offer value for money.

16th March 2012

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