NICE U-turn sees Gilenya MS pill recommended
pharmafile | March 16, 2012 | News story | Sales and Marketing | MS, NICE, UK, fingolimod, gilenya
NICE has changed its mind on Novartis’ multiple sclerosis pill Gilenya, and is now recommending the drug in a subgroup of patients.
The watchdog said in final draft guidance that it now recommends Gilenya (fingolimod), for MS patients that have an unchanged or increased relapse rate or ongoing severe relapses compared to the previous year, despite them taking interferon drugs.
This recommendation has restricted the drug for use in a subgroup of the patient population for which Gilenya is licensed.
NICE’s decision goes against the Scottish Medicines Consortium, which earlier this week decided not to recommend the drug for Scotland’s NHS.
If NICE gives the drug a positive recommendation next month, Gilenya will be the first MS pill to be funded by the NHS in England.
This decision comes after Novartis offered more information on Gilenya, and said it would provide the drug to the NHS at a discounted price.
NICE was originally minded not to endorse the drug, as it didn’t believe Gilenya was as cost effective when compared to existing, NICE-recommended treatments, even with the patient access scheme.
But since the last guidance was issued Novartis revised its analyses for a subgroup of the licensed population, for which it found Gilenya was deemed cost effective by NICE.
The discount will remain in place for the drug, but Novartis has asked for its size to be kept confidential.
The recommended dosage for fingolimod is 0.5mg once a day, with the list price for 28 capsules is £1,470. This is equivalent to an annual cost of around £19,196 per person, but this could be less given the patient access scheme.
Professor Carole Longson, director of the health technology evaluation centre at NICE, said: “The latest draft guidance from our committee recommends the NHS-use of fingolimod for a specific group of adults who have highly active relapsing-remitting multiple sclerosis.
“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.”
Nick Rijke, director of policy and research at the MS Society, 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.
“Making this new treatment available will increase patient choice for thousands of people with MS across England and Wales, but we’re deeply disappointed by the SMC’s decision in Scotland – and urge them to reconsider.”
Safety concerns
But it is not all good news for the drug: The European Medicines Agency is currently conducting a safety review into the drug after 11 patients died whilst taking the treatment.
It is unclear whether Gilenya was a contributor to the deaths as the patients were taking other medications at the time – the EMA is expected to report on its findings in April.
If the drug is found to no longer have a positive risk-benefit ratio, then the regulator could pull the drug from the market, or limit its use in Europe.
Ben Adams
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