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Novartis' MS Pill Gilenya Questioned By UK Regulator




The U.K. health cost body, in a provisional draft guidance, on Friday recommended not to reimburse Novartis AG's (NVS, NOVN.VX) multiple sclerosis medicine Gilenya because of uncertainties over the drug's clinical effectiveness for certain patients, dealing a potential blow to the Swiss pharmaceutical giant's efforts to increase sales of the drug.

Gilenya, which has been approved in the U.S., Europe and elsewhere, is one of Novartis' most promising medicines, expected to reach annual peak sales of more than $3 billion. The relatively high price for the pill -- more than $40,000 per patient per year -- has been considered justified because it is easier to use than standard treatments that require injections or infusions. Since first being approved last year, more than 13,000 patients have been treated with the drug, Novartis has said.

The U.K.'s National Institute for Health and Clinical Excellence, or NICE, while acknowledging that trial data showed that Gilenya benefits patients with highly active relapsing-remitting multiple sclerosis, said it was unclear how much the drug may help patients with other relapse forms.

NICE has rejected expensive drugs in the past, something analysts say is due to efforts to bring down health care costs. Other countries such as Germany, Greece and Spain have also urged drug companies to curb prices. On average, austerity measures in Europe and the U.S. have shaved off more than 2% of drug sales in the first half of 2011, pharmaceutical companies have said.

"Unfortunately our independent committee wasn't given sufficient evidence to show that Gilenya could reduce relapses considerably better than the other treatments currently being used," said Carole Longson, director of NICE's Health Technology Evaluation Center. "Based on the available clinical evidence and economic analysis, our independent committee concluded that Gilenya would not be effective good use of resources."

Novartis said it believes that Gilenya is a highly efficacious and cost-effective treatment for patients with multiple sclerosis and remains committed to engaging with NICE to ensure that patients will have access to the drug. Novartis in the past has offered alternative price schemes to NICE.

NICE, whose independent committee will meet in October to review comments from other parties, including Novartis, said it expects to publish its final guidance on Gilenya in December. Until then, the drug will continue to be reimbursed, NICE said.


-By Goran Mijuk, Dow Jones Newswires;; 41 434 438047


(END) Dow Jones Newswires

August 04, 2011 19:15 ET (23:15 GMT)

Copyright (c) 2011 Dow Jones & Company, Inc.

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