Novartis MS Pill Gilenya Rejected by U.K. Health-Cost Agency

Novartis AG’s multiple sclerosis pill Gilenya failed for a second time to gain the backing of the U.K.’s health-cost agency, denting the company’s ambitions to turn the drug into a multibillion-dollar-a-year blockbuster.

Novartis failed to show that Gilenya would be cost effective compared with existing options available even after the drugmaker proposed a discount, the National Institute for Health and Clinical Excellence said in a statement today. NICE said in August the annual cost for the medicine, also known as fingolimod, was about 19,196 pounds ($30,134).

Gilenya, approved in Europe in March as the first oral treatment for MS, is among the products that Basel, Switzerland-based Novartis is counting on to fuel sales growth as patents start to expire on the company’s best-selling treatments, including the hypertension pill Diovan.

“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,” Andrew Dillon, chief executive of NICE, said in the statement.

NICE advises the state-run National Health Service on which medicines represent value for money as the U.K. government works to save as much as 20 billion pounds a year on medical expenses.

Novartis “remains committed to engaging with NICE with the goal of ensuring that appropriate patients will have access to Gilenya,” the company said in an e-mailed statement. “This is not the final guidance from NICE.”

The company declined to disclose details on the discount it proposed to NICE.

Public comments on the draft decision will be accepted until Jan. 5, NICE said. The independent committee will meet in February to review comments before publishing final guidance in April on whether the NHS is legally obliged to pay for Gilenya.

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