Gilenya regulatory update

The U.K.'s NICE issued final guidance recommending the use of Gilenya fingolimod from Novartis in a subset of patients that have highly active relapsing-remitting multiple sclerosis (RRMS) despite treatment with beta interferon. The decision, which is in line with a March final appraisal determination (FAD), is contingent on Novartis providing Gilenya at an undisclosed discount under a patient access scheme (see BioCentury, March 19). Last year, NICE issued 2 appraisals against Gilenya for the full RRMS indication, including 1 that had a proposed discount for the drug under a patient access scheme (see BioCentury, Aug. 8, 2011 & Dec. 5, 2011). In its March recommendation, the agency said Novartis and clinicians submitted new analyses showing that Gilenya would be a cost-effective option for the highly active subgroup with the undisclosed discount.

The sphingosine 1-phosphate (S1P) receptor agonist is approved to treat RRMS in the U.S., EU, Switzerland, Australia and Canada. In Japan, the drug is approved as Imusera to prevent relapse and delay progression of physical disability in MS. Novartis has rights to Gilenya from Mitsubishi Tanabe. ...