Sunday, May 11

FDA-Approved Label Changes Clarify Tysabri’s Indications and Should Ease Coverage by Health Plans

Label changes recently approved by the U.S. Food and Drug Administration for the drug Tysabri® (natalizumab, Biogen Idec and Elan Pharmaceuticals) now generally recommend the drug for patients who have had an inadequate response to, or inability to tolerate, a single alternate MS therapy; previous wording had suggested that a patient would generally need to do poorly on more than one alternate therapy. This change should improve its coverage by health plans. The new label change also updates warnings related to the potential risk of developing PML, in light of two new cases that developed in individuals who were using it as a monotherapy.
“This labeling change is good news for many people with MS who may have had trouble getting their health plans to cover Tysabri before,” stated Kim Calder, Senior Manager of Insurance Initiatives at the National MS Society. Although the labeling does not preclude the drug’s use as a first-line therapy, she noted, “at the other extreme, some people had been expected to use and ‘fail’ every other approved MS disease-modifying therapy before their health plans would cover Tysabri. This change in labeling should clarify for health plans and prescribers that Tysabri may be appropriate for people with MS who have not gotten good results with a single other MS therapy,” she added.

For complete, updated prescribing information and medication guides, go to the drug’s Website:

National Multiple Sclerosis Society