Part B Insider (Multispecialty) Coding Alert

Physicians have been optimistic about the possibilities of using Tysabri to treat multiple sclerosis (see PBI, Vol. 6, no. 6). But now Biogen Idec and Elan Pharmaceuticals, the makers of Tysabri, have temporarily pulled the drug from the market.

In a Feb. 28 announcement, Biogen and Elan announced that they "are suspending supply of Tysabri from commercial distribution and physicians should suspend dosing of Tysabri until further notification." The suspension follows "recent reports of two serious adverse events that have occurred in patients treated with Tysabri in combination with Avonex (Interferon beta-1a) in clinical trials," including at least one fatal case of progressive multifocal leukoencephalopathy (PML), a rare and frequently fatal, demyelinating disease of the central nervous system.

"Because we believe in the promising therapeutic benefit of Tysabri, we are working to evaluate this situation thoroughly and expeditiously. While we work through this matter, we must place patient safety above all other considerations," says Burt Adelman, MD, executive vice president of development at Biogen Idec.

Biogen and Elan may choose to re-release Tysabri following investigation. In the meantime, expect payers to discontinue all reimbursement for Tysabri infusion.