All doctors who prescribe Tysabri and patients who take it will have to enroll in a monitoring program. The drug, which was priced at more than $20,000 a year before it was withdrawn, will now be available only through authorized infusion centers. Those centers must go through a checklist with each patient before each monthly infusion, in an effort to ensure that patients are eligible for the drug and to detect early signs of the rare side effect.
F.D.A. officials acknowledged the risks. "Yes, we expect there to be additional cases and probably additional deaths as well," Dr. Russell Katz, head of the office that regulates drugs for neurological diseases, told reporters yesterday. But he said that risk was balanced by considerable benefits of the drug.
Despite the risk, Biogen and Elan expect sizable demand for Tysabri. In fact, executives have said they were thinking of raising the price. The price was $23,500 a year at the time the drug was taken off the market, making it already hundreds or thousands of dollars more than other drugs for multiple sclerosis. Link.
technorati tag: multiple sclerosis