December 2, 2014
By Riley McDermid, BioSpace.com Breaking News Editor
British health regulator National Institute for Health and Care Excellence (NICE) has reversed an earlier decision and will instead approve Roche ’s new leukemia drug Gazyvaro, the agency said Tuesday, but only after achieving significant price concessions for U.K. consumers.
Gazyvaro’s usually costs around $42,850 per treatment course for the U.K.'s National Health Service, but the new agreement will provide it to British taxpayers at a discount, though neither the company nor the watchdog group would say how much.
Obinutuzumab works by attaching itself to the surface of abnormal white blood cells, which are overproduced in chronic lymphocytic leukemia, causing cell death.
“Half of the people who need treatment for their condition are not able to use the standard first-line treatment of fludarabine combination therapy,” said the agency in a statement.
“NICE recommends alternative treatment with bendamustine but there are some patients for whom this is also unsuitable,” it said. “Obinutuzumab is a clinically effective treatment which is associated with fewer adverse events and provides another option to help prevent people’s disease from progressing.”
NICE said it now recommends obinutuzumab for some people with CLL on the basis that Roche provides the treatment to the NHS at a reduced price. “The company has agreed with the Department of Health that the size of the discount is to be confidential,” it said in statement.
