FDAnews
www.fdanews.com/articles/63443-uk-s-nice-considering-velcade-for-treating-multiple-myeloma

UK'S NICE CONSIDERING VELCADE FOR TREATING MULTIPLE MYELOMA

October 23, 2006

The UK's National Institute for Health and Clinical Excellence (NICE) is currently appraising the use of Millennium Pharmaceutical's Velcade (bortezomib) for the treatment of multiple myeloma. Following newspaper reports last week on the content of draft guidance on this drug, NICE decided to publish the draft guidance on its website effective immediately.

The draft guidance recommends clinical studies to establish when Velcade should be used in the care of people with multiple myeloma rather than the other drugs currently used. Consultees have the opportunity to appeal the draft guidance. Subject to an appeal, final guidance is expected in December.

Among arguments raised in newspaper reports Friday were that Velcade can extend multiple myeloma patients' lives by roughly seven years, but that NICE has a policy of rejecting drugs that simply extend lives. NICE disagrees with these points on its website, saying that all 26 cancer treatments it has approved are meant to improve life expectancy, but that evidence shows Velcade does not significantly extend life.

"We are extremely concerned about misleading coverage that has appeared in some of today's national newspapers, hence our decision to publish this document early," NICE official Andrea Sutcliffe said Friday. "It is one thing to criticize our decision not to recommend the use of this drug, but quite another to unfairly raise patient expectations about the effect of this drug. …"

"The independent appraisal committee, having considered the comments received during consultation on the earlier draft of the guidance, has not changed its earlier conclusion that, although the drug is clinically effective compared with high-dose dexamethasone, its cost effectiveness has not been satisfactorily demonstrated and therefore further research is required," she added.