National Institute for Clinical Excellence (NICE) Rejects Another Roche Leukemia Drug Citing Data Uncertainties

October 3, 2014

By Riley McDermid, BioSpace.com Breaking News Staff

The British regulator National Institute for Clinical Excellence (NICE) has rejected a new leukemia drug from Swiss pharmaceutical giant Roche , saying in a statement Friday that its value remains uncertain.

The drug, Gazyvaro (obinutuzumab), is designed to combat chronic lymphocytic leukaemia (CLL). CLL affects bone marrow cells, which can then produce abnormal white blood cells. People with the disease experience fatigue, breathlessness, bruising and bleeding.

NICE’s decision is a major blow to the company’s European hopes for the therapy, because it thwarts Roche’s efforts to have the U.K. National Health Service reimburse it when used for its patient.

“Although obinutuzumab is a clinically effective treatment, there were too many uncertainties in the company’s submission and we cannot be confident that it is an effective use of NHS resources," said NICE's Chief Executive Andrew Dillon.

The world’s largest manufacturer of cancer drugs has tangled with NICE before, most recently when the agency rejected its breast cancer drug Kadcyla. That treatment can cost upwards of $145,000 per course of treatment. Gazyvaro runs about $42,850 for one course of treatment.

Those costs do not go unnoticed by European regulators pricing therapies for government-subsidized health plans. "With limited resources we need to ensure that each treatment we recommend gives patients not only the best care but is also of the best value to the NHS,” said Dillon.

Roche had not yet issued a formal statement as of publication time.