NICE reverses October decision and approves Roche's Gazyvaro

The UK’s National Institute for Health and Care Excellence (NICE) has reversed its decision on Gazyvaro (obinutuzumab), manufactured by Swiss drug major Roche (ROG: SIX). NICE initially rejected the drug, but after two months has now agreed to give patients access to Gazyvaro to treat chronic lymphocytic leukemia, the most common type of adult leukemia.

Many chronic lymphocytic leukemia patients suffer from other medical condition such as diabetes and heart disease, making them unsuitable to receive aggressive treatments, resulting in poorer outcomes. Combining Gazyvaro with chlorambucil has been shown to reduce the risk of death by 59% and keeps patients in remission for more than 15 months longer than using chemotherapy alone. Compared with Mabthera (rituximab), manufactured by US biotech firm Biogen Idec (Nasdaq: BIIB), Gazyvaro with chemotherapy gave patients nearly a year of extra remission time.

The list price of obinutuzumab is £3,312 ($5,216) per 1000 mg vial excluding VAT. The company stated that a course of treatment costs £26,496 (£9,936 for cycle 1 and £3,312 for cycles 2 to 6, excluding VAT).