The National Institute for Health and Care Excellence has changed its position on the National Health Service use of Roche’s Gazyvaro (obinutuzumab) to treat some patients with chronic lymphocytic leukaemia.

Back in October the cost regulator said it was minded not to recommend the drug because of uncertainties in the original submission, which Roche has since addressed with revised cost-effectiveness analyses and a patient access scheme to sweeten the deal.

NICE has now issued further draft guidance for consultation recommending Gazyvaro for some people with untreated CLL, as long as Roche provides the treatment to the NHS at a (confidential) reduced price to secure value for money. 

Half of patients needing treatment for CLL are unable to use the standard first-line treatment of fludarabine combination therapy, and while NICE recommends alternative treatment with bendamustine there are some patients for whom this is also unsuitable, highlighting the need for additional options. 

Gazyvaro is “a clinically effective treatment which is associated with fewer adverse events and provides another option to help prevent people’s disease from progressing,” said Professor Carole Longson, centre for health technology evaluation director at NICE, commenting on the decision.

Just how cost-effective the drug is has not been divulged by NICE because of the confidential nature of the discount agreed between Roche and the Department of Health. But the list price of the drug is £3,312 per 1000 mg vial (excluding VAT), and a course of treatment costs around £26,496 (excluding discount).