NICE rejects Roche drug in follicular lymphoma

NICE has said in first draft guidance that Roche's Gazyvaro (obinutuzumab) with bendamustine should not receive regular National Health Service funding for follicular lymphoma, a type of non-Hodgin's lymphoma.

The combination is used to treat follicular lymphoma in people who did not respond to, or whose condition has progressed after treatment with standard rituximab-containing regimens.

An independent appraisal committee concluded there were uncertainties in the evidence, which meant that the overall survival gain of patients was unclear – so could not recommend the drug as a cost-effective use of NHS resources.

Although the committee concluded that the combination is clinically effective compared with bendamustine alone, based on progression-free survival data, it was uncertain whether this translates into overall survival benefits.

However the committee noted that an updated analysis from the pivotal GADOLIN trial for the drug will soon be available.

NICE's cost-effectiveness calculations have not been fully published, as the company had agreed to provide the drug at a commercially confidential discount.

Draft guidance is out for consultation, allowing the manufacturer, healthcare professionals and members of the public to comment on the recommendations before NICE publishes a final draft.

In late 2014 NICE recommended Gazyvaro in chronic lymphocytic leukaemia, after Roche agreed to a price cut.

Earlier this month, NICE rejected another Roche drug combination, Cotellic (cobimetinib) and Zelboraf (vemurafenib) in advanced skin cancer.

NICE said that Novartis’ rival, Mekinist (trametinib) and Tafinlar (dabrafenib), which extended life by an average of six months in a clinical trial, was a more cost-effective alternative in patients with advanced, metastatic or unresectable BRAF V600 mutation-positive melanoma.