NICE Won’t Cover Roche’s Gazyvaro

The UK’s healthcare cost watchdog has recommended against covering Roche’s leukemia drug Gazyvaro for chronic lymphocytic leukemia (CLL) patients who are ineligible for fludarabine-based therapy.

The National Institute for Health and Care Excellence issued its negative decision last week, based on concerns it had over the integrity of data that Roche presented. Specifically, NICE called into question Roche’s analyses of the drug’s clinical utility and cost-effectiveness.

The European Medicines Agency in July approved Gazyvaro (obinutuzumab), known as Gazyva in the U.S., in combination with chlorambucil for this CLL subset.

According to Roche’s modeling, Gazyvaro showed incremental cost-effectiveness ratios of $50,000 for Gazyvaro and chlorambucil versus chlorambucil alone, $45,000 for the combination compared to chlorambucil and rituximab, $79,000 compared to bendamustine and $77,000 compared to bedamustine and rituximab.

NICE said it was concerned that Roche had compared actively treated patients with non-treated patients to arrive at progression-free survival ratios. The evaluators also questioned Roche’s utility study that was done with a sample of the general population instead of the CLL population. This led to unreliable utility values in the company’s cost-effectiveness modeling, NICE asserted.

Gazyvaro’s cost-effectiveness values may actually be higher than Roche had estimated, putting them at the top end of the range that the agency would normally accept, NICE concluded in its evaluation that claimed that the drug did not represent a cost-effective use of NHS resources.

The decision comes just two months after the same agency declined to recommend Roche’s breast cancer drug Kadcyla, stating that the drug was too expensive both before and after the company promised a discount.

Comments on the latest draft guidance are due Oct. 23. Should NICE’s decision ultimately stand, Gazyvaro may still end up being available via the UK’s Cancer Drugs Fund. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.