- Citing “uncertain” data, the National Institute of Care Health and Care Excellence (NICE) has decided to not fund Gazyvaro (obintuzumab) for treatment of chronic lymphocytic leukemia (CLL).
- NICE compared the cost of adding Gazyvaro to the standard of care for CLL -- cholrambucil -- and determined that the incremental costs associated with Gazyvaro were too high compared with outcomes.
- In the US, Gazyva (Gazyvaro's trade name in US) was given breakthrough status by the FDA based on the strength of its data.
NICE is often referred to as a funding watchdog, but given the nature of the UK’s healthcare system, that level of oversight is warranted. When the Appraisal committee evaluated incremental cost-effectiveness, they found that adding Gazyvaro to the standard of care (chlorambucil) for treatment of CLL was $49,800 per quality-adjusted life year (QALY); $45,000 per QALY compared with chlorambucil combined with rituximab; $78,700 per QALY compared with bendamusine monotherapy; and $77,130 compared with bendusamine/rituximab therapy.
When asked about the decision, Sir Andrew Dillon, Chief Executive of NICE, said that the agency cannot be confident that adding Gazyvaro therapy to standard of care is the most effective use of the agency’s funds. However, on the other side of the pond, the FDA gave Gazyva breakthrough status based on data showing that Gazyva combined with chlorambucil achieved progression-free survival of an average 23 months in CLL patients, compared with 11.1 months in patients treated with chlorambucil alone.
Most likely, Roche will resubmit data to NICE and try again.