NICE rejects first-line use of Roche’s Gazyvaro

The National Institute for Health and Care Excellence has turned down first-line use of Roche’s Gazyvaro in patients with untreated advanced follicular lymphoma on the NHS in England and Wales.

In an appraisal consultation determination, the cost watchdog said Gazyvaro (obinutuzumab) is not recommended, within its anticipated marketing authorisation - first as induction treatment with chemotherapy, then alone as maintenance therapy - for untreated advanced follicular lymphoma in adults.

Current first-line treatment for symptomatic advanced follicular lymphoma is induction therapy with rituximab (Roche’s MabThera is the branded form) plus chemotherapy, followed by maintenance treatment with rituximab when there has been a response.

According to NICE’s appraisal committee, data from an ongoing trial show that Gazyvaro plus chemotherapy followed by Gazyvaro maintenance therapy delays disease progression more than current treatment, but it also shows that undesirable side effects are more common and there are not enough data to know whether Gazyvaro increases life expectancy.

Furthermore, NICE noted that Gazyvaro costs more than branded rituximab and even more than the biosimilar versions of the latter, and cited concern about assumptions used in the company’s cost-effectiveness modelling, "for example that the treatment effect lasts nine years when there is no evidence for this".

Using the preferred modelling assumptions and discounted prices, the cost effectiveness of Gazyvaro within its licensed indication was "much higher than £30,000 per quality-adjusted life year gained", and therefore it "cannot be recommended for untreated advanced follicular lymphoma", the Institute said.

The decision follows a positive recommendation by NICE back in July for Gazyvaro in combination with bendamustine chemotherapy followed by Gazyvaro maintenance for patients with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with rituximab or a rituximab-containing regimen.

In this case the committee concluded that while the Gazyvaro-based approach is clinically effective the overall survival gain is uncertain, and so recommended its use in the CDF where further evidence can be collected.