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NICE backs Roche’s Gazyvaro after initial rejection

An undisclosed discount swayed the cost-effectiveness body


The UK’s National Institute for Health and Care Excellence (NICE) has recommended Roche’s Gazyvaro as a first-line treatment for lymphoma patients, reversing its earlier stance on the drug.

Last September the cost-effectiveness watchdog turned down Gazyvaro (obinutuzumab) for use with chemotherapy in previously-untreated patients with advanced follicular lymphoma (FL) at elevated risk of relapse, saying the dug was too expensive. It has now reversed its decision thanks to an undisclosed discount from Roche.

The reversal has been “welcomed by both the patient and clinical community”, according to the pharma company, which said the decision could affect around 1,200 patients across England out of around 1,900 diagnosed with FL every year. The Scottish Medicines Consortium (SMC) turned down Gazyvaro as a first-line option with chemotherapy last month.

Last September, NICE’s Appraisal Committee rejected routine use of the drug first-line with chemotherapy and as a maintenance monotherapy, saying there was not enough evidence to show that its clinical profile justified premium pricing over Mabthera (rituximab), Roche’s older drug for the FL indication.

That ruling came shortly after the agency also concluded that second-line use of the drug in patients who have failed MabThera therapy should be covered via the Cancer Drugs Fund (CDF) rather than the NHS’ regular budget. Previously, NICE also cleared Gazyvaro as a routine NHS treatment option for adults with chronic lymphocytic leukaemia (CLL).

Like MabThera, Gazyvaro targets the CD20 receptor but has been designed with sugar molecule side chains that improve its therapeutic and safety profile. Roche is trying to position the new drug as a successor to MabThera as biosimilars of its older drug start to roll out onto the market in Europe and eat into sales. Sales of the drug were stable overall in 2017 at CHF 7.4bn ($7.9bn) but dipped 11% in Europe to CHF 1.7bn as biosimilar competition took hold.

“Close collaboration between Roche, NHS England and NICE has resulted in NICE recommending Gazyvaro as a cost effective treatment, even when compared to recently introduced biosimilars of rituximab,” commented Richard Erwin, general manager of Roche UK.

The green light from NICE means “means more patients will have their disease controlled for longer compared to the existing standard of care, rituximab plus chemotherapy”, he added.

Article by
Phil Taylor

12th February 2018

From: Regulatory



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