The National Institute for Health and Care Excellence (NICE) in the United Kingdom has recommended Roche‘s Gazyvaro (obinutuzumab) as a first-line treatment for follicular lymphoma patients, after initially rejecting it.
Routine use of Gazyvaro first was rejected not only because it is expensive, but also because a NICE panel concluded there was not enough evidence that its clinical benefits justified premium pricing over MabThera (rituximab), Roche’s older therapy for follicular lymphoma.
At the time, the panel also said it was “not innovative,” objecting to Roche’s characterization of Gazyvaro in its application.
NICE now recommends Gazyvaro, marketed as Gazyva outside Europe, for use by the National Health Service (NHS) with chemotherapy in patients with higher risk of relapse. It reversed its stance after an undisclosed discount swayed the cost-effectiveness watchdog.
The decision is estimated to affect about 1,200 people annually in Britain. The reversal was “welcomed by both the patient and clinical community,” according to a statement from Roche, and arrives just after the Scottish Medicines Consortium (SMC) turned down Gazyvaro as a first-line option with chemotherapy.
The ruling follows the agency’s conclusion that second-line use of Gazyvaro in patients who failed MabThera therapy should be covered by the Cancer Drugs Fund (CDF) rather than the NHS regular budget. NICE previously had cleared Gazyvaro as a routine treatment option for adults with chronic lymphocytic lymphoma (CLL).
Gazyvaro is a more expensive follow-on to MabThera (marketed as Rituxan in the United States, Japan and Canada), Roche’s best-selling $7 billion-per-year medicine for follicular lymphoma and other indications, which has lost patent protection in Europe and is now seeing sales quickly eroding by cheaper generic drugs.
Gazyvaro was designed with sugar molecule side chains to target the CD20 receptor with an improved therapeutic and safety profile, Roche said. The company intends to market Gazyvaro as a successor to MabThera, as biosimilars of the older therapy start to roll out onto the market.
“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,” said Richard Erwin, general manager of Roche UK, in a press release.
Roche reportedly had been seeking expanded approval of Gazyvaro since it was first approved in 2013, for other blood cancer indications. The U.S. Food and Drug Administration (FDA) approved Gazyva in combination with chemotherapy as a first-line treatment for patients with advanced follicular lymphoma in November 2017.
