NICE Set To Recommend Roche's Gazyvaro For CLL

The National Institute for Health and Care Excellence (NICE) announced that it is set to recommend Roche’s (obinutuzumab) in its preliminary guidance to the National Health Service (NHS) as treatment for certain patients with chronic lymphocytic leukemia (CLL).

Gazyvaro is a novel monoclonal antibody (mAb) that binds to the B cell CD20 and targets abnormal white blood cells overproduced in CLL. The drug has been approved by the U.S. Food and Drug Administration (FDA) for CLL last year. Roche is investigating Gazyvaro versus MabThera/Rituxan in indolent non-Hodgkin lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL).

Though NICE has acknowledged Gazyvaro as a “clinically effective treatment,” the Institute rejected the drug in a preliminary guidance published earlier this year. NICE said at the time that there were too many uncertainties in Roche’s application and that Gazyvaro’s price was a major factor in its consideration. The company promptly responded by revising its cost-effectiveness analyses and offering a patient access program.

The pharmaceutical company’s revision allowed NICE to recommend Gazyvaro for adults with treatment-naïve chronic lymphocytic leukemia who have comorbidities that disqualify them for full-dose fludarabine-based therapy and bendamustine-based therapy.

Professor Carole Longson, centre for health technology evaluation director at NICE, said, “We are pleased that Roche responded to our consultation and provided further analyses to allow us to propose recommending obinutuzumab as a treatment option for untreated chronic lymphocytic leukemia… NICE recommends alternative treatment with bendamustine, but there are some patients for whom this is also unsuitable. Obinutuzumab is a clinically effective treatment that is associated with fewer adverse events and provides another option to help prevent people’s disease from progressing.” CLL is the leading form of leukemia in England, with an estimated 2,700 new cases diagnosed each year.

Neither Roche nor NICE revealed the cost-effectiveness analyses and discount offered by the company. However, Pharma Times reports that the listed price for the drug is currently £3,312 per 1000 mg vial and £26,496 without discount for a full course of treatment.