Roche has launched its novel biologic RoActemra in the UK, despite a negative opinion from NICE that leaves the drug unavailable on the NHS, and has published new trial data.
RoActemra (tocilizumab), a new product targeting the IL-6 pathway, has shown promising efficacy data in clinical trials in line with current first-line biologic therapies targeting tumour necrosis factor (TNF), says Datamonitor.
However, on October 1 2009 NICE announced its preliminary decision not to recommend tocilizumab for moderate-to-severe active rheumatoid arthritis (RA) in the UK.
Cost-efficiency was cited as the key factor for the drug’s rejection. Roche’s cost-effectiveness evaluation for tocilizumab put it below the £30,000 per quality-adjusted life year limit set by NICE; but the agency found fault with a number of calculations, including the lack of long-term data and non-inclusion of the impact of adverse events in the economic model.
The committee recommended that Roche conduct a head-to-head trial of tocilizumab versus rituximab.
Roche’s new data show that RoActemra, in combination with methotrexate (MTX), inhibits progression of joint damage in 83% of RA patients after two years, compared to just 66% of patients treated with placebo + MTX.
“These positive data clearly show the benefit of using tocilizumab, known as RoActemra, over the long term,” said top UK rheumatologist Professor John Isaacs, Institute of Cellular Medicine, Newcastle University.
“It is an innovative and exciting therapy, and a valuable addition to the treatments available to combat rheumatoid arthritis. RA is a chronic disease that can ultimately lead to severe disability, and so preventing joint damage is a major goal of therapy and vital to help patients maintain normal physical function.”
Despite this, Datamonitor has predicted a poor start for RoActemra, pointing out that Orencia was not backed by NICE and sales of the drug have not reached $1m in the UK, compared to its direct competitor MabThera (rituximab), whose sales are estimated at $12m.