NICE still saying ‘no’ to Roche’s RoActemra
pharmafile | December 17, 2009 | News story | Sales and Marketing | NICE, RoActemra, Roche
Roche will have to present a stronger case for arthritis drug RoActemra in order to gain approval, according to NICE.
The health technology assessment agency is standing by its preliminary verdict, issued in October, that RoActemra (tocilizumab) is not a cost-effective option for treating moderate-to-severe rheumatoid arthritis (RA) on the NHS. RoActemra carries a cost of more than £9,000 per year for a patient of average weight.
This isn’t an endgame for Roche, however, as NICE is not scheduled to deliver a final verdict on RoActemra until May 2010.
NICE concedes RoActemra may have a place in treating RA patients who fail to respond to other biologics and has asked Roche for additional evidence supporting its use in patients considered candidates for biological treatment, who have already been treated with existing drugs.
At the moment, NICE recommends initial biological treatment of RA be carried out using tumour necrosis factor-alpha inhibitors such as Merck & Co’s Remicade (infliximab), Abbott’s Humira (adalimumab) and Pfizer’s Enbrel (etanercept), with Roche’s own MabThera (rituximab) as a second-line option.
Specifically, NICE has asked for a re-analysis of the cost effectiveness of RoActemra in patients who are refractory to treatment with TNF blockers and “before, after, or as a replacement for, treatment with rituximab”.
NICE also wants an indirect comparison of the clinical and cost effectiveness of RoActemra versus MabThera in TNF blocker non-responders, and said it would also like to see a head-to-head trial of the two drugs.
“We want to know how tocilizumab can help, but we need to be sure that it offers real additional benefits for patients – and we need to be confident that those benefits justify the cost,” said NICE chief executive Andrew Dillon in a statement.
The UK’s National Rheumatoid Arthritis Society said it was “devastated” by the news, noting “this is … a bitter blow for patients who have failed on anti-TNF, particularly those who have sero-negative RA and for whom the only other biologic drug option, rituximab, may not be suitable”.
“We are at a complete loss to understand NICE’s decision here, particularly as the cost is the same as the TNFs already on the market,” said the NRAS’s chief executive Ailsa Bosworth.
RoActemra – which is known as Actemra elsewhere – was approved in Europe in January of this year and is the first in a new class of interleukin-6 receptor-inhibiting monoclonal antibodies to reach the market. It is also available in Japan.
Roche is still awaiting approval in the US, having resubmitted its application there in July to answer some questions raised about manufacturing and labelling in its first filing.
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