NICE asks Roche for RoActemra cost data
pharmafile | March 5, 2010 | News story | Sales and Marketing | RoActemra, Roche
Roche’s attempts to secure NICE approval for rheumatoid arthritis drug RoActemra have hit another hurdle.
NICE’s independent appraisal committee has asked the manufacturer for more information on cost-effectiveness – the major sticking point so far.
RoActemra (tocilizumab) is indicated for moderate to severe active rheumatoid arthritis, and carries an annual price tag of more than £9,000 for a patient of average weight.
The carrot for Roche is that this new data “could result in the final guidance being positive at specific stages of the treatment pathway”, according to NICE.
It currently recommends initial treatment with 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.
NICE chief executive Andrew Dillon explained: “We don’t think that using it before trying other, existing biologics (such as etanercept or rituximab) is the right approach.”
“But the additional information may be important in deciding whether – and how – tocilizumab can work effectively and cost-effectively for patients when these treatments aren’t working,” he said.
The committee accepted the view that “trying three biological treatments could be better than two”, NICE admits.
Having a range of treatment options is important for patients, Dillon added, saying he was “looking forward” to Roche’s response.
As recently as December, Roche was told that a stronger case was needed and NICE now wants financial figures on RoActemra’s use in patients who have not responded adequately to previous anti-TNFs.
It also wants similar information on those who cannot be treated with – or have found have an inadequate response to – MabThera.
It may be that this is the key place NICE envisages for RoActemra in the treatment pathway but it says Roche did not previously provide data on this particular use.
“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,” concludes Dillon.
A final decision on Roche’s RoActemra is not expected until May.
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