NICE wants more RoActemra data for juvenile idiopathic arthritis
pharmafile | August 9, 2011 | News story | Medical Communications | NICE, RoActemra, Roche
NICE has requested more evidence from Roche for RoActemra in childhood arthritis.
RoActemra (tocilizumab) is being assessed for the treatment of systemic juvenile idiopathic arthritis in children aged two years and older who have failed on ibuprofen, systemic corticosteroids and methotrexate.
It is also looking at the drug for use in systemic juvenile idiopathic arthritis (JIA) patients where methotrexate has not been used, but where drugs such as ibuprofen and systemic corticosteroids have already been prescribed.
In its first draft guidance the Institute says it needs more detailed data from Roche, which includes an analysis of RoActemra compared with other drugs commonly used to treat systemic JIA.
These drugs include Pfizer’s Enbrel, J&J’s Remicade and Amgen’s Kineret, all of which have been licenced to treat various forms of arthritis, but not the specific form of systemic JIA.
NICE wants Roche to submit direct comparisons between RoActemra and these three drugs because doctors in the NHS commonly use them.
NICE also wants more long-term data about joint damage for patients, and has requested a revised economic model.
NICE’s appraisal committee is currently minded to not recommend the RoActemra for systemic JIA in either setting because of this lack of information.
Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: “The committee needs more information from the manufacturer so that it can fully assess the benefits that tocilizumab might provide for those young patients whose condition has not responded well after trying other treatments.
“In the meantime, we welcome comments from patients and their carers and families, and clinicians, as part of our public consultation on the committee’s provisional recommendations.
The average cost of treatment with RoActemra is £7,987 per year for a 30kg patient and £9,984 per year for a 25kg patient.
The guidance is now open for consultation, with a second appraisal meeting scheduled for early September.
NICE recommended RoActemra for adults with rheumatoid arthritis in August, reversing an initial decision not to endorse the drug after Roche submitted extra cost-effectiveness data.
Ben Adams
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