The National Institute for Health and Clinical Excellence (NICE) has asked Roche for more information about the use of its product RoActemra (tocilizumab) in a form of childhood arthritis.
In just-published draft guidance, NICE has opened its public consultation on RoActemra for treating systemic juvenile idiopathic arthritis (JIA) in children and young people aged two years and older where specific previous treatments have not produced an adequate response.
Although arthritis is commonly associated with older people, children and young people can also be affected, says NICE. JIA, which has no known cause, covers various forms of the condition. Systemic JIA may start with symptoms such as a fever or rash, with joints eventually becoming swollen and inflamed. It can affect children of any age, causing severe pain and difficulties in their everyday life.
NICE's independent Appraisal Committee is asking Roche to provide a range of detailed information on RoActemra when it is used in treating systemic JIA, where the individual's condition has responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids and methotrexate. The data requested includes: analysis of RoActemra compared with other drugs commonly used to treat systemic JIA; data concerning joint damage for patients receiving RoActemra including long-term follow-up; and - a revised model.
"At present, without this information, the Committee is minded not to recommend the use of tocilizumab in this circumstance," it says.
The draft guidance also does not recommend RoActemra in this patient group where methotrexate has not yet been tried, but NSAIDs and systemic corticosteroids have already been used.
Systemic JIA "causes severe pain, fatigue and disability, impacting significantly on the child's family and school life, as well as their physical and emotion wellbeing," says Professor Carole Longson, director of the Health Technology Evaluation Centre at NICE.
"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," she adds.
The consultation is open until 5pm on September 1. NICE points out that it has not yet issued final guidance to the NHS and that, until it does, NHS bodies should make decisions locally on the funding of specific treatments.
- On August 3, Roche announced that RoActemra had received approval from the European Commission for the treatment of active systemic JIA in patients aged two years and older who had responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. It is also approved for this condition in the US, Mexico, India and Switzerland - in these countries it is marketed under the name Actemra.