NICE asks for more information on use of tocilizumab for systemic juvenile idiopathic arthritis
The National Institute for Health and Care Excellence (NICE) is asking the manufacturer of a drug for treating a form of arthritis in young people for more information, in draft guidance published today (10 August). NICE, the healthcare guidance body, has opened its public consultation on tocilizumab (RoActemra, Roche Products) for treating systemic juvenile idiopathic arthritis (JIA) in children and young people aged 2 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. 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 requesting that the manufacturer provides a range of detailed information on tocilizumab, when it's 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 tocilizumab compared with other drugs commonly used to treat systemic JIA, data about joint damage for patients receiving tocilizumab including long-term follow-up, and a revised model. At present, without this information, the Committee is minded to not recommend the use of tocilizumab in this circumstance.
The draft guidance also does not recommend tocilizumab in this patient group where methotrexate has not yet been tried, but NSAIDs and systemic corticosteroids have already been used. NICE has not yet issued final guidance to the NHS.
Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: “Systemic juvenile idiopathic arthritis causes severe pain, fatigue and disability, impacting significantly on the child's family and school life, as well as their physical and emotional well-being. 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 consultation is open until 5pm on 1 September. Until final guidance is issued NHS bodies should make decisions locally on the funding of specific treatments.
Notes to Editors
About the guidance ‘tocilizumab for the treatment of systemic juvenile idiopathic arthritis'
1. More information on this appraisal can be found here: http://guidance.nice.org.uk/TA/Wave14/86 .
2. The manufacturer of tocilizumab (RoActemra) is Roche Products.
3. Tocilizumab is a humanised monoclonal antibody that helps reduce inflammation in the joints, which can help prevent long-term damage, and improve quality of life and function.
4. The average cost of treatment is £7987.20 per year for a 30 kg patient and £9984 per year for a 25 kg patient assuming no wastage. Costs may vary in different settings because of negotiated procurement discounts.
5. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health
6. NICE produces guidance in three areas of health:
- public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
- health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.
7. NICE produces standards for patient care:
- quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
- Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
8. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.
This page was last updated: 10 August 2011