NICE provisionally recommends new drug for rheumatoid arthritis
In draft guidance, published today (13 May), the National Institute for Health and Care Excellence (NICE) provisionally recommends golimumab (Simponi) as an option for treating rheumatoid arthritis in specific circumstances where previous treatments haven't worked.
Golimumab in combination with methotrexate is provisionally recommended for adults whose rheumatoid arthritis has responded inadequately to conventional disease-modifying antirheumatic drugs (DMARDs) only, including methotrexate. In this case, golimumab is an option if it is used as described for other tumour necrosis factor (TNF) inhibitor treatments - adalimumab, etanercept and infliximab - covered by NICE technology appraisal 130, and the manufacturer provides the 100 mg dose of golimumab at the same cost as the 50 mg dose.
For adults whose rheumatoid arthritis has responded inadequately to other DMARDs, including a TNF inhibitor, golimumab in combination with methotrexate is also provisionally recommended as a treatment option. In this situation golimumab can be used only as described for other TNF inhibitor treatments in NICE technology appraisal guidance 195 (which covers the use of adalimumab, etanercept, infliximab, rituximab and abatacept after the failure of a TNF inhibitor), and the manufacturer provides the 100 mg dose of golimumab at the same cost as the 50 mg dose.
Golimumab is a treatment for moderate to severe active rheumatoid arthritis in adults where the response to DMARD therapy including methotrexate has been inadequate. This draft guidance is now with consultees, who have the opportunity to appeal against the proposed guidance. NICE has not yet issued final guidance to the NHS. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.
Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: “This draft guidance sets out the circumstances where golimumab could be a treatment option for people with rheumatoid arthritis for whom previous treatments have not worked. Finding ways to relieve pain, improve mobility and reduce long-term damage are the aims in treating rheumatoid arthritis. NICE has already recommended seven biological treatment options for patients living with this very disabling disease; these provisional recommendations indicate that golimumab could be another option.”
Notes to Editors
About the guidance
2. NICE currently recommends a range of treatments for rheumatoid arthritis: adalimumab, etanercept, infliximab, rituximab, abatacept, tocilizumab and certolizumab pegol. More information is at:
3. NICE technology appraisal guidance 130 recommends adalimumab, etanercept and infliximab as possible treatments for people with rheumatoid arthritis who
- have already tried methotrexate and another disease-modifying anti-rheumatic drug (DMARD), and
- Have 'active' rheumatoid arthritis, as assessed by a rheumatologist on two separate occasions. People who are treated with adalimumab, etanercept or infliximab should normally also be given methotrexate. If methotrexate does not suit them, they may be given adalimumab or etanercept on its own.
4. NICE technology appraisal guidance 195 recommends rituximab in combination with methotrexate as an option for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response to, or have an intolerance of, other DMARDs, including at least one TNF inhibitor.
- If rituximab is contraindicated or withdrawn, adalimumab, etanercept, infliximab and abatacept, each in combination with methotrexate, are now recommended as treatment options.
- If rituximab therapy cannot be given because methotrexate is contraindicated or withdrawn because of an adverse event, adalimumab and etanercept, each as monotherapy, are now recommended as treatment options.
5. The independent Appraisal Committee requested additional information from the manufacturer following a consultation on its first draft recommendation, which initially was minded to not recommend golimumab.
6. The manufacturer of golimumab (Simponi) is Schering Plough part of Merck Sharp and Dohme.
7. Golimumab is a human monoclonal antibody that prevents the binding of TNF to its receptors, thereby neutralising its activity. Golimumab is injected subcutaneously via a pre-filled injection pen. The recommended dosage is 50 mg given once a month, on the same date each month. The SPC states that in people who weigh more than 100 kg whose rheumatoid arthritis does not show an adequate clinical response after three or four doses, the dosage may be increased to 100 mg once a month. The cost of golimumab is £774.58 for a 50 mg vial (MIMS) and the annual cost is £9295. Costs may vary in different settings because of negotiated procurement discounts. The manufacturer has agreed a patient access scheme with the Department of Health, in which the 100 mg dose of golimumab will be available to the NHS at the same cost as the 50 mg dose.
8. NICE recently approved golimumab for psoriatic arthritis (guidance published 27 April) and is currently also appraising golimumab for use in treating ankylosing spondylitis.
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
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.
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
- 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: 12 May 2011