NICE asks for more data on new drug for rheumatoid arthritis
NICE's independent appraisal committee has asked the manufacturer of the rheumatoid arthritis treatment golimumab (Simponi), for additional information on its product. Golimumab is a new treatment for moderate to severe active rheumatoid arthritis where the response to disease-modifying anti-rheumatic drug (DMARD) therapy including methotrexate has been inadequate.
The Committee is minded not to recommend the use of the drug in specific circumstances. These are preliminary recommendations and the additional information NICE has asked for today (22 October) will inform the final recommendations on the use of golimumab in these circumstances. This draft guidance has been issued for consultation: NICE has not yet issued final guidance to the NHS.
The NICE appraisal is trying to establish in what circumstances using golimumab might be a good use of NHS funds for treating patients for whom previous treatments haven't worked. This includes patients who've tried conventional DMARDS (such as methotrexate) only, and people who have had therapy with both conventional DMARDs and a TNF inhibitor (such as adalimumab and etanercept) and who can't take rituximab. The Committee has asked the manufacturer to provide further information about the clinical and cost effectiveness of golimumab in both of these populations. The Committee's preliminary view is that golimumab should not be recommended if both conventional DMARDs and TNF inhibitors have already been tried and rituximab is an option, and so no further information is requested on this use.
Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: “Finding ways to relieve pain, improve mobility and reduce long-term damage are the aims in treating rheumatoid arthritis. The evidence indicates that using golimumab isn't cost effective if both conventional treatments and TNF inhibitors have already been tried and rituximab is an option. However, the additional information requested will be important in deciding whether golimumab can work effectively and cost effectively for patients in certain other circumstances. We need to be sure that golimumab offers real benefits for patients - and we need to be confident that those benefits justify the cost.
“We're looking forward to receiving the manufacturer's response to help us decide whether golimumab should be added to the options already available to patients living with this very disabling disease.”
NICE's preliminary recommendations are available for public consultation from 22 October 2010 until 12 November 2010. Comments received during this consultation will be considered by the committee and following this meeting the next draft guidance will be issued.
Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.
Notes to Editors
About the guidance
1. Information on the NICE appraisal on golimumab for the treatment of rheumatoid arthritis after failure of previous disease-modifying anti-rheumatic drugs.
2. The draft recommendations are:
a) The Committee is minded not to recommend golimumab as a treatment option for rheumatoid arthritis in people who have had therapy with conventional disease-modifying anti-rheumatic drugs (DMARDs) only.
b) Golimumab is not recommended for the treatment of rheumatoid arthritis in people who have had therapy with a tumour necrosis factor (TNF) inhibitor and for whom rituximab is appropriate.
c) The Committee is minded not to recommend golimumab as a treatment option for rheumatoid arthritis in people who have had therapy with a TNF inhibitor and for whom rituximab is contraindicated or is withdrawn because of an adverse event.
d) The Committee recommends that NICE asks the manufacturer of golimumab for more information about the clinical and cost effectiveness of golimumab in the populations in a) and c).
3. The manufacturer of golimumab (Simponi) is Schering Plough/Merck Sharp and Dohme.
4. 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. It should be given concomitantly with weekly methotrexate. The manufacturer's submission states that the cost of golimumab is £774.58 for a 50 mg vial, and estimates an annual cost of £9294.96. Costs may vary in different settings because of negotiated procurement discounts.
5. NICE currently recommends a range of treatments for rheumatoid arthritis.
1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.
2. 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 and procedures within the NHS
- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.
This page was last updated: 21 October 2010