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In draft final guidance published last week, NICE recommends rituximab, adalimumab, etanercept, infliximab and abatacept, in certain circumstances, as possible treatments for rheumatoid arthritis after treatment with a tumour necrosis factor (TNF) inhibitor has failed.

Following consultation on the preliminary draft guidance, the independent appraisal committee has made the following recommendations:

• Rituximab (MabThera, Roche Products), in combination with methotrexate, is recommended as an option for the treatment of adults with severe active rheumatoid arthritis that has responded inadequately to other disease-modifying anti-rheumatic drugs (DMARDs), including treatment with at least one TNF inhibitor, or who are intolerant of other DMARDs. Treatment with rituximab should not be given more frequently than every six months and should only be continued if there is an adequate response1.
• Adalimumab (Humira, Abbott Laboratories), etanercept (Enbrel, Wyeth Pharmaceuticals), infliximab (Remicade, Schering-Plough) and abatacept (Orencia, Bristol-Myers Squibb) are recommended for the treatment of people with severe active rheumatoid arthritis that has responded inadequately to other DMARDs, including treatment with at least one TNF inhibitor, or who are intolerant of other DMARDs and who have a contraindication to rituximab or methotrexate, or when either of these two drugs is withdrawn because of an adverse event. Treatment with adalimumab, etanercept, infliximab and abatacept should be continued only if there is an adequate response1 six months after the start of therapy.

Dr Carole Longson, Director, Health Technology Evaluation Centre at NICE said: “Around 87,000 people in England and Wales have severe rheumatoid arthritis, which can have a major impact on quality of life. Different people respond in different ways to treatment and the committee heard from clinical experts and patients about the importance of having multiple options available.

“We have already recommended the TNF inhibitors adalimumab, etanercept and infliximab for some people with rheumatoid arthritis as options for use after conventional treatments. The focus of this appraisal was to look at treatment options when a TNF inhibitor has not worked or when it has lost its effect. The evidence suggests that rituximab works in this context and is a cost-effective treatment option.

“However, not all patients are able to take rituximab, and so, following consultation, the appraisal committee has recommended that adalimumab, etanercept, infliximab or abatacept may be given in this context if a patient cannot take rituximab. We hope that this wider choice of options will mean that people will be able to manage their rheumatoid arthritis more effectively.”

Notes to Editors

• The guidance is available to view at: http://guidance.nice.org.uk/TA/WaveR/61 (from 23 June 2010).
• It is estimated that 580,000 people in England and Wales have rheumatoid arthritis. Of these, approximately 15%, around 87,000, have severe disease.
• DAS28 is a disease activity scoring system developed in Europe. It is calculated using a formula that includes counts for 28 tender and swollen joints, an evaluation of general health by the patient (on a scale of 0 to 100) and a measure of circulating inflammatory markers. A DAS28 score greater than 5.1 indicates high disease activity, between 3.2 and 5.1 moderate disease activity, and less than 3.2 low disease activity. A score of less than 2.6 indicates disease remission. An improvement in DAS28 score of 0.6 or less is considered a poor response, and improvements greater than 1.2 points indicate a good response.
• This appraisal combines an evaluation of adalimumab after the failure of a previous TNF inhibitor with reviews of previous NICE guidance on the use of adalimumab, etanercept and infliximab (technology appraisals TA 36) and also rituximab (technology appraisal 126) and abatacept (technology appraisal 141):
  • NICE guidance (technology appraisal 36) does not recommend etanercept or infliximab as treatment options for rheumatoid arthritis after the failure of a TNF inhibitor.
  • NICE guidance (technology appraisal 126) recommends the use of rituximab after the failure of a TNF inhibitor.
  • NICE guidance (technology appraisal 141) does not recommend the use of abatacept after the failure of a TNF inhibitor.
• NICE has previously recommended adalimumab, etanercept and infliximab as possible treatments for people with rheumatoid arthritis after the failure of conventional DMARDs (technology appraisal 130)

The annual acquisition costs of the technologies appraised are:

Rituximab - £3,492 for one course to £6,984 for two courses per year

Adalimumab - £9,295

Etanercept - £9,295

Infliximab - £10,072 in the first year, £7,553 - £8,812 in subsequent years (annual cost will vary depending on patient’s weight)

Abatacept - £10,171 in the first year, £9,444 in subsequent years (annual cost will vary depending on patient’s weight)

Costs may vary in different settings because of negotiated procurement discounts.

About NICE

1. The National Institute for Health and Clinical 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 and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

1 An ‘adequate response’ is defined as an improvement in disease activity score (DAS28) of 1.2 points or more.