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The National Institute for Health and Clinical Excellence (NICE) is currently appraising a number of drugs as possible treatments for rheumatoid arthritis after treatment with a tumour necrosis factor (TNF) inhibitor has failed.  This is a part review of NICE technology appraisal guidance 36, and a review of NICE

technology appraisal guidance 126 and 141.

NICE has today (3 March 2010) put its initial draft guidance on the NICE website, and this is now open for public consultation.

Following a thorough review of all the available evidence, an independent appraisal committee has made the following draft recommendations:

• Rituximab (MabThera, Roche Products), in combination with methotrexate, is recommended as an option for the treatment of adults with 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. 
• The TNF inhibitors adalimumab (Humira, Abbott Laboratories), etanercept (Enbrel, Wyeth Pharmaceuticals) and infliximab (Remicade, Schering-Plough) are recommended for the treatment of rheumatoid arthritis after the failure of a previous TNF inhibitor only in the context of research.
• Abatacept (Orencia, Bristol-Myers Squibb) is not recommended for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor.

Dr Carole Longson, Director, Health Technology Evaluation Centre at NICE said:  

 “Over half a million people in this country have rheumatoid arthritis.  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 they lose their effect The evidence suggests that rituximab works  in this context and is a cost-effective treatment option.

“There was limited evidence available to the appraisal committee on the clinical effectiveness of using a second TNF inhibitor (adalimumab, etanercept or infliximab) after a first one had failed. The limited evidence did not suggest that any of the three drugs would be a cost-effective use of NHS resources when compared to rituximab.  Given the limited evidence base, the appraisal committee felt that further research is needed into the clinical effectiveness of these drugs in this context.  Therefore,  the committee has recommended that the use of a second TNF inhibitor following the failure of treatment with a first TNF inhibitor should only happen as part of a research study.

“Abatacept appears to work no better than rituximab in this context, and it is more expensive, so the committee does not consider it to be good value for money.”

In line with the NICE technology appraisals process, this first draft of the guidance has been issued for consultation: NICE has not yet issued final guidance to the NHS.

These preliminary recommendations are available for public consultation until 24 March 2010. Comments received during this consultation will be considered by the committee at its next meeting. The next draft guidance will be issued following this meeting.