NICE, the health and social care guidance body, has recommended abatacept (Orencia) for rheumatoid arthritis after conventional drug treatments (disease-modifying anti-rheumatic drugs, DMARDs) have failed.

The recommendations say that abatacept in combination with methotrexate is recommended as an option for treating people with rheumatoid arthritis only if:

• the disease has responded inadequately to two conventional non-biological DMARDs including methotrexate and it is used in line with the recommendations for other biological DMARDs in Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis (NICE technology appraisal guidance 130), and
• the manufacturer provides abatacept with the discount agreed in the patient access scheme.

In August 2011, NICE issued guidance TA234 not recommending abatacept as a treatment option after conventional DMARDS, as it was not cost-effective for this use when compared to a range of alternatives (including adalimumab, etanercept and certolizumab pegol) which were already recommended. This new guidance is a rapid review of TA234 following the introduction of a patient access scheme which abatacept's manufacturer has agreed with the Department of Health.

NICE has previously recommended abatacept and other drugs as an option for people with rheumatoid arthritis if there has been an inadequate response to one or more TNF inhibitors and who cannot receive rituximab because it is contraindicated or withdrawn because of an adverse event (guidance TA195, August 2010).

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, said: “NICE has already recommended a range of treatments to help patients manage rheumatoid arthritis, which can be a disabling condition. This guidance, resulting from the rapid review of TA234, recommends that abatacept should be an option at an earlier stage after treatment with conventional drugs has failed. We have already recommended the TNF inhibitors adalimumab, etanercept, infliximab, certolizumab pegol and golimumab, and also the drug tocilizumab, for some people with rheumatoid arthritis as options for use at this stage.

“This guidance will widen the choice of treatments available at this stage of the treatment pathway, by offering abatacept in specific clinical circumstances, and only if the manufacturer provides it with the discount agreed as part of the patient access scheme.”

Ends

Notes to Editors

About the guidance

1. The guidance, ‘‘Abatacept for treating rheumatoid arthritis after the failure of conventional disease-modifying anti-rheumatic drugs (rapid review of technology appraisal guidance 234)', is available from Weds 24 April 2013.

2. Conventional DMARDS includemethotrexate, sulfasalazine and leflunomide.

3. Abatacept is administered as a 30-minute intravenous infusion. The annual drug costs associated with abatacept vary according to body weight and the number of infusions required. For a person weighing 60−100 kg, based on the list price, the cost is £12,700.80 in the first year, and £11,793.60 in subsequent years. Costs may vary in different settings because of negotiated procurement discounts. The manufacturer of abatacept has agreed a patient access scheme with the Department of Health in which abatacept within its licensed indications would be available with a discount. The level of discount is commercial-in-confidence at the manufacturer's request.

4. The manufacturer of abatacept (Orencia) is Bristol-Myers Squibb.

5. A rapid review facility is available to consider new patient access schemes if submitted within 16 weeks of original guidance publication. NICE can only consider these schemes after ministerial approval and confirmation by the Department of Health. Further information on the rapid review process, is given in the NICE Single Technology Appraisal process guide, sections 5. 11 and 5.12.

6. NICE has previously recommended the following drugs as possible treatments for people with rheumatoid arthritis after the failure of conventional DMARDs:

• TNF inhibitors adalimumab, etanercept and infliximab (technology appraisal 130, October 2007).
• Certolizumab pegol (technology appraisal 186, February 2010)
• Golimumab (technology appraisal 225, June 2011)
• Tocilizumab (technology appraisal 247, February 2012)

7. NICE has previously recommended abatacept and other drugs as options for people with rheumatoid arthritis if there has been an inadequate response to one or more TNF inhibitors and who cannot receive rituximab because it is contraindicated or withdrawn because of an adverse event (technology appraisal 195, August 2010).

About NICE

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