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NICE Draft Guidance Recommends Wider Use of Abatacept in Treating Rheumatoid Arthritis

The National Institute for Health and Clinical Excellence (NICE) has today (6 December 2012) opened a consultation on draft guidance which recommends abatacept (Orencia) for rheumatoid arthritis after conventional disease-modifying anti-rheumatic drugs (DMARDs) have failed.

The draft 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.

The draft guidance also says that people currently receiving abatacept, but whose disease does not meet these criteria, should be able to continue treatment until they and their clinician consider it appropriate to stop.

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 This new draft guidance is a rapid review of TA234 following the introduction of a patient access scheme which abatacept's manufacturer has agreed with the Department of Health.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an inadequate response to one or more TNF inhibitors and who cannot receive rituximab because it is contraindicated or withdrawn because of an adverse event (guidance TA195, August 2010).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 This draft guidance resulting from the rapid review of TA234 provisionally recommends that abatacept could be a treatment option at an earlier stage in the treatment pathway: 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.

“The draft guidance could potentially 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. We welcome comments on these draft recommendations as part of the consultation.”

This is draft guidance; NICE has not yet issued final guidance to the NHS.


Notes to Editors

About the appraisal

1. The draft guidance consultation document, ‘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 6 December. The consultation closes on 10 January 2013.

2. Conventional DMARDS include methotrexate, 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. 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. Until final guidance is published, the current guidance on abatacept for second-line treatment of rheumatoid arthritis, TA234, remains in force. Further information on the rapid review process, is given in the NICE Single Technology Appraisal process guide, sections 5. 11 and 5.12.

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

6. 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

7. The National Institute for Health and Clinical 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

8. 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.

9. 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
  • Commissioning Outcomes Framework - NICE develops the potential indicators for the COF, the scheme starting in 2013, which will help measure the health outcomes and quality of care commissioned by Clinical Commissioning Groups.

10. NICEprovides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates high quality guidance and evidence-based information to help professionals deliver the best patient care through NHS Evidence.

Posted: December 2012