Certolizumab Pegol for Treating Rheumatoid Arthritis after Inadequate Response to a TNF-Alpha Inhibitor (TA415)

Technology Appraisal Guidance No. 415

Source: National Institute for Health and Care Excellence

1. Guidance

1.1 Certolizumab pegol, in combination with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to, or who cannot tolerate, other disease-modifying antirheumatic drugs (DMARDs) including at least 1 tumour necrosis factor-alpha (TNF-alpha) inhibitor, only if:

  • disease activity is severe and
  • rituximab is contraindicated or not tolerated and
  • the company provides certolizumab pegol with the agreed patient access scheme.

1.2 Certolizumab pegol, as monotherapy, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to, or who cannot tolerate, other DMARDs including at least 1 TNF-alpha inhibitor, only if:

  • disease activity is severe and
  • rituximab therapy cannot be given because methotrexate is contraindicated or not tolerated and
  • the company provides certolizumab pegol with the agreed patient access scheme.

1.3 Continue treatment only if there is at least a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months. After an initial response within 6 months, withdraw treatment if at least a moderate EULAR response is not maintained.

1.4 This guidance is not intended to affect the position of patients whose treatment with certolizumab pegol was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.


    The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at www.nice.org.uk/guidance/ta415

    This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

    © Copyright National Institute for Health and Care Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.

    Enquiries concerning the guidance should be addressed to: National Institute for Health and Care Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email: nice@nice.org.uk

    Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor

    Issue Date: October 2016


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