Vedolizumab for Treating Moderately to Severely Active Crohn's Disease after Prior Therapy (TA352)

Technology Appraisal Guidance No. 352

Source: National Institute for Health and Care Excellence

1. Guidance

1.1 Vedolizumab is recommended as an option for treating moderately to severely active Crohn's disease only if:

  • a tumour necrosis factor-alpha inhibitor has failed (that is, the disease has responded inadequately or has lost response to treatment) or
  • a tumour necrosis factor-alpha inhibitor cannot be tolerated or is contraindicated.

Vedolizumab is recommended only if the company provides it with the discount agreed in the patient access scheme.

1.2 Vedolizumab should be given as a planned course of treatment until it stops working or surgery is needed, or until 12 months after the start of treatment, whichever is shorter. At 12 months, people should be reassessed to determine whether treatment should continue. Treatment should only continue if there is clear evidence of ongoing clinical benefit. For people in complete remission at 12 months, consider stopping vedolizumab, resuming treatment if there is a relapse. People who continue vedolizumab should be reassessed at least every 12 months to decide whether continued treatment is justified.

1.3 People whose treatment with vedolizumab is not recommended in this NICE guidance, but was started within the NHS before this guidance was published, should be able to continue treatment 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

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:

Vedolizumab for treating moderately to severely active Crohn's disease after prior therapy.

Issue Date: August 2015

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