Obeticholic Acid for Treating Primary Biliary Cholangitis (TA443)

Technology Appraisal Guidance No. 443

Source: National Institute for Health and Care Excellence

1. Guidance

1.1 Obeticholic acid is recommended, within its marketing authorisation, as an option for treating primary biliary cholangitis in combination with ursodeoxycholic acid for people whose disease has responded inadequately to ursodeoxycholic acid or as monotherapy for people who cannot tolerate ursodeoxycholic acid. Obeticholic acid is recommended only if the company provides it with the discount agreed in the patient access scheme.

1.2 Assess the response to obeticholic acid after 12 months. Only continue if there is evidence of clinical benefit.


A copy of the full document and background is available on the Internet at http://guidance.nice.org.uk/TA443

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

Obeticholic acid for treating primary biliary cholangitis.
Issue Date: April 2017


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