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Hepatic encephalopathy - rifaximin (maintenance) [ID496]

Rifaximin for the maintenance treatment of hepatic encephalopathy

Status: In development
Expected date of issue: TBC
Referral date: November 2011
Process: STA
Notes:

Scoped as part of Batch 20

Topic area:
  • Digestive system
 

NICE project team

Executive Lead: Carole Longson
Technical Lead: Ian Watson
Communications manager: Lyndsey Unwin
Project manager:

Kate Moore

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Provisional schedule

Closing date for invited submissions / evidence submission: 15 February 2013
1st appraisal committee meeting: 30 May 2013
2nd appraisal committee meeting 29 October 2013
3rd appraisal committee meeting: TBC
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Consultees and commentators

Consultees Commentators (no right to submit or appeal)

Manufacturers/sponsors

  • Norgine (rifaximin)

Patient/carer groups

  • British Liver Trust
  • Liver4Life

Professional groups

  • British Association for the Study of the Liver
  • British Infection Association
  • British Society of Gastroenterology
  • Royal College of Nursing
  • Royal College of Pathologists
  • Royal College of Physicians

Others

  • Department of Health
  • NHS England
  • South Essex PCT Cluster
  • Welsh Government

General

  • Commissioning Support Appraisals Service
  • Department of Health, Social Services and Public Safety for Northern Ireland
  • Healthcare Improvement Scotland

Comparator manufacturer(s)

  • Abbott laboratories (lactulose) (confidentiality agreement not signed, not participating)
  • Actavis UK (lactulose) (confidentiality agreement not signed, not participating
  • Amdipharm (neomycin) (confidentiality agreement not signed, not participating)
  • Arrow generics (lactulose) (confidentiality agreement not signed, not participating)
  • Co-Pharma (lactulose) (confidentiality agreement not signed, not participating)
  • Intrapharm laboratories (lactulose) (confidentiality agreement not signed, not participating)
  • Lloyds pharmacy (lactulose) (confidentiality agreement not signed, not participating)
  • Mylan (lactulose) (confidentiality agreement not signed, not participating)
  • Novartis (lactulose) (confidentiality agreement not signed, not participating)
  • LPC Pharmaceuticals (lactulose) (confidentiality agreement not signed, not participating)
  • Sandoz UK (lactulose) (confidentiality agreement not signed, not participating)
  • Teva UK (lactulose, neomycin) (confidentiality agreement not signed, not participating)

Relevant research groups

  • Foundation for Liver Research

Evidence Review Group

  • National Institute for Health Research Health Technology Assessment Programme
  • Peninsula Technology Assessment Group (PenTAG)

Associated guideline groups

  • None

Associated public health groups

  • None

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Project history

Date Update
6 February 2014 Following the release of a second Appraisal Consultation Document (ACD) in November 2013, the third committee meeting discussion has now been scheduled for 8 April 2014
12 November 2013

Following the committee meeting discussion on 29 October 2013, the committee have asked NICE to prepare a further Appraisal Consultation Document (ACD). We anticipate that the ACD will be released for consultation in the week commencing 18 November 2013.

We are in the process of scheduling the next committee meeting discussion for this topic and will update you as soon as possible.

13 August 2013 Following agreement to accept additional analyses   from  the manufacturer of rifaximin, Norgine, the second committee meeting discussion for this topic has now been rescued and will be held on Tuesday 29 October 2013.
17 July 2013

The manufacturer of rifaximin, Norgine, has requested to submit additional analyses in relation to the appraisal of rifaximin for maintaining remission from episodes of hepatic encephalopathy. This request has been considered and agreed by the NICE (Section 3.5.34, Guide to the single technology appraisal process, October 2009).

The second committee meeting discussion of this topic was due to be held on 30 July 2013. This has now been postponed to enable the manufacturer to submit the additional analyses and to commission an evidence review of the new analyses.

A further update will be provided in due course with confirmed timelines for the next committee meeting.

17 May 2012

 

Following on from the latest information received from the manufacturer, this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during early December 2012.

 

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Key documents

This page was last updated: 25 February 2014

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Selected, reliable information for health and social care in one place

Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.