8 Sources of evidence considered by the Committee

8 Sources of evidence considered by the Committee

A. The Evidence Review Group (ERG) report for this appraisal was prepared by Peninsula Technology Assessment Group (PenTAG):

  • Bacelar M, et al. The clinical and cost‑effectiveness of rifaximin for maintaining remission from episodes of hepatic encephalopathy: A critique of the submission from Norgine, April 2013

PenTAG also prepared reviews of the company's second and third evidence submissions (October 2013 and December 2013). A review of the company's final submission was prepared by Southampton Health Technology Assessments Centre (SHTAC; November 2014).

B. The following organisations accepted the invitation to participate in this appraisal as consultees and commentators. They were invited to comment on the draft scope, the ERG report and the appraisal consultation document (ACD). Organisations listed in I were also invited to make written submissions. Organisations listed in II and III had the opportunity to give their expert views. Organisations listed in I, II and III also have the opportunity to appeal against the final appraisal determination.

I. Company:

  • Norgine

II. Professional/expert and patient/carer groups:

  • British Liver Trust

  • British Infection Association

  • British Society of Gastroenterology

  • Royal College of Nursing

  • Royal College of Pathologists

  • Royal College of Physicians

III. Other consultees:

  • Department of Health

  • South Essex Primary Care Trust Cluster

  • Welsh Government

IV. Commentator organisations (did not provide written evidence and without the right of appeal):

  • Commissioning Support Appraisals Service

  • Department of Health, Social Services and Public Safety for Northern Ireland

  • Healthcare Improvement Scotland

  • Foundation for Liver Research

  • National Institute for Health Research Health Technology Assessment programme

  • Peninsula Technology Assessment Group (PenTAG)

  • Southampton Health Technology Assessment Centre

C. The following individuals were selected from clinical expert and patient expert nominations from the consultees and commentators. They gave their expert personal view on rifaximin by attending the initial Committee discussion and providing written evidence to the Committee. They were also invited to comment on the ACD.

  • Dr Sulleman Moreea, consultant Gastroenterologist/Hepatologist, nominated by the British Society of Gastroenterology – clinical expert

  • Dr Debbie Shawcross, Senior Lecturer and Honorary Consultant in Hepatology, nominated by Norgine – clinical expert

  • Andrew Langford, Chief Executive of the British Liver Trust, nominated by British Liver – patient expert

D. Representatives from the following company attended Committee meetings. They contributed only when asked by the Committee chair to clarify specific issues and comment on factual accuracy.

  • Norgine

  • National Institute for Health and Care Excellence (NICE)