8 Sources of evidence considered by the Committee

8 Sources of evidence considered by the Committee

A. The assessment report for this appraisal was prepared by the School of Health & Related Research, The University of Sheffield:

  • Archer R, Tappenden P, Ren S, et al. Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): Clinical effectiveness systematic review and economic model, June 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, assessment report and the appraisal consultation document (ACD). Organisations listed in I, II and III were also invited to make written submissions and have the opportunity to appeal against the final appraisal determination.

I. Companies:

  • AbbVie (adalimumab)

  • Celltrion Healthcare (infliximab)

  • Merck Sharp & Dohme (golimumab, infliximab)

II. Professional/expert and patient/carer groups:

  • British Society of Gastroenterology

  • British Society of Paediatric Gastroenterology, Hepatology and Nutrition

  • Crohn's and Colitis UK

  • Royal College of Nursing

  • Royal College of Physicians

  • United Kingdom Clinical Pharmacy Association

III. Other consultees:

  • Department of Health

  • NHS England

  • Welsh Government

IV. Commentator organisations (without the right of appeal):

  • Department of Health and Social Services and Public Safety, Northern Ireland (DHSSPSNI)

  • Healthcare Improvement Scotland

  • National Institute for Health Research Technology Assessment Programme

  • Pfizer (sulfasalazine)

  • School of Health & Related Research University Sheffield

C. The following individuals were selected from clinical expert and patient expert nominations from the consultees and commentators. They participated in the Appraisal Committee discussions and provided evidence to inform the Appraisal Committee's deliberations. They gave their expert personal view on infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262) by attending the initial Committee discussion and/or providing written evidence to the Committee. They were also invited to comment on the ACD.

  • Dr A Barney Hawthorne, Consultant Gastroenterologist, nominated by organisation representing British Society of Gastroenterology – clinical specialist

  • Ms Julie Duncan, Clinical nurse specialist – Inflammatory Bowel Disease & Inflammatory Bowel Disease Network National Committee Chair, nominated by organisation representing Royal College of Nursing – clinical specialist

  • Mr Mark Byrne, nominated by organisation representing Crohn's and Colitis UK – patient expert

  • Mr Joseph Fitzgerald, nominated by organisation representing Crohn's and Colitis UK – patient expert

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

  • AbbVie (adalimumab)

  • Celltrion Healthcare (infliximab)

  • Merck Sharp & Dohme (golimumab, infliximab)

  • National Institute for Health and Care Excellence (NICE)