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 School of Health and Related Research (ScHARR), The University of Sheffield:

  • Essat M, Tappenden P, Ren S et al. Vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis: A single technology appraisal (September 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 gave their expert views on vedolizumab by making a submission to the Committee. Organisations listed in I, II and III have the opportunity to appeal against the final appraisal determination.

I. Company:

  • Takeda

II. Professional/expert and patient/carer groups:

  • British Society of Gastroenterology

  • 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

  • NHS South Kent Coast CCG

  • Welsh Government

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

  • AbbVie (adalimumab)

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

  • Healthcare Improvement Scotland

  • Merck Sharp and Dohme (golimumab, infliximab)

  • National Institute for Health Research Health Technology Assessment Programme

  • School of Health and Related Research Sheffield (ScHARR)

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 vedolizumab by providing oral evidence to the Committee. They were also invited to comment on the ACD.

  • Dr AB Hawthorne, Consultant Gastroenterologist nominated by organisation representing British Society of Gastroenterology and Takeda – clinical expert (attended first meeting only)

  • Dr John Mansfield, Consultant Gastroenterologist nominated by organisation representing British Society of Gastroenterology – clinical expert

  • Miss Elizabeth Cleaver, nominated by organisation representing Crohn's and Colitis UK – patient expert

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

D. The following individuals were nominated as NHS commissioning experts by South Kent Coast clinical commissioning group. They gave their expert/NHS commissioning personal view on vedolizumab by providing oral evidence and a written statement to the Committee.

  • Mr Robert Brown, Senior Associate Medicines Management South East Commissioning Support unit, selected by South Kent Coast clinical commissioning group – NHS commissioning expert (attended first meeting only)

E. 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.

  • Takeda

  • National Institute for Health and Care Excellence (NICE)