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, Nakum M, Durand A, et al., Everolimus (Certican) for preventing organ rejection in liver transplantation: A critique of the submission from Novartis, 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 make written submissions. Organisations listed in I, II and III also have the opportunity to appeal against the final appraisal determination.

I. Company:

  • Novartis Pharmaceuticals (everolimus)

II. Professional/expert and patient/carer groups:

  • British Liver Trust

  • British Society of Gastroenterology

  • ESPRIT

  • Liver4Life

  • Royal College of Nursing

  • Royal College of Pathologists

  • Royal College of Physicians

  • United Kingdom Clinical Pharmacy Association

III. Other consultees:

  • Department of Health

  • NHS England

  • Welsh Government

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

  • Astellas Pharma (immediate‑release tacrolimus, prolonged‑release tacrolimus)

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

  • Foundation for Liver Research

  • Healthcare Improvement Scotland

  • National Institute for Health Research Health Technology Assessment Programme

  • Peninsula Technology Assessment Group (PenTAG)

  • Roche Products (mycophenolate mofetil)

  • Sandoz (azathioprine, mycophenolate mofetil, immediate‑release tacrolimus)

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 everolimus by attending the initial Committee discussion and providing a written statement to the Committee. They were also invited to comment on the ACD.

  • Professor Derek Manas, Consultant Hepatobiliary and Transplant Surgeon, nominated by organisation representing Novartis Pharmaceuticals – clinical expert

  • Mr Andrew Langford, Chief Executive of British Liver Trust, nominated by organisation representing British Liver Trust – patient expert

  • Mr Richard Hall, Co‑Founder of Liver4Life, nominated by organisation representing Liver4Life – 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.

  • Novartis

  • National Institute for Health and Care Excellence (NICE)