Ledipasvir–sofosbuvir for treating chronic hepatitis C

  • Technology appraisal guidance
  • TA363
  • Published: 
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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:

  • Thokala P et al. Ledipasvir–sofosbuvir for treating chronic hepatitis C: A single technology appraisal, January 2015

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:

  • Gilead Sciences

II. Professional/expert and patient/carer groups:

  • Haemophilia Society

  • Hepatitis C Trust

  • HIV i-Base

  • Liver4Life

  • Positively UK

  • British Association for the Study of the Liver

  • British HIV Association

  • British Society of Gastroenterology

  • 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):

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

  • Healthcare Improvement Scotland

  • Janssen (simeprevir, telaprevir)

  • Merck Sharp & Dohme (boceprevir, peginterferon alfa 2b, ribavirin)

  • Roche Products (peginterferon alfa 2a, ribavirin)

  • Foundation for Liver Research

  • School of Health and Related Research (ScHARR)

  • National Institute for Health Research Health Technology Assessment Programme

  • Public Health England

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 ledipasvir–sofosbuvir by attending the initial Committee discussion and providing a written statement to the Committee or attending subsequent Committee discussions. They were also invited to comment on the ACD.

  • Professor Matthew Cramp, Consultant Hepatologist, nominated by Gilead Sciences – clinical expert

  • Professor Geoff Dusheiko, Emeritus Professor of Medicine, nominated by Bristol–Myers Squibb – clinical expert

  • Dr Helen Harris, Clinical Scientist and Research Associate, nominated by Public Health England – clinical expert

  • Dr Ranjababu Kulasegaram, Consultant Physician, nominated by the British HIV Association and British Association for Sexual Health and HIV – clinical expert

  • Dr Charles Millson, Consultant Hepatologist, nominated by the British Society of Gastroenterology – clinical expert

  • Dr Terence Wong, Consultant Gastroenterologist and Hepatologist, nominated by the British Society of Gastroenterology – clinical expert

  • Mr Charles Gore, Chief Executive of the Hepatitis C Trust, nominated by the Hepatitis C Trust – patient expert

  • Mr Richard Hall, Co-Founder of Liver4Life, nominated by Liver4Life – patient expert

  • Mr Robert James, nominated by the British HIV Association and British Association for Sexual Health and HIV – patient expert

  • Ms Raquel Peck, nominated by the Hepatitis C Trust – patient expert

D. The following individuals were nominated as NHS commissioning experts by NHS England. They gave their expert/NHS commissioning personal view on ledipasvir–sofosbuvir for treating chronic hepatitis C by attending the Committee discussion. They were also invited to comment on the ACD.

  • James Palmer, Clinical Director, Specialised Commissioning selected by NHS England – NHS commissioning expert

  • Malcolm Qualie, Pharmacy Lead, Specialised Services selected by NHS England – NHS commissioning expert

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.

  • Gilead Sciences