Appendix B: Sources of evidence considered by the Committee

Appendix B: Sources of evidence considered by the Committee

A. The Evidence Review Group (ERG) report for this appraisal was prepared by the School of Health and Related Research, University of Sheffield:

  • Holmes M, Caroll C, Papaioannou D, Dabigatran etexilate for the prevention of venous thromboembolism in patients undergoing elective hip and knee surgery: A Single Technology Appraisal, May 2008.

B. The following organisations accepted the invitation to participate in this appraisal. They were invited to comment on the draft scope. Organisations listed in I were also invited to make written submissions. Organisations listed in II gave their expert views on dabigatran by providing a written statement to the Committee. Organisations listed in I and II have the opportunity to appeal against the final appraisal determination.

I) Manufacturer/sponsor:

  • Boehringer Ingelheim (dabigatran)

II) Professional/specialist and patient/carer groups:

  • Anticoagulation Europe

  • British Association for Surgery of the Knee

  • British Haematology Society

  • British Orthopaedic Association

  • British Society for Haemostasis and Thrombosis

  • British Thoracic Society

  • DVT Awareness Campaign

  • Lifeblood: The Thrombosis Charity

  • Royal College of Nursing

  • Royal College of Pathologists

  • Royal College of Physicians

III) Other consultees

  • Department of Health

  • Welsh Assembly 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

  • GlaxoSmithKline (fondaparinux sodium)

  • National Collaborating Centre for Acute Care

  • National Coordinating Centre for Health Technology Assessment

  • NHS Quality Improvement Scotland

  • Pfizer (dalteparin sodium)

  • sanofi-aventis (enoxaparin sodium)

  • School of Health & Related Research Sheffield (ScHARR)

C. The following individuals were selected from clinical specialist and patient advocate nominations from the non-manufacturer/sponsor consultees and commentators. They gave their expert personal view on dabigatran by providing oral evidence to the Committee.

  • Professor Roger Atkins, consultant orthopaedic surgeon, nominated by the British Orthopaedic Association – clinical specialist

  • Mrs Diane Eaton, nominated by Anticoagulation Europe (ACE) – patient expert

  • National Institute for Health and Care Excellence (NICE)