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 Centre for Reviews and Dissemination (CRD), Centre for Health Economics (CHE), University of York:

  • Spackman E, Burch J, Faria R, et al. Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation: Evidence Review Group Report (February 2011)

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 give their expert views. Organisations listed in I, II and III also have the opportunity to appeal against the final appraisal determination.

I Manufacturer/sponsor:

  • Boehringer Ingelheim

II Professional/specialist and patient/carer groups:

  • AntiCoagulation Europe (ACE)

  • Anticoagulation Specialist Association (ASA)

  • Arrhythmia Alliance (Atrial Fibrillation Association affiliated)

  • British Association of Stroke Physicians

  • British Cardiovascular Intervention Society (BCIS)

  • British Heart Foundation

  • British Society for Haematology

  • Clinical Leaders of Thrombosis (CLOT)

  • Heart Rhythm UK

  • Royal College of Nursing

  • Royal College of Pathologists

  • Royal College of Physicians

  • South Asian Health Foundation

  • Stroke Association

III Other consultees:

  • Department of Health

  • NHS Salford

  • Welsh Government

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

  • Bayer

  • Bristol-Myers Squibb

  • Centre for Reviews and Dissemination (CRD), Centre for Health Economics (CHE), University of York

  • Commissioning Support Appraisals Service

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

  • Health Care Improvement Scotland

  • National Institute for Health Research Health Technology Assessment Programme

  • Sanofi Aventis

C The following individuals were selected from clinical specialist and patient expert nominations from the non-manufacturer/sponsor consultees and commentators. They gave their expert personal view on dabigatran by attending the initial Committee discussion and providing written evidence to the Committee. They were also invited to comment on the ACD.

  • Professor Michael Laffan, Professor of Haemostasis and Thrombosis, nominated by the Royal College of Pathologists and British Society for Haematology − clinical specialist

  • Professor Gregory Lip, Clinical Cardiologist, nominated by the British Cardiovascular Society − clinical specialist

  • Dr Caroline Lovelock, Senior Clinical Lecturer, nominated by the Royal College of Physicians − clinical specialist

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

  • Joanne Jerrome, Assistant Director nominated by the Atrial Fibrillation Association – patient expert

D The following individuals were nominated as NHS Commissioning experts by the selected PCT allocated to this appraisal. They gave their NHS commissioning personal view on dabigatran by attending the initial Committee discussion and providing written evidence to the Committee. They were also invited to comment on the ACD.

  • Dr Andy Sutton, selected by NHS Salford – NHS commissioning expert

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

  • Boehringer Ingelheim

  • National Institute for Health and Care Excellence (NICE)