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

  • Claire McKenna, et al. Dronedarone for atrial fibrillation and atrial flutter, October 2009.

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 documents (ACDs). 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 and II also have the opportunity to appeal against the final appraisal determination.

I) Manufacturer/sponsor:

  • Sanofi-Aventis

II) Professional/specialist and patient/carer groups:

  • British Association of Stroke Physicians

  • British Cardiovascular Society

  • British Heart Foundation

  • Coronary Prevention Group

  • Heart Rhythm UK

  • Primary Care Cardiovascular Society

  • Royal College of Nursing

  • Royal College of Physicians

  • Society of Cardiothoracic Surgery of Great Britain and Ireland

  • Arrhythmia Alliance

  • Atrial Fibrillation Association

  • SADS UK – The Ashley Jolly SAD Trust

III) Other consultees:

  • Department of Health

  • Hounslow Primary Care Trust

  • Welsh Assembly Government

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

  • CRD, CHE, University of York

  • Commissioning Support Appraisals Service

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

  • Heart Failure Research Group, University of Glasgow

  • Medicines and Healthcare Products Regulatory Agency

  • NHS Quality Improvement Scotland

  • National Clinical Guideline Centre for Acute and Chronic Conditions

  • NIHR Coordinating Centre for Health Technology Assessment

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 dronedarone by attending the initial Committee discussion and providing written evidence to the Committee. They were also invited to comment on the ACD.

  • Dr Andreas Wolff, nominated by the Primary Care Cardiovascular Society – clinical specialist

  • Dr Uday Trivedi, nominated by the Society for Cardiothoracic Surgery – clinical specialist

  • Dr Neil Sulke, nominated by Heart Rhythm UK – clinical specialist (provided written statement only)

  • Mrs Jo Jerrome, nominated by Arrhythmia Alliance – patient expert

  • Mrs Eileen Porter, nominated by Atrial Fibrillation Association – patient expert

D. 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.

  • Sanofi-Aventis

  • National Institute for Health and Care Excellence (NICE)