Atrial fibrillation - dabigatran etexilate [ID94]

Dabigatran etexilate for the prevention of stroke or systemic embolism in people with atrial fibrillation

Status: History
Expected date of issue: TBC
Referral date: July 2009
Process: STA
Topic area:

NICE project team

Executive Lead: Gillian Leng
Technical Lead: Christian Griffiths
Communications manager: Phil Ranson
Project manager: Bijal Joshi


Provisional schedule

Closing date for invited submissions / evidence submission: 05 October 2010
1st appraisal committee meeting: 19 July 2011
2nd appraisal committee meeting 20 September 2011


Consultees and commentators



Commentators (no right to submit or appeal)



  • Boehringer-Ingelheim (dabigatran)

Patient/carer groups

  • Action Heart
  • Afiya Trust
  • AntiCoagulation Europe (ACE)
  • Arrhythmia Alliance (AFA Affiliated)
  • Atrial Fibrillation Association (AFA)
  • Black Health Agency
  • British Cardiac Patients Association
  • Cardiac Risk in the Young (CRY)
  • Cardiomyopathy Association
  • Chinese National Healthy Living Centre
  • Counsel and Care
  • Different Strokes
  • Equalities National Council
  • Heart Care Partnership (UK)
  • Muslim Council of Great Britain
  • Muslim Health Network
  • South Asian Health Foundation
  • Specialised Healthcare Alliance
  • Stroke Association

Professional groups

  • Anticoagulation Specialist Association (ASA)
  • British Association for Nursing in Cardiac Care
  • British Association for Service to the Elderly
  • British Association of Stroke Physicians
  • British Cardiovascular Intervention Society (BCIS)
  • British Cardiovascular Society
  • British Geriatrics Society
  • British Heart Foundation
  • British Society for Haematology (BSH)
  • British Society for Haemostasis and Thrombosis (BSHT)
  • British Society for Heart Failure
  • Clinical Leaders of Thrombosis (CLOT)
  • Heart Rhythm UK
  • National Heart Forum (UK)
  • Primary Care Cardiovascular Society
  • Royal College of General Practitioners
  • Royal College of Nursing
  • Royal College of Pathologists
  • Royal College of Physicians Cardiology Committee
  • Royal Pharmaceutical Society
  • Royal Society of Medicine – Intellectual Disabilities Forum
  • Society for Cardiological Science & Technology
  • United Kingdom Clinical Pharmacy Association
  • Vascular Society


  • Department of Health
  • NHS Richmond
  • NHS Salford
  • Welsh Assembly Government


  • Board of Community Health Councils in Wales
  • British Cardiovascular Industry Association
  • British National Formulary
  • Commissioning Support Appraisals Service
  • Department of Health, Social Services and Public Safety for Northern Ireland
  • Medicines and Healthcare products Regulatory Agency
  • National Association of Primary Care
  • NHS Alliance
  • NHS Confederation
  • NHS Purchasing and Supply Agency
  • NHS Quality Improvement Scotland
  • Public Health Wales NHS Trust
  • Scottish Medicines Consortium

Comparator manufacturers

  • Actavis UK (aspirin, warfarin)
  • Alliance Pharmaceuticals  (aspirin)
  • Arrow Generics (aspirin, warfarin)
  • Aspar Pharmaceuticals (aspirin)
  • Bayer (aspirin)
  • Bristol-Myers Squibb (aspirin)
  • Dexcel–Pharma (aspirin)
  • Focus Pharmaceuticals (aspirin)
  • Galpharm International (aspirin)
  • Generics UK (aspirin, warfarin)
  • Genus Pharmaceuticals (aspirin)
  • Goldshield Pharmaceuticals (warfarin)
  • Kent Pharmaceuticals (aspirin, warfarin)
  • Napp Pharmaceuticals (aspirin)
  • Pinewood Healthcare(aspirin)
  • Reckitt Benckiser (aspirin)
  • Sandoz (aspirin, warfarin)
  • Sigma Pharmaceuticals (aspirin)
  • Sinclair Pharmaceuticals (aspirin)
  • Teva UK (aspirin, warfarin)
  • Thornton & Ross (aspirin)
  • Winthrop Pharmaceuticals (warfarin, aspirin)
  • Wockhardt UK (aspirin)

Relevant research groups

  • British Society for Cardiovascular Research [BCS affiliated]
  • Cardiovascular Diseases Specialist Library (CVDSL)
  • Central Cardiac Audit Database
  • Cochrane Heart Group
  • Cochrane Peripheral Vascular Diseases Group
  • Cochrane Stroke Group
  • MRC Clinical Trials Unit
  • National Institute for Health Research
  • Policy Research Institute on Ageing and Ethnicity
  • Research Institute for the Care of Older People
  • Wellcome Trust - Cardiovascular Research Initiative

Evidence Review Group

  • National Institute for Health Research Health Technology Assessment Programme
  • NHS Centre for Reviews & Dissemination and Centre for Health Economics - York

Associated Guideline Groups

  • National Clinical Guidelines Centre

Associated Public Health Groups

  • None



Project history

Date Update
24 September 2009 Please note that following on from advice received from the manufacturer, this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during early March 2010. The deadline for submissions is expected in approximately late May 2010.
14 May 2010 The timelines have been extended due to the receipt of updated information from the manufacturer regarding the regulatory procedure / timings for this technology.
25 November 2010 NICE have re-scheduled the first Appraisal Committee meeting from 18th January 2011 to 17th March 2011. This date will correspond better with the anticipated regulatory approval of dabigatran for this indication. If a second discussion is needed, this will take place on 18th May 2011.
10 February 2011 Please note that following new information received from the manufacturer, NICE has had to reschedule this appraisal. The first appraisal committee discussion will now take place on 19 July 2011 and the second committee discussion (if required) will take place on 20 September 2011.


Key documents

This page was last updated: 15 March 2012

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Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.