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 School of Health and Related Research (ScHARR):

  • Simpson EL, Fitzgerald P, Evans P, et al. Bivalirudin for the treatment of ST-segment elevation myocardial infarction. March 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. Organisations listed in I were also invited to make written submissions. Organisations listed in II gave their expert views on bivalirudin for the treatment of adults with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention by providing a written statement to the Committee. Organisations listed in I, II and III have the opportunity to appeal against the final appraisal determination.

I Manufacturer/sponsor

  • The Medicines Company

II Professional/specialist and patient/carer groups:

  • Heart Care Partnership UK

  • HEART UK

  • British Association for Nursing in Cardiac Care

  • British Cardiovascular Intervention Society (BCIS)

  • British Cardiovascular Society

  • British Heart Foundation

  • Primary Care Cardiovascular Society Royal College of Nursing

  • 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):

  • British National Formulary

  • Commissioning Support Appraisals Service

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

  • Healthcare Improvement Scotland

  • Eli Lilly

  • GlaxoSmithKline

  • Merck Sharp & Dohme

  • Sanofi Aventis

  • National Institute for Health Research Health Technology Assessment Programme

  • School of Health & Related Research Sheffield (ScHARR)

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 Bivalirudin for the treatment of ST-segment elevation myocardial infarction by providing oral evidence to the Committee.

  • Dr Daniel Blackman, Consultant cardiologist, nominated by British Cardiovascular Intervention Society – clinical specialist

  • Dr Tim Kinnaird, Consultant Interventional Cardiologist, nominated by Welsh Assembly Government – clinical specialist

  • Valentino Oriolo, Acute Coronary Syndromes Advanced Nurse Practitioner, nominated by British Association for Nursing in Cardiovascular Care - clinical specialist

  • John Miller, nominated by Heart Care Partnership UK – 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.

  • The Medicines Company

  • National Institute for Health and Care Excellence (NICE)