Appendix B: Sources of evidence considered by the Committee

A The assessment report for this appraisal was prepared by Liverpool Reviews and Implementation Group (LRiG):

  • Fleeman N, Bagust A, Boland A, et al. Lapatinib and trastuzumab in combination with an aromatase inhibitor for the first-line treatment of metastatic hormone receptor positive breast cancer which over-expresses HER2, September 2010

B The following organisations accepted the invitation to participate in this appraisal as consultees and commentators. They were also invited to comment on the draft scope, assessment report and the appraisal consultation document (ACD). Organisations listed in I, II and III were also invited to make written submissions and have the opportunity to appeal against the final appraisal determination.

I Manufacturers/sponsors:

  • GlaxoSmithKline

  • Roche Products

II Professional/specialist and patient/carer groups:

  • Breast Cancer Campaign

  • Breast Cancer Care

  • Breast Cancer UK

  • Cancer Networks Pharmacists Forum

  • Cancer Research UK

  • Macmillan Cancer Support

  • Royal College of Nursing

  • Royal College of Pathologists

  • Royal College of Physicians, Medical Oncology Joint Special Committee

  • United Kingdom Oncology Nursing Society

III Other consultees:

  • Betsi Cadwalader University

  • Department of Health

  • Welsh Assembly Government

IV Commentator organisations (without the right of appeal):

  • AstraZeneca (anastrozole, tamoxifen)

  • Commissioning Support Appraisals Unit

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

  • Healthcare Improvement Scotland

  • Liverpool Reviews and Implementation Group, University of Liverpool

  • Medicines and Healthcare Products Regulatory Agency

  • National Collaborating Centre for Cancer

  • National Institute for Health Research Health Technology Assessment Programme

  • Pfizer (exemestane)

C The following individuals were selected from clinical specialist and patient expert nominations from the non-manufacturer/sponsor consultees and commentators. They participated in the Appraisal Committee discussions and provided evidence to inform the Appraisal Committee's deliberations. They gave their expert personal view on lapatinib and trastuzumab in combination with an aromatase inhibitor for the first-line treatment of metastatic hormone-receptor-positive breast cancer that overexpresses HER2 by attending the Committee discussions and/or providing written evidence to the Committee. They were also invited to comment on the ACD.

  • Professor David Cameron, nominated by organisation representing Healthcare Improvement Scotland – clinical specialist

  • Dr Rob Stein, nominated by organisation representing Royal College of Physicians (NCRI/RCP/RCR/ACP/JCCO) – clinical specialist

  • Mrs Emma Freeborn nominated by organisation representing Breast Cancer Care – patient expert

  • Mrs Jackie Harris nominated by organisation representing Breast Cancer Care – patient expert

  • Ms Maria Leadbeater nominated by organisation representing Breast Cancer Care – patient expert

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

  • GlaxoSmithKline

  • Roche Products

  • National Institute for Health and Care Excellence (NICE)