8 Sources of evidence considered by the Committee
The Evidence Review Group (ERG) report for this appraisal was prepared by the West Midlands Health Technology Assessment Collaboration:
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Edlin R, Connock M, Round J et al. Azacitidine for the treatment of myelodysplastic syndrome, chronic myelomonocytic leukaemia, and acute myeloid leukaemia, April 2009
The Decision Support Unit (DSU) prepared 3 reports for this appraisal:
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Miners A. DSU report for NICE – Azacitidine STA economic model 09/12/09, December 2009
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Davis S, Wailoo A and Carroll C. Myelodysplastic syndromes – Azacitidine: A critical appraisal of additional evidence submitted by Celgene and the MDS Foundation, September 2010
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Davis S. Myelodysplastic syndromes – Azacitidine: Review of Celgene's response to the post-appeal ACD, December 2010
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). Manufacturers or sponsors were also invited to make written submissions. Professional or specialist, patient or carer groups, and other consultees had the opportunity to give their expert views. Manufacturers or sponsors, professional or specialist, patient or carer groups, and other consultees also have the opportunity to appeal against the final appraisal determination.
Manufacturers or sponsors:
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Celgene
Professional or specialist and patient or carer groups:
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British Committee for Standardisation in Haematology
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British Society for Haematology
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Cancer Research UK
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Leukaemia CARE
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Leukaemia Research Fund
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Leukaemia Society (UK)
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Macmillan Cancer Support
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MDS Patient Support Group
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Rarer Cancers Forum
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Royal College of Nursing
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Royal College of Pathologists
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Royal College of Physicians, Medical Oncology Joint Special Committee
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United Kingdom Oncology Nursing Society
Other consultees:
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Department of Health
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Harrow PCT
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Stockton-On-Tees PCT
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Welsh Assembly Government
Commentator organisations (did not provide written evidence and without the right of appeal):
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Department of Health, Social Services and Public Safety for Northern Ireland
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National Collaborating Centre for Cancer
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NHS Quality Improvement Scotland
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Pharmacia
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West Midlands Health Technology Assessment Collaboration
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Winthrop Pharmaceuticals UK
The following individuals were selected from clinical specialist and patient expert nominations from the non-manufacturer or sponsor consultees and commentators. They gave their expert personal view on azacitidine by attending the initial Committee discussion and providing written evidence to the Committee. They were also invited to comment on the ACD.
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Dr David T Bowen, Consultant Haematologist, nominated by the NCRI Haematological Oncology Clinical Studies Group, RCP, RCR, ACP, JCCO – clinical specialist
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Dr Dominic J Culligan, Consultant Haematologist, nominated by the Royal College of Pathologists and British Committee for Standardisation in Haematology – clinical specialist
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Mr Paul Harford, nominated by MDS UK – patient expert
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Ms Stella Pendleton, nominated by the Rarer Cancers Forum – patient expert
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Professor Rodney Taylor, nominated by the MDS UK Patient Support Group – patient expert
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Ms Sophie Wintrich, nominated by the MDS UK Patient Support Group – patient expert
Representatives from the following manufacturer or sponsor attended Committee Meetings. They contributed only when asked by the Committee chair to clarify specific issues and comment on factual accuracy.
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Celgene