Appendix B: Sources of evidence considered by the Committee

Appendix B: Sources of evidence considered by the Committee

A. Extra analysis reports were prepared by the Decision Support Unit, the School of Health and Related Research, University of Sheffield (ScHARR).

  • Abrams K, Bird S, Evans S and Murray G. Comments on appraisal of strontium ranelate for the prevention of osteoporotic fragility fractures in postmenopausal women, September 2010

  • Stevenson M, Wailoo A. A review of comments submitted by consultees on the economic model, August 2009.

  • Stevenson M. Analyses of cost-effective BMD scanning and treatment strategies for generic alendronate, and the cost-effectiveness of risedronate and strontium ranelate in those people who would be treated with generic alendronate, February 2008.

  • Lloyd Jones M. Critique of evidence put forward by Servier suggesting an association between acid-suppressive medication and fracture risk, February 2008.

B. The assessment reports for this appraisal were prepared by the School of Health and Related Research, University of Sheffield, (ScHARR).

  • Stevenson M. Analyses of cost-effective BMD scanning and treatment strategies for generic alendronate, and the cost-effectiveness of risedronate and strontium ranelate in those people who would be treated with generic alendronate, February 2008.

  • Lloyd Jones M. Critique of evidence put forward by Servier suggesting an association between acid-suppressive medication and fracture risk, February 2008.

  • Stevenson M. Analyses of cost-effective BMD scanning and treatment strategies for generic alendronate, risedronate, strontium ranelate, raloxifene and teriparatide following corrections to the methodology associated with lower efficacy in some risk factors, November 2006.

  • Stevenson M, Davis S. Addendum to the assessment report: analyses of the cost-effectiveness of pooled alendronate and risedronate, compared with strontium ranelate, raloxifene, etidronate and teriparatide, September 2006.

  • Stevenson M, Lloyd Jones M, Davis S et al. Analyses of the cost-effectiveness of pooled alendronate and risedronate, compared with strontium ranelate, raloxifene, etidronate and teriparatide, July 2006.

  • Lloyd Jones M, Wilkinson A. Adverse effects and persistence with therapy in patients taking oral alendronate, etidronate or risedronate: systematic reviews, July 2006.

  • Stevenson M, Davis S, Lloyd Jones M et al. The clinical effectiveness and cost effectiveness of strontium ranelate for the prevention of osteoporotic fragility fractures in postmenopausal women, July 2005.

  • Stevenson M, Davis S. Addendum to the assessment report: the clinical effectiveness and cost effectiveness of technologies for the primary prevention of osteoporotic fragility fractures in postmenopausal women, July 2005.

  • Stevenson M, Lloyd Jones M, de Nigris E et al. The clinical effectiveness and cost effectiveness of prevention and treatment of osteoporosis, December 2003.

C. The following organisations accepted the invitation to participate in this appraisal as consultees and commentators. They were invited to comment on the draft scope, assessment report and the appraisal consultation document (ACD). They were also invited to comment on the Assessment Group's economic model and on the 2009 DSU report. Organisations listed in I and II were also invited to make written submissions and have the opportunity to appeal against the final appraisal determination.

I) Manufacturer/sponsors:

  • Alliance for Better Bone Health

  • Eli Lilly & Company

  • Merck Sharp & Dohme

  • Proctor & Gamble UK

  • Servier Laboratories

  • Teva UK

II) Professional/specialist and patient/carer groups:

  • Arthritis and Musculoskeletal Alliance

  • Bone Research Society (formerly Bone and Tooth Society)

  • British Geriatrics Society

  • British Menopause Society

  • British Orthopaedic Association

  • British Society for Rheumatology

  • Department of Health

  • Institute for Ageing and Health

  • National Osteoporosis Society

  • National Rheumatoid Arthritis Society

  • Primary Care Rheumatology Society

  • RADAR (The Royal Association for Disability and Rehabilitation)

  • Royal College of General Practitioners

  • Royal College of Nursing

  • Royal College of Pathologists

  • Royal College of Physicians

  • Society for Endocrinology

  • Southwark Primary Care Trust

  • The Society and The College of Radiographers

  • Women's Health

  • Women's Health Concern

  • Women's Nutritional Advisory Service

III) Commentator organisations (without the right of appeal)

  • British National Formulary

  • National Collaborating Centre for Nursing and Supportive Care

  • NHS Quality Improvement Scotland

  • Novartis Pharmaceuticals UK

  • Research Institute for the Care of the Elderly

  • Strakan Group

  • Roche Products

  • Nycomed UK

  • Welsh Assembly Government

D. 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 alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women by attending the initial Committee discussion and/or providing written evidence to the Committee.

  • Mrs Jackie Parrington, Deputy Chief Executive, National Osteoporosis Society, nominated by the National Osteoporosis Society – patient expert

  • Mrs Anthea Franks, nominated by the National Osteoporosis Society – patient expert

  • Professor Juliet Compston, Professor of Bone Medicine, University of Cambridge School of Clinical Medicine and Addenbrooke's NHS Trust, nominated by the Royal College of Physicians – clinical specialist

  • Dr RM Francis, Reader in Medicine (Geriatrics) and Honorary Consultant Physician, British Geriatrics Society, nominated by the British Geriatrics Society and the National Osteoporosis Society – clinical specialist

  • Dr Caje Moniz, Consultant and Clinical Director, King's Healthcare NHS Trust, nominated by the National Osteoporosis Society – clinical specialist

  • Dr Peter Selby, Consultant Physician, Central Manchester and Manchester Children's University Hospitals NHS Trust, nominated by the Society of Endocrinology and the National Osteoporosis Society – clinical specialist

E. Representatives from Servier attended the October 2010 Committee meeting. They contributed only when asked by the Committee chair to clarify specific issues and comment on factual accuracy.

  • Servier (2010)

  • National Institute for Health and Care Excellence (NICE)