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Osteoporosis - secondary prevention including strontium ranelate

Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women.

This Appraisal on secondary prevention is an update of the existing Technology Appraisal No. 87, including new provisional recommendations relating to strontium ranelate. As Strontium Ranelate is included within this update, it has not been appraised on its own as initially indicated.

Status: History
Expected date of issue: October 2008
Process: MTA
Topic area:
 

NICE project team

Executive Lead: Peter Littlejohns
Technical Lead: Dr Ruaraidh Hill
Communications manager: Tonya Gillis
Project manager: Jeremy Powell
Assessment Group / Evidence Review Group: School of Health & Related Research Sheffield
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Provisional schedule

Consultation on draft scope by stakeholders: August 2004
Information meeting with consultees: 25 November 2005
Closing date for invited submissions / evidence submission: 26 January 2005
Final scope published: October 2004
1st appraisal committee meeting: 06 September 2005
2nd appraisal committee meeting: 01 November 2005
3rd appraisal committee meeting: 06 September 2006
4th appraisal committee meeting: 07 February 2007
5th appraisal committee meeting: 11 April 2007
Schedule comments:
  • Appeal hearing:  22 October 2007
  • 1st committee meeting (Post Appeal):  6 March 2008
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Consultees and commentators

Consultees Commentators (no right of appeal)

Manufacturers / Sponsors

  • Servier Laboratories Ltd
  • Eli Lilly & Co Ltd
  • Merck Sharp & Dohme Ltd
  • Alliancefor Better Bone Health (ABBH)
  • Procter & Gamble UK

Patient / Carer Groups

  • Age Concern
  • Arthritis and Musculoskeletal Alliance
  • Backcare
  • Counsel and Care for the Elderly
  • Long Term Medical Conditions Alliance
  • National Osteoporosis Society
  • National Rheumatoid Arthritis Society
  • Women's Nutrition Clinic 
  • Women's Health
  • Women's Health Concern

Professional Groups

  • Bone Research Society
  • British Geriatrics Society
  • British Menopause Society
  • British Orthopaedic Association
  • British Society for Rheumatology
  • Medical Women's Foundation
  • Primary Care Rheumatology Society
  • Royal Association for Disability & Rehabilitation
  • Royal College of General Practitioners
  • Royal College of Nursing
  • Royal College of Pathologists
  • Royal College of Physicians
  • Royal Pharmaceutical Society
  • Society for Endocrinology
  • The Society and the College of Radiographers

Others

  • Department of Health
  • Southwark PCT
  • Welsh Assembly Government

General

  • British National Formulary
  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • NHS Quality Improvement Scotland
  • Osteoporosis Guideline Development Group

Comparator Manufacturers

  • Novartis Pharmaceuticals UK Ltd
  • Nycomed
  • Roche Products Ltd
  • Strakan Ltd

Assessment Team

  • National Coordinating Centre for Health Technology Assessment
  • School of Health and Related Research (ScHARR)
  • Associated Guideline Groups
  • Nursing and Supportive Care Collaborating Centre Guideline Development Group
  • Associated Public Health Groups
  • None

Research Groups

  • Institute for Aging and Health
  • Research Institute for the Care of the Elderly

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Project history

Date

 

Update

 

7 August 2004

 

Topic summary published.

 

18 October 2004

 

Responses and comments on draft scope and provisional matrix of consultees and commentators published.

 

19 October 2004

 

Final scope and final matrix of consultees and commentators published.

 

10 June 2005

 

Consultees and Commentators were advised that strontium ranelate would be included in the ongoing appraisal of technologies for the primary prevention of osteoporotic fracture in postmenopausal women and that an Appraisal Consultation Document for the secondary prevention of osteoporotic fractures in postmenopausal women would be issued, covering all referred technologies (both those already included in existing guidance TA 87 and strontium ranelate).

 

29 September 2006

 

Appraisal Consultation: Osteoporosis - secondary prevention including stronium ranelate added. Plus Evaluation report and Overview

 

2 March 2007

 

Expected date of issue scheduled; additional (5th) appraisal committee meeting scheduled

 

9 July 2007  

 

Appeal lodged

 

22 October 2007

 

Appeal hearing

 

13 December 2007

 

Appeal panel decision released

 

8 January 2008

 

The Chair gave a presentation at this committee meeting on the issues arising from the decision of the Appeal Panel. The Committee discussed how to proceed.

 

23 January 2008

 

Consultee and commentators forwarded progress update and informed if any comments or observations related to the Appeal Panel decisions which needed to be taken account at the next committee discussion to be forwarded to the institute.

 

23 January 2008  

 

The institute requested permission from the World Health Organisation to release the Institute from its undertakings relating to the academic-in-confidence data used to populate the economic model underpinning this appraisal. 

 

11 February 2008

 

Specification for extra work forwarded to Decision support unit and Consultees and commentators for information.

 

15 August 2008

 

Registration for the Osteoporosis appeal is available on the Osteoporosis - primary prevention page

 

29 January 2010

 

NICE has today announced that, following consultation with stakeholders on the economic model that underpinned NICE's 2008 guidance on the use of drugs for the prevention and treatment of osteoporotic fragility fractures in postmenopausal women, the resulting guidance remains unchanged.

In accordance with the Court's ruling on the technology appraisals of drugs for the prevention and treatment of osteoporotic fragility fractures in postmenopausal women, NICE released the fully executable economic model to stakeholders for their comment in May 2009. Having reviewed all the resulting comments, the independent Appraisal Committee concluded that the economic model was an appropriate basis for the previously made recommendations, and that the recommendations should therefore remain unchanged. Consultees then had a chance to appeal against this decision but no appeals were received.

NICE guidance on the use of alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the prevention and treatment of osteoporotic fragility fractures in postmenopausal women therefore remains unchanged.

8 December 2010

 

The Court of Appeal ordered NICE to reach a fresh decision on the efficacy, and therefore cost-effectiveness, of strontium ranelate for the prevention of osteoporotic fracture. The Appraisal Committee met on 20 October to discuss this topic. The Committee discussion was based on a document produced by Servier on the relative effectiveness of strontium ranelate and on an expert review of this document coordinated by the Decision Support Unit (DSU). Following this meeting a FAD was issued.

 

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This page was last updated: 08 December 2010

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Selected, reliable information for health and social care in one place

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.