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Osteoporosis - primary prevention

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

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 and Related Research, University of Sheffield
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Provisional schedule

Consultation on draft scope by stakeholders: July 2002
Information meeting with consultees: 25 September 2002
Closing date for invited submissions / evidence submission: 29 November 2002
Final scope published: August 2002
1st appraisal committee meeting: 10 April 2003
2nd appraisal committee meeting: 11 November 2003
3rd appraisal committee meeting: 12 February 2004
4th appraisal committee meeting: 12 April 2005
5th appraisal committee meeting: 06 September 2005
Schedule comments:
  • 6th appraisal committee meeting:
    1 November 2005
  • 7th appraisal committee meeting:
    6 September 2006
  • 8th appraisal committee meeting:
    7 February 2007
  • 9th appraisal committee meeting:
    11 April 2007
  • 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

  • Lilly
  • Merck Sharp and Dohme Ltd
  • Alliance for Better Bone Health (ABBH) - Proctor & Gamble in association with Aventis

Patient / Carer Groups

  • Medical Women's Federation
  • Arthritis and Musculoskeletal Alliance
  • Age Concern Cymru
  • Age Concern England
  • BackCare
  • Counsel & Care for the Elderly
  • Institute for Ageing and Health
  • National Osteoporosis Society
  • The Women's Nutritional Advisory Service
  • Women's Health Concern
  • Long Term Medical Conditions Alliance
  • National Rheumatoid Arthritis Society

Professional Groups

  • Bone Research Society
  • British Geriatrics Society
  • Royal College of General Practitioners
  • Royal College of Pathologists
  • Royal College of Physicians
  • Royal Pharmaceutical Society
  • Society for Endocrinology
  • Royal College of Nursing
  • British Society for Rheumatology
  • Primary Care Rheumatology Society
  • The Society and the College Radiographers

Others

  • Department of Health
  • Welsh Assembly Government

General

  • Health Technology Board for Scotland
  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • Health Development Agency
  • BNF
  • National Assembly for Wales

Comparator Manufacturers

  • Roche Products Ltd

Assessment Team

  • NCCHTA
  • ScHARR

Associated Guideline Groups

  • Guideline Development Group - Nursing and Supportive Care Collaborating Centre

Associated Public Health Groups

  • None

Research Groups

  • Research Institute for the Care of the Elderly

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Project history

Date Update
20 March 2002 The Institute is currently developing the scope for this appraisal. Following initial work it was clear that the remit of the referral from the Department of Health and Welsh Assembly Government should be reconsidered. It is anticipated there will be a 1 to 2 month extension to the appraisal timelines whilst the Department of Health, Welsh Assembly Government and Ministers consider proposals. As soon as a revised timeline is available it will be published on the Institutes website.
17 June 2003 At the first Appraisal Committee meeting for this appraisal held on 9/10 April, the committee requested that further analytical work be undertaken. Consequently the timeline has been extended for this appraisal and these are reflected in the revised timetable provided above.
17 March 2004 Further investigation of new data received during the consultation on the Appraisal Consultation Document
29 April 2004

This appraisal originally formed part of the Institute's appraisal of the clinical and cost effectiveness of technologies for the prevention and treatment of osteoporosis. However, following the independent Appraisal Committee's meeting on Thursday 12 February at which it discussed the responses received during consultation on the draft recommendations in the original Appraisal Consultation Document (ACD), the Institute accepted the committee's recommendation to separate the appraisal into two parts, which will be published separately.

This appraisal will address the prevention of osteoporotic fractures in post-menopausal women who have not yet had a fracture (primary prevention).

In order to determine the clinical and cost-effectiveness of treatments for the primary prevention of osteoporotic fractures, data is needed to enable a proper assessment of the contribution of risk factors for the development of osteoporotic fractures. This will be informed by work currently being undertaken by the World Health Organisation and by the NICE guideline development group on osteoporosis. This data is expected to be received towards the end of the year.

 

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)
8 November 2005
Letter sent to consultees and commentators regarding additional work
2 March 2007

Further appraisal committee dates notified:

  • 6th appraisal committee meeting 1 November 2005
  • 7th appraisal committee meeting 6 September 2006
  • 8th appraisal committee meeting 7 February 2007
  • 9th appraisal committee meeting 11 April 2007

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.

 

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: 07 December 2010

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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.