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Osteoporotic fractures - denosumab

Denosumab for the prevention of osteoporotic fractures in postmenopausal women

Status:	History
Expected date of issue:	October 2010
Referral date:	November 2008
Wave:	20
Process:	STA
Topic area: Injuries, accidents and wounds Musculoskeletal

Project team | Schedule | Stakeholders | Project history | Key documents

 

NICE project team

Executive Lead:	Andrew Dillon
Technical Lead:	Fay McCracken
Communications manager:	Tonya Gillis
Project manager:	Kate Moore

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Provisional schedule

Closing date for invited submissions / evidence submission:	21 January 2010
1st appraisal committee meeting:	27 April 2010
2nd appraisal committee meeting	27 July 2010

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Consultees and commentators

Consultees Commentators (no right to submit or appeal) Manufacturers/sponsors Amgen (denosumab) Patient/carer groups National Osteoporosis Society Professional groups British Health Professionals in Rheumatology British Society for Rheumatology Primary Care Rheumatology Society Royal College of Nursing Royal College of Pathologists Royal College of Physicians Royal College of Radiologists Society for Endocrinology Others Department of Health Coventry Teaching PCT Welsh Assembly Government General Commissioning Support Appraisals Service NHS Quality Improvement Scotland Comparator manufacturer(s) Novartis (calcitonin, zoledronic acid) Pfizer (lasofoxifene) Roche (calcitriol, ibandronic acid) Warner Chilcott Relevant research groups None Evidence Review Group Aberdeen HTA Group National Institute for Health Research Health Technology Assessment Programme Associated Guideline Groups None Associated Public Health Groups None

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Project history

Date Update 17 May 2010 The issue of an Appraisal Consultation Document was delayed pending further information from the manufacturer.  This is in accordance with the Single Technology Appraisal process that an ACD can only be released after UK regulatory approval has been granted, and after the technology’s price and indication are known.

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Key documents

Osteoporotic fractures - denosumab: final appraisal determination (FAD) 15 September 2010 Osteoporotic fractures - denosumab: appraisal consultation 18 June 2010 Osteoporotic fractures - denosumab: final scope 13 November 2009 Osteoporotic fractures - denosumab: final matrix 01 March 2010 Osteoporotic fractures - denosumab: response to consultee and commentator comments on the draft scope 13 November 2009 Osteoporotic fractures - denosumab: response to consultee and commentator comments on the provisional matrix 13 November 2009

This page was last updated: 27 October 2010