Advice

in the absence of a submission from the holder of the marketing authorisation

denosumab (Prolia®) is not recommended for use within NHS Scotland.

Indication under review: osteoporosis in men at increased risk of fractures

The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication.  As a result we cannot recommend its use within NHSScotland.

NICE (National Institute for Health and Clinical Excellence) is currently undertaking a multiple technology appraisal (MTA) that includes the use of denosumab in this indication. However, due to the significant time interval between product availability and the expected date of NICE guidance, not recommended advice has been issued.

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Medicine details

Medicine name:
denosumab (Prolia)
SMC ID:
1013/14
Indication:
Osteoporosis in men at increased risk of fractures
Pharmaceutical company
Amgen Ltd
BNF chapter
Endocrine system
Submission type
Non submission
Status
Not recommended
Date advice published
10 November 2014