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denosumab (Prolia)


Following a full submission:

denosumab 60mg solution for injection in a pre-filled syringe (Prolia) is accepted for restricted use in NHSScotland. Indication under review: treatment of osteoporosis in postmenopausal women at increased risk of fractures.  Denosumab significantly reduces the risk of vertebral, non vertebral and hip fractures.

SMC restriction: use only in patients with a bone mineral density (BMD) T-score < -2.5 and ≥ -4.0 for whom oral bisphosphonates are unsuitable due to contraindication, intolerance or inability to comply with the special administration instructions.

Treatment with denosumab for three years significantly reduced the incidence of new vertebral, non-vertebral and hip fractures compared with placebo in postmenopausal women at increased risk of fractures.

Drug Details

Drug Name: denosumab (Prolia)
SMC Drug ID: 651/10
Manufacturer: Amgen Ltd
Indication: Osteoporosis in postmenopausal women at increased risk of fractures
BNF Category:
Sub Category: 6.6 Drugs affecting bone metabolism
Submission Type: Full submission
Status: Restricted
Date Advice Published: 13 December 2010

Extra Notes

After the SMC advice for denosumab (Prolia) was published, the manufacturer provided SMC with minor revisions to the economic case initially submitted. The effect of these changes was a slight improvement in the cost effectiveness results that are reported in the Detailed Advice Document (DAD). Note that the DAD has not been updated.