romosozumab (Evenity)

following a full submission:

romosozumab (Evenity®) is accepted for restricted use within NHSScotland.

Indication under review: treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

SMC restriction: to use in patients who have experienced a fragility fracture and are at imminent risk of another fragility fracture (within 24 months).

In a phase III study in post-menopausal women with osteoporosis who were at high risk of fracture, romosozumab for 12 months followed by an oral bisphosphonate reduced the risk of fractures compared with an oral bisphosphonate alone.

This advice applies only in the context of approved NHSScotland Patient Access Scheme (PAS) arrangements delivering the cost-effectiveness results upon which the decision was based, or PAS/ list prices that are equivalent or lower.