Information intended for healthcare professionals only.
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Romosozumab (Evenity®) SMC22801
The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows:
Advice: 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.
About the SMC
The Scottish Medicines Consortium (SMC) provides advice to NHSScotland about the value for patients of newly licensed medicine. SMC reviews new medicines that have received a licence from the Medicines and Healthcare products Regulatory Agency (MHRA – the licensing body for the UK) or the European Medicines Agency (EMA – the licensing body for the European Union). They also review new formulations of, and new ways to use, established medicines. Before a medicine can be prescribed routinely in Scotland, it has to be accepted for use by SMC. SMC advice helps the health service plan for the quick, uniform introduction of beneficial treatments across NHSScotland.
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
- Scottish Medicines Consortium. romosozumab (Evenity®) SMC2280. SMC, November 2020. www.scottishmedicines. org.uk/medicines-advice/romosozumab-evenity-full-smc2280
The production, printing, and distribution of this Guidelines summary card has been commissioned by UCB Pharma Ltd. UCB Pharma Ltd has reviewed the card for technical accuracy and regulatory compliance and supplied the prescribing information. This summary card only displays the concise guidance; readers are strongly advised to refer to the full guidance at: www.scottishmedicines.org.uk/medicines-advice/romosozumab-evenity-full-smc2280
The guidance is reproduced with permission of the Scottish Medicines Consortium (SMC). Copyright of the guidance rests with the SMC, and it may be freely reproduced for educational and not-for-profit purposes. No reproduction by, or for, commercial organisations, or for commercial purposes, is allowed without the express written permission of the SMC.
MGP Ltd owns copyright of the Guidelines brand, logo, and the design and format of this summary card.
The views and opinions expressed are not necessarily those of UCB Pharma Ltd, or of Guidelines, its publisher, advisers, or advertisers. Amgen and UCB Pharma Ltd are co-developing Evenity®.
Date of preparation: December 2020