following a resubmission assessed under the orphan medicine process:
darolutamide (Nubeqa®) is accepted for use within NHSScotland.
Indication under review: treatment of adults with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.
Darolutamide plus androgen deprivation therapy (ADT) and docetaxel significantly improved overall survival compared with placebo plus ADT and docetaxel in adults with mHSPC.
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Download detailed advice388KB (PDF)
- Medicine name:
- darolutamide (Nubeqa)
- SMC ID:
Treatment of adults with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel
- Pharmaceutical company
- Bayer Plc
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Date advice published
- 09 October 2023