following a full submission:
darolutamide (Nubeqa®) is accepted for use within NHSScotland.
Indication under review: Darolutamide is indicated for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.
In a phase III study in men with high risk nmCRPC, treatment with darolutamide was superior to placebo for metastasis-free survival. High risk was defined as prostate specific antigen (PSA) doubling time ≤10 months and PSA ≥2 nanograms/mL. Both groups received on-going androgen-deprivation therapy or had undergone bilateral orchiectomy.
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.
- Medicine name:
- darolutamide (Nubeqa)
- SMC ID:
For the treatment of adult men with non-metastatic castration resistant prostate cancer who are at high risk of developing metastatic disease.
- Pharmaceutical company
- Bayer Plc
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Date advice published
- 09 November 2020