darolutamide (Nubeqa)

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.