NICE (UK) positive for Nubeqa (darolutamide) with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer – Bayer

NICE (UK): Darolutamide with androgen deprivation therapy (ADT) can be used as an option to treat hormone-sensitive metastatic prostate cancer in adults, only if: i) docetaxel is not suitable ii) the company provides darolutamide according to the commercial arrangement. Use the least expensive option of the suitable treatments (including darolutamide with ADT and apalutamide with ADT), having discussed the advantages and disadvantages of the available treatments with the person with the condition.

Why these recommendations were made: Usual treatment for hormone-sensitive metastatic prostate cancer usually includes ADT. ADT may be given alone, or with enzalutamide, apalutamide, docetaxel, or darolutamide plus docetaxel. Darolutamide plus ADT works in a similar way to enzalutamide plus ADT and apalutamide plus ADT. It would be offered to the same population as apalutamide plus ADT, that is, people who cannot have docetaxel. Clinical trial evidence shows that darolutamide plus ADT is more effective than placebo. Darolutamide plus ADT has not been directly compared in a clinical trial with apalutamide plus ADT. But indirect comparisons suggest that it is likely to be as effective. A cost comparison suggests that the costs for darolutamide plus ADT are similar to or lower than those for apalutamide plus ADT. To be recommended as a treatment option, darolutamide plus ADT has to cost less or have similar costs to 1 relevant comparator recommended in a published technology appraisal guidance (see NICE’s cost-comparison methods). So, darolutamide plus ADT can be used.