Darolutamide with androgen deprivation therapy (ADT) can be used as an option to treat hormone-sensitive metastatic prostate cancer in adults, only if:
docetaxel is not suitable
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. Take account of administration costs, dosages, price per dose and commercial arrangements.
These recommendations are not intended to affect treatment with darolutamide with ADT that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.
What this means in practice
Darolutamide with ADT must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Darolutamide with ADT must be funded in England within 30 days of final publication of this guidance.
There is enough evidence to show that darolutamide with ADT provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
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.
For all evidence, see the committee papers. For more information on NICE's evaluation of apalutamide plus ADT, see the committee discussion section in NICE's technology appraisal guidance on apalutamide with ADT for treating hormone-sensitive metastatic prostate cancer.