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NUBEQA® (darolutamide) GUIDELINES

Darolutamide, NICE

^|^{Darolutamide, SMC}^|^{International Guidelines}

Funding

How much does darolutamide cost in the UK?

The cost of darolutamide is funded throughout the UK as per the

National Institute for Health and Care Excellence (NICE)

and Scottish Medicines Consortium (SMC)
guidelines:

Darolutamide, NICE:

What does the NICE guidance say regarding when to use NUBEQA® (darolutamide)?

NICE recommends darolutamide as a treatment option in adults with:

non-metastatic castration resistant prostate cancer (nmCRPC) at high risk of developing metastatic disease
Metastatic hormone sensitive prostate cancer (mHSPC) in combination with docetaxel
Metastatic hormone sensitive prostate cancer (mHSPC) in combination with ADT

Darolutamide, SMC:

What does the SMC say regarding when to use NUBEQA® (darolutamide)?

The SMC accepts the use of NUBEQA + ADT for the treatment of adults with:

nmCRPC who are at high risk of developing metastatic disease
mHSPC in combination with docetaxel

International Guidelines:

Is NUBEQA recommended by international guidelines?

NUBEQA is recommended by EAU guidelines:

Guidelines for non-metastatic castrate-resistant disease

Recommendation:

Offer apalutamide, darolutamide or enzalutamide to patients with M0 CRPC and a high risk of developing metastasis (PSA-DT < 10 months) to prolong time to metastases and overall survival.

Guidelines for the first-line treatment of hormone-sensitive metastatic disease*

Recommendations:

Offer docetaxel only in combination with ADT plus abiraterone or darolutamide to patients with M1 disease and who are fit for docetaxel.
Offer ADT combined with darolutamide to patients with M1 disease who are fit for the regimen.

^{* metastatic disease defined by bone scintigraphy and CT scan/MRI.}

For further information please refer to the Full EAU Guidelines.

Resources about NUBEQA in nmCRPC and mHSPC?

Extend survival and radiographic progression-free survival. Maintain your patient’s QoL. The only second-generation ARI approved for mHSPC with and without docetaxel.

Learn about the NUBEQA Phase III trials in mHSPC

Delay metastases. Extend survival.

Maintain your patient’s QoL

Explore the outcomes the ARAMIS trial in nmCRPC

Abbreviations

^{ADT, androgen deprivation therapy; EAU, European Association of Urology; mHSPC, metastatic hormone sensitive prostate cancer; M0, non-metastatic; nmCRPC, non-metastatic castration-resistant prostate cancer; NICE, National Institute for Health and Care Excellence; PSA-DT, prostate-specific antigen-doubling time; SMC, Scottish Medicines Consortium.}

PP-NUB-GB-2749 | October 2025

References

1
NICE. Darolutamide with androgen deprivation therapy for treating hormone-relapsed non-metastatic prostate cancer. ta104761. 2020. Available at https://www.nice.org.uk/guidance/gid-ta10476/documents/final-appraisal-determination-document.
2
NICE. Darolutamide with androgen deprivation therapy and docetaxel for treating hormone-sensitive metastatic prostate cancer. Ta903. Available at https://www.nice.org.uk/guidance/ta903/resources/darolutamide-with-androgen-deprivation-therapy-and-docetaxel-for-treating-hormonesensitive-metastatic-prostate-cancer-pdf-82615424991685.
3
NICE. Darolutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer. 2025. GID-TA11557
4
SMC. Medicines advice darolutamide. SMC2297. Available at: https://www.scottishmedicines.org.uk/medicines-advice/darolutamide-nubeqa-full-smc2297 (last accessed October 2025).
5
SMC. Medicines advice darolutamide. SMC2604. Available at: https://www.scottishmedicines.org.uk/medicines-advice/darolutamide-nubeqa-ft-resub-smc2604 (last accessed October 2025).
6
European Association of Urology. Prostate cancer guidelines (2019; amended 2020). Available at: https://uroweb.org/guideline/prostate-cancer/ (last accessed October 2025).
7
Smith MR et al. N Engl J Med. 2022;386(12):1132–1142.
8
Saad F, et al. J Clin Oncol. 2024;42(36):4271–4281.
9
NUBEQA (darolutamide) Summary of Product Characteristics.
10
Fizazi K et al. N Engl J Med. 2020;383:1040–1049.