Darolutamide with Docetaxel approved for treatment of mHSPC in Scotland

09th October 2023

The Scottish Medicines Consortium (SMC) has issued guidance recommending the use of darolutamide with docetaxel for the treatment of adults with metastatic hormone sensitive prostate cancer (mHSPC) in the NHS in Scotland. This decision brings Scotland into line with England, where the drug combination was approved for men with mHSPC in June 2023. The decision comes following a resubmission after earlier advice from the SMC (March 2023) found that darolutamide in combination with docetaxel was not recommended for use within the NHSScotland for mHSPC.


The SMC advice states that, “Darolutamide plus androgen deprivation therapy (ADT) and docetaxel significantly improved overall survival compared with placebo plus ADT and docetaxel in adults with mHSPC. 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. This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.”



Darolutamide (also called Nubeqa®) is a type of hormone therapy which blocks the action of testosterone on prostate cancer cells. Darolutamide is usually taken as a tablet with food and in combination with androgen-deprivation therapy (ADT) and docetaxel chemotherapy. A phase 3 clinical trial (ARASENS) showed that patients were 32.5% less likely to die when darolutamide was included in their treatment than men taking ADT and docetaxel alone. The trial showed that addition of darolutamide not only improved life expectancy, but it also delayed disease progression.


It’s great news that this innovative treatment will now be made available to eligible patients across Scotland. Darolutamide is a drug proven to have significant benefits for patients, including those who have had limited success with other treatments. This decision means this group of prostate cancer patients have a better chance of not only of living longer but of maintaining their quality of life.” 

Oliver Kemp
CEO of Prostate Cancer Research
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