1 Recommendations
1.1 Apalutamide plus androgen deprivation therapy (ADT) is recommended as an option for treating hormone-sensitive metastatic prostate cancer in adults, only if:
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docetaxel is not suitable
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the company provides apalutamide according to the commercial arrangement.
1.2 This recommendation is not intended to affect treatment with apalutamide plus ADT that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Hormone-sensitive metastatic prostate cancer is usually treated with docetaxel plus androgen deprivation therapy (ADT), ADT alone or enzalutamide plus ADT. Enzalutamide was not available when this appraisal started.
Clinical trial evidence suggests that, compared with placebo plus ADT, apalutamide plus ADT increases the time until the disease progresses and how long people live.
Apalutamide plus ADT is not cost effective compared with docetaxel. However, compared with ADT, the cost-effectiveness estimates for apalutamide plus ADT are within what NICE considers to be an acceptable use of NHS resources. So, apalutamide plus ADT is recommended for people with hormone-sensitive metastatic prostate cancer only if they cannot have docetaxel.