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Apalutamide with androgen deprivation therapy for treating prostate cancer

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1 Recommendations

1.1 Apalutamide plus androgen deprivation therapy (ADT) is not recommended, within its marketing authorisation, for treating prostate cancer in adults who have:

  • hormone-relapsed non-metastatic disease at high risk of metastasising

  • hormone-sensitive metastatic disease.

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

This appraisal considers apalutamide for:

  • Non-metastatic prostate cancer that has stopped responding to hormone therapy (hormone relapsed) – this is usually treated with ADT alone or with darolutamide plus ADT.

  • Hormone-sensitive metastatic prostate cancer – this is usually treated with docetaxel plus ADT if people can have docetaxel, or ADT alone if people cannot have docetaxel.

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. But this evidence is uncertain because in the trials some people could switch from placebo plus ADT to apalutamide plus ADT. Also, some people could have treatments not available in the NHS.

Some of the assumptions in the economic modelling are also uncertain, including the time until the disease progresses and how long people live. The cost-effectiveness estimates are uncertain and higher than what NICE considers an acceptable use of NHS resources. Therefore, apalutamide plus ADT is not recommended for hormone-relapsed non-metastatic prostate cancer, or for hormone-sensitive metastatic prostate cancer.