1.1 Enzalutamide is not recommended, within its marketing authorisation, for treating high-risk hormone-relapsed non-metastatic prostate cancer in adults.
1.2 This recommendation is not intended to affect treatment with enzalutamide 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
Currently, when prostate cancer no longer responds to hormone treatment (androgen deprivation therapy), but has not yet spread beyond the prostate, the only option is to continue hormone treatment. The company proposes using enzalutamide in this setting.
Clinical trial evidence shows that adding in enzalutamide extends the time until the cancer starts spreading to other parts of the body. But there is no evidence that it increases how long people live.
Cost-effectiveness estimates comparing enzalutamide plus androgen deprivation therapy with androgen deprivation therapy alone are uncertain. This is because:
it is not possible to estimate accurately how long people who take enzalutamide live
the costs and benefits of treatments used after enzalutamide in the economic analysis do not reflect NHS practice.
The estimates are not within the range that NICE usually considers a cost-effective use of NHS resources. Therefore, enzalutamide is not recommended in the NHS for treating hormone-relapsed non-metastatic prostate cancer.