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Olaparib for previously treated BRCA-mutation positive hormone-relapsed metastatic prostate cancer

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1 Recommendations

1.1 Olaparib is not recommended, within its marketing authorisation, for treating hormone-relapsed metastatic prostate cancer with BRCA1 or BRCA2 mutations that has progressed after abiraterone or enzalutamide in adults.

1.2 This recommendation is not intended to affect treatment with olaparib 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

Treatment for BRCA-mutation positive hormone-relapsed metastatic prostate cancer that has progressed after enzalutamide or abiraterone includes docetaxel, cabazitaxel, or radium-223. In its evidence submission, the company restricted the treatment population to people who have had docetaxel already. This is narrower than olaparib's marketing authorisation.

Clinical trial evidence shows that people taking olaparib have more time before their disease progresses, and live longer overall, than people having re-treatment with abiraterone or enzalutamide. However, this evidence is uncertain because re-treatment with abiraterone or enzalutamide is not considered effective and is not standard care in the NHS.

It is uncertain how effective olaparib is compared with cabazitaxel, radium-223 or docetaxel because there is no evidence directly comparing them. An indirect comparison suggests that olaparib increases how long people live compared with cabazitaxel, but this is uncertain.

The cost-effectiveness estimates are uncertain because of the limitations in the clinical evidence and economic model. They are higher than what NICE normally considers an acceptable use of NHS resources. Therefore, olaparib is not recommended.