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

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

Treatments for BRCA-mutation positive hormone-relapsed metastatic prostate cancer that has progressed after enzalutamide or abiraterone include docetaxel, cabazitaxel and radium‑223 dichloride. In its initial evidence submission, the company restricted the treatment population to people who have already had a taxane (mainly docetaxel). This is narrower than olaparib's marketing authorisation. In its response to consultation, the company provided exploratory analyses for people who have not had a taxane.

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

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

The cost-effectiveness estimates for olaparib are higher than what NICE normally considers an acceptable use of NHS resources. Therefore, olaparib is not recommended.