Talazoparib with enzalutamide can be used as an option for untreated hormone-relapsed metastatic prostate cancer in adults, only when:
chemotherapy is not clinically indicated and
abiraterone plus prednisolone is not tolerated, or
there are clinical conditions that preclude the use of abiraterone plus prednisolone, and
the companies provide talazoparib and enzalutamide according to their commercial arrangements.
This recommendation is not intended to affect treatment with talazoparib 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 healthcare professional consider it appropriate to stop.
Talazoparib with enzalutamide must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Talazoparib with enzalutamide must be funded in England within 90 days of publication of this guidance.
There is enough evidence to show that talazoparib with enzalutamide provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
Usual treatment for untreated hormone-relapsed metastatic prostate cancer is abiraterone plus prednisolone, enzalutamide alone, or olaparib plus abiraterone and prednisolone.
For this evaluation, the company asked for talazoparib with enzalutamide to be considered only for people who cannot have abiraterone plus prednisolone. This does not include everyone who it is licensed for.
Clinical trial evidence shows that talazoparib plus enzalutamide increases how long people have before their condition gets worse and how long people live compared with placebo plus enzalutamide.
The cost-effectiveness estimates for talazoparib plus enzalutamide are within the range that NICE considers an acceptable use of NHS resources. So, it can be used.