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New HTA Decisions in England
August 2021
Drug name
ZYTIGA® (abiraterone)
Decision date
Therapeutic area
Therapeutic sub area
Not recommended
Newly diagnosed high-risk hormone sensitive metastatic prostate cancer in adults.
Decision Detail
Abiraterone with prednisone or prednisolone plus androgen deprivation therapy (ADT) is not recommended, within its marketing authorisation, for treating newly diagnosed high-risk hormone‑sensitive metastatic prostate cancer in adults.
Clinical evidence from two randomised controlled trials (LATITUDE and STAMPEDE) show that, compared with ADT alone, a combination of abiraterone plus ADT and either prednisone or prednisolone increases the time until the disease progresses and how long people live. When compared with docetaxel plus ADT, abiraterone plus ADT increases the time until the disease progresses, but not how long people live. Docetaxel plus ADT cannot be used by or is unsuitable for some people but there is no clinical evidence for abiraterone plus ADT compared with ADT alone for this group. There is a proposed commercial arrangement that would make abiraterone available to the NHS at a discount. When accounting for the confidential discount chosen by the company, the company's base case with the appraisal committee's preferred modelling assumptions was over £100,000 per quality-adjusted life year (QALY) gained when compared with docetaxel in combination and over £30,000 per QALY gained compared with ADT alone. For the whole population, these ICERs were above the range considered a good use of NHS resources and exceed what NICE considers cost effective. There was also considerable uncertainty around the cost effectiveness of abiraterone in people for whom docetaxel is contraindicated or unsuitable. Therefore, abiraterone is not recommended for treating newly diagnosed high-risk hormone-sensitive metastatic prostate cancer.