2 Information about abiraterone

Marketing authorisation

2.1 Abiraterone (Zytiga; Janssen) with prednisone or prednisolone has a UK marketing authorisation for treating 'newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT)'. In LATITUDE, a key trial in this appraisal, high-risk prognosis was defined as having at least 2 of the following 3 risk factors: a Gleason score of 8 or more; 3 or more lesions on bone scan; and measurable visceral metastasis (excluding lymph node disease).

Dosage in the marketing authorisation

2.2 The dosage is available in the summary of product characteristics.


2.3 The cost of abiraterone is £2,735 for a pack of 56 x 500 mg tablets (excluding VAT; BNF online, accessed June 2021). The company has a commercial arrangement that makes abiraterone available to the NHS with a confidential discount when it is used later in the disease pathway for treating hormone-relapsed metastatic prostate cancer before chemotherapy is indicated, or for hormone-relapsed metastatic prostate cancer previously treated with a docetaxel-containing regimen. Had abiraterone been recommended, it would have been available to the NHS with a discount for treating newly diagnosed high-risk hormone-sensitive metastatic prostate cancer.

  • National Institute for Health and Care Excellence (NICE)