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Abiraterone for newly diagnosed high-risk hormone-sensitive metastatic prostate cancer

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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.

Price

2.3 The cost of abiraterone is £2,735 for a pack of 56x500 mg tablets (excluding VAT; BNF online, accessed April 2020). The company has commercial arrangements 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.