following a full submission assessed under the orphan medicine process:

abiraterone acetate (Zytiga®) is accepted for use within NHSScotland.

Indication under review: abiraterone acetate with prednisone or prednisolone for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer in adult men in combination with androgen deprivation therapy.

Abiraterone acetate in combination with prednisone and androgen deprivation therapy demonstrated superiority over androgen deprivation therapy alone for improving progression-free survival and overall survival.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.

Medicine details

Medicine name:
abiraterone acetate (Zytiga)

with prednisolone for the treatment of adult men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT)

Pharmaceutical company
Janssen-Cilag Ltd
BNF chapter
Malignant disease and immunosuppression
Submission type
Date advice published
13 January 2020