Review Decision – April 2016

Review of NICE technology appraisal 259; Abiraterone for the treatment of metastatic, castrate-resistant prostate cancer following previous cytotoxic chemotherapy, and NICE technology appraisal 316; Enzalutamide for the treatment of hormone refractory prostate cancer

Decision to defer the review

The Institute has recently issued a Final Appraisal Determination (FAD) for ‘Abiraterone for the treatment of metastatic hormone relapsed prostate cancer not previously treated with chemotherapy’ [ID503]. In this FAD, abiraterone is recommended on the condition that a newly-agreed Patient Access Scheme is implemented by the company (Janssen).

The Patient Access Scheme agreed during the development of TA259 will be replaced by the newly-agreed Patient Access Scheme, and as such the cost-effectiveness of abiraterone in TA259 is likely to be affected.

Consequently we have decided to defer the consideration of a review of TA259 until further exploratory work has been carried out to determine whether the change in the PAS arrangements are likely to lead to a change in the existing recommendations in TA259.

TA316 is scheduled to be considered for review alongside TA259. As abiraterone is considered to be a comparator of enzalutamide, it remains appropriate for these two appraisals to be considered for review together. As a result, the review of TA316 will also be deferred.

The Institute will consult with stakeholders on any proposed changes to the existing guidance once the exploratory work has been carried out.

April 2016

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