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Published on 27 April 2015

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Janssen statement on Zytiga®

Following discussion with the Scottish Medicines Consortium (SMC) Janssen has requested that the SMC decision not to recommend the use of Zytiga® (abiraterone acetate) before chemotherapy for men with advanced prostate cancer in Scotland is referred to an Independent Review Panel.

Following discussion with the Scottish Medicines Consortium (SMC) Janssen has requested that the SMC decision not to recommend the use of Zytiga® (abiraterone acetate) before chemotherapy for men with advanced prostate cancer in Scotland is referred to an Independent Review Panel.

This follows publication of the SMC Detailed Advice Document on 9 February 20151 that did not recommend the use of Zytiga® (abiraterone acetate) with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.

Abiraterone is already approved by the SMC as cost effective for use after chemotherapy at a reduced cost, which was agreed under a patient access scheme three years ago.  This same discount has been offered to the SMC for men treated with abiraterone before chemotherapy.

Both Janssen and SMC have agreed that the evidence submitted to SMC for the use of abiraterone pre-chemotherapy fully meets their end-of-life criteria.  The men affected by the SMC decision are primarily those who will eventually be entitled to abiraterone after chemotherapy and earlier access would give them the option to delay or avoid chemotherapy treatment.

Janssen explored several access proposals and continues to work collaboratively with the SMC; however, on this occasion, Janssen firmly disagrees with the decision and has therefore requested an independent review.

Patients in Scotland can apply to receive abiraterone before chemotherapy via an Individual Patient Treatment Request (IPTR). Janssen will maintain the current patient access scheme and existing discount while the independent review takes place.

Mark Hicken, Managing Director of Janssen UK & Ireland, said:

From the volume of Individual Patient Treatment Requests that are made, we know that there is considerable demand for abiraterone from patients and clinicians in Scotland.

Given that the evidence we submitted fully meets the Scottish Medicines Consortium criteria for end of life medicines we hope they will now expedite this review and agree a way to make this important medicine routinely available before chemotherapy for all eligible men with metastatic prostate cancer in Scotland.



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