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Pharmaceutical company upset with SMC ruling

statement of objections

20 Feb 2015

Janssen has expressed disappointment at the decision not to allow Zytiga prior to chemotherapy.

Zytiga (abiraterone acetate) is used to treat metastatic castration resistant prostate cancer in adult men who are displaying symptoms after androgen deprivation therapy (ADT) has failed with chemotherapy not advised.

ADT reduces the amount of androgen available for prostate cancer cells to grow.

Zytiga is used with prednisone or prednisolone as a treatment for prostate cancer.

Abiraterone has already been approved by the Scottish Medicines Consortium (SMC) to be used after chemotherapy. It is available on the Scottish NHS at a reduced cost, which applies for men treated with the drug before chemotherapy.

Patients can however, apply to receive Zytiga as an individual patient treatment request (IPTR). It is not available for general use, as the SMC ruled Janssen dud “not present a sufficiently robust economic analysis” to gain their acceptance and their justification of the treatment costs in relation to its benefits was not adequate. Janssen is to meet with the SMC to determine what will happen next.

Janssen Medical Director, Dr Peter Barnes, said: “From the volume of IPTRs made, we know that there is considerable demand for abiraterone from patients and clinicians in Scotland and we are exploring various options in an attempt to secure access to this important medicine for all eligible men with metastatic prostate cancer.

We will work closely with the Scottish Medicines Consortium and hope we can agree a way to make abiraterone routinely available, before chemotherapy, in Scotland.”

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