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Thursday, 27 June 2013
Page: 7323

Prostate Cancer

(Question No. 1506)


Mr Fletcher asked the Minister for Health, in writing, on 14 May 2013:

In respect of the drug for the treatment of metastatic prostate cancer, abiraterone acetate (Zytiga®), that has been recommended three times by the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme (PBS), (a) why is it not listed on the PBS, (b) what aspects of the PBAC's recommendation is the manufacturer not satisfied with, and (c) what action has the Government taken to seek to resolve this impasse.


Ms Plibersek: The answer to the honourable member's question is as follows:

(a) The Australian Government recognises that metastatic prostate has a significant impact on the Australian community and is committed to improving outcomes for men affected by this disease and their families.

On 30 June 2013, I announced that the Australian Government had approved the listing of abiraterone acetate (brand name Zytiga®) on the Pharmaceutical Benefits Scheme (PBS) for the treatment of metastatic prostate cancer, at a cost of $46 million over four years. The listing is subject to final arrangements being met by the supplier of this medicine, but is expected to be made available from 1 August 2013.

Abiraterone acetate's availability on the PBS is a significant development in the treatment of prostate cancer - the most common cancer in Australian men. Over 1,000 patients will benefit from the PBS listing of abiraterone acetate.

(b) At its March 2012 meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the PBS listing of abiraterone acetate (Zytiga®) for the treatment of metastatic advanced prostate cancer, as an Authority Required listing.

However, Janssen-Cilag Pty Limited, the manufacturer of abiraterone acetate, was not satisfied with a number of aspects of the PBAC recommendation, including the price offered for a PBS listing of the medicine, and made a re-submission requesting the PBAC to review its decision.

The PBAC considered the re-submission for the review of the proposed PBS listing for abiraterone acetate at its July 2012 meeting, and again recommended listing abiraterone acetate tablets as an Authority Required listing.

The sponsor yet again decided not to proceed with the listing as it was again not satisfied with the price offered for the PBS listing of abiraterone acetate from the PBAC recommendation, and lodged another submission with the PBAC for its consideration at the November 2012 PBAC meeting. This was again recommended by the PBAC.

The sponsor has now accepted the PBAC recommendation of November 2012.

Had Janssen-Cilag Pty Limited proceeded with the PBAC's initial recommendation from its March 2012 meeting, the Australian Government's decision making processes would have enabled consideration and potentially PBS listing of this medicine in 2012.

(c) Refer to (a) and (b). It should also be noted that the Australian Government relies on the advice and recommendations of the PBAC. It would be inappropriate for the Government to interfere with or exert influence over the work of the independent PBAC.