Zytiga – Pharmaceutical Benefits Scheme Listing

Issue

The Pharmaceutical Benefits Scheme (PBS) listing of abiraterone acetate (Zytiga^®) for the treatment of metastatic prostate cancer.

Response

Abiraterone acetate (under the brand name Zytiga in Australia) is currently not available through the PBS for any condition.

The Pharmaceutical Benefits Advisory Committee (PBAC), an independent, expert advisory body comprising doctors, other health professionals and a consumer representative, makes recommendations to the Australian Government about PBS listings.

The PBAC considers each PBS listing submission having regard to the safety, clinical effectiveness and cost-effectiveness (value-for-money) of the medicine for the intended use, in comparison with other available treatments.

At its March 2012 meeting, the PBAC recommended the PBS listing of abiraterone acetate for the treatment of metastatic advanced prostate cancer, as an Authority Required listing. The Public Summary document with details of the March 2012 PBAC consideration of abiraterone acetate is available on the Department’s Public Summary Documents by Meeting web page.

However, Janssen-Cilag Pty Limited, the manufacturer of abiraterone acetate, was not satisfied with a number of aspects of the PBAC recommendation, 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 for the treatment, in combination with prednisone or prednisolone, of castration resistant metastatic carcinoma of the prostate in a patient who has failed treatment with docetaxel. The outcomes of the July 2012 PBAC meeting are available on the Department’s PBAC Outcomes by Meeting web page.

The sponsor yet again decided not to proceed with the listing and lodged another submission with the PBAC for its consideration at the November 2012 PBAC meeting and this was again recommended by the PBAC. Further information of the PBAC’s recommendation in November 2012 is available on the Department’s PBS website.

A medicine cannot be included on the PBS unless the PBAC recommends to the Government that it be listed. Therefore, a positive PBAC recommendation is a very important step in the listing process. However, other steps generally need to be taken before a listing is achieved, such as pricing negotiations with the product’s sponsor, finalisation of the conditions for listing, quality and availability checks and consideration by the Cabinet.

This is a high-cost medicine, with financial expenditure expected to cost the Government several tens of million dollars over four years. The Government will try to ensure that matters related to the listing of abiraterone acetate are resolved in as timely a manner as possible.

In the interim, a patient’s treating doctor may wish to contact Janssen-Cilag Pty Limited, to ascertain whether the sponsor would be able to advise about alternative access options. The contact details are as follows:

Janssen-Cilag Pty Limited
1-5 Khartoum Road
NORTH RYDE NSW 2113
Telephone: 1800 226 334

The Australian Government provides funds to each state and territory government to assist with the cost of providing public hospital services. It may be possible for a patient’s treating doctor to make an application to a local public hospital for assistance with the cost of a non-PBS listed medicine such as abiraterone acetate.

Patients may also be interested to know that on 1 August 2012, another medicine used to treat metastatic prostate cancer, Jevtana^® (containing cabazitaxel), was made available through the PBS for certain patients with prostate cancer.

Full details of these listings can be found in the online Schedule of Pharmaceutical Benefits which is available on the PBS website.

A patient’s treating medical professional would be best placed to advise whether Jevtana would be suitable for the treatment of the patient's condition, and whether the condition falls within the PBS listing restrictions for this medicine.

Reviewed: 7 March 2013