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Submissions and reviews

Submission to PBAC in support of ribociclib (Kisqali)

Update - April 2018

On 20 April, the PBAC announced that it had recommended the addition of both ribociclib (Kisqali) and Palbociclib (Ibrance) to the PBS, subject to successful price negotiations between the Australian Government and the two drug companies. See BCNA's news item for more information.


PBAC outcome - November 2017

The PBAC reconsidered the two CDK inhibitors, ribociclib and palbociclib, at its meeting in November 2017. BCNA provided a submission in support.  The PBAC did not recommend listing of either of drug. Both drugs will be resubmitted to the PBAC for further consideration at its next meeting in March 2018. Outcomes from the meeting are not expected until the end of April.


 PBAC outcome - July 2017

At its July meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) decided against recommending ribociclib for listing on the Pharmaceutical Benefits Scheme (PBS) for a number of reasons. You can read a summary of its decision in our Latest News article. BCNA is continuing to work towards having this drug subsidised for Australians who can benefit from it.


BCNA submission

BCNA has made a submission to the Pharmaceutical Benefits Advisory Committee (PBAC) in support of the new breast cancer drug ribociclib (Kisqali). The PBAC is the authority that makes recommendations to the Australian Government on which drugs should be subsidised through the Pharmaceutical Benefits Schedule (PBS). 

Ribociclib is one of a new class of drugs called CDK4/6 inhibitors. CDK4/6 inhibitors are used to treat hormone receptor positive, HER2-negative metastatic breast cancer. They are given as oral tablets with the hormone therapy drugs letrozole or anastrozole.

The MONALEESA clinical trial found that the combination of ribociclib and letrozole significantly extended progression free survival (the length of time before the cancer spreads) – 25.3 months – compared with 16 months for women who took letrozole and a placebo.

The trial also found ribociclib was well tolerated and did not result in side effects commonly associated with cancer treatment such as nausea, diarrhoea and hair loss.

Ribociclib is not currently available to buy in Australia. A separate application is currently with the Therapeutic Goods Administration seeking approval for it to be sold here.

BCNA has been advocating for the new CDK4/6 inhibitors, which include ribociclib and palbociclib, to be listed on the PBS.

The outcomes of the PBAC meeting are expected later in the year. We will keep this page updated.

Acknowledgements

BCNA thanks Julie and Donna, the two women quoted in our submission, for generously sharing their experiences of participating in the MONALEESA clinical trial.

More information