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BCNA News 21 Aug 2017

No PBS listing for new breast cancer drugs ribociclib and palbociclib

The Pharmaceutical Benefits Advisory Committee* (PBAC) has recommended to the Australian Government that the new breast cancer drug ribociclib (Kisqali) not be listed on the Pharmaceutical Benefits Scheme (PBS). This follows its decision earlier this year to not recommend palbociclib (Ibrance) be added to the PBS.

Ribociclib and palbociclib belong to a new class of drugs called CDK4/6 Inhibitors. They are used to treat a particular type of metastatic breast cancer. In clinical trials, they have been found to substantially improve progression free survival (the length of time before the cancer progresses, or spreads, and a new treatment, often chemotherapy, is recommended). Clinical trials are now underway to test these drugs in women with high risk early breast cancers.

BCNA has been advocating strongly for the CDK inhibitors to be listed on the PBS so that Australian women who can benefit from them can access them at an affordable price.

PBAC’s decision not to recommend ribociclib was based on ‘unfavourable and uncertain cost-effectiveness’ and uncertainty about whether it provides any overall survival or quality of life benefit.

BCNA CEO Christine Nolan and Director, Policy and Advocacy Danielle Spence met with the PBAC and, in a separate meeting, with Federal Health Minister Greg Hunt in June to discuss the importance of ribociclib and the CDK inhibitors more generally to Australian women.

‘BCNA is very disappointed with this decision by PBAC,’ Danielle said. ‘We spoke to the PBAC members about the important role of the CDK inhibitors in treating women with metastatic breast cancer. These drugs are already available to women in many other countries and Australia is lagging behind.

‘Overall survival is of course the ultimate aim of treatment but progression free survival or slowing down the course of disease is also important to women. These drugs are taken as tablet therapy and are very well tolerated, allowing women more time to live their lives to the full. Being able to delay the onset of chemotherapy and all of the associated toxicities and hospital visits that can bring can make a huge difference to the lives of women with metastatic breast cancer.

‘Australian women will be very disappointed with this decision by PBAC.’

Currently, ribociclib can only be accessed in Australia on a clinical trial or through a compassionate access program operated by Novartis, the pharmaceutical company which manufactures ribociclib. Read more about the Novartis scheme.

Palbociclib is available to buy, but costs around $5,000 per month and so it out of reach for most women. BCNA has called on Pfizer, which manufactures palbociclib, to open a compassionate access scheme in Australia. Pfizer has advised it has no plans to do so.

BCNA understands that both Novartis and Pfizer will make further applications to the PBAC with the aim of having these drugs listed on the PBS. The outcomes of these applications are not expected until 2018.

BCNA continues to work with our members who seek information about these drugs. We encourage any woman who is interested in understanding if these drugs are relevant for them to speak with their treating team.

* The PBAC is the independent body that reviews new drugs and makes recommendations on which should be subsidised by the Australian Government through the PBS.

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