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06 Jan 2015

Submissions for trastuzumab emtansine (T-DM1) and everolimus

The July 2013 meeting of the Pharmaceutical Benefits Advisory Committee (PBAC) considered applications for two new drugs used in the treatment of secondary breast cancer to be listed on the Pharmaceutical Benefits Schedule (PBS). BCNA made submissions in support of both applications, which you can download below.

PBAC outcomes

The PBAC recommended that Afinitor (everolimus) be listed on the PBS. Afinitor will be listed from 1 June 2014. For more information, read BCNA's media statement issued on 25 April 2014.

Unfortunately, the PBAC rejected the application for Kadcyla (trastuzumab emtansine or T-DM1). The pharmaceutical company that produces Kadcyla made a second application to the PBAC in 2014. BCNA provided a further submission to PBAC in support of PBS-listing Kadcyla.

You can read about the processes for listing new drugs on the PBS on the How breast cancer medicines are subsidised page.

Afinitor (everolimus)

Afinitor is a new drug for women with hormone positive secondary breast cancer, where the cancer has progressed on hormone therapy.

Clinical trials have found that Afinitor can extend women’s lives with less impact on quality of life than alternative IV chemotherapy treatments. For example, it does not cause hair loss, neuropathy or low blood counts, all of which can be side effects of chemotherapy.

Afinitor is taken in tablet form, so is also a useful treatment for women living in regional and rural areas who would otherwise have to travel long distances for IV chemotherapy. It is also useful for women who have poor veins as a result of previous intravenous treatments.

BCNA’s submission includes a letter to the PBAC from BCNA Member Barbara, who has been advised by her medical oncologist that everolimus is a treatment option for her. You can download our submission below.

Afinitor was previously considered by the PBAC at its March 2013 meeting, but was not approved at that time. A copy of our submission to that meeting is also available for download below.

Kadcyla (trastuzumab emtansine, also referred to as T-DM1)

Kadcyla is a new targeted therapy for women with HER2-positive secondary breast cancer. It combines a chemotherapy drug (emtansine) with Herceptin. The treatment is delivered directly to the cancer cells; healthy cells are not affected. This means that many of the usual side effects associated with chemotherapy, including hair loss, are avoided.

'After losing my hair several times during chemotherapy treatment, I really like that hair loss is not an issue on this drug.' – Amanda, clinical trial participant

Clinical trials have found that Kadcyla both prolongs life and offers women a better quality of life than the current standard treatment. It does not, for example, cause diarrhoea or hand-foot syndrome, and there is a lower incidence of febrile neutropenia and nausea and vomiting.

BCNA thanks Professor Fran Boyle, medical oncologist and BCNA Board and Strategic Advisory Group member, for her assistance in developing this submission.