Life prolonging breast cancer drug recommended for PBS subsidy, but it is not time to celebrate

Breast Cancer Network Australia (BCNA) today welcomed a decision by the Pharmaceutical Benefits Advisory Committee (PBAC) to recommend the life prolonging breast cancer drug Enhertu (trastuzumab deruxtecan) for government subsidy on the Pharmaceutical Benefits Scheme (PBS) for HER2-low metastatic breast cancer.

However, BCNA Director of Policy, Advocacy & Support Services, Vicki Durston, said that we are not yet able to celebrate because the drug remains out of reach to thousands who need it. This is because the pharmaceutical company AstraZeneca refuses to increase access by lowering the price of its Patient Access Program (PAP) for Enhertu.

Patient Access Programs are offered by pharmaceutical companies to facilitate cost-free or cheaper access to drugs before the implementation of government subsidy through the PBS.

“BCNA has been calling on AstraZeneca repeatedly to ensure greater equity of access to this life-prolonging drug. The current access program costs patients as much as $50,000 in co-payments, more than half the median household income in Australia,” Ms Durston said.

“At any time, let alone in the current cost of living crisis, it is unacceptable that such a significant treatment for a new subtype of breast cancer can only be accessed by the few who can afford it.”

“While we welcome this recommendation by the PBAC, we know that it often takes months for a drug to be listed on the PBS after a recommendation. We call on AstraZeneca to come to the table and reduce the cost of its access program to prevent unnecessary financial stress and potential deaths while people wait.”

Until recently, breast cancers with low HER2 protein expression were classified as HER2-negative and therefore not eligible for anti-HER2 targeted therapy. The emergence of the new subtype HER2-low is a significant step forward in cancer treatment and can offer patients with metastatic breast cancer further treatment options when they may have exhausted all others.

Metastatic breast cancer is breast cancer that has progressed beyond the breast tissue to other parts of the body. It is a treatable but life-limiting disease.

Last year Enhertu was listed on the PBS for people with metastatic breast cancer who are HER2-positive. Before it was subsidised, HER2-positive patients were able to access a full Patient Access Program with no co-payment, creating a significant disparity in access based solely on what type of breast cancer someone has.

BCNA submitted to the PBAC in support of Enhertu being subsidised for both HER2-positive and HER2-low metastatic breast cancer and voiced concerns at the disparities caused when a drug is subsidised or made cheaper for one type of cancer, and not for another.

BCNA now calls on the Australian Government to work with AstraZeneca to make Enhertu available on the PBS for HER2-low metastatic breast cancer as quickly as possible. In the meantime, the access program must be made more accessible as this process can take many months.

Enhertu is a type of antibody drug conjugate and works by directly targeting the HER2 proteins expressed by this type of cancer, killing the cancer cells.

Clinical trials have shown that Enhertu can extend the time without the cancer progressing by an average of 9.9 months, and overall survival by 23.4 months, compared to the current standard treatment.

Ms Durston said that oncology drugs take on average 537 days to reach the hands of patients following registration by the Therapeutic Goods Administration (TGA). This is much longer than in other comparable countries, and BCNA is amongst many patient groups calling for system reform to see this process become faster.

“Patients living with metastatic breast cancer do not have the time to wait,” she said.

Sarah, who was diagnosed with metastatic breast cancer in 2017 at the age of 41, has spent over $200,000 on Enhertu privately until she recently became eligible for the patient access program.

“The cost of Enhertu has been exhausting for our family. It causes me great mental anguish and moral dilemmas when I think about how much my life is worth,” she said.

“With my own financial struggles, I can’t even imagine the heartbreak a family who cannot afford this drug will experience, and this weighs very heavily on my mind.”

"[Enhertu means that] my children will have a mum who loves them unconditionally – for longer. My husband will have a wife – the love of his life – for longer.”

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