A PBS listing appears unlikely for fulvestrant for women with hormone receptor positive metastatic breast cancer because of disagreement over pricing, a patient advocacy group says.
The selective oestrogen receptor down‐regulator (SERD) has received a positive recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) to be used in combination with CDK4/6 inhibitor drugs but Breast Cancer Network Australia (BCNA) says manufacturer AstraZeneca has decided not to go ahead with the listing because it is unhappy with the price the Health Department has offered to pay for it.
According to BCNA, the decision means the only option for women is an access scheme that requires them to pay for the first three months of treatment of fulvestrant, at a cost of $1,600 per month.
BCNA said it was disappointed with the outcome as it had been calling for several years to have an application for fulvestrant to be listed on the PBS.
“These calls were driven by our members, who told us about their concerns with the cost. Many of them could not afford to buy it, although it had been recommended to them by their medical oncologist,” BCNA said in a statement.
The group said it was also concerned that lack of access to fulvestrant for people living in rural Australia and Indigenous people because of the set-up of the current access program
BCNA said it was now in discussion with stakeholders regarding a generic version of fulvestrant, which it hopes will be available next year.
At its September 2020 meeting the PBAC recommended the listing of fulvestrant for the treatment of patients with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) unresectable advanced or metastatic breast cancer (ABC).
However the PBAC said a PBS listing was subject to a price reduction to meet its cost effectiveness criteria.
The PBAC said it was satisfied that first line treatment with fulvestrant would an improvement in efficacy over NSAIs and also increased safety and tolerability in subsequent lines of therapy.
It acknowledged a submission received from a medical oncologist, who noted that fulvestrant was used regularly overseas, and is associated with better quality of life than chemotherapy.
“Without PBS access to fulvestrant, patients may be treated with chemotherapy earlier in their treatment,” it noted.