The CDK inhibitor abemaciclib (Verzenio) has been added to the PBS from 1 January as a treatment for advanced HR+/HER2- breast cancer in non-premenopausal patients.
The treatment, adds to ribociclib (Kisqali) and palbociclib (Ibrance) as PBS listed CDK inhibitors for first line treatment, is not associated with QT interval prolongation and therefore “provides a CDK inhibitor treatment for patients with cardiac issues,” a March 2019 PBAC Public Summary Document said.
It said abemaciclib must not be used in combination with ribociclib.
Support for the listing comes from an indirect comparison of the MONARCH-3 trial comparing abemaciclib plus anastrozole or letrozole to placebo plus aromatase inhibitor, and the MONALEESA-2 comparing ribociclib plus letrozole to placebo plus letrozole.
A statement from the federal health minister Greg Hunt said about 3,000 patients had the type of breast cancer that could potentially benefit from abemaciclib.
“Without the subsidy, patients would pay up to $55,500 a year to access this medicine,” the minister said.
“As a result of this listing on the PBS, they will now only pay $41 per script, or, for concessional patients, just $6.60 per script.”
The listing was welcomed by Breast Cancer Network Australia (BCNA) which noted that abemaciclib was also less likely than the other CDK inhibitors to cause neutropenia.
“Another benefit of abemaciclib is that it is a smaller molecule and more likely to cross the blood brain barrier than the other two CDK inhibitors. It may be more effective in preventing and/or treating brain metastases.”
However the BCNA also emphsised that there are no CDK inhibitors listed on the PBS as a second, or later-line, treatment for women with metastatic breast cancer.
“Currently, the only options for people wishing to use a CDK inhibitor for later-line treatment are to pay the full price (approximately $5,000 per month) or apply to one of the pharmaceutical companies for access through a patient access program,” it said.
Also on the PBS since 1 January 2020 is a new biosimilar brand of trastuzumab (Ontruzant).
In recommending the listing, the PBAC considered the biosimilar was equivalent in all of the indications for which Herceptin is PBS-listed including early breast cancer, locally advanced breast cancer and metastatic breast cancer, as well as advanced gastric cancer.