Two CDK4/6 inhibitors, palbociclib (Ibrance) and ribociclib (Kisqali) have received approval for listing on the PBS for the treatment of breast cancer.

At its March 2018 meeting, the Pharmaceutical Benefits Advisory Committee recommended the listing of palbociclib or ribociclib in combination with a non steroidal aromatase inhibitor (letrozole or anastrazole) as initial endocrine-based therapy in patients with HR-positive, and HER2-negative locally advanced inoperable or metastatic breast cancer.

The PBAC said it was satisfied the combination treatments could provide additional progression free survival compared with a non steroidal aromatase inhibitor alone, though the effects on overall survival are unknown.

However PBS listing will be dependent on a reduction in price by the manufacturers to make the acceptable cost effective. The drugs were rejected for PBS listing in November 2017 on the basis of uncertain cost effectiveness, given their likely cost of over $100 million over five years.

Lobby group Breast Cancer Network Australia said many women with metastatic breast cancer would remain in limbo and be unable to access the $5000 a month therapies through compassionate access schemes until the PBS listing was finalised through price negotiations.

BCNA board member and medical oncologist Professor Fran Boyle said the biggest benefit of the CDK4/6 inhibitors was that they could significantly slow down the progression of metastatic breast cancer when combined with a hormone therapy drug.

“Palbociclib and ribociclib are oral therapies. Many women taking these drugs report that they experience a good quality of life without the toxic side effects of chemotherapy treatment,” she said.

Other PBS listings recommended for oncology drugs include:

• Ramucirumab (Cyramza) for the treatment of gastric or gastro-oesophageal junction adenocarcinoma (subject to price reduction).
• Cetuximab (Erbitux) for previously untreated recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
• Nivolumab for the treatment of patients with SCCHN who progress within six months following platinum-based therapy.
• New tablet forms (100mg and 150mg) of olaparib (Lynparza) as an alternative to 50mg capsules for the treatment of high-grade serous ovarian, fallopian tube and primary peritoneal cancers.
• Expanded listing of pegfilgrastim for primary prophylaxis of chemotherapy induced neutropenia in patients with early stage breast cancer.