Patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma look set to receive another therapeutic option on the PBS, following a drug subsidy decision by the Pharmaceutical Benefits Advisory Committee.
The PBAC recommended the listing of ibrutinib for use in combination with venetoclax for the treatment of patients with previously untreated CLL/SLL.
Prescriptions would be via telephone/online authority, available as Imbruvica 140mg capsules as well as 280 and 420mg tablets, per the committee’s advice.
The combination is billed as the first fixed-duration, all-oral, chemotherapy-free treatment regimen recommended for this patient group, addressing a need not met by current treatment options, according to Janssen ANZ.
This point of difference was highlighted as a significant factor in the PBAC’s decision, which stressed the therapy would need to be cost-minimised against venetoclax in combination with obinutuzumab, in an outcome statement (link here).
“In making its recommendation, the PBAC also considered the clinical need and the equity of access advantages associated with an all-oral therapy,” it said.
“The PBAC recommended flow-on changes to the current venetoclax listing to allow its use in combination with ibrutinib in CLL/SLL.”
Win for ALLG on AML therapy
The committee’s March 2024 meeting also saw an advocacy win for HSANZ and the Australasian Leukaemia & Lymphoma Group (ALLG), which had written in regarding treatment for acute myeloid leukaemia.
The groups had sought advice on a requested change to the PBS clinical criteria for the gilteritinib 40 mg tablets (Xospata) continuing treatment listing to allow use in patients who have relapsed post-allograft and who have not previously received treatment with gilteritinib.
In response, PBAC said it supported rewording the listings to clarify that patients must not be undergoing or have undergone a stem cell transplant since initiating treatment with gilteritinib.
“This will allow patients who had relapsed after a prior allograft to access gilteritinib through the PBS, provided they met all other PBS criteria and had not used gilteritinib prior to transplant,” it said.
“The PBAC recalled its March 2022 recommendation for gilteritinib did not intend to exclude this patient group.”
Finally, the PBAC supported listing liposomal daunorubicin and cytarabine (Vyxeos) under the Section 100 Highly Specialised Drugs (HSD) Program, while implementation issues relating to a Section 100 Efficient Funding of Chemotherapy (EFC) listing are being resolved.
This would entail patients being required to pay a co-payment for repeat prescriptions, unlike a listing under the EFC scheme, it noted.