Advice for prescribing obinutuzumab in combination with acalabrutinib from 1 January 2024

On 1 January 2024, obinutuzumab was listed on the PBS as a combination treatment with acalabrutinib for Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL). This followed a positive recommendation for acalabrutinib from the Pharmaceutical Benefits Advisory Committee (PBAC) in July 2023.

As part of its recommendation, the PBAC considered that for patients where combination treatment of acalabrutinib and obinutuzumab was appropriate, dosing of obinutuzumab should occur in cycles 2 to 7. More information about the PBAC’s consideration is available at: www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2023- 07/files/acalabrutinib-psd-july-2023.pdf.

However, the current listings do not provide a sufficient number of repeats of obinutuzumab to complete treatment cycles 2 to 7 inclusive, according to the dosing in the Therapeutic Goods Administration Product Information (PBS item codes 13787P and 13793Y). Pending the PBS listings being amended, an additional script may be written by prescribers to provide an additional 2 repeats of obinutuzumab for patients who only received 5 repeats on their original prescriptions.

The Department is working to update the number of repeats for the PBS listing of obinutuzumab to 7 as a matter of priority.

Complete details of the PBS listings for obinutuzumab including all eligibility criteria are available at www.pbs.gov.au using the search term ‘obinutuzumab’.