The selective BTK inhibitor acalabrutinib (Calquence) will be listed on the PBS from 1 September for the second line treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma.
About 1600 patients are expected to gain subsidised access to AstraZeneca’s acalabrutinib which would otherwise cost more than $140,000 per course of treatment, following a positive recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) at its March meeting.
Listing of acalabrutinib was recommended for the treatment of patients with relapsed or refractory CLL/SLL considered unsuitable for treatment or retreatment with a purine analogue such as fludarabine.
The PBAC noted that acalabrutinib was a more selective inhibitor of Bruton’s tyrosine kinase (BTK) than ibrutinib and this may mean a lower incidence of some adverse events (e.g. haemorrhage and atrial fibrillation) for some patients.
The PBS listing was recommended based on results from the ASCEND clinical trial, in which use of acalabrutinib showed a significant reduction in the risk of death or disease progression for patients – including those with high risk features such as 17p deletion, compared current standard of care treatments such as idelalisib plus rituximab, or bendamustine plus rituximab (HR = 0.31).
According to the Leukaemia Foundation, acalabrutinib can be taken at home as a capsule twice daily, which is convenient for patients and their families.
At its July meeting, the PBAC made a positive recommendation for the listing of Abbvie’s venetoclax in combination with obinutuzumab for the first-line treatment of patients with CLL who have coexisting conditions and are unsuitable for fludarabine based chemoimmunotherapy.
However it rejected an application to have acalabrutinib listed for first line treatment of patients (either as monotherapy or in combination with obinutuzumab) with CLL or SLL considered unsuitable for treatment with a purine analogue, and those who harbour a 17p deletion.
Meanwhile, patients with relapsed or refractory primary mediastinal B-cell lymphoma will also benefit from widened PBS access to pembrolizumab from 1 September.
Up to 15 patients per year could benefit from the expanded listing, without which they might pay more than $130,000 per course of treatment.
[This story has been updated to clarify that the PBAC made a positive recommendation for the listing of Abbvie’s venetoclax in combination with obinutuzumab for the first-line treatment of patients with CLL. The original story stated that the PBAC had made a decision not to recommend, but this was based on the March 2020 meeting outcomes, which have been superseded by the July meeting outcomes. We apologise for the error.]