ACALABRUTINIB

The PBAC recommended acalabrutinib (in combination with bendamustine and rituximab, ABR) for the first line treatment of Stage III or IV mantle cell lymphoma (MCL) in patients who are ineligible for stem cell transplantation. 

The PBAC welcomed the input received via the Consumer Comments facility on the PBS website which highlighted the need for better treatment options for patients who are ineligible to receive a stem cell transplant in the first line setting noting these patients have a poor prognosis with existing therapies. The PBAC acknowledged the high need for new treatment options in this setting. 

Compared with the evidence in the submission considered at the July 2025 PBAC meeting, the submission presented updated results from the ECHO trial with longer follow-up. Based on this, the PBAC remained satisfied that ABR was more effective at preventing progression of MCL for some patients than treatment with bendamustine and rituximab alone. 

The PBAC considered the estimates of the benefits of acalabrutinib in support of the requested price were more realistic than those presented in the July 2025 submission. The PBAC noted the sponsor had proposed a lower price and a revised financial arrangement to manage the risk that the cost to the PBS of listing acalabrutinib is higher than expected. The PBAC advised that acalabrutinib would be acceptably cost-effective with a further small price reduction in order to reflect more realistic estimates of benefits and costs. The PBAC further advised that the financial arrangement should account for expected reductions in use of Bruton tyrosine kinase inhibitors in relapsed/refractory MCL. 

The PBAC indicated that flow-on changes to the existing bendamustine restriction would be required to allow use in combination with acalabrutinib and rituximab.