LONCASTUXIMAB TESIRINE

The PBAC did not recommend loncastuximab tesirine for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received two or more prior lines of therapy. 

The PBAC welcomed input from health care professionals and organisations. The PBAC acknowledged the need for therapies for patients unsuitable for, or relapsing after, CAR-T or bispecific therapies. The PBAC also noted some access and equity considerations, including the potential for delivery in regional cancer centres.

The PBAC considered that limitations in the submission evidence did not allow confidence about the extent to which loncastuximab tesirine was more effective than chemoimmunotherapy. However, the PBAC accepted that it was likely reasonable, if uncertain, that loncastuximab tesirine would improve overall survival (the length of time patients remain alive) compared to chemoimmunotherapy. The PBAC considered it was reasonable to accept that the safety of loncastuximab tesirine was similar to chemoimmunotherapy. 

The PBAC considered that the claims made by the sponsor on the benefits of loncastuximab tesirine to justify its requested price were too optimistic given the uncertain benefits from the clinical data. The PBAC considered that in, addition to the changes to the assessment of costs associated with loncastuximab tesirine proposed by its Sub-Committees, an additional price reduction to the price reduction proposed by the sponsor before the PBAC meeting would be required to achieve cost-effectiveness. The Committee indicated that a financial arrangement with the sponsor would be appropriate to manage any risk that the cost to the PBS of listing loncastuximab tesirine is higher than expected. The PBAC advised that these matters could be addressed in an early re-entry submission.