Reason for request

Indication extension

Summary of opinion

Unfavourable opinion for reimbursement in the indication “BRUKINSA in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies”.


Clinical Benefit

Insufficient

The Committee deems that the clinical benefit of BRUKINSA (zanubrutinib) is insufficient to justify public funding cover in the MA indication in view of the available alternatives.


Clinical Added Value

Not applicable