The Committee deems that the clinical benefit of BRUKINSA (zanubrutinib) is low only for the indication “as monotherapy for the treatment of adult Waldenstrom macroglobulinaemia (WM) patients who have received at least one prior treatment”.
Insufficient
The Committee deems that the clinical benefit of BRUKINSA (zanubrutinib) is insufficient to justify public funding for the indication “as monotherapy as a first-line approach for the treatment of adult Waldenstrom macroglobulinaemia (WM) patients ineligible for chemo-immunotherapy”.
Clinical Added Value
no clinical added value
In view of:
the lack of evidence of superiority in relation to IMBRUVICA (ibrutinib) and the uncertainties on the specific effect size of BRUKINSA (zanubrutinib), considering the methodological weaknesses of the ASPEN clinical study;
the longer follow-up period provided by the final findings of the ASPEN study, which do not suggest loss of chance for patients in terms of efficacy from receiving BRUKINSA (zanubrutinib);
the safety profile of BRUKINSA (zanubrutinib) benefitting from a longer follow-up period marked in particular by neutropenia, whereas the safety profile of the proprietary medicinal product IMBRUVICA (ibrutinib) includes signals of cardiac toxicity;
the benefit of having an additional alternative for relapsed or refractory patients after at least one line of treatment considering the profile of older patients at a cardiovascular risk or who already have cardiac comorbidities;
the Committee deems that BRUKINSA (zanubrutinib)provides no clinical added value (CAV V) in relation to IMBRUVICA (ibrutinib) as monotherapy for the treatment of adult Waldenstrom macroglobulinaemia (WM) patients who have received at least one prior treatment.
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