BESPONSA (inotuzumab ozogamicine)
Reason for request
Key points
Approval of reimbursement only for the treatment of adult patients with relapsed or refractory Philadelphia chromosome-negative (Phi-), CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL).
Actual clinical benefit is now deemed to be substantial (previously it was low) in this indication.
Therapeutic improvement?
No improvement in relation to chemotherapy.
Role in therapeutic strategy?
In adult patients with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL) with Philadelphia chromosome negative (Phi-), the treatment options (in addition to BESPONSA (inotuzumab ozogamicin)) are:
- further induction polychemotherapy (may or may not be similar to first line, conventional or clofarabine-based) followed by consolidation with allogeneic HSCT if a second complete remission is achieved, and if eligible,
- BLINCYTO (blinatumomab) in adult patients with CD 19 positive relapsed or refractory Philadelphia chromosome negative B-cell precursor ALL,
- KYMRIAH (tisagenlecleucel) in children and young adults (up to and including 25 years of age) with B-cell ALL that is refractory, in relapsed post-transplant or in second or later relapse,
- palliative supportive care.
Role of the medicinal product
BESPONSA (inotuzumab ozogamicin) is a treatment option for adult patients with acute relapsed or refractory Philadelphia chromosome-negative (Phi-), CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL).
Given the lack of direct comparative data (concurrent development) or indirect comparative data of an acceptable methodological quality, its role vis-à-vis BLINCYTO (blinatumomab) and KYMRIAH (tisagenlecleucel) cannot be specified.
Clinical Benefit
Substantial |
The Committee deems that the actual clinical benefit of BESPONSA (inotuzumab ozogamicin) is substantial in relapsed or refractory Philadelphia chromosome negative (Phi-), CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL). |
Clinical Added Value
no clinical added value |
Considering:
the Committee deems that BESPONSA (inotuzumab ozogamicin) provides no clinical added value (CAV V) compared to standard chemotherapy in adult patients with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL) (with Philadelphia chromosome negative (Phi-)). |