Besponsa (inotuzumab ozogamicin) from Pfizer is found not cost effective by NICE, in draft guidance, to treat relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia .

The National Institute for Health and Care Excellence (NICE) has published draft guidance not recommending Pfizer�s Besponsa (inotuzumab ozogamicin) to treat some patients with leukaemia on the NHS in England and Wales. The drug is being appraised by NICE for treating adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL). Besponsa (inotuzumab) is an antibody drug conjugate which is comprised of a monoclonal antibody targeting CD22, a cell surface antigen expressed on around 90 percent of B-cell malignancies, linked to a cytotoxic agent When the drug binds to CD22 on malignant B-cells it is taken into the cell, where the cytotoxic agent calicheamicin is released to destroy it.

Data from the INO-VATE trial, which compared the drug to standard of care chemotherapy in 326 adult patients with relapsed or refractory CD22-positive ALL, and showed that the therapy more than doubled complete remission rates. However, in draft guidelines, NICE says evidence from clinical trials showed no survival benefit from Bespona compared to current treatment, but more people who were treated with the drug were able to subsequently have a stem cell transplant and go into remission than those on standard care. Because of the �highly uncertain� survival benefits, the incremental cost effectiveness ratio (ICER) was over �100,000 per QALY for Bespona, which is substantially higher than the range considered cost effective for routine use in the NHS.