1 Recommendations

1.1 Inotuzumab ozogamicin is recommended, within its marketing authorisation, as an option for treating relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia in adults. People with relapsed or refractory Philadelphia-chromosome-positive disease should have had at least 1 tyrosine kinase inhibitor.

Inotuzumab ozogamicin is recommended only if the company provides it according to the commercial arrangement.

Why the committee made these recommendations

Treatment for relapsed or refractory B-cell acute lymphoblastic leukaemia is usually fludarabine, cytarabine and granulocyte colony-stimulating factor based chemotherapy (FLAG) with idarubicin. People with Philadelphia-chromosome-positive disease can have FLAG-based therapy with tyrosine kinase inhibitors or tyrosine kinase inhibitors alone. Clinical trial evidence does not show an overall survival benefit for people having inotuzumab ozogamicin compared with those having FLAG, high-dose cytarabine or cytarabine with mitoxantrone-based chemotherapy. However, more people having inotuzumab ozogamicin are able to go on to have a stem cell transplant when compared with people having the other treatments. Inotuzumab ozogamicin also meets NICE's criteria to be a life-extending treatment at the end of life.

The most plausible cost-effectiveness estimates for inotuzumab ozogamicin compared with standard care are in the range NICE considers an acceptable use of NHS resources. Therefore it can be recommended for treating relapsed or refractory B-cell acute lymphoblastic leukaemia.

  • National Institute for Health and Care Excellence (NICE)