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18
Aug
NICE does not recommend inotuzumab ozogamicin in the treatment of acute lymphoblastic leukaemia

written by

Leukaemia Care, Charity

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NICE have today issued their final appraisal determination (FAD) on inotuzumab ozogamicin for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ID893).  A monotherapy drug named Besponsaâ and manufactured by Pfizer.

Pfizer have revealed today that they will be appealing the recommendation. Unless the decision is overturned the ‘not recommended for use’ decision will remain in place and inotuzumab ozogamicin will only be considered for review 3 years after the recommendation publication date.

The NICE appraisal largely focussed on comparison with the standard treatment for relapsed or refractory B-cell precursor ALL in adults. This is combination chemotherapy (FLAG-IDA) or a FLAG-based therapy with a tyrosine kinase inhibitor (TKI) for patients with Philadelphia-positive ALL. These are intensive treatments that often cause debilitating side-effects and require extended hospitalisation for patients.

Evidence from trials demonstrated that there was no statistically significant difference in survival of patients treated with inotuzumab ozogamicin compared to the standard treatment. However, there was a significant increase in the number of patients in complete remission and more patients were able to have stem cell transplant (SCT) following inotuzumab ozogamicin treatment.

Additionally, inotuzumab ozogamicin treatment does not require patients to have extended hospitalisation and the side effects were much less severe than standard treatment.

Inotuzumab ozogamicin is however considered as a life-extending, end-of-life treatment. Therefore despite the potential benefits for ALL patients compared to current treatments, because the extension of life is not significantly different NICE have deemed that the extra cost implication is not cost-effective use of NHS resources.

“We are incredibly disappointed in this decision and the negative impact that it will have on patients with hard-to-treat ALL,” said Zack Pemberton-Whiteley, Head of Campaigns and Advocacy, Leukaemia CARE. “ALL is a rapidly developing disease and having the choice of all available treatment options can make a huge difference to a patient’s life. Intensive chemotherapy is the standard choice of care which requires lengthy inpatient stays and continuous infusions, taking a toll on the patient. The impact of this decision can’t be underestimated. Access to inotuzumab ozogamicin would have offered adult patients and physicians with a new treatment option, giving hope for patients, their friends and family.”

You can read out more about this here.

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