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Today, the Scottish Medicines Consortium (SMC) recommended the use of inotuzumab ozogamicin (known as Besponsa® and produced by Pfizer) as a monotherapy for treatment of:
- “adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL).”
- “adult patients with Philadelphia chromosome positive relapsed or refractory B cell precursor ALL”, providing that the patient has previously failed treatment with a tyrosine kinase inhibitor.
The SMC did, however, restrict access to the drug for use:
- “in patients for whom the intent is to proceed to stem cell transplantation.”
Current UK practice is to use inotzumab ozogamicin as a step towards stem cell transplant, with patients normally requiring two cycles of treatment. Some may require an additional cycle, while others only require one. Therefore, the SMC decision to restrict the use is in line with clinical practice in the UK.
In clinical trials, inotuzumab ozogamicin significantly increased the number of patients in complete remission and more patients were able to have stem cell transplant (SCT) compared to the current standard of treatment, FLAG-based chemotherapy.
Treatment with inotuzomab ozogamicin, also, does not require patients to have extended hospitalisation and the side effects are much less severe than standard treatment. Allowing patients, and their families, to have a much-improved quality of life.
The decision from the SMC in recommending the use of inotuzumab ozogamicin for relapsed or refractory adult ALL patients is very welcome.
In August last year, NICE did not recommend the same drug for use in England. The decision was, however, successfully appealed and the HTA has now gone back to the committee for a second decision.