NICE recommends inotuzumab ozogamicin as an option for treating relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL) in adults following a successful appeal process against the original recommendation a year ago.
NICE have today recommended the use of inotuzumab ozogamicin, within its marketing authorisation, as an option for treating relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia in adults.
Inotuzumab ozogamicin is a monotherapy treatment named Besponsa and manufactured by Pfizer.
The decision has come almost a year after NICE originally rejected the use of inotuzumab ozogamicin in August 2017, as the treatment was not deemed to be a cost-effective use of NHS resources. The decision was successfully appealed by Leukaemia Care, Pfizer and a joint appeal from the Royal College of Pathologists, Royal College of Physicians and the Association of Cancer Physicians.
NICE, in the initial appraisal, were provided with the necessary clinical evidence that demonstrated UK practice would largely consist of using inotuzumab ozogamicin as a step to enable patients to have a stem cell transplant (SCT). When used as a step towards SCT normally only two cycles of inotuzumab ozogamicin are necessary.
A clinical trial named INO-VATE showed that far more patients were able to have a SCT following treatment with inotuzumab ozogamicin, compared to those treated with current therapies, namely FLAG-based chemotherapy.
The model for cost-effectiveness was, however, based upon a maximum of six cycles of treatment as per the marketing authorisation of inotuzumab ozogamicin. In the case of six-cycles, the treatment is used for palliative care. This significantly increased the calculated cost of inotuzumab ozogamicin, going against the clinical evidence, and the treatment was deemed to be not cost-effective.
The appellant was successful in arguing that the decision was unfair in light of the clinical evidence and it is positive that patients now have access to inotuzumab ozogamicin through the NHS. It is, however, disappointing that there has been a year long delay in access to a potentially life-saving and life-extending treatment when NICE was provided with the necessary evidence. The delay means that several patients may have now crucially missed out on accessing inotuzumab ozogamicin.
In June 2018, the Scottish Medicines Consortium (SMC) approved the use of inotuzumab ozogamicin for adults with relapsed/refractory acute lymphoblastic leukaemia (ALL) in Scotland, with the restriction the drug would be used “in patients for whom the intent is to proceed to stem cell transplantation.” This means that access to the drug is similar across the UK in England, Wales and Scotland with NICE having now approved the use of inotuzumab ozogamicin.
“We are delighted that after successfully appealing NICE’s previous recommendation, people in England and Wales with this particular form of ALL will have access to inotuzumab ozogamicin, providing them and their families with an important new treatment option,” said Zack Pemberton-Whiteley, Campaigns and Advocacy Director, Leukaemia Care.