OBJECTIVES

: Gemtuzumab ozogamicin (GO) was approved for use in combination with chemotherapy for the treatment of previously untreated, de novo CD33-positive acute myeloid leukaemia (AML) in April 2018. GO is associated with a longer relapse free survival time and a more durable remission relative to chemotherapy alone. The objective of this research was to estimate the clinical benefits and cost-offsets resulting from the potential introduction of a GO at a national level.

METHODS

: Patient level data from the ALFA-0701 trial was used to develop a cost-utility model examining the long term effects of AML management. Economic cost inputs and analysis was from the perspective of the Irish healthcare system. Costs and resource use were calculated as per HIQA guidelines. AML incidence rates were generated by applying international references to Irish population demographics. Estimates for treatment eligibility were sourced from practising haematologists.

RESULTS

: Over a five year period, if all eligible patients were treated with GO it was projected to result in an incremental QALY gain of 328 and 433 additional life years respectively. It was estimated that approximately 14 fewer haematopoietic stem cell transplants (HSCT) would be required during this five-year time horizon. This results in a reduction in expenditure of -€ 1,707,782 on HSCT. Additional disease management savings were estimated to be -€1,461,818 for patients in salvage therapy and -€1,783,200 on non-curative treatment.

CONCLUSIONS

: The reimbursement of new and innovative drugs can result in increased drug expenditure. However, the availability of more efficacious therapies earlier in the treatment process can prevent downstream management costs for relapsed or refractory conditions.

In the case of GO in an Irish context, there is a potential to both improve patient outcomes and also achieve downstream cost-offsets of €4.95m over a five-year period.