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Abstract
Objective
To present a Canadian economic evaluation on the cost-utility of ulipristal acetate (5 mg orally daily) compared to leuprolide acetate (3.75 mg intramuscular monthly) in the treatment of moderate-to-severe symptoms of uterine fibroids in women eligible for surgery.
Methods
A probabilistic decision tree was constructed to model the pre-operative pharmacological management of uterine fibroids under the primary perspective of the Ontario public payer. The model parameterized data from clinical trials, observational studies, and public costing databases. The outcome measure was the incremental cost-utility ratio. Uncertainty in the model was explored through sensitivity and scenario analyses.
Results
Ulipristal was associated with faster control of excessive menstrual bleeding, fewer symptoms of hot flashes and lower health care resource consumption. The ulipristal strategy dominated leuprolide as it provided patients with more quality-adjusted life years (0.177 versus 0.165) at a lower cost ($1,273 versus $1,366). Across a range of sensitivity analyses, the results remained robust except to the dose of the comparator drug. If leuprolide was administered at 11.25 mg, once every 3 months, the expected cost for the leuprolide strategy would decline and the associated incremental cost-utility ratio for ulipristal would be $168/quality-adjusted life year.
Conclusion
Ulipristal offers a unique opportunity to effectively and rapidly control menstrual bleeding in patients with uterine fibroids; thereby improving their quality of life while minimizing the probability of moderate-to-severe hot flashes that are common with leuprolide. The current economic analysis suggests that ulipristal remains the dominant strategy across extensive sensitivity analyses.
Acknowledgments
The authors thank Dr Wilfred Marvin Steinberg (St Michaels Hospital, Toronto, ON) and Dr Amanda Selk (Mount Sinai Hospital, Toronto, ON) for their assistance in providing their clinical expertise in validating this economic model.
Disclosure
This work was supported by a grant from the Mitacs Accelerate Internship program awarded to Bernice Tsoi. Matched funding was provided by both Mitacs and Actavis Specialty Pharmaceuticals Co. The authors of this publication had full and independent control over the methods, analyses and preparation of the final report and the economic model.
Bernice Tsoi is further supported through an Award from the Father Sean O’Sullivan Research Centre, St Joseph’s Healthcare Hamilton. All authors report no other conflicts of interest in this work.