Repeated-intermittent use of ulipristal acetate for the management of uterine fibroids: an Italian pharmacoeconomic evaluation.

BACKGROUND: The aim of this paper was to evaluate an Italian pharmacoeconomic profile of repeated-intermittent (from 4 to 10 cycles) use of ulipristal acetate 5 mg (UPA 5 mg) in comparison with the use of UPA 5 mg before surgery (2 cycles) for the management of symptomatic uterine fibroids. METHODS: The pharmacoeconomic analysis was performed in two steps: 1) estimating an incremental cost-effectiveness ratio (ICER); 2) assuming a nationwide prediction of future expenditure in the Italian scenario. Effectiveness data were derived from the randomized-controlled trial, whilst quality of life and costs data were retrieved from the published literature. RESULTS: In comparison with the use of UPA 5 mg before surgery, the values of ICER per patient were the following: 1) €20,600 euros (UPA 5 mg 4 cycles); 2) €26,884 (UPA 5mg 6 cycles); 3) €30,244 (UPA 5 mg 8 cycles); 4) €31,906 (UPA 5 mg 10 cycles). In comparison with the use of UPA 5 mg before surgery plus subsequent surgery, the saving per patient for the National Healthcare System (NHS) by adding repeated-intermittent use of UPA 5 mg were the following: 1) €26 million (UPA 5 mg 4 cycles); 2) €17.6 million (UPA 5mg 6 cycles); 3) €8.9 million (UPA 5 mg 8 cycles); 4) €0.2 million (UPA 5 mg 10 cycles). CONCLUSIONS: The results showed that repeated-intermittent use of UPA 5 mg for the long-term treatment of uterine fibroids has a favourable pharmacoeconomic profile up to 10 repeated cycles and may be a cost-saving treatment option for the NHS. Although the data are encouraging, more data are needed regarding the benefits and risks of long-term treatment with UPA.