Ulipristal acetate for pre-operative management of uterine fibroids: Modeling outcomes and costs

Eur J Obstet Gynecol Reprod Biol. 2018 Mar:222:84-88. doi: 10.1016/j.ejogrb.2018.01.020. Epub 2018 Feb 3.

Abstract

Objectives: The aim of this study was to evaluate the pharmacoeconomic profile in Italy of preoperative treatment with ulipristal acetate at the dose of 5 mg/day for 13 weeks in comparison with placebo prior to surgical management of symptomatic uterine fibroids.

Study design: The pharmacoeconomic analysis was based on the calculation of incremental cost-effectiveness ratio (ICER). Effectiveness data were derived from the randomized-controlled trial PEARL-1, whilst costs data were retrieved from the published literature. A Markov model was employed to simulate the pattern of costs and two univariate sensitivity analyses tested the robustness of the results.

Results: In comparison with placebo, ulipristal acetate 5 mg for presurgical therapy was estimated to be associated with an incremental cost of €351 per patient. Costs per patient were €3836 for ulipristal acetate vs €3485 for placebo. The incremental effectiveness was 0.01931 QALYs per patient (around 7 quality-adjusted days per patient). Hence, the cost effectiveness ratio was calculated to be €18,177 per QALY gained.

Conclusions: Preoperative use of ulipristal acetate 5 mg in patients with uterine fibroids has a favourable pharmacoeconomic profile.

Keywords: Costs and cost analysis; Economic model; Leiomyoma; Markov chains; Quality-adjusted life years.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Cohort Studies
  • Combined Modality Therapy / adverse effects
  • Combined Modality Therapy / economics
  • Contraceptives, Oral, Hormonal / adverse effects
  • Contraceptives, Oral, Hormonal / economics
  • Contraceptives, Oral, Hormonal / therapeutic use*
  • Cost-Benefit Analysis
  • Female
  • Health Care Costs
  • Humans
  • Hysterectomy / adverse effects
  • Hysterectomy / economics
  • Italy
  • Leiomyoma / drug therapy*
  • Leiomyoma / economics
  • Leiomyoma / physiopathology
  • Leiomyoma / surgery
  • Leiomyomatosis / drug therapy*
  • Leiomyomatosis / economics
  • Leiomyomatosis / physiopathology
  • Leiomyomatosis / surgery
  • Models, Economic*
  • Norpregnadienes / adverse effects
  • Norpregnadienes / economics
  • Norpregnadienes / therapeutic use*
  • Preoperative Care* / adverse effects
  • Preoperative Care* / economics
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Tumor Burden / drug effects
  • Uterine Artery Embolization / adverse effects
  • Uterine Artery Embolization / economics
  • Uterine Hemorrhage / economics
  • Uterine Hemorrhage / etiology
  • Uterine Hemorrhage / prevention & control
  • Uterine Hemorrhage / therapy
  • Uterine Myomectomy / adverse effects
  • Uterine Myomectomy / economics
  • Uterine Neoplasms / drug therapy*
  • Uterine Neoplasms / economics
  • Uterine Neoplasms / physiopathology
  • Uterine Neoplasms / surgery

Substances

  • Contraceptives, Oral, Hormonal
  • Norpregnadienes
  • ulipristal acetate