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MT4 Safety Warnings about Power Morcellation in Hysterectomy: A Simulation of National Impact

      Objectives

      Laparoscopic hysterectomy has lower perioperative morbidity than abdominal hysterectomy. However, in 2014, the U.S. Food and Drug Administration warned that laparoscopic power morcellation increases tumor dissemination if patients have occult uterine cancer. This has increased use of abdominal hysterectomy. We simulated national health and financial impact of this practice change by accounting for both hysterectomy- and occult cancer-related outcomes.

      Methods

      Using the State Inpatient Database and State Ambulatory Surgery and Services Database from Florida, Iowa, Kentucky, Michigan, Minnesota, Nebraska, New Jersey, North Carolina, Oregon, Vermont, and Wisconsin, as well as data from the New York Statewide Planning and Research Cooperative System and New York State Cancer Registry, we examined hysterectomies in the pre-warning (2013Q1-2013Q4) and post-warning (2014Q4-2015Q3) period. Via multivariable regression, we estimated patient outcomes and the counterfactual distribution of hysterectomy route in the post-warning period had there been no morcellation warning. Extrapolating these estimates to the national population and incorporating additional parameter estimates from the literature, we simulated the lifetime costs (societal perspective) and quality-adjusted life-years (QALYs) of patients nationwide in the post-warning period, compared to the counterfactual scenario had there been no morcellation warning.

      Results

      The national simulation sample included 360,471 patients age ≥18 years undergoing hysterectomy for presumed benign indications in the post-warning period. In base-case microsimulation, the practice change led to more surgical complications but fewer morcellations of occult uterine cancers, resulting in an increase of $24.4 million in overall costs (in 2015 USD) and 1,353.4 in QALYs (incremental cost-effectiveness ratio=$18,021/QALY). In probabilistic sensitivity analysis (Monte Carlo simulation) accounting for uncertainty in input parameter values, the practice change was cost-effective in 51.6% of the iterations (threshold=$50,000/QALY).

      Conclusions

      Hysterectomy practice change induced by the power morcellation warnings is cost-effective in improving overall population health in base-case analysis. However, uncertainty in parameter values could substantially affect the cost-effectiveness results.