Objectives: To evaluate the efficiency of Botulinum Toxin (BT) for the management of severe dysmenorrhoea, after failure of Conventional Treatments (CT) (hormonal treatments+ analgesics) by an Incremental Cost-Effectiveness Ratio (ICER), from the perspective of the French Health Insurance (HI).
Methods: This was a retrospective study (before and after comparison) based on the patients' medical records (n=20). Data on health care consumption and quality of life were collected prospectively during the before phase, which corresponds to the CT period, and the after phase, which corresponds to the period after the addition of BT injection. The data were analyzed over a time horizon of one year, according to the perspective of the French HI. In the main analysis, total average costs included direct and indirect costs. Efficiency was assessed using the ICER. The innovative strategy was considered efficient at a threshold of 30,000 € /QALY. A probabilistic sensitivity analysis using the Monte Carlo method was performed to take into account the uncertainty around the ICER related to sampling fluctuations, as well as a deterministic sensitivity analysis to evaluate the sensitivity of the ICER to the model hypotheses.
Results: The results of the main analysis indicate, from the perspective of the French HI system, that the combination of TB+CT with an ICER: -981.98 € /QALY gained (-2187.48; 897.46), was the most efficient strategy at the 30,000 € efficiency threshold (dominant strategy). The combination of BT+CT: 714.82 € ± 336.43 € was less costly than CT alone: 1104.16 € ± 227.37 €. The main cost item in our study was the cost of daily allowances. In addition, BT was more efficient than CT in terms of QALYs gained. Therefore, the use of BT in addition to CT is an efficient and beneficial strategy that could be considered for the management of dysmenorrheic patients.
Conclusion: This study showed that, for patients with severe dysmenorrhea who are not adequately managed with CT alone, BT+CT appeared to be clinically effective and cost effective in the perspective of the French HI.
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