PURPOSE: The cost-effectiveness and budget impact of introducing sacral nerve modulation (SNM) as a treatment for fecal incontinence in Italy were evaluated in a simulation model.
METHODS: A decision-analysis model with a Markov submodel was used to represent clinical pathways for treatment of patients with fecal incontinence in a scenario with SNM and a scenario without SNM. Data were obtained from published studies and from an expert panel. Evaluation of resource consumption was conducted from the perspective of the Italian National Health Service, and costs were retrieved from the Italian NHS procedures reimbursement list. The time horizon was 5 years, and a 3% discount rate was applied to costs and outcomes. Effectiveness was measured in symptom-free years and in quality-adjusted life-years (QALYs). Fecal incontinence prevalence data and SNM usage forecasts were used to estimate budget impact over the next 5 years.
RESULTS: The incremental cost-effectiveness ratio for introducing SNM was €28,285 per QALY gained for patients with a structurally deficient anal sphincter and €38,662 per QALY gained for patients with intact anal sphincters. If a threshold of €40,000 per QALY gained is set as the level that a decision-maker would regard as cost-effective, the probability that the introduction of SNM will be cost-effective would be 99% for patients with a structurally deficient sphincter and 53% for patients with an intact sphincter. Budget impact analysis showed that introducing SNM would have an estimated budget impact of 0.56% over 5 years on the budget allocated for fecal incontinence treatment.
CONCLUSION: Our data show SNM to be an efficient investment with an acceptable incremental cost-effectiveness ratio and a limited impact on the total allocated budget for fecal incontinence.