Analytical approach:
This economic evaluation was based on a single study, which was modelled using two approaches: in the first model, all probabilities of cancelled cycles, pregnancies, deliveries, and miscarriages were derived from the single study, to assess the cost-effectiveness of a complete cycle; in the second model, after a cancelled cycle, no pregnancy, and miscarriage, patients started a new cycle (up to four) or stopped treatment. The time horizon of the analysis was not explicitly reported. The authors did not state the economic perspective.
Effectiveness data:
The clinical data came from a randomised controlled trial (RCT) that was published by the authors of this study (with others). The sample size was 65 patients, with 31 in the human FSH group and 34 in the recombinant FSH group. Other study characteristics were not reported. The key clinical endpoint was the pregnancy rate.
Monetary benefit and utility valuations:
Not relevant.
Measure of benefit:
The summary benefit measure was the pregnancy rate.
Cost data:
The economic analysis included only the costs of the drugs, which were derived from the Italian formulary. The quantities of ampoules used were based on resource consumption in the clinical trial. Costs were in Euros (EUR) and the price year was 2001.
Analysis of uncertainty:
The issue of uncertainty was investigated using two approaches. In a deterministic one-way sensitivity analysis, an arbitrary range of recombinant FSH costs and the available confidence interval for pregnancy rates were tested. In a Monte Carlo simulation, 10,000 iterations were used to generate cost-effectiveness acceptability curves according to different thresholds of willingness to pay.