title: Cost-effectiveness of recombinant follicle-stimulating hormone (FSH) versus human FSH in intrauterine insemination cycles: a statistical model-derived analysis.
abstract: OBJECTIVE
  Recently we proposed a randomized trial specifically designed to evaluate the cost-effectiveness of two different protocols of stimulation in intrauterine insemination (IUI) cycles. Computer-simulated clinical models have been developed to perform pharmacoeconomic studies, creating a decision tree in which the complex procedure is performed and repeated. The present study was designed to compare the cost-effectiveness of recombinant follicle-stimulating hormone (rFSH) and human-derived FSH (hFSH) in ovarian stimulation and to indicate which protocol should be used in IUI cycles.
  
  
  METHODS
  Two computer-generated decision tree models were constructed to compare the clinical effects and costs of rFSH versus hFSH in IUI cycles. A first decision tree model was built according to the trial previously published. In a second model, 10 000 hypothetical infertile patients were entered in a computer-generated simulation and were stimulated with two different protocols for IUI. IUI was hypothetically performed in both groups of patients with a known pregnancy, cancellation, miscarriage and abandonment rate. The two protocols were compared using a cost-effective analysis: cost-effectiveness ratios (CE) and incremental cost-effectiveness ratios (ICER) were calculated. The cost-effectiveness acceptability curve (CEAC) was constructed.
  
  
  RESULTS
  The overall estimated costs with each ovarian stimulation strategy in the first model demonstrated that rFSH was a less cost-effective strategy, with an ICER of euro 13,727. The CEAC showed that at a level of euro 0 of willingness to pay, hFSH was cost-effective in 73% of the samples while rFSH was cost-effective in 27% only. Recombinant FSH would be more cost-effective than hFSH at an effectiveness threshold of 0.170 and at a cost per cycle of euro 235. This finding was also confirmed by the acceptability curve obtained with 10,000 Monte Carlo simulations, in which hFSH was cost-effective in about 96-98% of samples at any threshold of willingness to pay.
  
  
  CONCLUSIONS
  This study represents the first statistical model developed with a computer-generated clinical simulation with the intent to elaborate a pharmacoeconomic comparison between rFSH and hFSH in ovarian stimulation for IUI cycles. Results demonstrated that hFSH is more cost-effective than rFSH.
authors.affiliation: Department of Medical-Surgical Specialties and Public Health, Obstetrics and Gynecology, University of Perugia, Perugia, Italy. gerber@unipg.it
authors.forename: Sandro
authors.initials: S
authors.lastname: Gerli
authors.forename: Vittorio
authors.initials: V
authors.lastname: Bini
authors.forename: Gian Carlo
authors.initials: GC
authors.lastname: Di Renzo
mesh_terms: D003198:Computer Simulation; D003362:Cost-Benefit Analysis; D003658:Decision Making, Computer-Assisted; D003663:Decision Trees; D005260:Female; D043373:Follicle Stimulating Hormone, Human / Q000191:economics* / Q000627:therapeutic use; D006801:Humans; D007315:Insemination, Artificial / Q000191:economics / Q000379:methods; D011247:Pregnancy; D011994:Recombinant Proteins / Q000191:economics* / Q000627:therapeutic use
chemical_list: D043373:Follicle Stimulating Hormone, Human; D011994:Recombinant Proteins