A Markov model of the cost-effectiveness of human-derived follicle-stimulating hormone (FSH) versus recombinant FSH using comparative clinical trial data.
ABSTRACT This study compared the cost and effectiveness of highly purified, human-derived follicle-stimulating hormone (FSH) (Bravelle) to recombinant FSH (Follistim) using Markov modeling and Monte Carlo simulation. One IVF treatment cycle resulted in costs of 11,584 dollars +/- 211 dollars for human-derived FSH and 12,762 dollars +/- 170 dollars for recombinant FSH, while three treatment cycles, holding the transition probabilities of the first cycle constant for the next two cycles, resulted in costs of 22,712 dollars +/- 1,107 dollars for human-derived FSH and 24,935 dollars +/- 1,205 dollars for recombinant FSH.
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ABSTRACT: Abstract Clinical efficacy of human-derived follicle-stimulating hormone (FSH) versus recombinant FSH (rFSH) in IVF-ICSI cycles has long been compared, but no clear evidence of the superiority of a preparation over the other has been found. Human gonadotropins have been often grouped together, but a different glycosylation may be present in each preparation, therefore influencing the specific bioactivity. To exclude confounding factors, a meta-analysis and a cost-effectiveness analysis were designed to compare effectiveness and cost-effectiveness of a specific highly purified human FSH (HP-hFSH) (Fostimon®) versus rFSH (Gonal-F®) in IVF/ICSI cycles. Research methodology filters were applied in MEDLINE, Current Contents and Web of Science from 1980 to February 2012. Eight randomized trials met selection criteria. The meta-analysis showed no significant differences between rFSH and HP-hFSH treatment in live-birth rate (odds ratio [OR] 0.84, 95% confidence interval [CI] 0.63-1.11), clinical pregnancy rate (OR 0.85, 95% CI 0.68-1.07), number of oocytes retrieved, number of mature oocytes and days of stimulation. The cost-effectiveness ratio was €7174 in the rFSH group and €2056 in the HP-hFSH group. HP-hFSH is as effective as rFSH in ovarian stimulation for IVF-ICSI cycles, but the human preparation is more cost-effective.Gynecological Endocrinology 01/2013; DOI:10.3109/09513590.2012.758703 · 1.14 Impact Factor
Article: Senior pharmaceutical executive with in-depth experience in the planning, implementation and management of U.S. and international discovery, R&D, and post-marketing clinical development programs. Broad experience at the medical/regulatory/marketing/sales interface. Extensive experience in clinical, academic and industry medical/biomedical research, 70 peer-reviewed publications, 8 INDs, 9 NDAs, 2 IRDs, writing, public speaking, contract/ agreement negotiations and technology assessment
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ABSTRACT: The purpose of this study was to compare Gonal-F(®), a recombinant follicle-stimulating hormone, with Menopur(®), a highly purified human menopausal gonadotrophin (hpHMG) in assisted reproduction in Greece. A decision tree in combination with a Markov model was used to assess the clinical and economical impact of comparators for up to three consecutive cycles. Transition probabilities were derived from the literature and validated by clinical experts. Cost components were derived from the electronic databases of selected private and public clinics. A probabilistic sensitivity analysis was performed to deal with uncertainty and to construct a cost-effectiveness acceptability curve. There was a statistically significant difference in favor of the recombinant follicle-stimulating hormone arm compared with hpHMG, which was associated with 52 more births (95% uncertainty interval 26-78, P = 0.001) per 1000 patients. The cost per birth was estimated at €16,906 and €17,286 in the recombinant follicle-stimulating hormone and hpHMG arms, respectively. The cost per in vitro fertilization was estimated at €4365 in the recombinant follicle-stimulating hormone arm and €3815 in the hpHMG arm, indicating a difference of €550. The incremental cost per birth for recombinant follicle-stimulating hormone versus hpHMG was estimated at €14,540, while the incremental cost per life-year was estimated at €175.41. Recombinant follicle-stimulating hormone may represent a cost-effective choice compared with hpHMG when used for ovarian stimulation for a pharmacoeconomic point of view in the Greek public health care setting. However, it must be noted that in clinical practice both agents may be used together to increase the number of follicles, oocytes, embryos, and/or pregnancies in treated patients, an approach which has not been evaluated in Greece or reported in the literature due to obvious limitations.ClinicoEconomics and Outcomes Research 01/2012; 4:185-92. DOI:10.2147/CEOR.S31972