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Analysis of the cost effectiveness of recombinant versus urinary follicle-stimulating hormone in in vitro fertilization/intracytoplasmic sperm injection programs in the United States |
Silverberg K, Daya S, Auray J P, Duru G, Ledger W, Wikland M, Bouzayen R, O'Brien M, Falk B, Beresniak A |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The health interventions examined in the study were two gonadotropin preparations for patients suffering from infertility and undergoing ovarian stimulation within in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) programmes: recombinant follicle-stimulating hormone (FSH) and urinary FSH.
Economic study type Cost-effectiveness analysis.
Study population The study population included women undergoing ovarian stimulation during IVF/ICSI. Further inclusion/exclusion criteria were not reported.
Setting The study setting was not reported. The economic study was conducted in the USA.
Dates to which data relate No dates for effectiveness and resource use were reported. No price year was reported.
Source of effectiveness data The effectiveness evidence was derived from expert opinion.
Modelling The authors stated that modelling based on Markov cycles was required as clinical trial designs were insufficient to derive useful cost-effectiveness information in IVF/ICSI programmes, due to the requirement of large sample size and lengthy follow-up data. The decision model used in the present analysis comprised three cycles of gonadotropin treatment for both urinary and recombinant FSH. The model was derived from one previously used in the UK, then specifically adapted to the US setting and treatment patterns, and applied to a hypothetical cohort of 100,000 patients undergoing ovarian stimulation during IVF/ICSI.
Methods used to derive estimates of effectiveness Effectiveness estimates used as model inputs were derived from expert opinion, using an international panel of practising clinicians with experience in clinical trials, epidemiology, and biostatistics. Panel experts estimated the ranges of each probability value derived from several clinical trials and national IVF databases (such as the Society of Assisted Reproductive Technology).
Estimates of effectiveness and key assumptions The model inputs estimated in the analysis were transition probabilities, whose values for recombinant and urinary FSH were as follows:
0.044 and 0.064 for cancelled ovum pick-up;
0.022 and 0.026 for no oocytes recovered;
0.054 and 0.042 for no fertilisation with IVF;
0.047 and 0.057 for no fertilisation with ICSI;
0.019 and 0.018 for no embryo transfer with IVF;
0.650 and 0.680 for no pregnancy with IVF;
0.640 and 0.660 for no pregnancy with ICSI;
0.700 for IVF/ICSI split;
0.035 for no embryo transfer with ICSI;
0.985 for no OHSS with IVF;
0.990 for OHSS with ICSI;
0.200 for abnormal pregnancy with and without OHSS IVF/ICSI;
0.400 for no embryos survived for frozen embryo transfer;
0.800 for no pregnancy after frozen embryo transfer; and
0.200 for abnormal pregnancy after frozen embryo transfer.
Measure of benefits used in the economic analysis The benefit measure used in the economic analysis was the number of successful pregnancies, defined as ongoing pregnancies at 12 weeks gestation confirmed by ultrasound scanning for both fresh and frozen-thawed embryo transfer. The number of treatment cycles required to achieve pregnancy was also reported.
Direct costs Discounting was not relevant as costs were incurred over a short period of time. Unit costs were reported, but quantities of resources were not given. A detailed breakdown of costs was not reported. The health service costs included in the economic evaluation were ovarian stimulation (recombinant and urinary FSH, other hormones, ultrasound and consultations), oocyte pick-up (ultrasound and fees), laboratory (IVF, ICSI, OHSS, and embryo transfer), pregnancy determination (HCG and ultrasound), and frozen cycle (cryopreservation and embryo preparation). The cost/resource boundaries adopted in the study were those of the health care system (total costs) and of the insurer (reimbursement rates). Quantities of resources used and unit costs were derived from authors' assumptions. The authors stated that, in the USA, reimbursement costs were equal to 70% of billed charges and this figure was applied to unit costs used in the model to derived total expenses from the perspective of the insurers. No price year was reported.
Statistical analysis of costs Costs were treated deterministically in the base case.
Indirect Costs Indirect costs were not included in the analysis.
Sensitivity analysis No sensitivity analyses were conducted, but 5,000 Monte Carlo simulations were performed to determine confidence intervals for the estimated costs and benefits.
Estimated benefits used in the economic analysis The number of successful pregnancies in the cohort of 100,000 women was 40,665 +/-747 for recombinant FSH and 37,890 +/-966 for urinary FSH, (p<0.0001). The number of treatment cycles required to achieve pregnancy was 4.3 (3.7 fresh and 0.63 with frozen embryo) with recombinant FSH and 4.7 (4.2 fresh and 0.51 with frozen embryo) with urinary FSH and the difference was statistically significant.
Cost results Total costs in the two decision trees were not reported. The authors stated that recombinant treatment led to a 13.6% reduction in costs.
Synthesis of costs and benefits An average cost-effectiveness ratio was calculated to combine costs and benefits of the two treatments. No incremental analysis was performed. From the healthcare system perspective (reported as a societal perspective by the authors) the cost per pregnancy was $40,688 +/-818 for recombinant FSH and $47,096 +/-1,346 for urinary FSH, (p<0.0001). From the insurers' perspective the cost per pregnancy was $28,481 +/-573 for recombinant FSH and $32,967 +/-942 for urinary FSH, (p<0.0001).
Authors' conclusions The authors concluded that recombinant FSH used for ovarian stimulation within IVF/ICSI programmes proved to be more effective and more cost-effective than urinary FSH in couples with infertility problems.
CRD COMMENTARY - Selection of comparators The two treatments compared in the analysis were selected as they represented two widely used gonadotropins used for ovarian stimulation during IVF/ICSI cycles. You, as a user of this database, should decide whether they are widely used in your own setting.
Validity of estimate of measure of effectiveness The analysis of effectiveness was based on expert opinion, derived from clinical trial data. This approach was used to identify confidence intervals around point estimates obtained from clinical trial studies. Monte Carlo simulations were performed to enhance the statistical accuracy of the effectiveness estimates. However, no sensitivity analyses were conducted. The process used to derive expert opinion was not reported.
Validity of estimate of measure of benefit The benefit measure used in the economic analysis was the number of ongoing pregnancies. This represents a widely used endpoint of studies assessing assisted reproduction technique, although the rate of birth may have been more appropriate. A decision model based on a Markov process was used as three cycles of treatment were considered and patients could either abandon or go on with the treatment.
Validity of estimate of costs The analysis of costs was conducted from two distinct perspectives and it appears that all relevant categories of costs were included in the study. Unit costs were reduced by 30% to reflect lower costs from the perspective of the insurers. No price year was reported, thus making reflation exercises in other settings difficult. Unit costs were reported, but quantities of resources were not given. Costs and quantities were based on author's assumptions as no source of data was reported. Sensitivity analyses were not conducted. Estimated total costs were not reported.
Other issues The authors compared their findings with those from published studies, but did not address the issue of the generalisability of the study results to other settings. As no sensitivity analyses were conducted, the external validity of the analysis was low. The study referred to the general population of patients undergoing IVF/ICSI and this was reflected in the conclusions of the analysis. However, it would have been useful to define more strictly the target population, as several causes and degrees of infertility exist and may significantly affect treatment outcomes. The authors appear to have presented their results selectively.
Implications of the study The authors suggest that recombinant FSH should be considered the treatment of choice for ovarian stimulation during IVF/ICSI cycles due to its superior cost-effectiveness in comparison with urinary FSH, as demonstrated in the present study as well as in other publications.
Bibliographic details Silverberg K, Daya S, Auray J P, Duru G, Ledger W, Wikland M, Bouzayen R, O'Brien M, Falk B, Beresniak A. Analysis of the cost effectiveness of recombinant versus urinary follicle-stimulating hormone in in vitro fertilization/intracytoplasmic sperm injection programs in the United States. Fertility and Sterility 2002; 77(1): 107-113 Indexing Status Subject indexing assigned by NLM MeSH Cost-Benefit Analysis; Female; Fertilization in Vitro /economics /methods; Follicle Stimulating Hormone /therapeutic use /urine; Humans; Infertility, Male /therapy; Male; Markov Chains; Pregnancy /statistics & Recombinant Proteins /therapeutic use; Sperm Injections, Intracytoplasmic /economics; United States; numerical data AccessionNumber 22002000295 Date bibliographic record published 30/06/2003 Date abstract record published 30/06/2003 |
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