Abstract
Infertility is recognized by the WHO as a condition leading to disability, and it is widely acknowledged that patients have a right to treatment. One of the treatment options is ART. The International Glossary on Infertility and Fertility care defines procedures of ART as “all interventions that include the in vitro handling of both human oocytes and sperm or of embryos for the purpose of reproduction. This includes, but is not limited to, IVF and ET, ICSI, embryo biopsy, PGT, assisted hatching, gamete intrafallopian transfer, zygote intrafallopian transfer, gamete and embryo cryopreservation, semen, oocyte and embryo donation, and gestational carrier cycles.
Overview of Public Funding of ARTs (In Selected Countries)
Infertility is recognized by the WHO as a condition leading to disability, and it is widely acknowledged that patients have a right to treatment[1]. One of the treatment options is ART. The International Glossary on Infertility and Fertility care defines procedures of ART as “all interventions that include the in vitro handling of both human oocytes and sperm or of embryos for the purpose of reproduction. This includes, but is not limited to, IVF and ET, ICSI, embryo biopsy, PGT, assisted hatching, gamete intrafallopian transfer, zygote intrafallopian transfer, gamete and embryo cryopreservation, semen, oocyte and embryo donation, and gestational carrier cycles. Thus, ART does not, and ART-only registries do not, include assisted insemination using sperm from either a woman’s partner or sperm donor[2].” This right to treatment and the wide scope of ART that is available to patients is, however, confronted with limited and often already pressurized healthcare budgets. The unavoidable question is, therefore, which ART programs should be funded by public health insurance and which can be referred to private resources or private health insurance? This chapter discusses the public funding of ARTs and hence the access to them by large segments of the population.
Even though most common ARTs are technically available worldwide, substantial differences in access exist between and within countries (Figure 9.1). The most generous funding policies exist in Europe and the resulting highest utilization rates are found in Denmark, the Czech Republic, and Belgium. In Denmark 15 449 ART cycles per million females of reproductive age were performed, compared to 3844 cycles in Portugal. With a need for fertility treatments that is likely to be comparable over these countries, these large differences illustrate the impact of regulation and public funding on access to ARTs and hence the importance of finding a fair and sustainable funding scheme.
Table 9.1 provides an overview of funding policies for the three most frequently used ARTs in Europe (in terms of treatment cycles in 2014): ICSI (46.6%), followed by FER (24.7%), and IVF (18.8%)[3]. Reported in this table are the European countries included in the International Federation of Fertility Societies (IFFS) and ESHRE reports and, to provide a broader comparison, six non-European countries (China, India, Israel, Japan, Russia, and the United States).
| Country | Public coverage regulated by federal/ national law[2] | Type of coverage provided[3] | Public insurance typically covers[2] | Age limit for coverage[2] (age women) | |||
|---|---|---|---|---|---|---|---|
| IVF (maximum number of cycles) | ICSI | Cryopreservation of embryos for FP for medical indications | Cryopreservation of embryos from IVF cycle | ||||
| Austria | Yes | Partial (~70%)[4] | Yes | Yes | Yes | Yes | Yes (40, men 50) |
| Belarus | No | None | No | No | No | No | Yes |
| Belgium[5] | Yes | Complete | Yes (6) | Yes | No | Yes | Yes (43) |
| Bulgaria | Yes | Partial | Yes | Yes | No | Yes | Yes |
| China | No | None | No | No | No | No | NA |
| Czech republic[6] | Yes | Complete | Yes (4) | No | No | No | Yes (40) |
| Croatia[4] | NA | Partial | Yes (6) | NA | NA | NA | Yes (42) |
| Denmark | Yes | Complete | Yes | Yes | Yes | Yes | Yes |
| Estonia[4] | Yes | NA | Yes | Yes | No | Yes | Yes (40) |
| Finland | Yes | Partial | Yes | Yes | Yes | Yes | Yes |
| France[6] | Yes | Complete | Yes | Yes | Yes | Yes | Yes (43) |
| Germany[6] | Yes | Partial (50% + 25% federal states) | Yes | Yes | No | No | Yes (40, men 50) |
| Greece | NA | Partial | No | No | No | No | Yes (50 unrelated to reimbursement) |
| Hungary[4] | Yes | Partial (75%) | Yes (5) | Yes | No | Yes | Yes (45–49) |
| India | NA | None | No | No | No | No | NA |
| Ireland | No | None | No | No | No | No | No |
| Israel | Yes | Complete | Yes | Yes | Yes | Yes | Yes |
| Italy[6] | Yes | Partial (~65%) | Yes | Yes | No | Yes | Yes (50) |
| Japan | Yes | Partial | Yes (6) | Yes | No | Yes | Yes |
| Netherlands | Yes | Complete | Yes (3) | Yes | Yes | Yes | Yes (43) |
| Norway | Yes | Partial | Yes | Yes | Yes | Yes | No |
| Poland[6] | Yes | None | No | No | No | No | NA |
| Portugal[4] | Yes | Partial | Yes (3) | Yes | No | Yes | Yes (40) |
| Romania[6] | Yes | Partial (up to €1375) | Yes (1) | No | Yes | Yes | Yes (40) |
| Russia | Yes | Complete | Yes | Yes | No | No | No |
| Slovak Republic[4] | Yes | NA | Yes | No | No | No | Yes (40) |
| Spain[6] | No | Complete | Yes | Yes | Yes | Yes | Yes |
| Sweden[6] | Yes | Complete | Yes (3) | Yes | Yes | Yes | Yes (40, men 46) |
| Switzerland | NA | No | No | No | No | No | NA |
| Turkey | Yes | Partial | Yes | Yes | Yes | Yes | Yes |
| United Kingdom[6] | No | Partial | Yes (Scotland 3[7], Wales 2, Northern Ireland one 2-part cycle) | Yes | Yes | Yes | Yes (40)1 |
| United States | No | No | No (6 – state specific) | NA | NA | No | NA |
NA: not available
1 Applicable in Scotland, Wales, and Northern Ireland; in England funding is region-dependent.
Ireland, Poland (since 2016), and Switzerland are the only European countries not providing any public coverage for ART programs. Of the countries that do offer reimbursement, all of them cover IVF. ICSI is not covered in the Czech Republic, Romania, and Slovakia. However, “complete coverage” does not imply that costs are fully reimbursed for all patients. Additional restrictions often apply: restrictions can be related to the patient’s marital status, a maximum number of reimbursed cycles can be stated ranging from one cycle (Romania) to six (Belgium, Croatia, and Japan) and most countries impose an age limit for women, most commonly between 40 and 45 years. This age limit for reimbursement can differ from the legal age limit to undergo fertility treatment. In Belgium for example, the legal age limit for egg retrieval is 45 and 48 for ETs whereas these treatments are only reimbursed when the patient is younger than age 43 on the day of the insemination of the eggs[4].
These substantial discrepancies in public insurance coverage and usage of ART are the result of differences in priority setting and resource allocation among countries. How can policymakers decide which ART programs to fund, to which extent (fully or partially?), on which scale (for whom?) and how much money should in total be spent on ARTs? In this chapter, we explain some of the answers to these questions offered by cost-effectiveness analyses and their limitations in prescribing a fair and efficient public funding scheme.
Health-economic Evaluation of ARTs
Available methods
Important first answers to the question which ART to fund are offered by economic evaluation studies. These analyses systematically compare two or more interventions on their costs and expected outcomes and express the value of the more promising option in terms of an incremental cost-effectiveness ratio (ICER): the additional costs required by a program per effect gained. Different types of economic evaluation exist, with the unit in which the health effects are expressed determining the type of evaluation. The broadest form of evaluation is cost–benefit analysis (CBA), expressing outcomes in monetary terms (e.g., the money equivalent of a clinical pregnancy achieved), which can be compared to the costs incurred. The advantage of this approach is that everything is expressed in money terms and this allows incorporating all possible sources of value of the outcome (not just clinical aspects of an ART but also its impact on, e.g., well-being to parents or economic benefits of having a child). The estimated return-on-investment can then be compared to the money returns of any other way of spending available resources. The disadvantage is that such a broad monetization of outcomes (especially of those that are typically kept out of the economic sphere) is considered ethically sensitive and highly challenging, and available estimates often lack reliability and validity.
Alternative evaluation techniques are cost-effectiveness analysis (CEA) and cost-utility analysis (CUA). In CEA, the outcomes considered are restricted to particular natural units of effects gained by the program. The ICER will hence be reported in terms of, e.g., a cost per live birth achieved, without specifying how valuable a live birth is. The advantage is its straightforwardness and, often, such estimates are meaningful to clinicians or decision-makers who have to allocate a ring-fenced budget (e.g., a fixed budget only to be used for ARTs). The disadvantage is that cost comparisons are only possible within the sphere of the particular effect that was considered (e.g., per live birth/per clinical pregnancy or per cycle) and a consensus on the most meaningful denominator for ARTs is currently lacking[5]. Furthermore, cost-effectiveness comparisons of interventions that operate in different healthcare domains, and where different health outcomes are “produced,” become impossible. This means that from cost-effectiveness estimates we can judge which intervention is the most “technically efficient” one (producing desired outcomes at minimal cost), but we cannot judge whether the overall ART budget size is appropriate, and whether from a more global perspective on healthcare funding, resources are used where they create the most value (i.e., “allocative efficiency”).
A third evaluation technique is somewhere in between CBA and CEA in terms of scope: CUA. Here, health effects are translated into “utilities” such as quality-adjusted life years (QALYs). A QALY is a generic “unit” of health, representing one life year in perfect health. Health effects of an intervention will thus consist of a certain number of QALYs gained, determined by the expected increase in life years, adjusted for the expected quality of life during those years. Quality-of-life weights are attributed to each year ranging from zero for a life that has the same value as death and one for a life in perfect health. CUA is the commonly-used method in the economic evaluation of healthcare programs as it allows cost-effectiveness comparisons of interventions in different health domains in terms of €/QALY, while avoiding the problems of monetizing health in CBA[6].
Cost-Effectiveness of IVF, ICSI, and Cryopreservation of Embryos
We summarize 18 recent cost-effectiveness studies in Table 9.2. This table is based on a targeted (rather than systematic) review, selecting recent economic evaluations related to the assessment of cost-effectiveness of IVF, ICSI, and cryopreservation of embryos (as these subjects were also included above). This search was conducted for articles published between 2009 and 2019, on PubMed and in high-impact journals focusing on fertility, human reproduction, or health economics. We discuss the reported cost-effectiveness results for the most common research questions and explore existing discrepancies in methodology.
Table 9.2 Summary of cost-effectiveness studies
| First author (year) country of publication | Focus of study | No. of observations | Costs | Effectiveness | Reported cost-effectiveness (CE) | |
|---|---|---|---|---|---|---|
| Elective single ET (eSET) versus double ET (DET) | ||||||
| Assessment of costs and outcomes of DET and projection of the difference in costs and outcomes had the double ET cycles been performed as sequential eSETs | 10 001 cycles DET, 4129 cycles eSET, patients <35 years with no prior ART use consisting of cryopreservation |
|
|
| Assumes no infants stillborn in a multiple birth, assumes same success rates for DET as the projected sequential eSET group. Ignores higher risk of drop-out in the case of eSET |
|
| 308 couples who started their first IVF cycle |
|
|
| Costs from societal perspective including health-care costs and costs outside healthcare sector. From two weeks before randomization up to six weeks after birth/two weeks after last ovum pickup |
| CE of IVF-ICSI with eSET followed by the transfer of cryopreserved embryos (eSFET), versus DET | 121 women <38 years old undergoing their first or second IVF cycle; 57 eSET + eSFET and 64 DET |
|
|
| Costs include direct medical costs associated with AR treatment, pregnancy, childbirth, and neonatal care |
| Assessment of cumulative costs and consequences of eSET and DET in women commencing IVF with treatment ages 32, 36, and 39 years | 6153 women, 10 511 fresh cycles, 3106 frozen cycles. Up to three full cycles per patient | Not stated | Not stated |
|
|
| CE of SET followed by an additional frozen-thawed (eSFET), compared to DET, in relation to female age | 3390 patients undergoing IVF/ICSI |
|
|
| Including direct medical costs, including cost of singleton/twin birth until six weeks after birth |
| CE of eSET compared to DET |
|
|
|
| Total treatment charges and medication costs for fresh and frozen embryo transfer (FET) cycles until pregnancy test. Costs from complications of ovarian stimulation were not included |
| Freeze-only versus fresh ETs | ||||||
| CE of freeze-only strategy compared to fresh ET after one complete IVF/ICSI cycle in women without PCOS | 782 infertile couples |
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| CE of IVF freeze-all policy (entire cohort of embryos is cryopreserved) compared with fresh ET (only supernumerary embryos are cryopreserved) | Patients: 67 freeze-all policy, 189 fresh transfer |
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| CE of freeze-all cycles compared to fresh ETs | 530 ICSI cycles: 351 fresh embryo cycles and 179 freeze-all cycles |
|
|
| Freeze-all patients: progesterone level on trigger day <1.5 ng/mL. Exclusion of patients with ovarian hyperstimulation syndrome (OHHS) risk. Exclusion of indirect costs |
| Delayed versus immediate IVF | ||||||
| 5962 couples with primary infertility |
|
|
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| |
| CE of delaying IVF for six months in couples with unexplained infertility compared to immediate IVF treatment | 8781 couples aged <40 years. 17 418 fresh and 10 230 frozen ET cycles |
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| |
| Other studies | ||||||
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| 1994 MNC cycles and 392 fresh COH cycles with subsequent transfer of cryopreserved embryos |
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| Cost of singleton, twins included. Costs of medication, costs of treatment procedures, cost of ongoing pregnancies for singletons and twins including costs of pregnancy, delivery, and costs up to six weeks after delivery |
| CE of TA to IVF in women who desire fertility after tubal ligation | 2256 tubal anastomosis procedures, number of IVF observations not specified | Average cost not stated |
|
| The charges for IVF included physician visits, ultrasound and laboratory evaluation, oocyte retrieval, ICSI, ET, embryology fees, and all medications [2014; USD] |
|
| Computer-simulated cohort of subfertile women aged 20–45 years old, based on prospective cohort study following 4928 couples during 12 months |
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| Costs of IVF cycle, ovarian reserve testing, and gonadotropin dose increase (limited cost inclusion) |
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| 602 couples with unexplained infertility, age 18–38 |
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| ART treatment costs, medication, and pregnancy leading to delivery. Costs of pregnancy and delivery included |
| CE of split IVF-ICSI for the treatment of couples with unexplained fertility | 154 couples |
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| Direct costs of IVF and ICSI (procedure, medication, and cryopreservation, ET, donor insemination) |
| Yilmaz (2017) Turkey[17] | Perinatal outcomes and CE of patients with advanced age. (Assessment of the current age cut-off in Turkey at 40 years old) | 456 patients: 158>39 years old,298 <39 years old |
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| No cost details provided |
1. Crawford S et al. Costs of Achieving Live Birth from Assisted Reproductive Technology: A Comparison of Sequential Single and Double Embryo Transfer Approaches. Fertil Steril. 2016; 105(2): 444–50.
2. Fiddelers AAA et al. Cost-Effectiveness of Seven IVF Strategies: Results of a Markov Decision-Analytic Model. Hum. Reprod. 2009; 24(7): 1648–55.
3. Hernandez Torres E et al. Economic Evaluation of Elective Single-Embryo Transfer with Subsequent Single Frozen Embryo Transfer in an in Vitro Fertilization/Intracytoplasmic Sperm Injection Program. Fertil Steril. 2015; 103(3): 699–706.
4. Scotland GS et al. Minimising Twins in in Vitro Fertilisation: A Modelling Study Assessing the Costs, Consequences and Cost-Utility of Elective Single Versus Double Embryo Transfer over a 20-Year Time Horizon. BJOG. 2011; 118(9): 1073–83.
5. van Loendersloot LL et al. Cost-Effectiveness of Single Versus Double Embryo Transfer in IVF in Relation to Female Age. Eur J Obstet Gynecol Reprod Biol. 2017; 214: 25–30.
6. Veleva Z, Karinen P, Tomas C, Tapanainen JS, Martikainen H Elective Single Embryo Transfer with Cryopreservation Improves the Outcome and Diminishes the Costs of IVF/ICSI. Hum Reprod. 2009; 24(7): 1632–9.
7. Le KD et al. A Cost-Effectiveness Analysis of Freeze-Only or Fresh Embryo Transfer in IVF of Non-PCOS Women. Hum Reprod. 2018; 33(10): 1907–14.
8. Papaleo E et al. A Direct Healthcare Cost Analysis of the Cryopreserved Versus Fresh Transfer Policy at the Blastocyst Stage. RBM Online. 2017; 34(1): 19–26.
9. Roque M, Valle M, Guimarães F, Sampaio M, Geber S Cost-Effectiveness of the Freeze-All Policy. JBRA Assist Reprod. 2015; 19(3): 125–30.
10. Eijkemans MJC et al. Cost-Effectiveness of “Immediate IVF” Versus “Delayed IVF”: A Prospective Study. Hum Reprod. 2017; 32(5): 999–1008.
11. Pham CT, Karnon JD, Norman RJ, Mol BW Cost-Effectiveness Modelling of IVF in Couples with Unexplained Infertility. RBM Online. 2018; 37(5): 555–63.
12. Groen H, Tonch N, Simons AHM, van der Veen F, Hoek A, Land JA. Modified Natural Cycle Versus Controlled Ovarian Hyperstimulation IVF: A Cost-Effectiveness Evaluation of Three Simulated Treatment Scenarios. Hum Reprod. 2013; 28(12): 3236–46.
13. Messinger LB et al. Cost and Efficacy Comparison of in Vitro Fertilization and Tubal Anastomosis for Women After Tubal Ligation. Fertil Steril. 2015; 104(1): 32–8.e4.
14. Moolenaar LM et al. Cost Effectiveness of Ovarian Reserve Testing in in Vitro Fertilization: A Markov Decision-Analytic Model. Fertil Steril. 2011; 96(4): 889–94.
15. Tjon-Kon-Fat RI et al. Is IVF – Served Two Different Ways – More Cost-Effective Than IUI with Controlled Ovarian Hyperstimulation? Hum Reprod. 2015; 30(10): 2331–9.
16. Vitek WS, Galárraga O, Klatsky PC, Robins JC, Carson SA, Blazar AS. Management of the First in Vitro Fertilization Cycle for Unexplained Infertility: A Cost-Effectiveness Analysis of Split in Vitro Fertilization-Intracytoplasmic Sperm Injection. Fertil Steril. 2013; 100(5): 1381–8.
17. Yilmaz N et al. Perinatal Outcomes and Cost-Effectivity of the Assisted Reproduction Pregnancies with Advanced Age: A Retrospective Analysis. J Obstet Gynaecol. 2017; 37(4): 450–3.
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