The In-Vitro Fertilization Program
In Vitro Fertilization (IVF) program involves a procedure in which eggs from a female’s ovary are removed. They then undergo fertilization process where they are mixed with the male sperms in a laboratory process, and the fertilized embryos are taken back to the female’s uterus. The IVF program is one of the Assisted Reproductive Techniques (ART) programs that is normally applied to enable the infertile couples conceive (Brinsden & Bourn Hall Clinic, 1999). IVF is one of the techniques that is normally applied for the purpose of increasing the chances of an unproductive couple to conceive. Its use normally depends on the grounds for infertility. IVF is normally an alternative in case there is a blockage in the fallopian tube, endometriosis in the female or in cases where the male has low sperm count or even if the male has poor quality sperms. IVF normally does not function for women who do not ovulate or men who are not capable of producing even the slightest healthy sperms (Wolf & University of Wisconsin, 1988). The testing processes and medications for sterility may take longer periods, may be very costly and at times the process may be unsatisfactory. Each IVF attempt normally takes at least a complete menstrual succession, which may cost between $ 5,000- $ 10,000, which sometimes is not covered by the health insurance. The nervousness of dealing with sterility issues can be challenging to the spouses and their relationship. The additional stress and expenditure on several clinic visits, tests, treatment procedures and surgical processes can become devastating. It is therefore very important for couples to receive counseling and support when undergoing the process (Elder & Dale, 2003).
Brief description of the IVF program
The IVF program is generally a process where the fusion of eggs and sperms occurs outside the female’s body. A lady may be offered fertility medication before the actual process so that she may have enough eggs maturing in the ovaries at the same instance. The eggs are then detached from the female’s ovaries by the use of a long thin needle. The eggs are then mixed with sperms in a laboratory and then monitored for a number of days until there is evidence that fertilization has taken place (Sher, Davis & Stoess, 1995). This is when the eggs are taken back to the female’s uterus. In a research that was carried out in Mayo clinic in 2004, it was discovered that iced up sperm was just as useful as the fresh sperms for the IVF procedure. Customarily, infertility has been a part of health system whereby physicians initially had very limited means of helping their patients. The perception of this field changed radically after the declaration of the birth of the first baby to be conceived through this method in 1978. IVF has been utilized productively since the year 1978, when the first kid that was produced using this procedure in England. During the past twenty years, more than a thousand of spouses have utilized this technique of ART and have been successful. Globally, more than seventy million spouses are afflicted with infertility (Charlesworth, 2004). Ever since the initial triumphant IVF process, the IVF expertise and other similar technologies have become very common globally. During the past years, the utilization of ART services has advanced at a rate of about 5-10% per annum (Brezina & Zhao, 2011).
In the year 1996, about 60,000 IVF cycles were carried out in the U.S. with about 17,000 medical expectancies and about 14,000 successful births. At present, IVF accounts for about 1% of all the successful births in the U.S. By 2009, about 3.4 million newborns were given birth to globally after the ART procedure (Zhao et al, 2011; Brezina, P. R., & Zhao, 2012). Currently, ART procedure is increasing at an annual rate of 5-10% in some of the developed countries (Stern, 2013). The ART such as the IVF is currently a typical therapy for infertility, with about 4.5 million children conceived by ART having been given birth to globally over the past three decades (Andersen et al, 2008). At present level of IVF activity in Australia, about 3.5% of children, or almost on kid in every Australian classroom, is given birth to as a result of the IVF procedure. Arguably, the biggest challenge facing IVF globally is the high rate of twin and triplet births that necessitates the transfer of multiple embryos (Carter, 2013). Multiple births are usually associated with significantly increased risks for the mother and the baby as well as pregnancy and delivery complications, preterm births, long periods of disability or even death. Australia has been marked as the world leader in decreasing the cases of ART multiple births through applying a voluntary shift to Single Embryo Transfer (SET) (Chambers, Illingworth& Sullivan, 2011). IVF has become very common in the Australian medical care scheme as a process for lessening of infertility. There are several IVF medical centers in all the states in Australia. Initially this kind of treatment was only available in the private sector; however, currently a global fee under the medical benefit program now covers the IVF services (Hammarberg, 2010). Regardless of the acceptability of the process, very little research has focused on establishing the effectiveness of the treatment administered, especially as related to alternative processes for the treatment of infertility.
Assuming the process is effective, in addition there may be issues concerning quantifying the costs and benefits of the program. Thus, some of the researches carried out in Australia that have considered financial perspective have tended on documenting the result of the medication in forms of the birth of the newborn. Unluckily, however, the birth of a newborn baby takes place in only a few cases, and the most likely result of the process is the failure to have a baby. For the purpose of presenting an accurate illustration of the results of the treatment, concentration should be given on the emotional and health effects that are experienced by spouses who take part in the program as well as the newborns. A framework for assessment is necessary, for which IVF may be compared with other available procedures for the treatment of infertility, and also compared with other medical processes that are offered within the medical system that compete for resources that are spent on the IVF (Chambers, 2011).
The Criteria Used for Access
The IVF clinics are credited by the Reproductive Technology Accreditation Committee. This is a self-governing association that is in charge of ensuring particular minimum standards are met by all the IVF clinics that are within Australia. The association was founded in the year 1987 and since that time their guidelines have been modified in the years 1992, 1997, 2002 and 2009. This code of practice guides the treatment of patients with monitored ovulation stimulation, synthetic insemination, the IVF and other similar techniques and all processes that involves the gametes or embryos that are donated. The 2004 guideline offered information on the cost per every single successful birth applying IVF by age and cycle, with the rate of successful births predicted using the 1995-1999 data (NCCWCH, 2012). The guideline necessitated that IVF be provided to women who are between the age of 23 and 39, where the average success for every IVF transfer was greater than ten percent. For this update, there exist various approaches that have been adopted in the health economic analysis which includes;
- The availability of an expectant management comparator – recognizing that even as for some females IVF is the only option of getting pregnant, for the majority there is the probability of a spontaneous conception.
- An approximation of the total successful births over a female’s reproductive life to reflect that expectant management is not time restricted and that is a possibility of spontaneous conception to occur after the failure of the IVF treatment.
- The application of multi-factorial models in approximating the success of IVF and expectant management other than only the age incorporating numerous other predictors such as the period of infertility, cause of infertility, type of infertility, sperm assessment, ovarian response and the number of embryo transferred.
- The utilization of the Quality Adjusted Life Years (QALYs) in measuring benefits reflecting NICEs favored approach to cost effectiveness.
A review of the literature that exists was carried out for the health economic issue, which identified about 15 health economic studies that examined the cost effectiveness of the IVF. Despite the fact that some of the Health economic models were established from Random Clinical Trials (RCTs) several of them used either unit data or published literature from various sources. Many of the studies observed the value of a single cycle of IVF in isolation instead of a sequential IVF strategy. It is only the studies carried out in the last decade that addressed the issues of fresh versus the iced up embryos as well as the single verses the double embryo transfer strategies. A few of the researches evaluated the impact of female’s age. Only two researches looked at the impact of the reason and period of infertility on the cost effectiveness. It is only one study that integrated the cost effectiveness of IVF in relation to the expected conception rate without treatment. There is no study that looked into obstetric history and prior IVF results in their modeling. Even though all the studies incorporated multiple pregnancies as part of the cost modeling, it’s only half of them that incorporated the extra costs of Ovarian Hyperstimulation Syndrome (OHSS) and the cost savings of cancelled cycles (NCCWCH, 2012).
The level of subsidy MBS in Australia
The citizens of Australia continue to have access to very good fertility treatments. Most of the fertility treatment costs in Australia are covered by Medicare, and if an individual has private health insurance, the costs may be reduced further. The Medicare Benefits schedule (MBS) offers a repayment for the out of pocket charges for the services out- of the hospitals, which includes the consultant attendances. The Extended Medicare Safety Net (EMSN) offers an extra reimbursement for costs that are above a yearly threshold. The EMSN offers a limited reimbursement for IVF related services provided once a yearly threshold is attained. Individuals’ Medicare safety net privilege starts at the beginning of every calendar year, and one an individual reaches the threshold; Medicare usually offers a refund of the proportion of an individual’s upfront payment for several medical services where one was never admitted to a hospital (Brinsden, 1999). Apart from the IVF, a number of the ART treatments in Australia receive some level of Medicare refund such as IUI (Intra-uterine insemination), Transfer of frozen embryo, and ICSI. Ovulation induction is normally refunded when it involves an insemination process. These refunds are usually available to all individuals who have the Medicare card. There is usually no limit to the amount that an individual can claim (Brinsden, 1999).
The Extended Medicare Safety Net (EMSN) privilege of Australia does not include the surgical treatment associated services like the egg gathering and embryo transfer and it does not offer refund for items that do not have the Medicare item number like fertility conservation carried out for social reasons. Like several other medicinal services, the charges of having IVF differ depending on the medical specialist and the individual centers. There is no single specified cost for all the fertility clinics in Australia. Each hospital has its own set cost structure for the services offered. However, Medicare has set clear principles regarding the amounts which the patients can claim back and the percentage of charges for which Medicare provides a financial refund. If an individual is considering to have the IVF treatments, it is usually wise for one to organize the health insurance cover first in order to make sure that it covers fertility assistance together with other medical services. Pathology, radiology and ancillary insurance is also significant so that one may not encounter huge unanticipated bill for services that one can not claim at the end of the medication. Additionally, it is significant to make sure that childbirth is covered in ones health cover. In any case, the key reason of embarking on IVF is for one to be able to have her own child at the end of it all. It is also necessary for an individual to make sure that he/she is registered with the Medicare Australia and fits the criteria for eligibly holding a Medicare card (Chambers & Sullivan, 2006).
There is an inadequate amount of subsidy that is available for Government-subsidized healthcare (Medicare), which requires careful distribution in order to result in maximum benefit for the society. An area of inefficiency in Australia includes the untested Medicare subsidy to carry out IVF fertilization process and this requires reformation. Medicare funding of IVF is a very delicate issue. Infertility is not a disease; so can be argued that its medication should receive public financial support. Because of the emotional anguish caused by sterility, sterility treatment is also considered to be in the public’s concern. Medicare financial support for IVF should continue, but be limited to specific patient groups to maximize the benefits to the people of Australia. In the year 2010, there were about 57000 IVF cycles that were carried out in Australia, which resulted to 10500 successful births. Presently, Medicare subsidizes $ 4420 for the 1st and $ 4930 for every subsequent cycle (Bartels, 1987). Different from other developed states like UK and New Zealand, one can claim the funding for an unlimited number of cycles, and it is usually not constrained by age or the health status of a woman. The sum that Medicare spends on IVF is usually considerable and the number of females accessing IVF is incessantly increasing. In order for Medicare funded IVF to be resourceful, it needs to be limited to a maximum of two to three cycles per female and be restricted to individuals who are mostly likely to benefit from it.
These includes the women who are not capable of responding to other less demanding fertility medication, and are under 40 years of age (Herbert, Lucke & Dobson, 2012).
The ICER and cost utility evaluation
Cost Utility evaluation is a kind of financial evaluation that investigates both the charges and health consequences of optional intrusion strategies. It compares the cost of an intervention such as the IVF to its effectiveness as measured in natural health results. The cost utility analysis is normally presented in terms of a cost effectiveness ration which conveys the cost per health result. Lately, there ahs been numerous cost utility comparisons across IVF and other available infertility solutions (Robinson, 1993). The earlier IVF supervisory models have not been sensible as pragmatic models should account for cancelled cycles, reduction in pregnancy rates of subsequent cycles, transfer of frozen embryos and dropout. Pashayan et al (2006), sought to a cost utility modeling which he compared the cost effectiveness of initial IVF offer to IVF in partners after the failure of the IUI attempts. IUI and IVF fertilization have been regarded as the first line of treatment for spouses suffering from unknown male sub fertility. The total cost was interpreted as the summation of IUI nad IVF medical services with an incremental cost utility ratio that was represented as [((cost of “IUI + IVF” arrangements) – (cost of IVF))/(difference in number of live births produced)] (Melton, 2013). Six cycles of IUI incorporated with one cycle of IVF amounted to a total of £495, 9003. ICER for the first round of IVF versus IUI and succeeding IVF was found to range from £18,000 to £14,200 per successful birth, and increased with every secondary IVF cycle. To put the costs in a more societal point of view, 6 cycles of IUI followed by a single IVF cycle amplified the total fertility spending of about 100 modeled couples by a minimum of £174,200 (Chambers, 2009). In the end it was discovered that it is more cost effective for spouses with male or unknown sub fertility to solely undertake IVF instead of pursuing IUI. The opportunity cost of IUI was discovered to induce unnecessary economic as well as psychological wastefulness ( Melton, 2013).. Even though cost effectiveness of the first IVF versus the first IUI followed by IVF in spouses with unknown subfertility, the cost effectiveness of 7 IVF approaches: outcomes of Markov decision analytic model, are new in their field, legislators should bear in mind that such models are restricted by their inability to be extrapolated to the mainstream (Fiffelers, 2009).
The novelties surrounding IVF
The IVF process has so far been very successful and has continued to improve due to the selection criteria. Proper choice of ova and sperm as well as the embryo evaluation at a phase prior to the implantation is a significant way to a successful IVF. Genetic analysis is an important stage in this selection. The IVF is the key solution to male sterility, thus presently it can be stated that sterility is now considered as a problem of the past. One of the greatest novelties of the IVF procedure is that made it possible to separate the embryo from the body of its mother, and through this a new distinct entity, which is the early human embryo was created. The conceptualization of the embryo has a huge effect on the way in which technology that involves embryos are regulated. The second effect of IVF technology is about the disintegration of parenthood. For instance, the genetic parenthood was able to be broken down into gestational parenthood (Hommels, Mesman & Bijker, 2014). Additionally, IVF has resulted in an increase in the number of parties involving themselves in child creation. This has created new responsibilities of the numerous parties taking part in the creation process, sustenance, raising or disposal of the new life. Thirdly, IVF technology is among the technologies that have contributed to the emergence of a novel practice within the health system; an exercise that is considered productive rather than curative. The exercise has helped individuals fulfill their desires rather than cure the alleviate symptoms. This novel emerging exercise has created new roles and responsibilities for practitioners and patients and it requires the establishment of new guiding principles and moral routines (Hommels, Mesman & Bijker, 2014).
The IVF is one among the Assisted Reproductive Techniques (ART) that is usually applied to enable the sterile spouses conceive. IVF is among the most cost effective sterility treatment; it has resulted to thousands of successful births since the first baby to be conceived using the IVF method in 1978. But there is no assurance that every cycle of the IVF will always result in successful birth, even though the healthiest embryos are used. Averagely IVF have success rate of about 33% per the embryo transferred for the females who are under 35 years of age. The rate of success cycle is normally higher when more than one embryo is removed. During the past years, the utilization of the ART procedures has advanced at an annual rate of 5-10%. Presently the level of IVF activity in Australia accounts for about 3.5% of the children, or almost one kid in every Australian classroom, was given birth to as a result of the IVF procedure. Debatably, the key problem facing IVF globally is the high rate of double and triplet births that usually necessitates the movement of numerous embryos. In Australia, most of the fertility medication charges are covered by Medicare. This makes their fertility treatment very cost efficient. The Australian Medicare Benefits Schedule (MBS) offers a repayment for the out of the hospital services which includes expert attendances.
This subject is very significant in informing patients, the service providers and the community as a whole about the potential long term safety of ART. IVF and other ART entail sperm and egg infusion in the laboratory, with hypothetical impacts on the growth of the succeeding embryo. Though, while the initial successful birth following IVF was over 31 years ago, there is relatively very little long term research that has been carried out concerning the subject. It is vital to offer the individuals who are considering the IVF treatment, up to date information about the long term health consequences which may include the multiple pregnancies of the procedure.
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