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New strategy to reduce multiple births &
complications after fertility treatment
London Thursday December 6 2007-
The Human Fertilization and Embryology Authority (HFEA), a governmental
authority that regulates and inspects all UK fertility clinics that provide
assisted reproductive technology (ART), on Tuesday called for a national
strategy to reduce the number of multiple births that occur after fertility
treatment. More than a quarter of in vitro fertilization (IVF) conceptions
result in multiple births, which are far more likely to result in premature
or other forms of problematic births. According to a new report* by
independent market analyst Datamonitor, almost 40,000 British women will
have infertility treatment in 2007, however, HFEA’s new strategy will
greatly reduce the number of mothers and babies at risk.
The potential
negative consequences of multiple births
Many assisted
pregnancies have led to multiple births following excessive follicular
stimulation in ovulation induction cycles and multiple embryo transfers,
which are practiced in order to increase the chances of success. European
and US registries of assisted reproduction indicate that 25% of IVF and
intracytoplasmic sperm injection (ICSI) cycles result in twins and another
three to five percent result in higher order multiple pregnancies (HOMP)(1).
In addition to the potentially fatal ovarian hyperstimulation syndrome (OHSS),
multiple pregnancies have been associated with a statistical increase in
maternal risk for obstetric complications, congenital malformations and
long-term neurological conditions, and lower gestational age and birth
weight.
According to
Datamonitor women’s health analyst Anna Nesbitt the wider implications of
multiple births must also be considered. “The healthcare costs of neonatal
and delivery services are increased for multiple pregnancies and the
pressure of raising more than one child can generate familial complications
of a psychological, social and financial nature which are further
exacerbated by disability,” she says.
Calls for tighter
regulation
These concerns over mother and baby safety have seen a
move towards milder stimulation protocols in recent years and Datamonitor
predicts that this trend is set to continue. Shorter stimulation protocols
involve a gonadotropin-releasing hormone
(GnRH) antagonist co-treatment with a low dose gonadotropin and single
rather than multiple embryo transfer. The HFEA has announced that they
expect multiple birth rates to fall so that they account for just 10% of all
IVF pregnancies and have called on professional bodies to develop an
all-encompassing, national strategy to ensure this prediction is met.
Work on these
guidelines is due to begin immediately and with the first discussion
scheduled in February 2008, change for the UK infertility market is
imminent.
IVF in the UK
There are around
80 clinics in the UK that offer some form of infertility treatment. While
30% are NHS practices, private patients can also be treated there. The
market is boosted by partial reimbursement of treatment, making assisted
reproductive technology (ART) accessible to more than just the very wealthy.
Datamonitor estimates that in 2007, 38,000 British women were willing and
able to have infertility treatment and based on this, forecasts the UK
infertility drug market to be worth around $95million. Additionally,
Datamonitor forecasts the seven major markets** combined to be worth $3.5
billion in 2007, the majority of which is generated by three large
pharmaceutical companies; Ferring, Merck Serono and Organon.
Winners and losers
A reduction in the
number of multiple births will have several impacts on current treatment
cycles. The transfer of a single embryo is likely to be enforced and the use
of mild stimulation protocols is likely to become more widespread. Market
players will feel the result of a reduction in the administration of
gonadotrophins as a reduction in sales volume. However, Nesbitt sees an
upside in the situation. “The shorter stimulation protocol and the transfer
of a single embryo may allow more IVF cycles to be conducted within the same
period of time as conventional treatment. More cycles will require more
drugs and with careful management of pricing and reimbursement strategies,
revenue may even increase,” she says.
A key
consideration in this debate is the infertile couples themselves. For some,
the desire to conceive may be so great that they are willing to risk the
complications of a multiple pregnancy. Others will prefer the safer, faster
and less expensive mild stimulation protocol, and the ethics of removing a
patient’s choice must be considered.
In Belgium, as a
result of savings made in reducing multiple births, a reimbursement system
has been funded which allows couples six IVF/ICSI cycles in a lifetime.
Results the first year after implementation show an increase in the total
number of treatment cycles is advantageous for the industry and patients
alike.
Other market
forces
As infertility
treatment becomes more accessible, the improving success rates of IVF
treatment across key markets will continue to boost the number of cycles
initiated. As a European expert told Datamonitor: “as IVF becomes a more
standard procedure, the more confident we become that these children are
doing well, the more it will be liberally employed”.
Additionally, a
range of embryological techniques, such as in vitro maturation,
cryopreservation and microarrays are currently being refined and will
rapidly expand the treatable patient population as all women with the
intention of preserving and protecting embryos will be eligible for
treatment, not just those that are infertile, Nesbitt says. “The trend
towards later parenthood will also increase the number of women eligible for
infertility treatment.
“Given these
factors, growth of the infertility market looks certain. With careful
monitoring of the regulations called for by the HFEA, the trend towards
single births has the potential to benefit both the patient and infertility
industry while delivering the ultimate goal, a much desired, healthy child,”
she says.
Ends
Notes for editors
** the seven major
pharmaceutical markets are France, Germany, Italy, Japan, Spain, UK and US.
References
(1) Gerris, J.M.R.,
(2007) Single embryo transfer, Cape Town, Juta & Co.
Datamonitor’s
report Commercial and Pipeline Insight: Infertility - Optimizing a
market bounded by social opinion and physician preference provides
full analysis of the current and future infertility drug market, with
indication-specific forecasts to 2016 for marketed and key pipeline drugs.
Analysis is supplemented with opinion leader comment.
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