Evidence submitted by the National Infertility
Awareness Campaign (NICE 44)
EXECUTIVE SUMMARY
NICE fertility guideline
1. NIAC welcomed the publication in February
2004 of a clinical guideline by NICE which aimed to address the
inequalities in access to NHS funded treatment for infertility
by setting a national standard of service that all patients should
expect to receive across England and Wales. [101]Amongst
other recommendations, the guideline stated that three full cycles
of in vitro fertilisation (IVF) should be made available
on the NHS to all those meeting agreed clinical criteria. On its
publication, the then Secretary of State for Health, Rt Hon Dr
John Reid MP, asked Primary Care Trusts (PCTs) to make at least
one full cycle of IVF available to all those eligible by April
2005, with the expectation of progress being made towards full
implementation of the guidance in the longer term. [102]It
was the first time that Government had issued such an announcement
on the implementation of a NICE guideline.
Implementation of NICE fertility guideline
2. In March 2005, NIAC conducted a survey
of PCTs in partnership with the All Party Parliamentary Group
on Infertility to assess progress being made across England towards
implementing the NICE guideline and meeting the April 2005 deadline.
[103]The
results showed that significant inequalities in access to NHS
funding continued to exist, including wide variations in the eligibility
criteria set by individual PCTs. Since then, NIAC has also been
made aware of a number of PCTs that have decided to reduce or
suspend funding for infertility treatment altogether.
Central guidance to PCTs
3. In Scotland, Wales and Northern Ireland,
guidance on the provision of NHS funded infertility treatment
was accompanied by centrally set eligibility criteria. NIAC welcomed
these efforts to ensure that patients received equal access to
treatment, regardless of where they lived. However, in England,
PCTs are able to set their own eligibility criteria for access
to NHS funding, over and above the clinical criteria recommended
in the NICE guideline. This has perpetuated the inequality of
access and NIAC would call on the Government to set the criteria
centrally in order to remove this unfairness.
Single Embryo Transfer
4. A potential move towards single embryo
transfer (SET) has now made full implementation of the NICE guideline
of paramount importance, both in terms of funding the three full
cycles of IVF that NICE recommended, and in ensuring they are
funded as quickly as possible. In October 2006, an independent
expert group set up by the Human Fertilisation and Embryology
Authority (HFEA) to look at reducing the number of multiple births
from IVF, recommended the introduction of SET. [104]However,
they also concluded that failure to implement the NICE guideline
was the single greatest obstacle to its introduction in the UK.
NIAC would welcome a move towards SET for appropriate patients,
but would call on the Government to issue a clear direction to
PCTs to implement the NICE guideline in full as quickly as possible
and ensure that three full cycles of IVF include both fresh and
frozen embryo transfers.
KEY POINTS
Why NICE's decisions are increasingly being challenged
5. The publication in February 2004 of a
clinical guideline by NICE on assessment and treatment for people
with fertility problems aimed to address the inequalities in access
to NHS funded infertility treatment that existed across England
and Wales. [105]Amongst
other recommendations covering a full range of infertility treatments,
the guideline stated that three full cycles should be made available
on the NHS to all those meeting agreed clinical criteria.
6. On its publication, the then Secretary
of State for Health, Rt. Hon Dr John Reid MP, asked PCTs to make
at least one full cycle of IVF available to all those eligible
by April 2005 with the expectation of progress being made towards
full implementation of the guidance in the longer term. [106]It
was the first time that Government had issued such an announcement
on the implementation of a NICE guideline. At the same time, the
Welsh Assembly Government also announced that one cycle of IVF
would be made available to eligible patients in Wales by April
2005. [107]
7. However, unlike technology appraisals,
it is not mandatory for NICE clinical guidelines to be implemented
by PCTs. In the case of the fertility guideline, this means that
it is up to individual PCTs to prioritise the commissioning of
infertility services for their population, alongside a range of
competing health needs.
8. NIAC is concerned that in some cases,
the low prioritisation of infertility, coupled with PCT deficits,
have led to a lack of progress in implementing the guideline.
Yet it is important to note that the NICE guideline defines infertility
as a disease process worthy of investigation and treatment. [108]It
is crucial that PCTs recognise the status of infertility as a
disease and prioritise the implementation of the NICE guideline
accordingly, in order to ensure patients have access to the treatment
they were promised.
9. Furthermore, the publication of the NICE
guideline was met with some concern in the media that it would
be very costly for PCTs to implement and possibly divert resources
away from other health needs.
10. To coincide with the publication of
the guideline, the All Party Parliamentary Group on Infertility
(APPGI) published a report looking at the structures needed to
implement the guideline on the NHS in the most cost-effective
way. The report recommended that considerable cost savings could
be made in implementing the guideline if services were commissioned
effectively and unnecessary or inappropriate investigations and
treatment were avoided. [109]
Whether public confidence in the Institute is
waning
11. When the Government first referred infertility
treatment to NICE, it was with the aim of helping to "ensure
that in future, infertile couples get fairer, faster access to
clinically, cost effective and appropriate treatments".[110]
It is fair to say therefore, that patients' expectations around
the publication of the guideline were high, and that these expectations
were raised further upon publication of the guideline when the
former Secretary of State called for at least one full cycle to
be funded by April 2005. The Prime Minister too announced that
he hoped to see over the next couple of years "at least very
substantial progress towards implementation of the full NICE guidelines".[111]
12. However, three years' on from its publication,
and PCTs are still far from implementing the guideline in full
and, in some cases, are even failing to meet the one cycle called
for by the Government. It is therefore understandable that patients
and health professionals might start to lose confidence in the
NICE guideline's ability to overcome the inequalities in access
to NHS funded infertility treatment that it was intended to achieve.
13. Moreover, the 2005 PCT survey showed
that the PCTs that were funding infertility treatment were interpreting
NICE's own recommendations in different ways. [112]For
example, a number were setting their own female age ranges outside
the 23-39 range recommended by NICE. NIAC is also concerned that
some PCTs may not be clear as to the definition of a full cycle
of IVF, which should include both fresh and frozen embryo cycles.
[113]
14. In Scotland, Wales and Northern Ireland,
guidance on the provision of NHS funded infertility treatment
was accompanied by centrally set eligibility criteria. NIAC welcomed
these efforts to ensure that patients received equal access to
treatment, regardless of where they lived.
15. However, in England, PCTs are able to
set their own eligibility criteria for access to NHS funding,
as well as prioritise whether to fund at all. This has perpetuated
the inequality of access and NIAC would call on the Government
to issue central guidance to PCTs on the number of cycles that
should be provided and the eligibility criteria to access those
cycles. In fact, NICE itself commented in a press release issued
at the time of the guideline's publication, that:
"A consistent approach by the NHS to the
treatment of fertility problems is long overdue... We have therefore
suggested to the Department of Health that they consider giving
advice to NHS organisations on how they should approach putting
our recommendations into practise." [114]
16. Last year, the British Fertility Society
issued a number of recommendations on national eligibility criteria
for NHS funding and implementation of the NICE Guideline. They
were supported by NIAC as a means of providing a framework for
centrally set criteria that could be applied to patients across
England, regardless of where they lived. [115]
The implementation of NICE guidance
17. In March 2005, NIAC conducted a survey
of PCTs in partnership with the All Party Parliamentary Group
on Infertility to assess progress being made across England towards
implementing the NICE guideline and meeting the April 2005 deadline.
[116]The
results showed that significant inequalities in access to NHS
funding continued to exist, including wide variations in the eligibility
criteria set by individual PCTs and the fact that some PCTs were
funding nothing.
18. They also highlighted unacceptably long
waiting lists in some parts of the country and evidence that some
PCTs were intending to reduce the current number of cycles they
funded down to one, where they were previously funding more than
one. Since then, NIAC has also been made aware of a number of
PCTs that were funding treatment, but have subsequently decided
to reduce or suspend it altogether.
19. Unfortunately, patients have little
recourse available to them if their PCT decides not to implement
the NICE guideline, as it is not mandatory. However, the Government
has made a clear statement of its expectations with regard to
meeting NICE's recommendations and PCTs should be showing progress
towards achieving them. It is therefore important not only for
the Government to take action to ensure that progress is made,
but also for PCTs to be involving both patients and clinicians
in the decision-making process when allocating resources for local
services.
20. A potential move towards single embryo
transfer (SET) has now made full implementation of the NICE guideline
of paramount importance, both in terms of funding the three full
cycles of IVF that NICE recommended, and in ensuring they are
funded as quickly as possible. In October 2006, an independent
expert group set up by the Human Fertilisation and Embryology
Authority (HFEA) to look at reducing the number of multiple births
from IVF, recommended the introduction of SET. [117]However,
they also concluded that failure to implement the NICE guideline
was the single greatest obstacle to its introduction in the UK.
RECOMMENDATIONS
21. It is incredibly frustrating for the
one in seven couples affected by difficulties in conceiving that
more than three years after the publication of the NICE fertility
guideline, huge inequalities in access to NHS funded treatment
continue to exist. This is not what patients were promised and
many feel let down. They want to see the NICE guideline fully,
not geographically, implemented.
22. NIAC remains committed to raising awareness
of the need for the Government to take action to address these
areas of concern. It therefore calls for a clear direction to
be issued to PCTs to implement the NICE guideline in full, ensuring
that a full cycle of IVF includes the transfer of both fresh and
frozen embryos.
Clare Brown
Chair, National Infertility Awareness Campaign
March 2007
101 Department of Health press release, Working
Towards Ending The Postcode Lottery Of Infertility Treatment,
30 November 2000. Back
102
Department of Health press release, Health Secretary welcomes
new fertility guidance, 25 February 2004. Back
103
NIAC/All Party Parliamentary Group on Infertility PCT Survey,
March 2005. Back
104
Expert Group on Multiple Births after IVF, One child at a time,
October 2006. Back
105
Department of Health press release, Working Towards Ending
The Postcode Lottery Of Infertility Treatment, 30 November
2000. Back
106
Department of Health press release, Health Secretary welcomes
new fertility guidance, 25 February 2004. Back
107
Welsh Assembly Government press release 2004. Back
108
NICE Fertility Guideline, February 2004. Back
109
All Party Parliamentary Group on Infertility, February 2004. Back
110
Department of Health press release, Working Towards Ending
The Postcode Lottery Of Infertility Treatment, 30 November
2000. Back
111
Prime Minister's Questions, 25 February 2004. Back
112
NIAC/All Party Parliamentary Group on Infertility PCT Survey,
March 2005. Back
113
NICE Fertility Guideline, February 2004. Back
114
NICE press release, New NHS guidelines on fertility treatment,
25 February 2004. Back
115
Implementation of the NICE Guideline-Recommendations from the
British Fertility Society for National Criteria for NHS funding
of assisted conception; R Kennedy, C Kingsland, A Rutherford,
M Hamilton, W Ledger, August 2006. Back
116
NIAC/All Party Parliamentary Group on Infertility PCT Survey,
March 2005. Back
117
Expert Group on Multiple Births after IVF, One child at a time,
October 2006. Back
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