GYNAECOLOGY / INFERTILITY - National Specialist Guidelines for Investigation of Infertility Priority Criteria for Access to Public Funding of ...
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GYNAECOLOGY / INFERTILITY
National Specialist Guidelines for Investigation of Infertility
Priority Criteria for Access to
Public Funding of Infertility Treatment
In 1997/98 the publication of the National Health Committee’s consultation document
“Access to infertility services: development of priority criteria” received numerous
In 1997/98 the publication of the National Health Committee’s consultation document “Access to
public and professional submissions, almost all being in favour of the general principles
infertility services: development of priority criteria” received numerous public and professional
that fair and equitable access to publicly funded could be achieved by these criteria.
submissions, almost all being in favour of the general principles that fair and equitable access to
These criteria have been tested in at least 2 NZ tertiary centres and with minor
publicly funded treatment
modifications couldproposal
the original be achieved by these
is being criteria.
presented These
to the HFAcriteria have been
to introduce tested
to the
in at
NZleast 2 NZ
Health tertiary centres and, with minor modifications, the original proposal is being
system.
presented to the HFA to introduce to the NZ Health system.
This document is not about directing therapy. It is about guiding the evaluation of
Thisthe
document
infertile is not about
couple directing
to achieve therapy. It is
a standardised about guiding
diagnosis the providing
and then evaluationaof the infertile
rationing
basis
couple to for public
achieve access for treatment,
a standardised especially
diagnosis and usinga the
then providing assisted
rationing basisreproductive
for public access
for techniques. It is intended
treatment, especially to benefit
using the assistedthose who aretechniques.
reproductive most in need
It isfor therapy,
intended to but
benefit
balanced by a system that will ensure maximum benefit. The actual level of
those who are most in need for therapy, but balanced by a system that will ensure maximumaccess
will be dictated by the proportion of public funds available for treating infertility.
benefit. The actual level of access will be dictated by the proportion of public funds available for
Evaluation of the pilot application of these criteria for IVF funding have, however,
treating infertility. Evaluation of the pilot application of these criteria for IVF funding have, however,
confirmed the view that infertility services are severely underfunded. We see these
confirmed the view that infertility services are severely underfunded. We see these criteria as
criteria as an essential step in establishing the level of funding needed for infertility
an essential step in establishing the level of funding needed for infertility treatment and request
treatment and request that Health Practitioners, working with them, use the criteria
thatwith
Health Practitioners,
diligence working Already
and honesty. with the criteria,
the HFAusehavethem with diligence
declared and by
its support honesty. Already
providing
the significant
HFA has declared itsto
funding support
assist by
in providing significant
clearing the waiting funding to Assisted
lists for assist in clearing the waiting
Reproduction.
lists for Assisted Reproduction.
We emphasize that the application of the criteria and their weighting is just the
Webeginning.
emphasize that thecriteria
These application
needof to
these criteria andbytheir
be validated weighting
ongoing is justand
research the beginning.
public
Thediscussion.
criteria need to be validated by ongoing research and public discussion.
Wayne R Gillett,
Wayne John
R Gillett, Peek,
John July
Peek, 1999
July 1999
Version 1 Gynaecology Referral Guidelines and Priorisation Criteria • Date: 14/3/2001 • Authorised: Elective Services, HFAPAGE
PAGE 25
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GYNAECOLOGY / INFERTILITY
Section
SECTION 1I
Investigation and Diagnosis – a Standardised Approach
Investigation in Primary Care
Investigation in Primary Care
Refer to National Referral Recommendations: Gynaecology; Infertility
Refer to National Referral Recommendations: Gynaecology; Infertility
Investigation in Secondary Care
Investigation in Secondary Care
AsAs
forfor primary
primary care.InInaddition:
care. addition:
• A post–coital test may be used in the early investigation of a referred couple,
! A post–coital test may
but the results be used
should in the earlywith
be interpreted investigation of a referredofcouple,
caution. Performance but
this test is the results
not
should beessential to complete
interpreted the diagnostic
with caution. categorisation
Performance of this testofisthe
notcouple (seeto complete the
essential
diagnostic
diagnostic categories).
categorisation of the couple (see diagnostic categories).
• Screening for antisperm antibodies is not a routine test, but is suggested when
! Screening for anti-sperm antibodies is not a routine test, but is suggested when there is a
there is a history of testicular trauma or vasectomy reversal. Performance of
history of testicular trauma or vasectomy reversal. Performance of this test is not essential
this test is not essential to complete the diagnostic categorisation of the couple.
to complete the diagnostic categorisation of the couple.
• Sperm function tests and sperm assessment procedures (e.g. swim-up tests)
! Spermshould
function
nottests andinsperm
be used assessment
secondary procedures
care practice. They may(e.g.
beswim-up tests)
of value in should not be
helping
used aincouple
secondary
choosecare practice. They
an appropriate ART inmay be of level
a tertiary valueservice.
in helping a couple choose an
appropriate ART in a tertiary level service.
• A hysterosalpingogram may be used to test tubal patency. Laparoscopy is the
! gold standard test may
A hysterosalpingogram for tubo-peritoneal
be used to testdisease and is the
tubal patency. preferred method,
Laparoscopy is the gold standard
especially when evaluation of the pelvis is required. If there is a severe semen
test for tubo-peritoneal disease and is the preferred method, especially when evaluation of
defect (score of 6, see next page) then there is no need for laparoscopy unless
the pelvis is required. If there is a severe semen defect (score of 6, see next page) then
indicated for other gynaecological reasons (or following failed DI treatment).
there is no need
Furthermore forfor
laparoscopy unless
ovarian defects, indicated
a trial for other
of therapy gynaecological
is indicated reasons (or following
before laparoscopy
failed isDIconsidered.
treatment).Otherwise
Furthermore for ovarian defects, a trial of
laparoscopy should be booked within 6 monthstherapy is indicated
in the before
laparoscopy
following is considered.
circumstances:Otherwise laparoscopy should be booked within 6 months in the
following circumstances:
1. severe cyclical pain or suspected pelvic pathology
1. severe
2. cyclical
infertility pain
of 18 or suspected
months duration pelvic pathology
and where there is a female history of any
pelvic surgery, STDs or PID
2. infertility of 18 months’ duration and where there is a female history of any pelvic
3. infertility
surgery, STDs of 18
or months
PID duration and a female age ≥ 30 years of age
4. otherwise unexplained infertility ≥ 3 years duration
3. infertility of 18 months’ duration and a female age ≥ 30 years of age
5. failed DI or ovulation induction (3-6 cycles of treatment)
4. otherwise unexplained infertility ≥ 3 years duration
Diagnostic categories – to be completed at the secondary
5. failed DI or ovulation induction (3-6 cycles of treatment)
(specialist) level
The diagnostic model given here recognises the importance of the severity of a
diagnosis and
Diagnostic a combination
Categories – toofbe
infertility
completed factorsatonthe
thesecondary
probability of(specialist)
a successful level
outcome without treatment. To define the prognosis calculate the points for each
The diagnostic
diagnostic model 1,2,3,4,5
category given here
andrecognises
6. the importance of the severity of a diagnosis
and a combination of infertility factors on the probability of a successful outcome without
treatment. To define the prognosis calculate the points for each diagnostic category 1, 2, 3,
4, 5 and 6.
Version 1 Gynaecology Referral Guidelines and Priorisation Criteria • Date: 14/3/2001 • Authorised: Elective Services, HFAPAGE
PAGE 26
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GYNAECOLOGY / INFERTILITY
Patient ID: Complete patient details or place patient sticker here
Nat. Hospital No.: Consultant:
Name: D.O.B.
Name of Assessor:
Address:
Date of Assessment:
Initial Assessment
(1) Ovulation Defects Categories
From history, including amenorrhoea - any cause 6
• a plasma progesterone timed for 5-9 days before oligomenorrhoea from any cause / luteal defect 3
the next expected period. If cycle is long to be
repeated at weekly intervals until next period anovulation with normal menstrual cycle 2
• plasma FSH, LH, prolactin, thyroid function if the intermittent anovular cycles 1
cycle is prolonged and/or irregular. FSH (day 2- no ovulation defect 0
5 cycle) for older women (is measure of biological
age of ovary). SCORE 1
(2) Semen Defects Categories
Semen sample collected after 2-3 days abstinence.PAGE
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27
(4) Other Tubo-peritoneal Disease Categories
Although classification can be based on experience Proximal or distal (complete or partial) occlusion 6
of examining specialist, we encourage the use of the on best-side / severe encapsulating tubal or ovarian
American Fertility Society classification of adnexal adhesions on best-side, / missing tubes / or
adhesions (1988). In many cases the pathology may unsuccessful proximal or distal surgery after 12
be different on each side. The adnexa with the least months
pathology should be used (best side). 3
Moderate encapsulating tubal or ovarian adhesions
Surgical treatment at the time of diagnosis will be on best-side adnexa / unsuccessful surgery after 6
at the discretion of the gynaecologist conducting the months
procedure, depending on the common practice of
tubal polyps / mild encapsulating adhesions on 2
the clinic.
best-side or / normal tube on best-side with tubal
occlusion on the other-side or uterine adhesions
minimal tubal or ovarian adhesions on best-side 1
adnexa
No tubo-peritoneal pathology 0
SCORE 4
(5) Other Factors Categories
These should be classified at discretion of specialist, severe 6
e.g. psycho-sexual disorders moderate 3
fibroids
mild 2
intrauterine pathology
minimal 1
absent 0
SCORE 5
No diagnosis abnormality identified, i.e. unexpained infertility
(6) Unexplained Infertility Categories
If no diagnostic abnormality then define the duration Unexplained infertility ≥ 5 years 6
of the unexplained infertility
Unexplained infertility ≥ 4 < 5 years 3
Unexplained infertility ≥ 3 years < 4 years 2
Unexplained infertility < 3 years 1
SCORE 6
Final Score for Diagnosis
Add scores 1,2,3,4,5,6 = Score D
Version 1 Gynaecology Referral Guidelines and Priorisation Criteria • Date: 14/3/2001 • Authorised: Elective Services, HFAPAGE
PAGE 28
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GYN AE COL OGY / I N F E R T I L I T Y
SE CTION 2
Access to Publicly Funded Treatment
A
A General Principles:
General Principles:
1. Provision of basic support and guidance at the primary level should be subject to
1. Provision of basic support and guidance at the primary level should be subject to normal primary care
normal primary care charging.
charging
2. Simple ovulation induction may be managed by the GP in consultation with a specialist
2. Simple ovulation induction may be managed by the GP in consultation with a specialist service.
service.
3.3.Simple conditions
Simple requiring
conditions medical medical
requiring or psychological therapy should
or psychological be provided
therapy should within the primary
be provided within
or secondary services without need for access criteria
the primary or secondary services without need for access criteria.
3. Conditions with organic disease requiring surgery to enhance physical health (e.g. ovarian cysts,
4. Conditions with organic disease requiring surgery to enhance physical health (e.g.
endometriosis) should be subject to the same criteria as for Gynaecology access criteria
ovarian cysts, endometriosis) should be subject to the same criteria as for Gynaecology
4. Conditions that can be managed equally as well with A RT or surgery (e.g. tubal occlusion) should be
access criteria
subject to access criteria for infertility. These treatments include A IH, IV F, IV F and ICSI, DI, ovulation
5.induction
Conditions that can be managed
using gonadotrophins ( A IH). The equally
treatmentas well withper
available ART or surgery
individual (e.g.
couple tubal
should be
occlusion)
directed should in
by the specialist becharge
subject to access
of the criteria
individual for infertility.
/ couples These
infertility and treatments
in consultation include
with that
individual
AIH, /IVF,
couple.
IVFTheandcumulative
ICSI, DI, amount
ovulationof treatment
inductionavailable to people will depend
using gonadotrophins on public
(± AIH). The
funding available.
treatment available per individual couple should be directed by the specialist in charge
of the individual / couples infertility and in consultation with that individual / couple.
The cumulative amount of treatment available to people will depend on public funding
B Stepsavailable.
in defining access criteria
B 1. ESteps in defining
xclusion access
factors for criteria:
access to treatment
The first is absolute - with access refused if there are situations that compromise the safety of the couple
1.a child.
or Exclusion
However no factors
factor for
mayaccess to treatment
be used that is unlawful and that might breach the Human Rights A ct
The
or the Bill of first
Rightsis Aabsolute - withitaccess
ct. Ultimately refused
will be the doctor,ifpracticing
there areatsituations
a primary, that compromise
secondary or tertiarythe
safety
level, who of the -couple
will decide and thatordoctor
a child.
wouldHowever, no factor
need to defend this may be used that is unlawful and
decision.
that might breach the Human Rights Act or the Bill of Rights Act. Ultimately it will be
the doctor, practicing at a primary, secondary or tertiary level, who will decide - and
2. Modifying factors for access to treatment
that doctor would need to defend this decision.
These are conditions that can be modified to improve the chance of conception:
2. Hydrosalpinges
Modifying factors for access to treatment
These are conditions that
Complete distal tubal occlusion, or thecan be modified
hydrosalpinx, to improve
accumulates tubalthe chance
fluid of drain
that may conception:
into the
uterine cavity giving a detrimental effect on pregnancy rates with IV F. Depending on the severity of the
tubal
! disease, either salpingostomy or salpingectomy should be performed in women planning entry into
Hydrosalpinges
an IVF programme. The surgery should be performed by specialists trained in microsurgery or laparoscopic
Complete distal tubal occlusion, or the hydrosalpinx, accumulates tubal fluid that
surgery. Each main centre in New Zealand has such specialists.
may drain into the uterine cavity giving a detrimental effect on pregnancy rates with
Body weight
IVF. Depending on the severity of the tubal disease, either salpingostomy or
W eight improvement programmes should be instituted before treatment is begun in women who are
salpingectomy should be performed in women planning entry into an IVF programme.
outside the BM I range of 28-32. W omen with a BM I higher than 32 should be given a stand down
Theclassified
period and surgeryasshould
active be performed
review to see if by specialists
they trained
can achieve a lower inBM
microsurgery or laparoscopic
I. There are factors that limit
surgery.
the success Each
of weight main centre
improvement and,ininNew Zealand hasit such
this circumstance, specialists.
is reasonable to proceed with treatment
providing the ovarian response is closely monitored. Treatment should continue only if the response
is satisfactory.
! Body weight
Weight improvement programmes should be instituted before treatment is begun in
women who are outside the BMI range of 28-32. Women with a BMI higher than 32
should be given a stand down period and classified as active review to see if they can
achieve a lower BMI. There are factors that limit the success of weight improvement
and, in this circumstance, it is reasonable to proceed with treatment provided the
ovarian response is closely monitored. Treatment should continue only if the response
is satisfactory.
Version 1 Gynaecology Referral Guidelines and Priorisation Criteria ¥ Date: 14/3/2001 ¥ A uthorised: Elective Services, HFAPAGE 29
PAGE 29
GYNAECOLOGY / INFERTILITY
3. Calculation of the Priority Score
3. Each
Calculation of the
of the following Priority
criteria should Score
be recorded following diagnosis and request for therapy, and modified
onEach of the
an annual following
basis. criteriaJune
For example, should
1 of be recorded
each year mayfollowing diagnosis
be regarded and request
as the ‘annual’ date of for therapy
revision,
since
andnew HFA funding
modified on an rounds
annualfollow on July
basis. For1.example,
Simple spreadsheet
June 1 ofprogrammes
each yearare may available that canas
be regarded
recalculate a priority
the ‘annual’ datescore, simply by since
of revision, addingnew
a new date.funding
HFA Copy of rounds
programme available
follow from
on July 1.Wayne
SimpleGillett,
Dept. O&G PO Box 913.
spreadsheet programmes are available that can recalculate a priority score simply by adding
The final score is the product of a group of objective factors (O1 – O4) and a group of s
a new date. Copies of the programme are available from Wayne Gillett,
factors (S1 – S3). Points for each of the objective factors are directly proportional to the pregnancy rate.
Deptfor
Points O&G, PO Box factors
the subjective 913, Dunedin.
were derived from the results of questionnaires returned by health
professionals and consumers.
• The finalofscore
The age is thepartner
the female product of a group of objective factors (O1–O4) and a group of social
(subjective) factors (S1–S3). Points for each of the objective factors are directly proportional
The weighting of the points reflects the probability of conceiving with therapy..
to the pregnancy rate. Points for the subjective factors were derived from the results of
• The prognosis of conceiving without treatment
questionnaires returned by health professionals and consumers.
See section I for calculation of diagnostic scores.
If Score
! DThe
=6 age then prognosis
of the female 50% probability of conception in 1 year
See Section 1 for calculation of diagnostic scores.
The weighting of these points reflect the inverse relationship of the likelihood of conceiving
If Score D = 6 then prognosis < 5% probability of conception in 1 year
• The basal plasma FSH
If score D = 3 < 6 then prognosis 6-20 % probability of conception in 1 year
Ovarian reserve is commonly measured by basal FSH levels between days 2-5 of the menstrual cycle.
If Score D = 2 < 3 then prognosis 21-50% probability of conception in 1 year
The normal range will depend on the local assay. The weighting of points reflect the chance of conceiving.
If Score D < 2 then prognosisthe
If donor oocytes are used in an IVF programme, >50% probability
donor’s of conception
FSH level should in 1 FSH
be measured. yearshould
be measured within 6 months before the first planned ART cycle, and repeated at least every 6 months.
The normal
The value beof≤ these
weighting 12 IU; borderline be >12≤15;
points reflects and abnormal
the inverse be >15. of the likelihood of
relationship
• conceiving
A history of current smoking in female partner
The point system reflects the relative risk on pregnancy outcome of smoking.
!
Although The basal
this will plasma
become FSHfactor we envisage most women, by stopping smoking, will increase
a priority
Ovarian
their priorityreserve is commonly
points after 6 months andmeasured by basal
improve their FSH
eligibility levels between
depending days 2-5
on the threshold forof the
access
to menstrual
treatment. We believe every effort should be made by women seeking any form of fertility
cycle. The normal range will depend on the local assay. The weighting of points treatment
to reflects
give up smoking. Duration
the chance of smoke freeIfto
of conceiving. be three
donor months
oocytes and
are no cigarettes
used in an IVFat programme,
all. the
• DurationFSH
donor’s of infertility
level should be measured. The best or lowest FSH in the last 6 months should
Thebepoints
the figure used.
given here AntoFSH
relate howin the range
people of 11-15
feel about is a modifying
the burden factorofand
of the duration an FSH
infertility, of
rather
than how it affects the chance of pregnancy.
greater than 15 is an exclusion factor. The duration of infertility to cumulative of previous and
current relationships. For single women or lesbians it will be on the basis of either biological infertility
or in the case or unexplained infertility to be confirmed by 12 cycles of DI of which 6 should be within
an ! A history
accredited of current smoking in female partner
RTAC unit.
•
The points system reflects the relative risk on pregnancy outcome of smoking.
Number of children
Although this will become a priority factor we envisage that most women, by stopping
A child may include an adopted child. These are children currently living with the couple or person.
smoking, will increase their priority points after 6 months and improve their eligibility
• Previous sterilisation
depending on the threshold for access to treatment. We believe that every effort should
The
bepoints
made given here recognise
by women the any
seeking burden of some
form people
of fertility never having
treatment had children,
to give or theNote:
up smoking. burdenthe
of
having lost a child (children) by death.
duration of the smoke-free period is to be 3 months with no cigarettes at all and with the
male partner counselled as the effect of his smoking.
Version 1 Gynaecology Referral Guidelines and Priorisation Criteria • Date: 14/3/2001 • Authorised: Elective Services, HFAPAGE 30
PAGE 29
GYNAECOLOGY / INFERTILITY
3. Calculation of the Priority Score
! of the
Each Duration
following of infertility
criteria should be recorded following diagnosis and request for therapy, and modified
on The pointsbasis.
an annual givenForhere relateJune
example, to how
1 of people feel
each year mayabout the burden
be regarded as theof‘annual’
the duration
date ofofrevision,
infertility,
since new than
rather HFA funding
how it rounds
affectsfollow on July 1.
the chance of Simple spreadsheet
pregnancy. programmes
The duration are available
of infertility that
is to becan
recalculate
cumulative of previous and current relationships. For single women or lesbians it willGillett,
a priority score, simply by adding a new date. Copy of programme available from Wayne be on
Dept. O&G PO Box 913.
the basis of unexplained infertility to be confirmed by 12 cycles of DI of which 6 should be
The final score is the product of a group of objective factors (O1 – O4) and a group of social (subjective)
within an accredited RTAC unit.
factors (S1 – S3). Points for each of the objective factors are directly proportional to the pregnancy rate.
Points for the subjective factors were derived from the results of questionnaires returned by health
! Number
professionals of children
and consumers.
• This is defined
The age as children
of the female partner currently living with the couple or person. Children living at
home is defined as children under the age of 12 who have lived with the couple for most
The weighting of the points reflects the probability of conceiving with therapy..
or all of the child’s life. A child may include an adopted child.
• The prognosis of conceiving without treatment
See section I for calculation of diagnostic scores.
! Previous sterilisation
If Score
Points =given
D 6 thenrecognise
here prognosis 12≤15; and abnormal be >15.
• A history of current smoking in female partner
The point system reflects the relative risk on pregnancy outcome of smoking.
Although this will become a priority factor we envisage most women, by stopping smoking, will increase
their priority points after 6 months and improve their eligibility depending on the threshold for access
to treatment. We believe every effort should be made by women seeking any form of fertility treatment
to give up smoking. Duration of smoke free to be three months and no cigarettes at all.
• Duration of infertility
The points given here relate to how people feel about the burden of the duration of infertility, rather
than how it affects the chance of pregnancy. The duration of infertility to cumulative of previous and
current relationships. For single women or lesbians it will be on the basis of either biological infertility
or in the case or unexplained infertility to be confirmed by 12 cycles of DI of which 6 should be within
an accredited RTAC unit.
• Number of children
A child may include an adopted child. These are children currently living with the couple or person.
• Previous sterilisation
The points given here recognise the burden of some people never having had children, or the burden of
having lost a child (children) by death.
Version 1 Gynaecology Referral Guidelines and Priorisation Criteria • Date: 14/3/2001 • Authorised: Elective Services, HFAPAGE
PAGE 31
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GYNAECOLOGY / INFERTILITY
National Clinical Assessment Criteria (CPAC) for Treatment
of Infertility
Patient ID: Complete patient details or place patient sticker here
Nat. Hospital No.: Consultant:
Name: D.O.B.
Name of Assessor:
Address:
Date of Assessment:
Calculation of priority criteria points for publicly-funded infertility treatment
Criteria Points
symbol Points awarded Criteria and their categories available
≤ 5% 10
Chance of pregnancy 6-20% 7
O1 without treatment 21-50% 4
>50% 2
≤ 39 years 10
O2 Woman’s age 40-41 5
42+ 1
always within 10
Basal FSH, day 2-5 cycle, with
O3 respect to reference range
sometimes above
mostly/always above
8
2
non smoker 10
O4 Woman’s smoking
smoker 6
Multiply O1 x O2 x O3 x O4 = OC (points from objective criteria)
OC ROC
= Now divide OC by 10000 = Revised OC (ROC)
< 1 year 5
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