Docstoc

NORCOM COMMISSIONING POLICY

Document Sample
NORCOM COMMISSIONING POLICY Powered By Docstoc
					NORCOM IVF ICSI IUI Eligibility Criteria




 NORCOM COMMISSIONING POLICY

     North Derbyshire, South Yorkshire and Bassetlaw
               Commissioning Consortium
  NHS Eligibility Criteria for In vitro fertilisation (IVF) Intracytoplasmic
 sperm injection (ICSI) and Intra-uterine insemination (IUI) treatment for
    people with infertility in North Derbyshire, South Yorkshire and
                     Bassetlaw Primary Care Trusts.


Completed:             November 04
Effective date:        1 April 2005
Reviewed October 2005:
                                               Extended to 31 March 2006
                                               (11 November 2005 NORCOM meeting)
Reviewed January 2006: Extended to 31 March 2007
                                               (10 February 2006 NORCOM meeting)
Reviewed January 2007: Extended to 31 March 2008
                                               (12 January 2007 NORCOM meeting)
Reviewed March 2008                            Extended to 30 September
                                               2008
                                               (14 March 2008 Y&H SCG South
                                               meeting)
Reviewed September                             Extended to 31 March 2009
2008                                           (12 September 2008 Y&H SCG South
                                               meeting)
Reviewed January 2009                          Updated and Extended to 31
                                               March 2010
                                               (9 January 2009 Y&H SCG South
                                               meeting)

Originally prepared by Rotherham PCT on behalf of North
Derbyshire, South Yorkshire and Bassetlaw Commissioning
Consortium (NORCOM). Updated by the SCT on behalf of
Rotherham, Sheffield, Doncaster and Barnsley PCTs.




D:\Docstoc\Working\pdf\ae26d5a9-086f-43d7-86a9-38bc5d9b2c20.doc                    -1-
NORCOM IVF ICSI IUI Eligibility Criteria




Introduction
This paper sets out the criteria for access to NHS funded specialist fertility
services for patients who are the responsibility of the 4 PCTs covered by the
South Yorkshire Commissioning Consortium (SCG South).

It sets out the minimum entitlement for NHS funding of In vitro fertilisation

(IVF) Intracytoplasmic sperm injection (ICSI) and Intra-uterine insemination

(IUI) across the consortium.




There are currently differences between the PCTs in respect of existing

specialist fertility treatment policies. Phased introduction will be required to

bring all health communities up to a common policy. It is envisaged that each

PCT will adopt at least the minimum eligibility criteria. It is not intended that

any PCT or health community adopt a more restrictive policy than their current

policy.


Initial investigation of patients is usually carried out by a network of specialist
gynaecologists at District General Hospitals throughout the SCG South area.

In any healthcare system there are limits set on what is available and on what

people can expect.               Primary Care Trusts (PCT‟s) are required to achieve

financial balance; they have a complex task in balancing this with individuals‟

rights to health care. It is the purpose of the criteria set out here to make the

limits on fertility treatment fair, clear and explicit. Nationally this is undertaken

through the work of the National Institute for Clinical Excellence (NICE) and

this paper reflects this. The paper should be read in conjunction with the NICE

Fertility Guidance available on their web site at www.nice.org.uk-pdf-




D:\Docstoc\Working\pdf\ae26d5a9-086f-43d7-86a9-38bc5d9b2c20.doc                   -2-
NORCOM IVF ICSI IUI Eligibility Criteria




CG011niceguideline.pdf.url (for ease of reference the NICE Guidance practice

algorithms are included as part of this document at Appendix C).


The NICE Guidance places NHS assisted fertility services firmly in the

mainstream of NHS provision. Patients as a result will expect the NHS to

provide this. This document includes recommendations for the first part of the

phased introduction of the Guidance. Further phases of the implementation

will be defined in the light of future Department of Health requirements and

the prioritisation and availability of resources.




EXCEPTIONAL CIRCUMSTANCES




Each PCT in SCG South has a procedure for dealing with patients who

consider themselves exceptions to these criteria.                 These patients may

approach their PCT or General Practitioner who will be aware of these

arrangements.




Abbreviations used in the document are explained in Appendix A.




Definitions of technical terms are contained in Appendix B.




D:\Docstoc\Working\pdf\ae26d5a9-086f-43d7-86a9-38bc5d9b2c20.doc                  -3-
NORCOM IVF ICSI IUI Eligibility Criteria




Eligibility Criteria

     1. Availability of In vitro fertilisation (IVF), Intracytoplasmic sperm
                                  injection (ICSI)

Couples suffering from infertility will be eligible for IVF and ICSI. Infertility is
the failure to conceive after regular unprotected sexual intercourse for 2
years. Where there is clear reproductive pathology, couples with infertility of
any duration will be considered. This will include couples who cannot achieve
full sexual intercourse due to disability.

To achieve full compliance with the NICE Guidance an increase in the
availability of IVF and ICSI will require phased introduction.

No element of surrogacy related infertility treatment will be eligible for NHS
funding.

Any cycle of infertility treatment whether self or NHS funded will be taken into
account when determining NHS funding entitlement.


Initial Phase

All women aged 23 to 39 who meet the NORCOM eligibility criteria will be
offered a minimum of one full cycle of IVF. This includes ovarian stimulation,
egg recovery, embryo transfer and frozen embryo transfers until all frozen
embryos are used.

Couples who have a definitively diagnosed cause of their infertility of any
duration, or unexplained infertility of at least three years duration, and where
the woman‟s age is 39 years and 364 days or less should be offered one
complete full cycle. Unexplained infertility includes mild endometriosis and
mild semen abnormality. One complete full cycle of IVF is ovarian stimulation,
egg recovery and embryo transfer and frozen embryo transfers.

Where frozen embryos are available they should be transferred before the
next stimulated treatment cycle.




D:\Docstoc\Working\pdf\ae26d5a9-086f-43d7-86a9-38bc5d9b2c20.doc                  -4-
NORCOM IVF ICSI IUI Eligibility Criteria




                                           2. Existing Children

Only couples with no children (including adopted children) living with them1,
who fulfil all other criteria, will be eligible.

In the interests of welfare of the child where a previous child has been taken
into care as a result of child protection procedures and is not living with that
parent then that parent will not be eligible.

                                             3. Female age

Assisted reproductive technology will be available to women aged 23 to 39
years and 364 days at the start of a treatment cycle. A treatment cycle begins
with the administration of drugs for IVF, IUI and hormone replacement
treatment.

1st definitive treatment within specialist fertility services should commence
within 18 weeks of the referral into tertiary care. Where further tertiary
treatment is required, this should be completed within 18 weeks of the
decision to treat (Scenarios enclosed in Appendix D). Once treatment is
started a woman will be entitled to one full cycle even if they reach age 40
during treatment. All treatment will cease by the woman‟s 42 nd birthday.


4. Male age

Assisted reproductive technology will be available to men aged less than 55
years and 0 days at the start of a treatment cycle.
             5. Availability of Intrauterine Insemination (IUI)

Couples who fail to conceive after 2 years unprotected sexual intercourse and
fulfill the eligibility criteria for IVF may be offered intrauterine insemination if
clinically appropriate.

Couples will normally be offered no more than 6 IUI treatments.

COUPLES WHO DO NOT CONCEIVE AFTER IUI WILL HAVE A FULL
ENTITLEMENT TO IVF IN LINE WITH THE STATED ELIGIBILITY
CRITERIA.


11
  The definition of “living with” should be interpreted in consistence with the Community Charge
Benefits (General) Regulation 1989, which states that,
           (2) Where a child or young person spends equal amounts of time in different households, or
          where there is a question as to which household he is living in, the child or young person shall
          be treated for the purposes of paragraph (1) as normally living with-
                    (a) the person who is receiving child benefit in respect of him; or
                    (b) if there is no such person-
                               (i) where only one claim for child benefit has been made in respect of him,
                              the person who made that claim, or
                               (ii) in any other case the person who has the primary responsibility for him.




D:\Docstoc\Working\pdf\ae26d5a9-086f-43d7-86a9-38bc5d9b2c20.doc                                          -5-
NORCOM IVF ICSI IUI Eligibility Criteria




6. Obesity

Women with a body mass index of more than 29.99 before starting a course
of IVF ICSI or IUI will not be eligible.

Women with a body mass index of more than 29 are likely to take longer to
conceive.

7. Low Weight

Women with a body mass index of less than 19.0 before starting a course of
IVF ICSI or IUI will not be eligible.

Women with a body mass index of less than 19 are less likely to conceive.




8. Donor Sperm

This will be funded only where the male has azospermia or severe

oligospermia or to avoid transmission of inherited disorders to a child where

the couple meet the other eligibility criteria.




This would mean up to 4 cycles of donor insemination. In addition IUI if

required and in addition IVF entitlement if required.


9. Donor Egg

This will be available to women who have undergone premature ovarian

failure due to an identifiable pathological or iatrogenic cause before the age of

40 or to avoid transmission of inherited disorders to a child where the couple

meet the other eligibility criteria.


10. Egg and Sperm Storage




D:\Docstoc\Working\pdf\ae26d5a9-086f-43d7-86a9-38bc5d9b2c20.doc                 -6-
NORCOM IVF ICSI IUI Eligibility Criteria




Egg and Sperm will be stored according to HFEA Guidance. This includes

freezing of sperm for patients undergoing chemotherapy and radiotherapy.

Patients whose sperm has been frozen prior to chemotherapy or radiotherapy

will be entitled to NHS funded infertility treatment provided they meet the

eligibility criteria.


11. Sterilisation

Couples where one or both partners have been sterilised will not be eligible
for treatment.

12. Review

These treatment criteria were reviewed in October 2005, January 2006,
January 2007, March 2008, September 2008 and January 2008. The
treatment criteria will be reviewed again as part of a full review of fertility
commissioning policy across Yorkshire and The Humber during 2009/10.

13. Future Phasing

Further phases of the implementation of the NICE Guidance will be defined in
the light of future Department of Health requirements and the prioritisation and
availability of resources.

27 October 2004 – Updated 9 January 2008




D:\Docstoc\Working\pdf\ae26d5a9-086f-43d7-86a9-38bc5d9b2c20.doc               -7-
NORCOM IVF ICSI IUI Eligibility Criteria




                                                                               Appendix A

Abbreviations used



                                                     Body Mass Index
BMI
DI                                                   Donor Insemination

GP                                                   General Practitioner

HFEA                                                 Human Fertilisation and

                                                     Embryology Authority

ICSI                                                 Intracytoplasmic sperm injection

IUI                                                  Intra-uterine insemination

IVF                                                  In vitro fertilisation

NICE                                                 National Institute of Clinical

                                                     Excellence

                                                     Primary Care Trust
PCT




D:\Docstoc\Working\pdf\ae26d5a9-086f-43d7-86a9-38bc5d9b2c20.doc                         -8-
NORCOM IVF ICSI IUI Eligibility Criteria




                                                                                         Appendix B


Definitions


Term        Definition                                             Further information

BMI         The healthy weight range is based                     BBC Healthy Living
            on a measurement known as the                         http://www.bbc.co.uk
            Body Mass Index (BMI). This can
            be determined if you know your                        NHS Direct
            weight and your height.       This                    http://www.nhsdirect.nhs.uk
            calculated as your weight in
            kilograms divided by the square of
            your height in metres. In England,
            people with a body mass index
            between 25 and 30 are categorised
            as overweight, and those with an
            index above 30 are categorised as
            obese.

ICSI        Intra Cytoplasmic Sperm Injection                     Glossary, HFEA
            (ICSI): Where a single sperm is                       http://www.hfea.gov.uk
            directly injected into the egg.

IUI         Intra Uterine Insemination (IUI):                     As above
            Insemination of sperm into the
            uterus of a woman.

IVF         In Vitro Fertilisation (IVF): Patient's As above
            eggs and her partner's sperm are
            collected and mixed together in a
            laboratory to achieve fertilisation
            outside the body. The embryos
            produced may then be transferred
            into the female patient.

DI          Donor Insemination (DI): The                          As above
            introduction of donor sperm into the
            vagina, the cervix or womb itself.




D:\Docstoc\Working\pdf\ae26d5a9-086f-43d7-86a9-38bc5d9b2c20.doc                                 -9-
NORCOM IVF ICSI IUI Eligibility Criteria

                                                                           Appendix C




D:\Docstoc\Working\pdf\ae26d5a9-086f-43d7-86a9-38bc5d9b2c20.doc   - 10 -
NORCOM IVF ICSI IUI Eligibility Criteria




D:\Docstoc\Working\pdf\ae26d5a9-086f-43d7-86a9-38bc5d9b2c20.doc   - 11 -
NORCOM IVF ICSI IUI Eligibility Criteria


                                                                                      Appendix D


www.18weeks.nhs.uk

                            Scenarios to accompany the
                      18 Weeks Fertility Commissioning Pathway

 The scenarios in this document should be read to aid understanding of
the application of 18 Weeks rules to the fertility commissioning pathway.
     This should be read in conjunction with local guidelines for the
                    commissioning of fertility services.

Scenario 1
GP refers a couple, both under 35 years old, for investigations into infertility of
three years standing, after performing baseline investigations. The semen
analysis is abnormal.
Consultant repeats the semen analysis in 3 months time for clinical reasons.
Outcome A: repeat sample is abnormal, decision to treat with IVF/ICSI
Outcome B: repeat semen analysis normal, further investigations confirm
“unexplained” fertility.

Answers
Clock start on receipt of referral (or conversion of UBRN if via Choose and
Book)
Clock stop for “active monitoring” on date seen in outpatients where the
decision to repeat the semen analysis in 3 month is made (as per NICE
guidelines).
Outcome A: New clock start at Decision to Treat with IVF/ICSI.
Outcome B: New clock start at decision to undertake further investigations.


Scenario 2
Couple have been trying to conceive for 12 months, GP sends into secondary
care after completing baseline investigations – all normal.
Couple seen by Consultant in secondary care, where following further
investigations no reason for their infertility can be found.
Consultant sends couple back to GP and advises referral after a further 12
months trying to conceive naturally (as per PCT guidelines)

Answer
Clock starts on receipt of referral in secondary care, or UBRN conversion, and
stops:
• For „no treatment‟ at referral back to GP
• If the couple are being referred for counselling or other support in
secondary care then the clock stops at the first counselling (or other)
appointment

Scenario 3
GP refers a couple to secondary care after preliminary investigations for
D:\Docstoc\Working\pdf\ae26d5a9-086f-43d7-86a9-38bc5d9b2c20.doc                        12
NORCOM IVF ICSI IUI Eligibility Criteria
infertility. Investigations in secondary care confirm tubal disease and a
referral is made to tertiary care to consider IVF. In tertiary care a baseline
scan demonstrates what appears to be a hydrosalpinx. A laparoscopy
confirms the hydrosalpinx, which is surgically removed, and a few weeks later
the patient commences treatment with IVF.

Answer
Clock starts on receipt of referral in secondary care and stops at the removal
of the hydrosalpinx, as this is the start of the definitive treatment process.
Providers must ensure that systems are in place to protect the patient toensure there is no undue capacity
and/ or funding related delay before she commences IVF treatment.


Scenario 4
GP refers a couple for investigation for infertility after completing preliminary
tests as per local protocol. Further investigations in secondary care indicate
polycystic ovaries with anovulation. Both fallopian tubes are patent. Ovulation
induction therapy commences with clomifene, monitored by ultrasound, but is
unsuccessful, despite increasing the dose of clomifene. Gonadotropin therapy
is successful in inducing ovulation, but there is no conception after 6 cycles.
Consultant in secondary care refers couple for IVF. Couple seen in tertiary
care and counselled about the procedures and risks of IVF.
Outcome A: Couple wish to proceed immediately with treatment and
treatment starts during the next menstrual cycle
Outcome B: Couple wish to proceed immediately with treatment but the trust
that cannot start treatment for 6 months due to capacity restraints
Outcome C: Couple wish to have time to consider their options for a week
before proceeding with treatment

Answer
Clock starts on receipt of referral in secondary care, or conversion of UBRN,
and stops at the start of treatment with clomifene.
A new clock starts upon receipt of the referral / conversion of UBRN for IVF
and stops or continues in the examples:
Outcome A: Clock stops using active monitoring at the DTT. Due to the
different types of treatment available and the variation of menstrual cycle and
treatment start dates within the cycle, treatment can very often not start
immediately.
Outcome B: The clock keeps ticking as use of active monitoring to stop the
clock where there are capacity (or funding) restraints is inappropriate.
Outcome C: There is difference between wanting time to think (not a clock
stop), and taking an active decision to delay (patient initiated active
monitoring). The default position is that the clock should continue but that
local access policies may, with agreement of the patients, stop the clock as
patient initiated active monitoring should they wish to take longer than the
amount of time agreed in the local policy.
Therefore, in outcome C, the clock continues. Had the couple wanted to delay
for longer, then Patient Initiated Active Monitoring could be applied.

Scenario 5
A couple present in primary care with a failure to conceive after one year of
unprotected intercourse. Preliminary investigations demonstrate the man has
azoospermia. GP refers the couple direct to tertiary care. Further
investigations indicate obstructive azoospermia is the likely diagnosis. The

D:\Docstoc\Working\pdf\ae26d5a9-086f-43d7-86a9-38bc5d9b2c20.doc                              13
NORCOM IVF ICSI IUI Eligibility Criteria
man is offered a diagnostic surgical sperm retrieval (SSR) with a view to
freezing recovered sperm.
Outcome A: IVF/ICSI offered when sperm successfully recovered
Outcome B: Further investigations confirm the man has congenital absence of
the vas deferens due to a cystic fibrosis mutation. His partner is screened and
the couple are referred for genetic counselling.

Answer
Clock starts on receipt of referral in tertiary care/conversion UBRN.
Outcome A: First clock stops at the offer of IVF/ICSI after SSR if clinically
appropriate (as per scenario 4).
Outcome B: Clock stops at commencement of genetic counselling, and
IVF/ICSI commences when patient willing and able with a new clock start.

Scenario 6
GP refers to secondary care for investigation into infertility.
Secondary care performs a diagnostic HSG, which is inconclusive.
Outcome A: A diagnostic and operative laparoscopy confirms bilateral tubal
occlusion not suitable for surgery and the patient is referred for IVF.
Outcome B: A diagnostic and operative laparoscopy confirms peritubal
adhesions that are divided restoring patency. Patient is advised to continue to
try and get pregnant during an agreed time period. Patient returns to hospital
at the end of this given time period after failing to conceive, and is referred to
specialist centre to consider IVF treatment.

Answer
Clock starts on receipt of referral in secondary care/conversion of UBRN.
Outcome A: If patency is not restored during the laparoscopy then clock
continues ticking with the referral to specialist centre for IVF
Outcome B: Where tubal patency restored, pregnancy might occur naturally,
therefore the clock stop is after the laparoscopy using active monitoring. If no
conception within agreed time period receipt of referral for IVF starts a second
clock.

Scenario 7
GP refers couple with two years of primary infertility to infertility clinic in
secondary care after completing preliminary investigations. The patient‟s
history and examination suggest endometriosis. At laparoscopy the diagnosis
of endometriosis is confirmed (ASRM grade II disease), and all visible lesions
are treated by diathermy. The couple are asked to try to conceive naturally for
nine months. After nine months, the couple return to clinic as the woman has
not conceived. Consultant refers to tertiary care for consideration of IVF.

Answer
First clock starts when referral received/UBRN converted and stops when
woman has a diagnostic and treatment laparoscopy.
Second clock starts when referral received/UBRN converted requesting
supraspecialist treatment of infertility.



Scenario 8
GP refers couple with two years of primary infertility to infertility clinic in
secondary care after completing preliminary investigations. The patient‟s
D:\Docstoc\Working\pdf\ae26d5a9-086f-43d7-86a9-38bc5d9b2c20.doc                      14
NORCOM IVF ICSI IUI Eligibility Criteria
history and examination suggest endometriosis. At laparoscopy the diagnosis
of endometriosis is confirmed (ASRM grade IV disease). Surgery is arranged
in a tertiary centre and pelvic disease removed. Post-operative ovarian
suppression with GnRH analogue (Zoladex) for 6 months is recommended,
followed by IVF.

Answer
Clock starts when referral received / UBRN converted and stops when has
definitive surgery in tertiary centre. At end of 6 months IVF should be initiated
without need for clock to restart.
As for scenario 3, providers must ensure that systems are in place to protect
the patient to ensure there is no undue capacity and/or funding related delay
before she commences IVF treatment.


Scenario 9
GP refers a couple directly through to tertiary care as the woman is known to
have premature ovarian failure. The couple request egg donation and after
appropriate counselling the couple decide they would like to proceed with egg
donation. There is a shortage of egg donors.

Answer
The clock starts when received / UBRN converted and stops with active
monitoring when they are offered egg donation. This is similar to other
specialities where donor organs are in short supply.




D:\Docstoc\Working\pdf\ae26d5a9-086f-43d7-86a9-38bc5d9b2c20.doc                     15
NORCOM IVF ICSI IUI Eligibility Criteria




D:\Docstoc\Working\pdf\ae26d5a9-086f-43d7-86a9-38bc5d9b2c20.doc   16

				
DOCUMENT INFO
Shared By:
Categories:
Stats:
views:4
posted:6/11/2011
language:English
pages:16