GYNAECOLOGY / INFERTILITY

Transcription

1 National Specialist Guidelines for Investigation of Infertility Priority Criteria for Access to Public Funding of Infertility Treatment PAGE PAGE 4 4 In 997/98 the publication of the National Health Committee s consultation document Access to infertility services: development of priority criteria received numerous In 997/98 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 NZ tertiary centres and with minor publicly modifications funded treatment the original could proposal be achieved is being by these presented criteria. to the These HFA criteria to introduce have been to the tested in at NZ least Health NZ system. tertiary centres and, with minor modifications, the original proposal is being 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 This the document infertile is couple not about to achieve directing a standardised therapy. It is diagnosis about guiding and then providing evaluation a of rationing the infertile couple basis to for achieve public a standardised access for treatment, diagnosis and especially then providing using a the rationing assisted basis reproductive for public access for techniques. treatment, especially It is intended using the to benefit assisted those reproductive who are techniques. most in need It is for intended therapy, to but benefit those balanced who are by most a system in need that for will therapy, ensure but maximum balanced benefit. by a system The that actual will level ensure of access maximum 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 that with Health diligence Practitioners, and honesty. working Already with the criteria, the HFA use have them declared with diligence its support and by honesty. providing Already the significant HFA has declared funding its to support assist by in providing clearing the significant waiting funding lists for to Assisted assist in clearing Reproduction. the waiting lists for Assisted Reproduction. We emphasize that the application of the criteria and their weighting is just the We beginning. emphasize that These the criteria application need of to these be validated criteria and by their ongoing weighting research is just and the beginning. public The discussion. criteria need to be validated by ongoing research and public discussion. Wayne Wayne R Gillett, R Gillett, John John Peek, Peek, July July Version Gynaecology Referral Guidelines and Priorisation Criteria Date: 4// Authorised: Elective Services, HFA

2 PAGE 5 Section SECTION I 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 As As for for primary primary care. care. In In addition: A post coital test may be used in the early investigation of a referred couple, A post coital but the results test may should be used be interpreted the early with investigation caution. Performance of a referred of couple, this test but is the results should not be essential interpreted to complete with caution. the diagnostic Performance categorisation of this test of is the not couple essential (seeto complete the diagnostic diagnostic categorisation categories). 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) Sperm should function not tests be used and in sperm secondary assessment care practice. procedures They may (e.g. be swim-up of value in tests) helping should not be used a in couple secondary choose care an appropriate practice. They ART in may a tertiary be of level value service. 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 A hysterosalpingogram gold standard test may for tubo-peritoneal be used to test disease tubal patency. and is the Laparoscopy preferred method, 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, see next page) then there is no need for laparoscopy unless the pelvis is required. If there is a severe semen defect (score of, see next page) then indicated for other gynaecological reasons (or following failed DI treatment). there is Furthermore no need for for laparoscopy ovarian defects, unless a trial indicated of therapy for other is indicated gynaecological before laparoscopy reasons (or following failed is DI considered. treatment). Otherwise Furthermore laparoscopy for ovarian should defects, be booked a trial within of therapy months is indicated the before laparoscopy following is considered. circumstances: Otherwise laparoscopy should be booked within months in the following circumstances:. severe cyclical pain or suspected pelvic pathology.. severe infertility cyclical of 8 pain months or suspected duration pelvic and where pathology there is a female history of any pelvic surgery, STDs or PID. infertility of 8 months duration and where there is a female history of any pelvic. surgery, infertility STDs of 8 or months PID duration and a female age years of age 4. otherwise unexplained infertility years duration. infertility of 8 months duration and a female age years of age 5. failed DI or ovulation induction (- cycles of treatment) 4. otherwise unexplained infertility years duration Diagnostic categories to be completed at the secondary (specialist) level 5. failed DI or ovulation induction (- cycles of treatment) The diagnostic model given here recognises the importance of the severity of a Diagnostic diagnosis and Categories a combination to of be infertility completed factors at on the the secondary probability of (specialist) a successful level outcome without treatment. To define the prognosis calculate the points for each The diagnostic diagnostic category model,,,4,5 given here and recognises. 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,,, 4, 5 and. Version Gynaecology Referral Guidelines and Priorisation Criteria Date: 4// Authorised: Elective Services, HFA

3 PAGE GYNAECOLOGY / INFERTILITY Patient ID: Complete patient details or place patient sticker here Nat. Hospital No.: Consultant: Name: Address: D.O.B. Name of Assessor: Date of Assessment: Initial Assessment () Ovulation Defects Categories From history, including a plasma progesterone timed for 5-9 days before the next expected period. If cycle is long to be repeated at weekly intervals until next period plasma FSH, LH, prolactin, thyroid function if the cycle is prolonged and/or irregular. FSH (day - 5 cycle) for older women (is measure of biological age of ovary). amenorrhoea - any cause oligomenorrhoea from any cause / luteal defect anovulation with normal menstrual cycle intermittent anovular cycles no ovulation defect SCORE () Semen Defects Categories Semen sample collected after - days abstinence. To be repeated in 4- weeks if abnormal. The measurement of antisperm antibodies, post coital test or other sperm function tests are not essential for this category, but may be included as indicated < million motile sperm/ml / severe ejaculatory dysfunction / severe sperm antibodies < 5 million motile sperm /ml / moderate antibodies / repeat negative PCT or sperm function abnormality 5- million motile sperm/ml Any other semen defect No semen defect SCORE To be completed following laparoscopy () Endometriosis Categories The American Fertility Society Classification (American Society for Reproductive Medicine 997). This requires direct visualization by laparoscopy. Surgical treatment at the time of diagnosis will be at the discretion of the gynaecologist conducting the procedure, depending on the common practice of the clinic. stage IV AFS classification stage III AFS classification stage II AFS classification stage I AFS classification No endometriosis SCORE Version Gynaecology Referral Guidelines and Priorisation Criteria Date: 4// Authorised: Elective Services, HFA

4 PAGE 7 (4) Other Tubo-peritoneal Disease Categories Although classification can be based on experience of examining specialist, we encourage the use of the American Fertility Society classification of adnexal adhesions (988). In many cases the pathology may be different on each side. The adnexa with the least pathology should be used (best side). Surgical treatment at the time of diagnosis will be at the discretion of the gynaecologist conducting the procedure, depending on the common practice of the clinic. Proximal or distal (complete or partial) occlusion on best-side / severe encapsulating tubal or ovarian adhesions on best-side, / missing tubes / or unsuccessful proximal or distal surgery after months Moderate encapsulating tubal or ovarian adhesions on best-side adnexa / unsuccessful surgery after months tubal polyps / mild encapsulating adhesions on 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 adnexa No tubo-peritoneal pathology SCORE 4 (5) Other Factors Categories These should be classified at discretion of specialist, e.g. psycho-sexual disorders fibroids intrauterine pathology severe moderate mild minimal absent SCORE 5 No diagnosis abnormality identified, i.e. unexpained infertility () Unexplained Infertility Categories If no diagnostic abnormality then define the duration of the unexplained infertility Unexplained infertility 5 years Unexplained infertility 4 < 5 years Unexplained infertility years < 4 years Unexplained infertility < years SCORE Final Score for Diagnosis Add scores,,,4,5, = Score D Version Gynaecology Referral Guidelines and Priorisation Criteria Date: 4// Authorised: Elective Services, HFA

5 SECTION Access to Publicly Funded Treatment PAGE 8 A A B General Principles:. Provision of basic support and guidance at the primary level should be subject to. Provision of basic support and guidance at the primary level should be subject to normal primary care normal primary care charging. charging. Simple ovulation induction may be managed by the GP in consultation with a specialist. Simple ovulation induction may be managed by the GP in consultation with a specialist service. service... Simple Simple conditions conditions requiring requiring medical medical or psychological or psychological therapy should therapy be provided should within be provided the primary within or secondary services without need for access criteria the primary or secondary services without need for access criteria.. 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 ART or surgery (e.g. tubal occlusion) should be access criteria subject to access criteria for infertility. These treatments include AIH, IVF, IVF and ICSI, DI, ovulation 5. induction Conditions using gonadotrophins that can be managed ( AIH). The equally treatment as well available with per ART individual or surgery couple (e.g. should tubal be directed occlusion) by the specialist should in be charge subject of the to access individual criteria / couples for infertility. and These in consultation treatments with include that individual AIH, / IVF, couple. IVF The and cumulative ICSI, DI, amount ovulation of treatment induction available using gonadotrophins to people will depend (± AIH). on public 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 Steps available. in defining access criteria B. Exclusion Steps in defining factors for access access criteria: to treatment The first is absolute - with access refused if there are situations that compromise the safety of the couple or. a child. Exclusion However no factors factor for may access be used that to treatment is unlawful and that might breach the Human Rights Act or the Bill The of first Rights is Act. absolute Ultimately - with it access will be the refused doctor, if practicing there are at situations a primary, that secondary compromise or tertiarythe level, who safety will decide of the - couple and that or doctor a child. would However, need to defend no factor this may decision. be used that is unlawful and 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 that doctor would need to defend this decision. These are conditions that can be modified to improve the chance of conception:. Hydrosalpinges Modifying factors for access to treatment Complete These distal are tubal conditions occlusion, or that the can hydrosalpinx, be modified accumulates to improve tubal the fluid chance that may of drain conception: into the uterine cavity giving a detrimental effect on pregnancy rates with IVF. Depending on the severity of the tubal disease, Hydrosalpinges either salpingostomy or salpingectomy should be performed in women planning entry into 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 Weight 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 BMI range of 8-. Women with a BMI higher than should be given a stand down period and The classified surgery as should active be review performed to see if by they specialists can achieve trained a lower in BMI. microsurgery There are factors or laparoscopic that limit the success surgery. of weight Each improvement main centre and, in in New this circumstance, Zealand has it such is reasonable specialists. 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 8-. Women with a BMI higher than 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.. Modifying factors for access to treatment Version Gynaecology Referral Guidelines and Priorisation Criteria Date: 4// Authorised: Elective Services, HFA

6 PAGE 9 9 GYNAECOLOGY / INFERTILITY. Calculation of the Priority Score. Each Calculation of the following of the criteria Priority should Score be recorded following diagnosis and request for therapy, and modified on Each an annual of the basis. following For example, criteria June should of be each recorded year may following be regarded diagnosis as the annual and request date of for revision, therapy since and new modified HFA funding on an rounds annual follow basis. on July For. example, Simple spreadsheet June of programmes each year are may available be regarded that canas recalculate the annual a priority date score, of revision, simply by since adding new a new HFA date. funding Copy of rounds programme follow available on July from. Wayne Simple Gillett, Dept. O&G PO Box 9. 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 (O O4) and a group of s a new date. Copies of the programme are available from Wayne Gillett, factors (S S). Points for each of the objective factors are directly proportional to the pregnancy rate. Dept O&G, PO Box 9, Dunedin. Points for the subjective factors were derived from the results of questionnaires returned by health professionals and consumers. The age final of score the female is the partner product of a group of objective factors (O O4) and a group of social (subjective) factors (S S). 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 D The = age then of the prognosis female < partner 5% probability of conception in year If score The D weighting = < then of the prognosis points reflects - % the probability of conception of conceiving in year with therapy. If Score D = < then prognosis -5% probability of conception in year If Score D The < prognosis then prognosis of conceiving >5% probability without treatment of conception in year See Section for calculation of diagnostic scores. The weighting of these points reflect the inverse relationship of the likelihood of conceiving If Score D = then prognosis < 5% probability of conception in year The basal plasma FSH If score D = < then prognosis - % probability of conception in year Ovarian reserve is commonly measured by basal FSH levels between days -5 of the menstrual cycle. If Score D = < then prognosis -5% probability of conception in year The normal range will depend on the local assay. The weighting of points reflect the chance of conceiving. If If donor Score oocytes D < are used in an IVF then programme, prognosis the >5% donor s probability FSH level should of conception be measured. in FSH year should be measured within months before the first planned ART cycle, and repeated at least every months. The The normal weighting value be of these IU; borderline points reflects be > 5; the inverse and abnormal relationship be >5. of the likelihood of conceiving A history of current smoking in female partner The point system reflects the relative risk on pregnancy outcome of smoking. Although The this will basal become plasma a priority FSHfactor we envisage most women, by stopping smoking, will increase their Ovarian priority reserve points after is commonly months and measured improve their by basal eligibility FSH depending levels between on the threshold days -5 for of access the to menstrual treatment. We cycle. believe The every normal effort range should will be depend made by on women the local seeking assay. any form The of weighting fertility treatment of points to reflects give up smoking. the chance Duration of conceiving. of smoke free If to donor be three oocytes months are and used no cigarettes in an IVF at programme, all. the donor s Duration FSH of infertility level should be measured. The best or lowest FSH in the last months should The be points the figure given here used. relate An to FSH how in people the range feel about of -5 the burden is a modifying of the duration factor of and infertility, an FSH rather of than greater how it than affects 5 the is chance exclusion of pregnancy. 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 cycles of DI of which should be within an accredited A history RTAC unit. of current smoking in female partner 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 months and improve their eligibility Previous sterilisation depending on the threshold for access to treatment. We believe that every effort should The be points made given by women here recognise seeking the any burden form of some of fertility people treatment never having to give had children, up smoking. or the Note: burden the of having duration lost a of child the (children) smoke-free by death. period is to be months with no cigarettes at all and with the male partner counselled as the effect of his smoking. Version Gynaecology Referral Guidelines and Priorisation Criteria Date: 4// Authorised: Elective Services, HFA

7 PAGE 9. Calculation of the Priority Score Each of the Duration following of criteria infertility should be recorded following diagnosis and request for therapy, and modified on The an annual points basis. given For here example, relate June to how of people each year feel may about be regarded the burden as the of annual the duration date of of revision, infertility, since rather new than HFA funding how it rounds affects follow the chance on July. of Simple pregnancy. spreadsheet The duration programmes of infertility are available is to that becan recalculate cumulative a priority of previous score, simply and by current adding relationships. a new date. Copy For of programme single women available or lesbians from Wayne it will Gillett, be on Dept. O&G PO Box 9. the basis of unexplained infertility to be confirmed by cycles of DI of which should be The final score is the product of a group of objective factors (O O4) and a group of social (subjective) within an accredited RTAC unit. factors (S S). 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 professionals Number and consumers. of children This The age is defined of the female as children partnercurrently living with the couple or person. Children living at home is defined as children under the age of 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 D = given here then recognise prognosis < the 5% burden probability of some of conception people in never yearhaving had children or the If score burden D = of < having then lost prognosis a child (children) - % probability by death. of conception in year If Score D = < then prognosis -5% probability of conception in year If Score D < then prognosis >5% probability of conception in year The weighting of these points reflect the inverse relationship of the likelihood of conceiving The basal plasma FSH Ovarian reserve is commonly measured by basal FSH levels between days -5 of the menstrual cycle. The normal range will depend on the local assay. The weighting of points reflect the chance of conceiving. If donor oocytes are used in an IVF programme, the donor s FSH level should be measured. FSH should be measured within months before the first planned ART cycle, and repeated at least every months. The normal value be IU; borderline be > 5; and abnormal be >5. 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 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 cycles of DI of which 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 Gynaecology Referral Guidelines and Priorisation Criteria Date: 4// Authorised: Elective Services, HFA

8 PAGE PAGE National Clinical Assessment Criteria (CPAC) for Treatment of Infertility Patient ID: Complete patient details or place patient sticker here Nat. Hospital No.: Consultant: Name: Address: D.O.B. Name of Assessor: Date of Assessment: Calculation of priority criteria points for publicly-funded infertility treatment Criteria symbol Points awarded Criteria and their categories O Chance of pregnancy without treatment Points available 5% -% 7-5% 4 >5% O Woman s age 9 years O O4 Basal FSH, day -5 cycle, with respect to reference range Woman s smoking always within sometimes above 8 mostly/always above non smoker smoker Multiply O x O x O x O4 = OC (points from objective criteria) OC = Now divide OC by = Revised OC (ROC) ROC S S S Duration of infertility Number of children Sterilisation reference range < year 5 < year <5 years 4 5 years 5 None by current relationship > by current relationship 5 child by prev relationship 8 neither partner sterilised death of child one partner sterilised Sum S + S + S = SC (points from social criteria) = SC Multiply ROC x SC = Priority Score (PS) = PS