LOW PRIORITY PROCEDURE Policy. T39 Fertility Policy

Transcription

1 LOW PRIORITY PROCEDURE Plicy T39 Fertility Plicy Plicy authr: NHS Ipswich and East Sufflk Clinical Cmmissining Grup and NHS Plicy start date: April 2014 Review date: March 2016 Plicy Summary This plicy sets ut the entitlement and service that will be prvided by the CCG fr NHS funded specialist fertility services fr the ppulatin f CCG. This specifically includes In Vitr Fertilisatin (IVF) and Intracytplasmic Sperm Injectin (ICSI). Cuples will be eligible t receive IVF/ICSI where they meet the specified referral criteria. All cuples must underg the fertility investigatins in primary and secndary care as per the existing CCG plicy apprpriate t them befre eligibility fr NHS-funded assisted reprductin services is cnsidered. IVF An IVF prcedure includes the stimulatin f the wmen s varies t prduce eggs which are then placed in a special envirnment t be fertilised. The fertilised eggs are then transferred t the wman s uterus. An embry transfer is frm egg retrieval t transfer t the uterus. The fresh embry transfer wuld cnstitute ne such transfer and each subsequent transfer t the uterus f frzen embrys wuld cnstitute anther transfer. Previus IVF Having received nn-nhs funded/ self-funded IVF previusly des nt preclude wmen aged less than 40 frm accessing NHS funded IVF hwever the number f cycles received previusly will determine eligibility fr further NHS funded cycles. Evidence shws a decrease in success after three cycles and therefre n wmen will receive mre than a ttal f three cycles (including nn NHS funded cycles). If they have selffunded ONE cycle previusly, they are eligible fr up t TWO fresh cycles. If they have self-funded TWO cycles previusly, they are eligible fr nly ONE fresh cycle. If they have self-funded THREE cycles, they are nt eligible fr any further treatment. Wmen between age 40 t less than 42 years shuld nt have had any IVF cycle (self r NHS funded) t be eligible fr NHS funding. Cuples will nt be allwed t pay fr any additinal interventins as part f the treatment within a cycle f NHS fertility treatment. This includes, but is nt limited t, any drugs (including drugs prescribed by the cuple s GP), recmmended treatment that is

2 utside the scpe f the service specificatin agreed with the Secndary r Tertiary Prvider r experimental treatments. Where a patient meets the CCG eligibility criteria, but agrees t cmmence treatment n a privately funded basis, they may nt retrspectively apply fr any assciated payment relating t the private treatment. Embry strage The CCG will fund strage f the embrys fr ne year nly. Patients must be cunselled by the clinician and infertility cunsellr t this effect. Any csts relating t the cntinued strage f the embrys beynd the first calendar year f the retrieval date is the respnsibility f the cuple. If any fertility treatment results in a live birth, then the cuple will n lnger be cnsidered childless and will nt be eligible fr further NHS funded fertility treatments, including the implantatin f any stred embrys. Egg and sperm strage fr patients underging cancer treatments This is cvered under separate arrangements. Egg dnatin where n ther treatment is available This will be available t wmen wh have undergne premature varian failure (lnger than six mnths amenrrhea and FSH greater than 25IU/L) due t an identifiable pathlgical r iatrgenic cause, befre the age f 40 years, r t avid transmissin f inherited disrders t a child where the cuple meets the ther eligibility criteria. The patient may be able t prvide an egg dnr; alternatively the patient can be placed n the waiting list, until an altruistic dnr becmes available. If either f the cuple exceeds the age criteria prir t a dnr egg becming available, they will n lnger be eligible fr treatment. Dnr inseminatin Dnr inseminatin may be indicated where: the male partner is likely t pass n an inheritable genetic cnditin; severe rhesus incmpatibility has been a prblem because f the male partner s hmzygus status; the male partner des nt prduce suitable sperms (quantity r quality) and, therefre, ICSI is nt pssible. Anvulatry wmen can have vulatin inductin prir t dnr inseminatin. A maximum f six cycles f dnr inseminatin will be funded fllwed by IVF with dnr sperm if all ther eligibility criteria are met.

3 The need t prevent transmissin f sexually transmitted diseases (including HIV) by dnr inseminatin has led t the mandatry quarantine f dnr sperm fr six mnths by crypreservatin prir t its use in the UK. Intra uterine inseminatin (IUI) Due t pr clinical evidence, IUI will nly be ffered under exceptinal circumstances. Chrnic viral infectins Interventins t prevent the transmissin f bld brne viruses in fertile serdiscrdant cuples (fr example, where ne partner has HIV r Hepatitis C) where all ther criteria are met is cmmissined frm specialist centres. Sperm washing will nt be ffered fr men with Hepatitis B Surrgacy Surrgacy is nt cmmissined as part f this plicy. This includes part funding during a surrgacy cycle. Exceptinal Circumstances Cuples wh d nt meet the criteria and cnsider they have exceptinal clinical circumstances, which suggest that they are likely t gain significantly mre benefit than might generally be expected, can be referred t CCG s Individual Funding Request panel. Nt included in Plicy Gamete strage, preimplantatin genetic diagnsis and intrauterine inseminatin are nt part f this plicy. These will be dealt with under existing Clinical Cmmissining Grup (CCG) arrangements including the prir apprvals prcess. Individual Prir Apprvals The CCG is likely t perate an individual prir apprvals prcess t supprt the implementatin f parts f this plicy. Referral criteria 1. Age f wman and number f cycles a. Wman aged 23 t less than 40 years tw fresh cycles. If the wman reaches age f 40 years during treatment, the current cycle will be cmpleted, but n further cycles will be ffered. b. Wman aged 40 t less than 42 years ne fresh cycle prviding all the fllwing criteria are met: i. Never previusly had IVF treatment ii. There is n evidence f lw varian reserve (FSH less than 8.9IU/L)

4 iii. There has been a discussin f the additinal implicatins f IVF and pregnancy at this age 2. Embry transfers a. Wmen aged 23 t less than 40 years ne embry will be transferred during each cycle t reduce the risk f multiple pregnancies. A maximum f fur embry transfers (fresh plus frzen) will be funded. All frzen embrys shuld be used befre a fresh cycle is funded. Where cuples have previusly self-funded a cycle then the cuples must utilise the previusly frzen embrys, rather than underg varian stimulatin, egg retrieval and fertilisatin again. b. Wmen aged 40 t less than 42 years up t tw embrys may be transferred during each cycle. A maximum f tw embry transfers (fresh plus frzen) will be funded. 3. Age f male partner Less than 55 years 4. Duratin f infertility/waiting time a. Cuples with unexplained fertility must have infertility f at least three years f vulatry cycles, despite regular unprtected vaginal sexual intercurse with the partner seeking treatment r 12 cycles f artificial inseminatin ver a perid f three years. b. If the wman has a miscarriage, the cuple will wait fr a further 3 years f unexplained infertility frm the date f the miscarriage t be eligible fr NHS funded IVF. Cuples with unexplained infertility shuld be referred frm primary care after 12 mnths expectant management. c. Cuples with a diagnsed cause f abslute infertility which precludes any pssibility f natural cnceptin, and wh meet ther eligibility criteria, will have immediate access t NHS funded assisted reprductin services. d. Fr same sex cuples, see pint Minimum Investigatins a. The minimum investigatins required prir t referral t the Tertiary centre are: Female: Laparscpy and/r hysterscpy and/r hystersalpinggram r ultrasund scan where apprpriate Rubella antibdies Day 2 FSH. Chlamydia screening Hepatitis B including cre antibdies and Hepatitis C and HIV status and cre, within the last 3 mnths f treatment and repeated every 2 years. Male: Preliminary Semen Analysis and apprpriate investigatins where abnrmal (including genetics) Hepatitis B including cre antibdies and Hepatitis C, within the last 3 mnths and repeated after 2 years. HIV status

5 6. Fllicle Stimulating hrmne a. FSH less than 8.9 IU/L n day tw f any menstrual cycle within three mnths f referral frm secndary care t the specialist IVF prvider. 7. Residency a. Bth partners must be registered with a GP practice in Ipswich and East Sufflk r s fr at least 12 mnths prir t referral frm primary care t secndary care and be eligible fr NHS care. 8. Parental Status a. There shuld be n living child frm the cuple s current r any previus relatinships, regardless f whether the child resides with them. This includes any adpted child within their current r previus relatinships; this will apply t adptins either in r ut f the current r previus relatinship 9. Smking a. Cuples wh smke will nt be eligible fr NHS funded specialist assisted reprductin assessment r treatment, and shuld be infrmed f this criterin at the earliest pssible pprtunity in their prgress thrugh infertility investigatins in primary care and secndary care. Cuples presenting with fertility prblems in primary care shuld be prvided with infrmatin abut the impact f smking n their ability t cnceive naturally, the adverse health impacts f maternal and passive smking n the fetus, and the adverse health impacts f passive smking n any children; and smking cessatin supprt shuld be prvided as necessary. b. Bth partners must be nn-smking at the time f referral frm secndary care t specialist IVF services and maintained during treatment. Smking status shuld be ascertained by carbn mnxide testing in secndary care and specialist IVF services. 10. BMI a. Wmen must have a BMI f between kg/m 2 and men a BMI f kg/m 2 at time f referral fr specialist assisted reprductin assessment and at the time f any specialist treatment b. Cuples presenting with fertility prblems in primary care shuld be prvided with infrmatin abut the impact f BMI n their ability t cnceive naturally. Where apprpriate, cuples shuld be ffered advice and supprt t achieve weight lss, and shuld be infrmed f the weight criterin in relatin t NHS funded assisted reprductin services at the earliest apprpriate pprtunity in their prgress thrugh infertility investigatins in primary care and secndary care. 11. Child Welfare a. The welfare f any resulting children is paramunt. In rder t take int accunt the welfare f the child, cnsideratin will be given t factrs which are likely t cause serius physical, psychlgical r medical harm, t the child t be brn. This is a requirement f the licensing bdy, Human Fertilisatin and Embrylgy Authrity. Cuples must cnfrm t the statutry Welfare f the Child requirements. 12. Previus Sterilisatin

6 a. Cuples are ineligible if previus sterilizatin has taken place (either partner), even if it has been reversed. 13. Rubella Status a. The wman must be rubella immune 14. Medical Cnditin a. Treatment may be denied n ther medical grund nt explicitly cvered in this dcument. 15. Legal Respnsibility a. Bth members f the cuple must accept jint legal respnsibility fr any child prduced thrugh fertility treatment. 16. Same Sex Cuples (female) a. Same sex cuples will be required t demnstrate infertility prir t cmmencing any investigatins in line with the plicy fr hetersexual cuples. b. Same sex cuples must have undergne a minimum f 6 verified and dcumented cycles f artificial inseminatin within 12 mnths befre being eligible t access NHS funded fertility assessment and treatment. c. Cuples are encuraged t maximise pprtunities within these 6 cycles by explring the ptin f bth partners underging artificial inseminatin. d. In line with the plicy fr hetersexual cuples, same sex cuples with unexplained infertility must wait a ttal f three years befre becming eligible fr IVF treatment. Cuples are encuraged t cntinue t try and cnceive during this waiting perid by safe methds. e. Cuples with a diagnsed cause f abslute infertility which precludes any pssibility f a natural cnceptin, and wh meet ther eligibility criteria, will have immediate access t NHS funded assisted reprductin services. f. CCGs will nt rutinely fund dnr sperm, but will fund the assciated IVF/ICSI treatment in line with the eligibility criteria within this plicy, prviding the sperm meet the criteria set ut by the treating prvider unit. g. The partner f a prspective mther wh has undertaken NHS funded fertility treatment, whether successful r nt, will be deemed t have received their entitlement t NHS funded fertility treatment upn cmpletin f this cycle, in line with the criteria fr hetersexual cuples, and will nt be eligible fr additinal cycles with their partner r any future partners. h. Same sex fertile cuples will nt be funded fr assisted cnceptin methds under this plicy. i. Cuples will be required t fit all ther criteria within this plicy in line with hetersexual cuples. 17. Same sex cuples (male) a. Same sex male cuples are nt included in this plicy. Backgrund t the cnditin and treatment

7 It is estimated that infertility affects ne in seven hetersexual cuples in the UK and there has been a small increase in the prevalence f fertility prblems, and a greater prprtin f peple nw seeking help fr such prblems (NICE CG 156). The main causes f infertility in the UK are: unexplained infertility (n identified male r female cause) (25%); vulatry disrders (25%); tubal damage (20%); factrs in the male causing infertility (30%); uterine r peritneal disrders (10%); IVF (In Vitr Fertilisatin) is a fertility treatment whereby an egg is fertilised by sperm utside f the bdy. A wman s varies are stimulated t prduce eggs which are then fertilised in a special envirnment utside the bdy. The fertilised egg is then transferred t a wmen s uterus with the intentin f establishing a successful pregnancy. ICSI (Intracytplasmic Sperm Injectin) is a type f IVF prcedure whereby a single sperm is injected directly int an egg. Ratinale behind the plicy decisin This plicy is designed t ensure that limited healthcare resurces are put t best pssible use, benefitting patients with the best likelihd f success (live singletn birth). A new clinical guidance n Fertility was published by NICE in February 2013 (CG156) and this plicy has cnsidered the evidence presented by NICE in recmmending changes and the views f stakehlders thrugh an established cnsultatin prcess. The decisin t include access fr wmen aged wh meet specific criteria was based n high t lw quality evidence presented by NICE but recgnizes the imprved success rates f IVF since the publicatin f the previus plicy. The decisin t maintain waiting times as per the previus plicy fr wmen with unexplained fertility was made based upn mderate t lw quality f evidence presented by NICE and the difficulties in justifying additinal spend in cnstrained NHS resurces. The decisin t reduce the number f cycles frm 3 t 2 was made t partially mitigate the extra resurce needed t increase the age limit. In rder t be fair and try t standardise the access t IVF fr patients acrss the regin, this plicy is in line with ther East f England Clinical Cmmissining Grups. Further infrmatin n the evidence that infrmed this plicy is available in the accmpanying evidence brief. References

8 NICE Fertility CG156 (2013). Available at: Plicy develpment prcess led by: Andrea Clement, Speciality Registrar in Public Health & Dr P Badrinath, Cnsultant in Public Health Medicine, Public Health Sufflk. March 2014