Commissioning Policy. Tertiary Treatment for Assisted Conception Services

Transcription

1 Commissioning Policy Tertiary Treatment for Assisted Conception Services April 2013 This commissioning policy applies to patients within: South Worcestershire Clinical Commissioning Group (CCG) Redditch & Bromsgrove Clinical Commissioning Group (CCG) Wyre Forest Clinical Commissioning Group (CCG) Version: 2.12 Ratified by: Clinical Senate February 2013 NHS R&B CCG March 2013 NHS WF CCG March 2013 NHS SW CCG April 2013 Date ratified: April 2013 Date issued: April 2013 (original policy 2007) Expiry date: (Document is not valid after this date) Any revisions to the policy will be based on local and national evidence of effectiveness and cost effectiveness together with recommendations and guidelines from local, national and international clinical professional bodies. Minimum 3 yearly Review date: April 2016 Senior Responsible Lead: Chris Emerson, Head of Commissioning & Service Redesign Name of originator/author: Previous Iterations: Helen Edwards/Anita Roberts Commissioning Manager Revisions to this document: Helen Bryant Commissioning Manager/Jane Gjordin Commissioning Support Manager Target audience: NHS Trusts, Independent Providers, GP s, patients Distribution: NHS Trusts, Independent Providers, GP s, patients, Public & Patient Involvement Forum Equality & Diversity Impact 9 th March 2012 Assessment If you would like this document in other languages or formats (i.e. large print), please contact the Communications Team on or communications@worcestershire.nhs.uk

2 CONTRIBUTION LIST Key individuals involved in developing the document Name Ms Chris Emerson Mr Stuart Bourne Ms Mandy Matthews Mrs Anita Roberts Mrs Helen Bryant Ms Rachael Blundell Mrs Jane Gordijn Dr Jan Adams Dr J Watts Ms A Macken Ms C Brettell Designation Head of Commissioning & Service Redesign Consultant in Public Health Secondary Care Medicines Lead Deputy to the Head of Commissioning & Service Redesign Commissioning & Redesign Manager Commissioning Support Manager Commissioning Support Manager Worcestershire LINk Representative Consultant in Gynaecology and Obstetrics, Worcestershire Acute Hospitals NHS Trust Birmingham Women s Hospital BMI The Priory Hospital, Edgbaston Table of Contents 1. Definitions: Commissioning Policy: Patient Eligibility Principles in NHS Funded Treatment Options Co-Funding Initial GP Assessment and Referral Cases of Clinical Exceptionality Documents Which Have Informed This Policy... 9 CCG Tertiary Treatment For Assisted Conception Services - April 2013 V2 - FINAL Page 2 of 10

3 COMMISSIONING STATEMENT: NHS Redditch & Bromsgrove Clinical Commissioning Group, NHS South Worcestershire Clinical Commissioning Group and NHS Wyre Forest Clinical Commissioning Group (also termed the Commissioner in this document) will support a maximum of 2 embryo transfers with a maximum of 2 fresh cycles of IVF or ICSI. This includes provision for donor egg or sperm where necessary. In addition, the Commissioner will fund up to 3 cycles of IUI in patients/couples who meet the clinical criteria for sub-fertility treatment included within this document. 1. Definitions: 1.1 Infertility/Sub Fertility - The NICE Summary document, page 10, section defines infertility as follows: Infertility should be defined as failure to conceive after regular unprotected sexual intercourse for 2 years in the absence of known reproductive pathology. Note: A further definition for infertility/subfertility is provided in section 1.9 of this document, to provide guidance for single persons or same sex couples. 1.2 Exceptional - refers to a person who demonstrates characteristics, which are highly unusual, uncommon or rare. 1.3 Exceptional clinical circumstances - refer to a patient who has clinical circumstances which, taken as a whole, are outside the range of clinical circumstances presented by a patient within the normal population of patients with the same medical condition at the same stage of progression as the patient. 1.4 An individual funding request (IFR) - is a request received from a provider or a patient with explicit support from a clinician, which seeks funding for a single identified patient for a specific treatment. 1.5 Coasting - refers to a clinical process used, when clinically appropriate, to avoid the over stimulation of the ovaries and to help couples achieve a fresh cycle. Coasting is defined as the discontinuation of stimulation injections, with daily measurement of blood oestrogen hormone levels and then continuing with treatment when the blood oestrogen hormone levels have dropped to a safe level. 1.6 Intrauterine Insemination (IUI) - refers to a relatively simple reproductive procedure in which a fine catheter (tube) is inserted through the cervix (the natural opening of the uterus) into the uterus (the womb) to deposit a sperm sample directly into the uterus. The purpose of IUI is to achieve fertilization and pregnancy. 1.7 Intra Cytoplasmic Sperm Injections (ICSI) - refers to a reproductive technology in which an egg is removed from a woman and a sperm cell from a man is injected directly into the egg. If the cells fuse (achieve fertilisation) a single cell (zygote) is formed, which then starts dividing becoming an embryo. When the zygote/embryo is only a few cells large, it is implanted into the woman s uterus and, if successful, will develop as a normal embryo. 1.8 In Vitro Fertilisation (IVF) - refers to a reproductive technology in which an egg is removed from a woman, joined with a sperm cell from a man in a test tube (in vitro). The cells fuse (achieve fertilisation) to form single cell called a zygote, which then starts dividing, becoming an embryo. When the zygote/embryo is only a few cells large, it is implanted in the woman's uterus, and, if successful, will develop as a normal embryo. CCG Tertiary Treatment For Assisted Conception Services - April 2013 V2 - FINAL Page 3 of 10

4 2. Commissioning Policy: 2.1 This policy should be considered in line with all other Worcestershire Commissioning Policies. Copies of these Commissioning Policies are available on the Clinical Commissioning Group website at the following address: 3. Patient Eligibility 3.1 The Commissioner considers all lives of all patients whom it serves to be of equal value and, in making decisions about funding treatment for patients, will seek not to discriminate on the grounds of sex, age, sexual orientation, ethnicity, educational level, employment, marital status, religion or disability except where a difference in the treatment options made available to patients is directly related to the patient s clinical condition or is related to the anticipated benefits to be derived from a proposed form of treatment Age Funding will be provided for women in the age range 23 to 39 at the time of treatment, i.e. upto their 40 th birthday. Referrals into the service should be made in appropriate time to ensure that treatment can take place by the woman s 40 th birthday. Any treatment cycle must be commenced before the male is 55 years of age Body Mass Index (BMI) To secure funding women should have a body mass index (BMI) in the range 19 to 30 inclusive. There is clinical evidence to demonstrate that a BMI within this range improves pregnancy rates. Patients/couples should be informed of this criterion at the earliest possible opportunity in their progress through infertility investigations in primary and secondary care. It is recommended that male BMI should be below 30, as per NICE guidance. It is advised that the GP discusses access to the lifestyle weight management service available in primary care with the patient/couple Defining infertility The NICE Summary document, page 10, section defines infertility as follows: Infertility should be defined as failure to conceive after regular unprotected sexual intercourse for 2 years in the absence of known reproductive pathology. Where a woman has recently registered with a GP Practice, the new GP should seek and evidence the period of reported infertility in the patient/couple s medical notes. A referral to secondary care should not be made until the GP is satisfied that a patient/couple has tried unsuccessfully to conceive for 2 years Living children Treatments for assisted conception will only be funded if the patient/couple do not have any children for whom they have parental responsibility. This includes a child adopted by the patient/couple or a child from a previous relationship. Once accepted for treatment, should a child be adopted or a pregnancy leading to a live birth occur, the patient/couple will no longer be eligible for NHS funded treatment Previous assisted conception treatment NHS funded fertility treatment will not be endorsed for patients/couples if either partner in the relationship has already undertaken 2 or more attempts at fertility treatment for fertility problems, regardless of whether the treatment was funded by the NHS or privately funded; or have undertaken fertility treatment where 4 or more embryos were transferred (whether fresh or frozen). CCG Tertiary Treatment For Assisted Conception Services - April 2013 V2 - FINAL Page 4 of 10

5 Note: This does not affect a new patient s ability to receive fertility investigations if their partner has previously undertaken 2 or more attempts at fertility treatment for fertility problems within an earlier relationship. Please see section 3.1.9(c) for more information Smoking Maternal and paternal smoking can adversely affect the success rates of assisted reproduction procedures and smoking during the antenatal period leads to increased risk of adverse pregnancy outcomes. Smokers who wish to be referred for fertility treatment should discuss with their GP referral on to the Commissioner s smoking cessation supportive programme Sterilisation NHS funded fertility treatment will not be available if the patient or either partner within a couple has received a sterilisation procedure or has undertaken a reversal of sterilisation procedure HFEA Code of Practice Patients/couples who do not conform to the HFEA s Code of Practice, 8 th edition, will be excluded from having access to NHS funded assisted fertility treatment. This includes consideration of the welfare of the child which may be born. This will take account of a patient/couple s ability to provide a stable and supportive environment for a child and family medical histories. Treatment Centres will undertake this assessment Couples who meet the clinical eligibility criteria noted in section 1 be will able to receive NHS funding for: a) Up to three cycles of intrauterine insemination (IUI). b) A maximum of 2 fresh cycles of in-vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI) (with or without donor sperm or donor egg as clinically appropriate). However, a maximum of 2 embryos can be transferred in total during each cycle undertaken. Note: Note: A fresh cycle would be considered completed if it leads to egg retrieval, even if fertilisation of the eggs is not achieved An embryo transfer is from egg retrieval to transfer of a developed embryo to the uterus. Providers should apply the HFEA national strategy to reduce multiple pregnancies following fertility treatment. This strategy recommends that Providers should only transfer a maximum of 2 embryos (or 3 eggs) per treatment for women aged 40 and under. If a patient is assessed as suitable for SET (single embryo transfer) and a decision is made to transfer more than 1 embryo or egg, this clinical decision must be clearly documented in the patient s medical records and reported appropriately. c) For men with obstructive azoospermia, NHS funding is in place for one needle aspiration or one open testicular biopsy. A decision to use the most appropriate procedure to recover a patient s sperm should be made by the specialist clinician during the treatment process. Exceptions to these treatment options would be in rare cases where: A woman with a normal Follicle Stimulation Hormone (FSH) level fails to respond adequately in the first cycle of stimulation. This woman would be eligible for one further fresh cycle at maximum dose gonadotrophins. If she fails to respond during CCG Tertiary Treatment For Assisted Conception Services - April 2013 V2 - FINAL Page 5 of 10

6 the second cycle she could be considered for a third cycle with egg donation as an exception via the Commissioner s Individual Funding Request (IFR) process. Two fresh cycles of IVF have not resulted in embryo transfer, under these circumstances, couples would be eligible for one cycle of ICSI. In extremely rare cases, a second aspiration or biopsy procedure will be funded if the sperm taken at the initial biopsy was not of a satisfactory quality once thawed and a second procedure is required on the day of the female partner s treatment. The treatment options undertaken will depend on diagnosis and clinical appropriateness. For example, if clinically appropriate, women with true unexplained fertility problems will be referred for upto 3 * cycles of IUI initially. If unsuccessful, a patient/couple would then be eligible for up to 2 fresh cycles of IVF/ICSI with or without semen and/or egg donation (as deemed clinically appropriate), subject to a limit of 2 embryo transfers. Alternatively, following clinical assessment, women may be referred directly for IVF, ICSI or egg donation rather than IUI. To be eligible for NHS funding under this policy a woman s Follicle Stimulation Hormone (FSH) level must be 10 miu/ml or below. The FSH level must be checked between days 3 5 of the cycle. If the initially tested FSH level is more than10 miu/ml this is to be repeated in another cycle. If the repeat FSH level is10 miu/ml or less, the woman will be accepted for NHS funded treatment. If, however, the repeat level is more than 10 miu/ml, NHS funded treatment will not be provided Single People and Same Sex Couples The Commissioner does not support sub fertility treatment for patients (single people or couples) where there is no discernible fertility problem. For either a single individual or a same sex couple to be considered for NHS funded assisted conception treatment, sub-fertility would have to be demonstrated. Subfertility in this instance can be defined as: A failure to conceive, resulting in a live birth, following insemination at or just before the known time of ovulation, on at least 10 non-stimulated cycles or six cycles of clinically delivered insemination; or A defined fertility problem that is confirmed by an NHS gynaecologist or specialist in infertility following appropriate clinical investigations. Note: Where a single individual or same sex couple has demonstrated proven sub-fertility as defined above, the other criteria for access to NHS funded assisted conception treatment will be applied when considering their eligibility for NHS funding. In the case of a same sex couple where one partner is defined as sub-fertile, clinicians should also discuss the possibility of the other partner becoming the biological parent before undertaking any interventions on the sub-fertile partner. Single individuals and same sex couples identified as eligible for NHS funded assisted conception treatment should be provided with access to professional experts in reproductive medicine for advice on the treatment options available in relation to their assisted conception treatment. * NICE recommend up to 6 cycles IUI. 3 cycles is a move towards this. CCG Tertiary Treatment For Assisted Conception Services - April 2013 V2 - FINAL Page 6 of 10

7 Prescribing Within The Treatment Pathway For couples who meet the clinical criteria for NHS funded treatment for assisted conception, the prescribing of any drugs to increase fertility and/or assist with conception should be undertaken by the Provider to which that couple was referred. These drugs include, but are not exclusive to, gonadotrophin drugs for men with hypogonadotrophic hypogonadism and anti-oestrogens, gonadotrophins and gonadotrophin-releasing hormone analogues in women. Under no circumstances should the patient s GP be approached to prescribe these drugs as they are part of the treatment pathway provided by the Service Provider. The Commissioner does not support the NHS funding of any drugs to assist in conception outside of an agreed NHS treatment pathway Residency Patients must be permanently registered with a GP in Worcestershire and have a documented history of sub-fertility as defined in section 3.3 in this document. 4. Principles in NHS Funded Treatment Options 4.1 NHS principles have been applied in the agreement of this policy. This policy covers the fertility treatments of: intrauterine insemination (IUI), In vitro fertilisation (IVF), intra cytoplasmic sperm injection (ICSI) egg donation, Egg and Sperm Preservation for clinical reasons. The policy was written following the publication in February 2004 of NICE clinical guidance entitled Fertility, assessment and treatment for people with fertility problems. 4.2 Once a baby is born, the couple are no longer considered childless. 4.3 Cancelled cycles are chargeable and rates have been agreed with Providers. If a cycle is cancelled for clinical/medical reasons related to the treatment or by the patient/couples for other reasons then patient/couples will not be eligible for further NHS funded cycles. 4.4 Oocyte and Sperm storage for patients undergoing cancer treatments 4.5 The procedures recommended by the Royal College of Physicians and the Royal College of Radiologists should be followed before commencing chemotherapy or radiotherapy likely to affect fertility, or management of post- treatment fertility problems. 4.6 Patients preparing for medical treatment, that is likely to make them infertile, should be offered oocyte or semen cryostorage because the effectiveness of this procedure has been established. 4.7 Local protocols should exist to ensure that health professionals are aware of the values of oocyte and semen cryostorage in these circumstances, so that they deal with the situation sensitively and effectively. 4.8 Pre-implantation Genetic Diagnosis (PiGD) - is not covered by this commissioning policy. CCG Tertiary Treatment For Assisted Conception Services - April 2013 V2 - FINAL Page 7 of 10

8 5. Co-Funding 5.1 The Commissioner has adopted the West Midlands Regional Commissioning Policy WM13: Defining the boundaries between NHS and private care, which provides further clarification on the Commissioner s position on co-funding. This, along with all other commissioning policies, is available at the following internet address: Co-payment is seldom permitted in the NHS, other than where, pursuant to Regulations made under the National Health Service Act 2006, specified patients are required to make a specified contribution e.g. prescriptions. 6. Initial GP Assessment and Referral 6.1 An initial assessment of a patient/couple s sub-fertility should be undertaken by their GP. This should include lifestyle advice in accordance with NICE recommendations, for example on BMI, smoking cessation, occupational hazards, alcohol and caffeine consumption and prescribed, over the counter and recreational drug use. For example: Patient/Couples should be informed that the consumption of more than one unit of alcohol per day reduces the effectiveness of assisted reproduction procedures, including in vitro fertilisation treatment. Patient/Couples should be informed that either partner smoking can adversely affect the success rates of assisted reproduction procedures, including in vitro fertilisation treatment and should be referred onto an NHS Smoking Cessation Programme Patient/Couples should be informed that caffeine consumption has adverse effects on the success rates of assisted reproduction procedures, including in vitro fertilisation treatment. 6.2 In cases where patients/couples meet all of the commissioning criteria, they should be referred by their GP to secondary care. Patients may choose a provider from the gynaecology choice menu. However, The Commissioner recommends referral to a Consultant Obstetrician and Gynaecologist with a special interest in infertility at Worcestershire Acute Hospitals NHS Trust. Referrals should be marked Infertility Clinic. A range of diagnostic tests will be undertaken within secondary care, including measurement of FSH levels. 6.3 Following secondary clinical investigation, patient/couples who require sub-fertility treatment will be referred to a tertiary centre. The normal tertiary pathway for Worcestershire patients is to BMI The Priory Hospital, Birmingham or to Birmingham Women s Hospital. 6.4 In cases where a patient/couple meet the eligibility criteria noted within this policy for NHS funded treatment and the woman is approaching 40 GPs may refer direct to one of the providers noted in section 4.3 to ensure a patient s treatment is completed by the time of her 40th birthday. 7. Cases of Clinical Exceptionality 7.1 If there is demonstrable evidence of a patient/couple s clinically exceptional circumstances, the referring practitioner should refer to the Commissioner s Individual Funding Request Commissioning Policy document for further guidance on the process for consideration. 7.2 For a definition of the term clinically exceptional circumstances, please refer to the Definitions section of this document. CCG Tertiary Treatment For Assisted Conception Services - April 2013 V2 - FINAL Page 8 of 10

9 7.3 The clinician should provide a full history of the patient/couple s medical condition, a full description of the patient/couple s present medical condition and as comprehensive an assessment of the patient/couple s future medical condition and prognosis as the Clinical Team treating the patient/couple is able to provide. 8. Documents Which Have Informed This Policy NHS Worcestershire: Individual Funding Request Policy NHS Worcestershire: Prioritisation Framework for the Commissioning of Healthcare Services West Midlands Strategic Group Commissioning Policy 1: Guiding principles and considerations to underpin priority setting and resource allocation within collaborative commissioning arrangements West Midlands Strategic Group Commissioning Policy 4: Use of cost-effectiveness, value for money and cost effectiveness thresholds West Midlands Strategic Group Commissioning Policy 16: Prior approval West Midlands Strategic Group Commissioning Policy 9: Individual funding requests West Midlands Strategic Group Commissioning Policy 13: Defining the boundaries between NHS and private care National Institute of Health and Clinical Excellence (NICE) Clinical Guidelines CG11: Fertility HFEA Statement on Elective Single Embryo Transfer Guidelines: HFEA (Human Fertilisation Embryology Authority) Code of Practice 8 th Edition CCG Tertiary Treatment For Assisted Conception Services - April 2013 V2 - FINAL Page 9 of 10

10 Equality Analysis Report Template Your Equality Analysis Report should demonstrate what you do (or will do) to make sure that your function/policy is accessible to different people and communities, not just that it can, in theory, be used by anyone. 1. Name of policy or function: Tertiary treatment for assisted conception services 2. Responsible Manager: Mrs Helen Bryant Commissioning & Service ReDesign Manager Date Equality Analysis completed: 9 h March Description of aims of function/policy: This policy is intended to provide guidance about the clinical eligibility criteria that patients need to meet before they can receive NHS funded assisted conception services (fertility treatment like IVF, ICSI and IUI), for example, maternal and paternal age ranges and maternal BMI. This policy should be available to patients, GPs and specialist clinicians (in hospitals) so that everyone has clarity about what is and is not funded. 5. Brief summary of research and relevant data: NHS Worcestershire: Individual Funding Request Policy NHS Worcestershire: Prioritisation Framework for the Commissioning of Healthcare Services West Midlands Strategic Group Commissioning Policy 1: Guiding principles and considerations to underpin priority setting and resource allocation within collaborative commissioning arrangements West Midlands Strategic Group Commissioning Policy 4: Use of cost-effectiveness, value for money and cost effectiveness thresholds West Midlands Strategic Group Commissioning Policy 16: Prior approval West Midlands Strategic Group Commissioning Policy 9: Individual funding requests West Midlands Strategic Group Commissioning Policy 13: Defining the boundaries between NHS and private care National Institute of Health and Clinical Excellence (NICE) Clinical Guidelines CG11: Fertility HFEA Statement on Elective Single Embryo Transfer Guidelines: - HFEA (Human Fertilisation Embryology Authority) Code of Practice 8 th Edition 6. Methods and outcomes of consultation: Face to face discussions, clinical meetings, independent policy review (including all of the above noted stakeholders) with comments taken into account and discussed at various clinical and PWG meetings 7. Results of Equality Analysis Equality Analysis Protected Characteristics Age: Disability: Gender reassignment: Marriage and Pregnancy: Marriage and Civil Partnership: Race: Religion or Belief: Sex: Sexual Orientation: Any other groups: Assessment of Impact Medium risk age range evidence based NICE CG11 and to maximise the welfare of the child (HFEA) Not Applicable 8. Decisions and or recommendations (including supporting rationale) Policy criteria justified, mitigation actions identified continue to publish policy 9. Equality action plan (if required) None 10. Monitoring and review arrangements (include date of next full review) Department Public Health and Acute Commissioning Directorate Public Health and Directorate of Delivery Director Mr Simon Hairsnape Report produced by and job title Mrs Helen Bryant Commissioning & ReDesign Manager Date report produced 9 th March 2012 Date report published 19 th March 2012 CCG Tertiary Treatment For Assisted Conception Services - April 2013 V2 - FINAL Page 10 of 10