18 September 2015 FERTILITY ASSESSMENT AND TREATMENT AMENDMENT CONSULTATION

Transcription

1 18 September 2015 FERTILITY ASSESSMENT AND TREATMENT AMENDMENT CONSULTATION

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3 FOREWARD We know that good commissioning happens when patients and the public are at the heart of the decisions being made. This means that, for health services to be improved, understanding and acting on what matters to local people is of the highest importance. It is our ambition and duty to make sure that all patients and public can contribute effectively to healthcare commissioning to improve the quality of those services and the experience of patients in Somerset There are very real financial pressures within the NHS and unfortunately hard decisions have to be made over which services the local NHS prioritises for increased investment. The publication of NICE Clinical Guideline 156 Fertility ( provided an opportunity for Somerset CCG and clinicians from provider organisations to discuss whether the existing policy for fertility assessment and treatment provided the best clinical outcomes for patients within the existing financial resources. Somerset CCG identified early that it was not in a financial position to invest additional resources to fully implement all of the recommendations in the NICE clinical guideline. We are asking the people of Somerset to consider our proposals, which were arrived at after careful consideration of the evidence available including within NICE guidance, and to respond to a series of consultation questions. Responses received during the consultation period will then be considered alongside the local context of Somerset CCG and our duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity and foster good relations. You may wish to review this consultation alongside our equality and patient engagement objectives, within the Somerset CCG Equality, Diversity, Human Rights and Patient Engagement Strategy. Click here for the E&D Strategy

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5 FERTILITY ASSESSMENT AND TREATMENT AMENDMENT CONSULTATION CONTENTS Section Page FOREWARD SECTION 1 INTRODUCTION... 1 SECTION 2 BACKGROUND AND CURRENT SITUATION... 1 SECTION 3 NATIONAL AND LOCAL CONTEXT... a) Background and guidance b) Clinical effectiveness metrics c) Financial considerations 2 SECTION 4 SOMERSET CCG PROPOSAL... 6 SECTION 5 CONSULTATION PROCESS... 7 SECTION 6 CONSULTATION QUESTIONS... 9

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7 FERTILITY ASSESSMENT AND TREATMENT AMENDMENT CONSULTATION 1 INTRODUCTION 1.1 This document explains the context and reasons for this proposal, as well as outlining the consultation process and steps which will follow thereafter. 1.2 The consultation process is in line with Transforming Participation in Health and Care 2013 (NHS England s statutory guidance around public involvement for CCGs and NHS England commissioners) and the Government s Consultation Principles Given the sensitive nature of fertility assessment and treatment, NHS Somerset CCG wishes to receive as many responses as possible from the people of Somerset during this consultation period. We are looking for responses from a range of different people across Somerset (including people from different protected groups) 1.4 The consultation period will run from 21 September 2015 until 31 October NHS Somerset CCG is clear that engagement with patients, carers, the public and other interested stakeholders is not limited simply to periods of formal consultation. Throughout its commissioning function NHS Somerset CCG will seek to remain open, engaged and transparent. 2 BACKGROUND AND CURRENT SITUATION 2.1 The NHS fertility assessment and treatment Policy in Somerset was produced following NICE guidance issued in 2004 and a review of the policies of the four primary care trusts which joined to form Somerset Primary Care Trust in This Primary Care Trust s guidance ceased to exist when the new NHS Somerset Clinical Commissioning Group (CCG) was established in April All policies transferred to the CCG. 2.2 The current policy defines what fertility assessment and treatment is commissioned by the NHS in Somerset and sets out eligibility criteria for patients wishing to access these services. 2.3 The current policy defines that the Somerset fertility assessment and treatment service was restricted to women aged years at the time of referral into the services. 2.4 The current policy offers two cycles of IVF. 2.5 The current policy states that the couple must have a three year period of infertility with the same partner. 1

8 2.6 Clinical options may vary between heterosexual couples and same sex couples. 2.7 Since the policy was agreed the National Institute for Clinical Excellence (NICE) Clinical Guidance has been updated and republished (NICE Clinical Guidance 156, February ) and the Equality Act (amended 2012) has come into force. This necessitated a review of the current policy. 2.8 The review was undertaken by the Somerset Clinical Commissioning Policy Forum with input from provider organisations and senior clinicians across the Somerset Healthcare Community. 2.9 The Somerset Clinical Commissioning Policy Forum made recommendations to amend the Somerset fertility assessment and treatment policy. 3 NATIONAL AND LOCAL CONTEXT Background and guidance 3.1 The commissioning of fertility assessment and treatment services has a direct and significant impact on all couples identified as meeting the criteria for services in Somerset. 3.2 Somerset CCG acknowledges that it believes both locally and nationally people (both the public and clinicians themselves) have a very diverse views about fertility treatment. These range from whether this is something that the NHS should fund at all to all infertile patients should have full access to all recommended interventions made in NICE clinical guideline National evidence based research and NICE guidance advises that although most women fall pregnant within two years of unprotected sexual intercourse, around 10% of couples are unsuccessful. This is called infertility and there are a range of reasons why couples do not conceive, including various clinical factors in the man or the women, such as age, obesity and/or lifestyle factors such as smoking or drinking. 3.4 There are a number of potential treatments for infertility in heterosexual and same sex couples, including medical and surgical interventions. However some couples can only conceive with the help of complex treatments such as in-vitro fertilisation (IVF) Intracytoplasmic sperm injections (ICSI) Intrauterine insemination (IUI) assisted conception. 3.5 IVF involves drug treatments, ultrasound-guided egg collection from the woman, mixing of eggs and sperm in the laboratory and implantation of a fertilised egg(s) into the woman s womb. Any suitable embryo(s) not used in the initial treatment, can also be frozen for future use

9 3.6 In February 2013 the NICE Clinical Guidance was updated and republished (NICE CG 156, February 2013). This guidance is not statutory but offers best practice advice on assisting people of reproductive age who have problems conceiving. 3.7 The new NICE clinical guideline 156 made many recommendations, three of which were significantly different from the current policy: Women under 40 (who meet certain criteria) be offered 3 full cycles of IVF. If the women reaches the age of 40 during treatment, the cycle should be completed but no further cycles offered. Women aged (who meet certain criteria) be offered 1 full cycle of IVF. Access to fertility assessment and treatment should be after a two year period of infertility with the same partner 3.8 NICE states that the term full cycle is used to define a full IVF treatment, which should include 1 episode of ovarian stimulation and the transfer of any resultant fresh and frozen embryo(s). 3.9 The Equality Act 2010 means that people should not be discriminated against, directly or indirectly based on age, sex, sexual orientation, gender reassignment, race, religion and belief, marital status, disability and whether they are pregnant. Clinical effectiveness metrics 3.10 The effectiveness and cost-effectiveness, of IVF falls rapidly as age increases and female fertility declines The Human Fertilisation Embryology Authority 3 (HFEA) publishes evidence of effectiveness of assisted conception; the latest published evidence is set out below Live Birth rate, per cycle started, fresh own eggs as reported by HFEA AGE Year of treatment % 41.5% % 35.9% % 29.7% % 21.7% % 10.7% % 3.4% 3 3

10 3.13 Live birth rate per cycle started, after frozen embryo transfer using women s own eggs AGE Year of treatment % 30.1% % 28.6% % 25.0% % 22.7% % 13.3% NB* Multiple embryo transfer HFEA guideline of 10% maximum multiple live birth rates was implemented in 2010 Financial considerations 3.14 The financial and demographic pressures facing the NHS mean that health and social care services must change. Continuing with the current model of care will result in the NHS facing a funding gap of around 30 billion (approximately 22% of projected costs), between 2013/14 and 2020/ In Somerset, health and social care services are facing the same pressures locally, and making small changes to the current system will not be enough. In Somerset the aggregate funding gap for the same period is calculated at around 200m, therefore fundamental transformational change is required NHS Somerset CCG must rationalise service delivery ensuring high-quality services in Somerset that are consistent with safe standards of care which are clinically and financially sustainable. 4

11 3.17 NHS Somerset CCG has finite resources to fund a whole range of health services and treatments. IVF is an expensive treatment which can often be unsuccessful. There is a need to balance funding for this treatment with all other treatments/services across the whole NHS Removing the lower age range and increasing the upper age range to 42 for access to assisted conception would have financial implications Increasing the number of cycles of IVF funded from 2 to 3 cycles would have financial implications Reducing the period of infertility with the same partner from 3 years to 2 years before access to fertility assessment and treatment would have financial implications. Cost and clinical Modelling 3.21 Some cost modelling was carried out to review the implications of widening the age range, giving consideration to the number of full IVF cycles commissioned and reducing the period of infertility with the same partner before access to fertility assessment and treatment The cost modelling was calculated using the NICE 156 (2013) costing template. Where possible local assumptions and costs have been built into the model, however it is recognised that any model has limitations and as such it is not possible to define an exact cost/risk analysis The current assisted conception contract annual value is 667,536, based on funding two cycles from which NICE assumes that on average 1.7 cycles are actually used Increasing the number of cycles to 3 would increase the number of cycles actually used to 2.2 cycles at an annual cost of 863, Reducing the number of cycles to 1 would increase the number of cycles actually used to 1 cycle at an annual cost of 392, Widening the age rate to those recommended by NICE would result in an additional cost pressure which was difficult to model as the numbers of women below 23 and who would come forward is unknown Reducing the period of infertility with the same partner from 3 years to 2 years before access to fertility assessment and treatment would increase the costs by an estimated non-recurring amount 666,000 over up to three years In a model where no additional funding was available, a number of different fertility assessment and treatment models were assessed to see which would give the best clinical outcome whilst ensuring compliance with statutory duties to eliminate unlawful discrimination, advance equality of opportunity and foster good relations. 5

12 4 NHS SOMERSET CCG PROPOSALS 4.1 NHS Somerset CCG has finite resources to fund a whole range of health services and treatments and must rationalise service delivery to ensure high quality services that are consistent with safe standards of care and are clinically and financially sustainable. 4.2 Fully implementing NICE Clinical Guideline 156 is not a statutory requirement and while it is recognised that it reflects national best practice guidance it does not take into account the local context of NHS Somerset CCG. NHS Somerset CCG has previously decided that full implementation of NICE guideline 156 should not be a commissioning priority 4.3 With all of this in mind, NHS Somerset CCG is proposing that from April 2016: There should be no change to the female age limits for which access to fertility assessment and treatment is commissioned There should be a new male age limit of <54 for access to fertility assessment and treatment as male fertility has been shown to decrease with age, with evidence of greater incidence of disability poor sperm function and DNA degradation Somerset CCG would not fund donor sperm for same sex couples. Couples who have not conceived after 6 cycles of donor insemination at a private clinic over a period of two years, will then be eligible for fertility assessment and treatment The number of full IVF cycles should be reduced from two to one. One full cycle of treatment is defined as a full IVF treatment, which should include 1 episode of ovarian stimulation and the transfer of any resultant fresh and frozen embryo(s). The period of infertility with the same partner should be reduced from 3 years to 2 years before access to fertility assessment and treatment. The successful outcome for fertility treatment reduces with the increasing age of the woman so the wait should not be prolonged over the recommended period advised in the NICE guideline 156 Neither partner should have any living children to access fertility assessment and treatment. This includes genetic and legally adopted children and offspring who are adults, but does not include foster children or stepchildren 6

13 Current policy Women s age should be between NICE Recommendation CG 156 Women aged under 42 Proposed policy Women s age should be between No male age criteria No male age criteria Male should be aged <54 Fund donor sperm for same sex couples Fund donor sperm for same sex couples Do not fund donor sperm for same sex couples Fund 2 cycles of IVF Fund 3 cycles of IVF Fund 1 cycle of IVF Access to fertility service after 3 years infertility with the same partner No restriction on IVF if one partner has children by a former partners Access to fertility service after 2 years infertility No mention of living children Access to fertility service after 2 years infertility with the same partner Neither partner should have any living children to access fertility assessment and treatment 4.4 In conducting a thorough consultation on the future commissioning practice of fertility assessment and treatment within Somerset, with a focus upon the number of treatment cycles to be commissioned and a reduction in the period of infertility required, NHS Somerset CCG is seeking to ensure that its commissioning is well informed, evidence led and informed by the views of local people. 5 CONSULTATION PROCESS 5.1 The consultation process is in line with Transforming Participation in Health and Care 2013 (NHS England s statutory guidance around public involvement for CCGs and NHS England commissioners) and the Governments Consultation Principles The consultation process will include all Somerset GP practices and patient participation groups. Somerset CCG also intends to share its consultation with PPG chairs, health forums, SEAG, Healthwatch, Maternity Services Liaison Committee, Parents / Carer Forum, voluntary sector partners, Diversity Trust, Fertility Fairness and HEFA, and fertility service providers. 5.3 This document supports a consultation, which is open to all Somerset residents, people registered with a Somerset GP and other interested stakeholders for a period, from 21 September 2015 through to 31 October Somerset CCG believes that it will reach a comprehensive audience, to ensure that a full range of stakeholders, including hard-to-reach or vulnerable groups are given the opportunity to provide their views in writing or electronically. This has also been informed by an equality impact assessment. 7

14 5.5 A comprehensive communication plan has been developed, and includes mailings, press releases, social media coverage and online posting. 5.6 Listed below are a series of questions relating to the information provided within this consultation document. 5.7 You can respond to the questions online by using this link You can reply by post, by printing section 6, completing and returning to: Freepost RRKL-XKSC-ACSG Engagement and Communications Team Somerset CCG Wynford House Lufton Way Yeovil Somerset BA22 8HR 5.9 Once the consultation deadline of 31 October 2015 has passed the feedback will be collated and reported to the NHS Somerset CCG Clinical Operations Group by the end of NHS Somerset CCG will consider all feedback before reaching a final decision on the fertility assessment and treatment policy Both the report and the Clinical Operations Group response will be made available on the CCGs website or on request using the contact details above or by calling

15 6 QUESTIONS Question 1: Please tell us whether you are: (please tick one box): Member of the general public living in Somerset/registered with a Somerset GP A Somerset GP An NHS provider A social care provider A private provider A representative from the voluntary sector Other (please specify) Question 2: Having read the information provided above do you agree NHS Somerset CCG should be commissioning fertility assessment and treatment services for the people of Somerset? Strongly agree Partially disagree Partially agree Strongly disagree No view Question 3: How many full cycles of treatment do you think NHS Somerset CCG should commission for women between the ages of 23-39? One Two Three Question 4: Do you agree that NHS Somerset CCG should not commission fertility treatment for women aged >40? Strongly agree Partially disagree Partially agree Strongly disagree No view Question 5: Do you agree there should be a new male age limit of <54 for access to fertility assessment and treatment? Strongly agree Partially disagree Partially agree Strongly disagree No view 9

16 Question 6: Do you agree that the period of infertility with the same partner should be reduced from 3 years to 2 years before access to fertility assessment and treatment? Strongly agree Partially disagree Partially agree Strongly disagree No view Question 7: Do you agree that, to pay for increased costs of access to treatment caused if the period of infertility with the same partner is reduced from 3 years to 2 years, the number of IVF cycles funded by Somerset CCG should be reduced from 2 cycles to 1 cycle?. Strongly agree Partially disagree Partially agree Strongly disagree No view Question 8: Do you agree that neither parent should have any living children in order to access fertility assessment and treatment? Strongly agree Partially disagree Partially agree Strongly disagree No view Question 9: Do you agree that Somerset CCG should stop funding donor sperm for same sex couples? Strongly agree Partially disagree Partially agree Strongly disagree No view Please feel free provide us with any other comments about this consultation. 10

17 Somerset CCG is committed to providing equal access to healthcare services to all members of the community. To achieve this, gathering the following information is essential and will help us ensure that we deliver the most effective and appropriate healthcare. There are some guidance notes on the next page. Responding to these questions is entirely voluntary and any information provided will remain anonymous. What is your age? please write in the box below What is your gender? Male Female Prefer not to state Prefer not to state Do you/have you ever identified yourself as trans or transgender? Prefer not to state Yes No What is your status? Single Widow(er) Separated Are you a carer? for a relative or friend Yes No Married/Civil partnership With partner Divorced/Dissolved Prefer not to state Prefer not to state Are you pregnant or have you had a baby in the last six months? Prefer not to state Yes No Not applicable Which of the following best describes how you think of yourself? Prefer not to state Heterosexual (attracted to the opposite sex) Bisexual (attracted to both sexes) Lesbian/Gay (attracted to the same sex) Other Do you consider that you have a disability? Prefer not to state Yes No I don t know If yes, how would you describe your disability? Prefer not to state Sensory Learning Mental Health Physical Other Do you have a religion or belief? Prefer not to state Buddhism Islam No Religion Christianity Judaism Other Religion/Belief Hinduism Sikhism What is your first language? please write in the box below Prefer not to state Please tell us your ethnic group Prefer not to state White British Irish Gypsy, Romany or other traveller heritage Any other White background, please state Dual-Heritage White and Black Caribbean White and Asian White and Black African Any other Dual-Heritage, please state Asian or Asian British Indian Pakistani Bangladeshi Any other Asian background, please state Black or Black British Caribbean African Any other Black background, please state Chinese or other ethnic group Chinese Any other ethnic background, please state

18 Guidance notes to help you complete the form If there is any information that you do not want to provide just tick the box Prefer not to state Do you/have you ever identified yourself as trans or transgender? The process of transitioning from one gender to another. A person who is transgender is someone who expresses themselves in a different gender to the gender they were assigned at birth. Although legislation covers gender reassignment, for the purposes of analysis we adopt the term trans to encompass the wider community. What is your status? Marriage is defined as a legally or formally recognised union between a man and a woman or two people of the same sex. Same-sex couples can also have their relationship legally recognised as a civil partnership. Civil partners must be treated the same as married couples on a wide range of legal matters. Are you a carer? Carers provide care for anyone (such as a parent, child, other relative, an elderly person, friend or neighbour) who has any form of disability (sensory loss, physical, learning disability, mental health problem) long or terminal illness. Which of the following best describes how you think of yourself? Whether a person s sexual attraction is towards their own sex, the opposite sex or to both sexes. Do you consider that you have a disability? The Equality Act 2010 says that a person has a disability if they have a physical or mental impairment which has a long term and substantial adverse effect on their ability to carry out normal day to day activities. Physical or mental impairment includes sensory impairments such as those affecting sight or hearing. Do you have a religion or belief? Religion has the meaning usually given to it but belief includes religious and philosophical beliefs including lack of believe (such as atheism). Generally, a belief should affect your life choices or the way you live for it to be included in the definition. Please tell us your ethnic group Refers to the protected characteristic of race. It refers to a group of people defined by their race, colour and nationality (including citizenship), ethnic or national origins.

19 As previously state in section 5, you can respond to the questions online by using this link: You can reply by post using the following FREEPOST address: Freepost RRKL-XKSC-ACSG Engagement and Communications Team Somerset CCG Wynford House Lufton Way Yeovil Somerset BA22 8HR If you are hard of hearing, have sight impairment, English is not your first language or you require this in an easy read format please contact the Engagement and Communications Team on or telephone Thank you for your time completing this questionnaire