ASSISTED CONCEPTION POLICY Amendment Consultation

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1 ASSISTED CONCEPTION POLICY Amendment Consultation 16 th June 15 th August 2014 Page 0

2 FOREWORD Dr. Karen Kirkham, Local Dorset GP and Clinical Lead for Maternity, Reproduction and Family Health Removing the lower age limit and increasing the upper age limit represents a significant improvement meaning that more couples in Dorset can access treatment for assisted conception across a longer period in their lives when they may wish to try and have a family. However, we must remember that there are very real financial considerations and pressures in today s NHS and we must think about the impact of changes that we make on the whole health community. We are asking people to consider our proposals and the reasons for them and then invite a response to a series of consultation questions. We are also liaising with all of our GP practices, consultants and other colleagues so their views, alongside the views of local people can help inform future plans for the service. Page 1

3 NHS DORSET CLINICAL COMMISSIONING GROUP ASSISTED CONCEPTION POLICY AMENDMENT CONSULTATION CONTENTS Page Foreword 1 1. Introduction 3 2. Background and current situation 4 3. National and local context 5-8 a. Background and guidance b. Clinical effectiveness metrics c. Financial considerations 4. NHS Dorset CCG Governing Body proposal 9 5. Consultation Process Consultation Questions Page 2

4 1. INTRODUCTION 1.1 In April 2014, in line with the Equality Act (2010 amended 2012) NHS Dorset Clinical Commissioning Group (CCG) introduced changes to the age limits that women living in Dorset can qualify for assisted conception, including in vitro fertilisation (IVF). 1.2 The lower age limit of 30 was removed and the upper age limit was increased from 35 to 39 (with treatment being completed by the woman s 40 th birthday) as criteria for referral to assisted conception services. The widening of the age limit for access to treatment means that more couples in Dorset can have fertility treatment. Same sex and heterosexual couples have equal access to the service. 1.3 The policy with the above addendum is an interim policy for a year i.e. April 2014 March The CCG Governing Body is proposing that from April 2015 these wider age limits continue to be recognised, while the number of full IVF cycles be reduced from two to one. One full cycle of treatment would consist of both one fresh cycle and one frozen cycle, where embryos have been stored during the fresh cycle. 1.5 This document explains the context and reasons for this proposal, as well as outlining the consultation process and steps which will follow thereafter. 1.6 The consultation process is in line with Transforming Participation in Health and Care (NHS England s statutory guidance around public involvement for CCGs and NHS England commissioners) and the Governments Consultation Principles Given the sensitive nature of assisted conception, NHS Dorset CCG commenced a thorough consultation process which began in April 2014 with Dorset GPs and includes this 9 week formal written consultation which will run from Monday 16th June until Friday 15th August NHS Dorset 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 Dorset CCG will seek to remain open, engaged and transparent. (1) (2) tation-principles-oct-2013.pdf Page 3

5 2. BACKGROUND AND CURRENT SITUATION 2.1 The NHS Policy for Assisted Conception in Dorset was produced in 2011/12. It was a joint policy produced by both NHS Dorset Primary Care Trust and NHS Bournemouth and Poole Primary Care Trust. These Primary Care Trusts ceased to exist when the new NHS Dorset Clinical Commissioning Group (CCG) was established in April 2014.All policies transferred to the CCG. 2.2 The policy defines what assisted conception treatments are offered by the NHS in Dorset and sets out eligibility criteria for patients wishing to access these services. 2.3 This policy was developed following extensive stakeholder consultation with GPs, service providers (including assisted conception clinicians), patients and the public. 2.4 When published, this policy defined that the assisted conception service was restricted to women aged at the time of referral into the services, with completion of all cycles by age 37. Two cycles of IVF were offered. 2.5 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. 2.6 In April 2014, in line with the Equality Act, NHS Dorset CCG introduced changes to the age limits that women living in Dorset can qualify for assisted conception, including in vitro fertilisation (IVF). The lower age limit of 30 was removed and the upper age limit was increased from 35 to 39, with treatment being completed by the woman s 40 th birthday. 2.7 The widening of the age limit for access to treatment means that more couples in Dorset can have fertility treatment, across a longer period of their lives. 2.8 Same sex and heterosexual couples have equal access to the service. 2.9 The policy with the addendum is an interim policy for a year i.e. April 2014 March The current policy with the addendum can be seen here Widening the age limit for access to treatment has financial implications. NHS Dorset CCG identified the required additional financial investment ( 1 million) to secure the service until further consultation to inform future commissioning practice has been completed. (3) (4) (5) Page 4

6 3. NATIONAL AND LOCAL CONTEXT Background and guidance 3.1 The commissioning of assisted conception (fertility) services has a direct and significant impact on all couples identified as meeting the criteria for assisted conception services in Dorset. 3.2 National evidence based research and 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 medical conditions in the man or the women, such as age, obesity and/or lifestyle factors such as smoking or drinking. 3.3 There are a number of potential treatments for infertility 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. 3.4 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. 3.5 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. 3.6 The new guidance includes that: 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. 3.7 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). 3.8 The Equality Act (2010 amended 2012) 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. Page 5

7 Clinical effectiveness metrics 3.9 The effectiveness and cost-effectiveness, of IVF falls rapidly as age increases and female fertility declines The Human Fertilisation Embryology Authority 6 (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% 3.12 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 (6) Page 6

8 Financial considerations 3.13 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 Dorset health and social care services are facing the same pressures locally, and making small changes to the current system will not be enough. In Dorset the aggregate funding gap for the same period is calculated at around 592m, therefore fundamental transformational change is required NHS Dorset CCG must rationalise service delivery ensuring high-quality services in Dorset that are consistent with safe standards of care which are clinically and financially sustainable NHS Dorset 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 39 for access to assisted conception in April 2014 has had financial implications. NHS Dorset CCG identified the required additional financial investment ( 1 million) to secure the service until further consultation to inform future commissioning practice has been completed. Cost Modelling 3.18 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. Page 7

9 3.19 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 427,000, based on two cycles Widening the age range to ensure legal compliance would result in a potential cost pressure of between 1m and 3m, depending on the number of cycles commissioned. Number of cycles commissioned Full year affect at 5 years 3 (compliance with NICE ) 3.4 million 2 (current Dorset policy) 2.2 million 1 (proposed from April 2015) 1.3 million 3.22 A further risk which has not been modelled, is the potential switch from private to NHS providers with the amendments to the age limits. This cost has not been accounted for in the figures above, which assumes that 50% of patients continue to go privately. Page 8

10 4. NHS DORSET CCG GOVERNING BODY PROPOSALS 4.1 Having considered the national guidance, financial information and clinical evidence in detail NHS Dorset CCG Governing Body agreed the following points which were reflected in the addendum to the assisted conception policy (April 2014): Investment in Fertility services to ensure compliance with the Equality Act (2010 amended 2012) must be supported; There appeared to be no clinical justification for restriction at the lower age, therefore the lower age limit would be removed; The clinical evidence of success for women at the older age group (i.e. 40 +) was a reasonable justification for retaining an upper age limit and would allow the CCG to remain compliant with the Equality Act. The upper age limit would therefore be raised from 35 to 39, with treatment being completed by the woman s 40 th birthday. Same sex and heterosexual couples have equal access to the service. 4.2 NHS Dorset 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. 4.3 Widening the age range for access to assisted conception in April 2014 has financial implications. These increase significantly with the number of cycles commissioned. 4.4 The NICE Guideline 156 is not a statutory requirement and while it is recognised that service delivery should be aligned to best practice wherever possible, it is proposed that full implementation of NICE guideline 156 should not be adopted. 4.5 With all of this in mind, NHS Dorset CCG Governing Body is proposing that from April 2015 the wider age limits continue to be recognised, with same sex and heterosexual couples having equal access to the service, while the number of full IVF cycles 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). 4.6 In conducting a thorough consultation on the future commissioning practice of assisted conception within Dorset, with a focus upon the number of treatment cycles to be commissioned, NHS Dorset CCG is seeking to ensure that its commissioning is well informed, evidence led and informed by the views of local people. Page 9

11 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 commenced with a survey to all Dorset GPs in April This document supports a formal written consultation, which is open to all Dorset residents, people registered with a Dorset GP and other interested stakeholders for a period of nine weeks, from Monday 16 th June through to Friday 15 th August A thorough audience analysis has been carried out, to ensure that a full range of stakeholders, including hard-to-reach or vulnerable groups are given the opportunity to provide their views. This has also been informed by an equality impact assessment. 5.5 A comprehensive communication plan has been developed, based on the audience analysis 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 RSSZ-XBUY-RUSR FAO Engagement and Communications Team NHS Dorset CCG Canford House Wallisdown Road Poole, BH12 5AG 5.9 Once the consultation deadline of 15 August 2014 has passed the feedback will be collated and reported to the NHS Dorset CCG Governing Body in September NHS Dorset CCG will consider all feedback before reaching a final decision on the assisted conception policy and specification, calling upon further advice from its service-specific clinical reference group as required Both the report and the Governing Body s response will be made available in November 2014 on the CCGs website or on request using the contact details above or by calling Page 10

12 6. QUESTIONS Question 1: Please tell us whether you are (please tick one box): Member of the general public living in Dorset/registered with a Dorset GP. A Dorset 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 believe NHS Dorset CCG should be commissioning assisted conception services for the people of Dorset? Yes No Question 3: Please explain your answer to Question 2. If you answered No please go to Question 8. Page 11

13 Question 4: If you answered Yes to Question 2 - how many full cycles of treatment do you think NHS Dorset CCG should commission for women up to the age of 39, with treatment being completed by the woman s 40 th birthday? Question 5: Please explain your answer to Question 4. Question 6: Do you think NHS Dorset CCG should commission 1 full cycle of treatment for women aged 40 42? Yes No Question 7: Please explain your answer to Question 6. Question 8: Please feel free provide us with other comments about this consultation. Page 12

14 Question 9: We need to show that we are consulting with a representative demographic. To help us to do this please complete the following information. Thank you. What is your age range? Up to I do not wish to disclose my age What is your gender? Male Female Transgender I do not wish to disclose my gender What is your marital status? Single Married Civil partnership Widow/widower I do not wish to disclose this information What is your ethnic origin? Asian or Asian British Bangladeshi Indian Pakistani Other Asian background Black or Black British African Multi-cultural Caribbean Other Black background White & Asian White& Black African White & Black Caribbean Other mixed background White British English Irish Scottish Welsh Other White background Other Ethnic Group Chinese Gypsy Traveller Eastern European Page 13

15 Other ethnic group Please state. I do not wish to disclose my ethnic origin Which best describes your sexuality? Heterosexual Bisexual Lesbian Gay I do not wish to disclose my sexuality What is your religion or belief? Christianity Atheism Buddhism Islam Jainism Sikhism Judaism Hinduism None Other (please state) I do not wish to disclose my religion or belief Disability Do you consider yourself to have a disability? Yes No I do not wish to disclose this information As previously stated 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 RSSZ-XBUY-RUSR FAO Engagement and Communications Team NHS Dorset CCG Canford House Wallisdown Road Poole BH12 5AG 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 Page 14

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