National Infertility Group Report January 2013

8. What do we recommend?

8.1 Infertility in the context of the Healthcare Quality Strategy for NHSScotland

153. The 20:20 Vision provides the strategic narrative and context for taking forward the implementation of the Healthcare Quality Strategy for NHSScotland², and the required actions to improve efficiency and achieve financial sustainability. The National Infertility Group suggests the following Vision be considered for adoption by Ministers for all levels of infertility treatment: "The NHS will provide equitable, timely investigation, intervention and/or support for couples with infertility needs."

154. The Group supports a further vision for IVF/ICSI treatment: "By 2020, the NHS will meet the needs of all eligible infertile couples within 12 months of being diagnosed as requiring IVF or ICSI treatment." The 20:20 Vision is what Scotland's healthcare system will look like by the year 2020. In the context of infertility services, the National Infertility Group suggests the following as narrative for the approach we will take to achieve this:

• An integrated approach to infertility services, and more effective working with third sector organisations such as the Scottish Health Council³⁵ and Infertility Network Scotland¹⁴.
• A focus on prevention, and being aware of the risks of infertility and declines of fertility.
• When hospital treatment is required, and cannot be provided in a community setting, day case treatment should be the norm and it should be provided in the place which can guarantee highest quality, safety and a good experience.
• A focus on ensuring that people get back into their home or community environment as soon as appropriate, with minimal risk of re-admission.
• Care will be provided to the highest standards of quality and safety.

155. The Group's Vision fits well with the manifesto commitment made by the Scottish Government in April 2011: "We will continue to address the variation in waiting times for IVF treatment and during the next Parliament we will work to establish a maximum waiting time of 12 months."

8.2 Raising awareness of the risk of infertility in the general population

156. It is important that women are made aware of the age-related decline in their fertility and the increased risk of maternal and fetal complications associated with obesity and smoking.

157. It is vital that primary care services ensure that all women of childbearing age have the opportunity to optimise their weight before pregnancy. Advice on weight and lifestyle factors such as smoking, drinking alcohol and information on their declining fertility should be given during family planning consultations.

158. Couples presenting with concerns about their fertility should be given advice and support on weight, body mass index and the importance of stopping smoking and drinking if planning a family, prior to being referred for treatment in secondary care.

8.3 Improving the pathway of care

159. This would, in turn, lead to an appropriate streamlined referral system beginning with Primary Care providers within Scotland, where lifestyle advice is given and basic investigations carried out prior to onward referral. In secondary care services more complex investigations may be undertaken, with appropriate treatment provided in a timely and cost-effective manner. Thereafter couples requiring tertiary care services, including IVF, are referred to specialist centres appropriately and timeously.

160. An Infertility Referral Pathway and explanatory notes have been developed showing the expected pathway from primary to secondary care, with a further pathway outlining secondary to tertiary care. These have been updated to reflect access criteria as agreed by the Group, and have been amended to reflect comments from BMA Scotland, and a number of GP representatives. Whilst the Group is happy for the mode of referral to be left to individual NHS Boards as not all areas use the same referral systems, the Pathway must be followed in the timeframe indicated.

161. The aim of both Pathway documents is to guide timely, appropriate investigations and referral whilst providing consistent advice, from primary care through to tertiary care, which can improve fertility, enable couples to access treatment (where appropriate), optimise the success rates of treatment and reduce pregnancy risk. The Pathways should be refreshed as necessary, in line with the 2015 review.

162. The Group recommends that a meeting is held with regional leads in secondary care in early 2013 to ensure that the Pathways are used in all Board areas.

163. Further discussions should take place within NHS Boards to ensure that GPs are made aware of forthcoming changes to access criteria, in particular, support in weight loss and smoking cessation, and how they can support patients who need to make lifestyle changes to access treatment.

164. The Pathways are set out in full at Appendix J.

8.4 Better patient support

165. The Group recommends a more person centred approach with the patient's needs seen within the context of various other services including where necessary smoking cessation, weight management, and eventually maternity services for many couples. The Group's Pathways documents will help with some of this.

166. NHS Boards and patient groups should develop a more joined up and collaborative approach with clearer roles and responsibilities, as improvement in this area is likely to improve public confidence overall as well as the patient experience.

167. The illustration given earlier in the report at 6.4 of NHS Lothian and Infertility Network Scotland is a good example of collaborative working.

8.5 The same criteria for all Health Boards

168. It will no longer be acceptable for Boards to have different criteria in different areas. There will be no equity if Boards maintain separate access criteria and the Scottish Government should put in place robust plans so that a single agreed set of national access criteria for Scotland is in place and stays in place.

8.6 Definitions of a cycle of treatment and when waiting time clock starts and stops

8.6.1 Definition of 'one cycle of IVF'

169. The report from EAGISS⁶ set out the number of NHS funded cycles of IVF for eligible patients as: Couples meeting the above eligibility criteria should be entitled to a maximum of three NHS funded cycles of assisted conception. Each couple should be entitled to a minimum of two transfers of fresh embryos obtained following a full cycle of down-regulation, ovarian stimulation and egg recovery. Where frozen embryos are available, the third NHS funded cycle should involve transfer of stored embryos.

170. The National Infertility Group has reached agreement that the definition of 'one full cycle of IVF' should be: "One fresh cycle includes ovulation induction, egg retrieval, fertilisation, transfer of fresh embryos followed by freezing of suitable embryos and subsequent replacement of these, provided the couple still fulfil access criteria. Self-funding for replacement will be required if the couple no longer fulfil access criteria. If suitable embryos are frozen then these should be transferred before the next stimulated treatment cycle as this will avoid ovulation induction and egg collection, both of which carry risks for the woman."

171. Whilst the Group understands that all NHS Boards across Scotland have voluntarily moved to this definition, we believe that it should remain a recommendation.

8.6.2 Definition of waiting time

172. We recommend the following definitions of the waiting time for IVF treatment after treatment:

• Clock starts when tertiary care agrees that treatment is required and all access criteria are fulfilled.
• Clock stops when the couple reaches the top of the waiting list and is seen for screening and consent.

173. Time between clock starting and stopping should be no more than 12 months and is the 'Waiting time'.

174. Data should measure the Waiting time, but also:

• time from referral from secondary care to the point of clock starting, and time from the clock stopping until first administration of the medical drug used to initiate the treatment cycle. If large variations exist in these additional measurements, then the pathways may need to be reviewed, and service development/re-design be considered. The short life Data Group should help to define these measurements.

175. Couples must fulfil all of the access criteria before being placed on the waiting list, including recommended BMI and non-smoking criteria. Smoking status should not rely on patient report but should be assessed using a cotinine test, which indicates nicotine use in the previous few days. It is important that couples do not reach IVF tertiary centres unless they meet all access criteria.

8.7 Recommended criteria for treatment and the date of introduction

176. The Group has considered criteria for tertiary level treatment only, examining current evidence of clinical effectiveness and best practice alongside the care dimensions of the Quality Strategy² and 20:20 Vision. The Group has also considered, where appropriate, obstetric, fetal and neonatal risks, along with the Scottish Government's National Outcome of giving every child the best possible start in life. The recommendations are based on the assumption that patients must be ready for treatment, and therefore must meet all criteria before they can be referred:

8.7.1 Definition of infertility for couples

• Infertility with an appropriate cause, of any duration

or

• Unexplained infertility of 2 years - heterosexual couples
• Unexplained infertility following six to eight cycles of donor insemination - same sex couples

IVF treatment should be offered to couples who meet all of the following criteria:

8.7.2 Welfare of the child

• The HFE Act¹² extract relevant to the welfare of the child provision is set out as follows:

"No treatment services regulated by the HFEA may be provided unless account has been taken of the welfare of any child who may be born as a result (including the need of that child for supportive parenting) and of any other child who may be affected by the birth."

8.7.3 Sterilisation

• Neither partner to have undergone voluntary sterilisation.
• Couples who have undertaken a sterilisation reversal, even if paid for privately, will not be offered treatment.

8.7.4 Stable relationship

• Couples must have been co-habiting in a stable relationship for a minimum of 2 years.

8.7.5 Other medical conditions

• GPs and treating clinicians must take into account other medical conditions and offer pre-conception counselling with an appropriate specialist if required.

8.7.6 Previous or existing children

• One partner has no genetic child - this will eliminate cases where one partner is disadvantaged because their partner has a genetic child. A caveat should be added stating that if a woman has previously given up a child for voluntary adoption, then she would remain eligible for treatment.
• However, both partners must meet all other criteria without exception, including neither partner previously sterilised or received the maximum number of IVF treatment cycles in a previous relationship.

Members of the Group aspire to this as a criterion. However, until equity and reasonable waiting times are established along with further evidence on the effects this may have on the service, the Group's recommendation is to keep the current criterion.

• Currently the criterion that there should be no child in the home, as outlined in EAGISS⁶, stands.

8.7.7 Smoking, alcohol and drugs*

• Both partners must be non-smoking for at least 3 months before treatment and continue to be non-smoking during treatment.
• Both partners must abstain from illegal and abusive substances.
• Both partners must be Methadone free for at least one year prior to treatment.
• Neither partner should drink alcohol prior to or during the period of treatment.

*There is a responsibility on patients to follow these access criteria which are in the interest of the welfare of the child and the effectiveness of treatment. Clinicians may conduct testing to ensure that patients adhere to the criteria, and in the event of a positive result, the patient will not be given treatment.

Where there is a known history of former drug addiction, alcohol abuse or domestic violence, patients must receive appropriate counselling prior to being referred as suitable for treatment, and will still be required to meet the welfare of the child criteria. NHS Boards should ensure engagement with the appropriate counselling services.

8.7.8 Body Mass Index (BMI)

• BMI of female partner must be above 18.5 and below 30. Couples should be advised that a normal BMI is best for both partners.

The International Classification of adult underweight, overweight and obesity according to BMI:

• BMI less than 18.5 - underweight
• BMI between 18.5 and 24.9 - normal weight
• BMI between 25.0 and 29.9 - overweight
• BMI 30.0 or above - obese
• Source: World Health Organization³ website.

8.7.9 Age - female

• Fresh cycles of treatment must be initiated by the date of the female partner's 40th birthday, and all subsequent frozen transfers must be complete before the woman's 41st birthday.

8.7.10 Equalities Act

NHS Boards should be reminded that there should be no discrimination in the provision of infertility services on the grounds of race, faith, gender identity, sexual orientation or disability. NHS Boards should be advised to reconsider their current policy in the light of the Equalities Act (2010)³⁶. The requirement of the Act has to be balanced against the duty of licensed provider units under the HFE Act¹². An extract from the welfare of the child provision is set out below.

• No treatment services regulated by the HFEA (including intra-uterine insemination - IUI) may be provided unless account has been taken of the welfare of any child who may be born as a result (including the need of that child for supportive parenting) and of any other child who may be affected by the birth.

8.8 Number of cycles

177. Eligible patients may be offered up to three cycles of IVF/ICSI where there is a reasonable expectation of a live birth. Clinical judgement should be used to determine this.

However, until equity and reasonable waiting times are established across Scotland, and the implications of new pathways and new definitions are understood, the Group's recommendation is to constrain this to up to 2 cycles of IVF/ICSI where there is a reasonable expectation of a live birth. Clinical judgement should be used to determine this.

178. Response to treatment must be clinically assessed at the end of each cycle. Where indications are that treatment is unlikely to be clinically effective, no further treatment will be given.

179. An assessment of ovarian reserve should be performed before the first cycle. If this is judged to be poor (e.g. low AMH, or low antral follicle count, or high FSH) eligible patients can be offered one cycle of treatment, if, in the treating clinician's view, it is in the patients' interest. This is on the understanding that, if there is no response to stimulation or a poor response (<3 eggs retrieved), no further IVF/ICSI treatment will be offered.

8.8.1 Previous cycles - NHS

180. NHS funding will not be provided to couples where either partner has already received the number of NHS funded IVF treatment cycles supported by NHSScotland regardless of where in the UK they received treatment.

181. No individual (male or female) can access more than the number of NHS funded IVF treatment cycles supported by NHSScotland, under any circumstances, even if they are in a new relationship.

8.8.2 Previous cycles - self-funded

182. NHS funding may be given to those patients who have previously paid for IVF treatment, if in the treating clinician's view, the individual clinical circumstances warrant further treatment.

8.8.3 Frozen embryos

183. It is essential that patient consent is sought for the freezing of embryos and, if given, couples are informed at the outset that once they have exhausted their NHS quota of IVF, or have a successful live birth, or no longer meet any of the eligibility criteria, self-funding for any future transfers will be required.

184. Patients should also be advised at the outset of any constraints to storage time and costs that may apply.

8.9 Waiting list management

185. Patients should not be placed at the end of the waiting list following an unsuccessful treatment cycle.

• Normally, there would be a gap of 6 to 11 months between cycles of IVF, for patients who remain eligible.

8.10 Increased activity within current capacity to reduce waiting times

186. The Scottish Government has established funding to support the 12-month waiting time for IVF and will include it as a HEAT target for the period 2013-15 to underpin the commitment.

187. Individual level data cannot be collected, therefore, anonymised aggregate data tables will be collected from each of the four units. The Scottish Government and Information Services Division¹ will continue to discuss the detail of this during 2013.

8.11 Communication

188. A short Communications plan has been produced, with key themes to be transmitted by the Government once the recommendations of the National Infertility Group have been considered by Ministers. These themes take into account the various stakeholders with an interest, namely, NHS Boards, fertility practitioners, general practitioners and the general public.

189. This plan provides a clear framework to help ensure that stakeholders have access to the right information about all aspects of the provision of infertility treatment in Scotland. An essential role will be around education and health promotion, including educating the public about the 'lifespan' of their fertility. Diet and lifestyle measures can improve the natural chance of conception as well as the chance of success of any treatment, and furthermore reduce risks to the pregnancy.