National Infertility Group Report January 2013

9. Summary of recommendations

Infertility Treatment Vision

• The National Infertility Group suggests that 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."

Vision for IVF

• The National Infertility Group suggest that the following Vision be considered for adoption by Ministers for IVF/ICSI treatment: "The NHS will meet the needs of all eligible infertile couples within 12 months of being diagnosed as requiring IVF or ICSI treatment."

Increased investment announced by Scottish Government Ministers, has been made available to enable this to be achieved by March 2015.

Definition of a Cycle of IVF

• The Group recommends that NHS Boards should be advised that the definition of a cycle is considered to be one which includes the replacement/transfer of any viable embryos which have been frozen and stored after the fresh cycle, provided the couple still fulfil access criteria.

Single Embryo Transfer Core Principles

• The Group recommends that NHS Boards are advised that there is now a national set of core principles on single embryo transfer. These principles have been agreed by representatives of all four tertiary centres and should be used.

Equalities Act

• The Group recommends that NHS Boards 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 light of the Equalities Act (2010)⁴⁸, taking into account the 'welfare of the child' provision in the HFE Act 2008⁴⁹.

Preventative Work

• The Group further recommends that any central funding for infertility services includes a sum for preventative work, aimed at highlighting the risks to fertility of delayed conception and health related behaviours.

Gametes

• The National Infertility Group recommends a stand alone Group to look at the provision of Gametes in the NHS in Scotland. A representative from each of the four NHS centres should be involved in this work. The Group has suggested some further work around fertility preservation which could also be considered by a Gametes Group.

9.1 Information to NHS Boards

• The National Infertility Group recommends the Scottish Government drafts new guidance for NHS Boards to complement this work and the forthcoming waiting time, but separately and urgently gives new access criteria, in the form of a Chief Executive Letter to NHS Board Chief Executives, to be implemented by 1 April 2013, to NHS Boards.
• The Group recommends that a meeting is held with regional leads in secondary care during spring 2013 to ensure that the Pathways are used in all NHS Board areas.

9.2 Implementation of criteria

190. All new patients from 1 April 2013 must meet all criteria. The Group recognises that criteria changes will have an impact on some existing patients, and this needs to be handled sensitively by NHS Boards, who are ultimately responsible for meeting the needs of their patients. NHS Boards should ensure consistency in their approach.

191. Timing of the implementation of new criteria is key, and the Group recommends a phased approach to implementation. The Group accepts that patients in some areas may find some of the recommendations difficult, but the majority will benefit over the next few years.

192. Scottish Government Ministers and NHSScotland will need to be satisfied that the four NHS Centres have the appropriate support, funding and capacity beyond the £12 million committed by the Scottish Government.

193. The sustainability of NHS IVF provision is essential for the success of the phased approach set out below. Scottish Government funding should remove the current backlog to achieve a 12-month waiting time. But the long term sustainability of both the 12-month waiting time commitment, and changes to eligibility criteria, will need recurring funds from the Scottish Government along with further investment by Boards to ensure that no matter where couples live in Scotland, they will be able to access the same level of service.

194. The National Infertility Group recognises that three full cycles of IVF gives patients the optimum chance of a live birth and the Group remains committed to the implementation of this criterion across Scotland. However, due to long waiting times, and uncertainty regarding the impact of new treatment pathways, it is recommended that up to two full cycles of treatment be the normal pathway for couples from 1 April 2013. This is already the case for 80% of couples across Scotland. Phasing in new access criteria recommendations over the coming years, including moving to three cycles of treatment, will give NHSScotland time and capacity to recover waiting times and establish equity.

9.3 Definition of infertility from 1 April 2013

Infertility with an appropriate cause, of any duration - all couples

or

Unexplained infertility of 2 years - heterosexual couples

Unexplained infertility following six to eight cycles of donor insemination - same sex couples

9.4 Access criteria recommendations for all couples from 1 April 2013

• Eligible patients may be offered up to two cycles of IVF/ICSI where there is a reasonable expectation of a live birth.
• 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.
• BMI of female partner must be above 18.5 and below 30.
• Neither partner to have undergone voluntary sterilisation, even if sterilisation reversal has been self-funded.
• 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.
• 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.
• 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.
• Couples must have been co-habiting in a stable relationship for a minimum of 2 years.
• 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.
• 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.
• 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.
• Patients should also be advised at the outset of any constraints to storage time and costs that may apply.

9.5 Phasing in of further criteria

195. Group recommends a short focused review at end March 2015 to reflect on the implementation of the access criteria changes from 1 April 2013 and emerging clinical evidence in light of new treatment pathways, and also to consider the recurring service cost before any further criteria, including a third cycle of treatment are implemented.

196. Consideration should be given to an earlier review if waiting times have reduced to 12 months across Scotland, and modelling proves quickly to be too conservative.

197. The Group is keen to introduce the following criteria, when affordable and suggests the 2015 review proposes a timescale for further reassessment.

The recommended next step would be adoption by all NHS Boards of:

• Eligible patients may be offered up to three cycles of IVF/ICSI where there is a reasonable expectation of a live birth
• One partner has no genetic child - as long as all further criteria are met by both partners

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

It is important that decisions on these criteria introductions should be taken at national level to ensure that equity is retained across Scotland as services are expanded.