Cass Review – implications for Scotland: findings report

Current Context

This section provides a brief update on Scotland’s Young People Gender Services, the current position on the prescribing of puberty-supressing hormones (also referred to as puberty blockers) and gender-affirming hormones (also referred to as cross-sex hormones) and the research that the Scottish Government has commissioned in this area to date.

Definitions

Gender incongruence is defined as a marked and persistent incongruence (difference) between an individual’s experienced gender and their sex recorded at birth. There is a distinction between gender incongruence arising in childhood before the onset of puberty, and where the incongruence has persisted for at least two years, and in adolescence after the onset of puberty. At any developmental stage, gender variant behaviour and preferences alone are not a basis for making the diagnosis.

Gender dysphoria is defined as a clinically significant distress and/or impairment of function associated with gender incongruence.

Gender identity healthcare is used to encompass a range of non-surgical and surgical interventions available via the NHS in Scotland for people seeking medical support to manage distress caused by gender incongruence, and/or gender dysphoria.

Gender Identity Services

Gender identity clinics (GICs) in Scotland offer assessment and access to medical interventions in relation to gender incongruence and/or dysphoria. Currently, the National Gender Identity Clinical Network for Scotland includes four GICs providing clinical assessment, treatment and specialist support to adults in Scotland. These are based within four Health Boards: NHS Grampian, NHS Greater Glasgow and Clyde (GGC), NHS Highland and NHS Lothian.

A separate gender service for children and young people is based within NHS GGC’s Gender Service at the Sandyford Clinic and accepts referrals from all Health Boards across Scotland for children and young people up to the age of 18 years old.

There are several different entry routes to Gender Identity Services, such as via a GP, a psychologist, a paediatrician and historically through self-referral.

Sandyford Young People’s Gender Service

The Sandyford Clinic provides integrated specialised sexual health services across NHS GGC, delivering sexual, reproductive and emotional health services. It also provides a Gender Service for those who are uncomfortable or uncertain about their gender identity, and adult transgender and non-binary people considering feminising or masculinising treatment.

Both the Adult Gender Service and the Young People Gender service at the Sandyford Clinic are delivered by a multi-disciplinary team (MDT). The adult service is for anyone over the age of 17 years. The Young People’s Gender Service is for those under the age of 18 years.

Management information provided by NHS GGC indicates that as of February 2024 there were around 1,100 children and young people on the waiting list for the young people gender service at the Sandyford, with typical waiting times of one to three years. Data from Q3 2023 shows that at that time 1253 people were on the waiting list. Approximately 72% of them had been waiting longer than one year and 39% longer than two years with 14% waiting longer than three years. The number of young people seen per year by the Young Persons Service in the last five years is shown in the table below.

Individuals

• 2019: 303
• 2020: 215
• 2021: 270
• 2022: 148
• 2023: 90
• Total: 478

Attendances

• 2019: 762
• 2020: 434
• 2021: 865
• 2022: 519
• 2023: 216
• Total: 2,796

A key challenge for both Adult and Young People’s Gender Services at the Sandyford Clinic has been the recruitment and retention of clinical staff, with the clinic being unable to fill several vacancies in recent years, affecting how many children and young people who can be seen safely. The reasons for this are varied but include the highly specialist nature of the field and the polarised context of the work. These recruitment challenges are mirrored in NHS England, as reflected in the Cass Review.

NHS GGC conducted a clinical review of their waiting list. As part of that process children and young people and their families waiting to be seen were asked a series of questions relating to their current situation. They reported finding the process of clinical waiting list validation helpful. A snapshot of the findings is detailed below:

• 49% of those asked were self-referrals, 30% were referred by their GP and the remainder from other sources.
• 73% of those questioned were natal females with male gender identity.
• 55% of those on the waiting list had a formal diagnosis of a neurodevelopmental condition with a further 15% awaiting a formal diagnosis.
• 35% of those asked had a formal co-existent mental health diagnosis although when asked about a range of symptoms, 58% of those on the waiting list registered scores in the clinical range for symptoms of anxiety, depression and suicidal or self-harm thoughts.

NHS GGC has contracted with a consortium of third sector support for this population to address social isolation, inactivity and mental and emotional wellbeing. The range of support includes physical activity groups, 1:1 coaching and group therapy.

The Young People’s Gender Service at Sandyford can refer children to paediatric endocrinology services in either NHS GGC or NHS Lothian for further specialist assessment around pubertal stage, and/or to consider if it may be appropriate to prescribe puberty-suppressing hormones, or gender-affirming hormones for selected young people. Only a minority of young people referred to the young people’s service proceed to being referred to paediatric endocrinology services and not all of those will be prescribed puberty-suppressing or gender-affirming hormones.

Puberty-suppressing hormones and gender-affirming hormones

Medicine Regulation

The regulation for the licensing of medicines is reserved to the UK Government. The regulations involved are the Human Medicine Regulations 2012. The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK regulator for medicines and medical devices. Before a medicine can be marketed, a pharmaceutical company must be able to demonstrate its safety, quality and efficacy. This is done through a series of rigorous clinical trials, consisting of four phases. Applications to the MHRA for a marketing authorisation, sometimes referred to as a licence, must include data demonstrating the quality, safety and efficacy of the medicine. After detailed assessment and providing the data is satisfactory, a licence may be granted. It is granted to the manufacturer to market the medicine for a specific indication and not to the medicine itself.

Puberty-supressing hormones

Gonadotrophin-releasing hormone (GnRH) analogues are licensed for use in the UK for precocious puberty in children and several different indications in adults, including the treatment of endometriosis, precocious puberty, infertility, anaemia due to uterine fibroids (together with iron supplementation), breast cancer, prostate cancer and before intra-uterine surgery.

There are no licensed medicines in the UK for the specific indication of supressing the onset of puberty.

GnRH analogues are currently prescribed off-label (which means outside of the licensed indication) for the purpose of supressing puberty. Prescribing medicines off-label may be necessary if, for example, there is no suitably licensed medicine to meet the person’s need (often the case with children where a medicine is licensed only for adult patients), or the prescribing is part of research. Occasionally, clinicians may prescribe a medicine when the product licence does not cover the indication if they consider there would be significant clinical benefit to an individual, but only in line with local Health Board governance processes and protocols.

Prescribing governance

Prescribers should usually prescribe licensed medicines in accordance with the terms of their marketing authorisation. However, they may prescribe unlicensed medicines or medicines ‘off-label’ (outside the UK marketing authorisation) where, based on an assessment of the individual person, they conclude, for medical reasons, that it is necessary to do so to meet the specific needs of that person.

Prescribers are professionally and clinically responsible for any medicine that they prescribe. The responsibility that falls on them, and on the dispenser of that medicine, when prescribing either a medicine off-label or an unlicensed product is greater than when prescribing a licensed medicine within its licence.

The GMC guidance on Good Practice when Prescribing and Managing Medicines and Devices advises that when prescribing in these circumstances: the prescriber must be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy; take responsibility for prescribing the medicine and for overseeing the person’s care, monitoring and any follow up treatment, or make sure that arrangements are in place for another suitable doctor to do so; and make a clear, accurate and legible record of the reasons for prescribing an unlicensed/off-label medicine.

Taking GnRH analogues stops the progress of puberty by competing with the body’s natural gonadotrophin releasing hormone. This competition blocks the release of two gonadotrophin hormones, Follicle Stimulating Hormone (FSH) and Luteinising Hormone (LH), from the pituitary gland. These two hormones play an important part in sexual maturation during puberty.

GnRH analogues have been used in the UK and other countries as a component of gender identity healthcare for several years in a small number of children/young people exhibiting gender dysphoric distress. However, as highlighted in the Cass Review, the evidence base for this indication is weak and the risk of short- or long-term harm remains uncertain. In addition, Dr Cass highlighted that a focus purely on puberty suppressants and belief in their efficacy has meant that other treatment options, including medicines, have not been studied or developed to support children and young people, which is ultimately a disservice to them.

It is worth noting that the prescribing of puberty-suppressing hormones forms a very small part of the clinical pathway for gender incongruence and/or dysphoria within the NHS in Scotland, which, for those under 16 years of age, consists primarily of talking therapies.

Management data provided by NHS GGC and NHS Lothian, from 2012 to December 2023, show that around 90 to 100 young children and young people have received puberty-suppressing hormones and/or gender-affirming hormones having been referred from the Sandyford Clinic to paediatric endocrinology for further assessment. In April 2024, 21 patients were recorded as attending in NHS GGC and the remaining 22 in NHS Lothian to access puberty-suppressing hormones and/or gender-affirming hormones. It is worth noting that not all children and young people will be on both puberty-suppressing hormones and gender-affirming hormones.

We recognise that this may be an under-representation of those currently on waiting lists to be assessed or those accessing puberty supressing hormones privately. The numbers of children and young people referred to endocrinology have fallen over the last three years due to slow throughput in the service, exacerbated by staff recruitment challenges.

Gender-Affirming Hormones

Gender-affirming hormones (masculinising or feminising hormones) are sex hormones prescribed as part of a medical transition for gender incongruence and/or dysphoria. Testosterone is prescribed to transgender males (female to male) and oestrogen for transgender females (male to female).

Prescribing of Puberty-Suppressing and Gender-Affirming Hormones

UK Government restrictions on the Prescribing of GnRH Analogues

On the 29 May 2024, the Department of Health and Social Care (DHSC), in response to one of the recommendations in the Cass Review, introduced emergency restrictions through a temporary order (which came into effect from the 3 June 2024) to prevent the sale or supply of GnRH analogues to suppress puberty as part of treating gender incongruence and/or gender dysphoria in children and young people who are under 18 years of age. These restrictions mean it is a criminal offence for a doctor, pharmacist or any other individual to sell or supply a GnRH analogue to child or young person under the age of 18 years other than in the specific circumstances. The restrictions will affect private prescriptions for GnRH analogues authorised by non-UK registered and UK registered prescribers although the way in which they are affected differs depending on whether the prescriber is registered in the UK.

Interim policy setting out the position of NHS England on the prescribing of puberty-suppressing hormones and gender-affirming hormones

In an interim policy published in July 2023, NHS England announced that it would only make puberty-suppressing hormones a treatment option for gender dysphoria available as part of a research study being established by the National Institute of Health and Care Research (NIHR). This study is not expected to go live until December 2024 at the earliest.

On 12 March 2024, NHS England published an updated clinical policy commissioning position, stating that puberty-suppressing hormones were no longer available as a routine commissioned treatment option for the treatment of children and young people who have gender incongruence and/or gender dysphoria. Whilst this had technically been its position since July 2023, in the absence of the establishment of the proposed research study, this updated position means that that there will be no new prescribing of puberty-suppressing hormones as a treatment for gender dysphoria in NHS England until the research study is established.

In England, gender-affirming hormones are available as a routine commissioned treatment option for young people with continuing gender incongruence and/or gender dysphoria from around their 16th birthday subject to individuals meeting the eligibility and readiness criteria set out in a commissioning policy. The policy is restricted to certain age groups as there is insufficient evidence to confirm safety in those age groups not included in the policy.

The position of the NHS in Scotland on the prescribing of puberty-suppressing hormones and gender-affirming hormones

The Medical Directors of NHS GGC and NHS Lothian wrote to the CMO in March 2024 to advise of their Boards’ intention to follow NHS England’s position to pause new prescriptions for puberty-suppressing hormones.

Based on the latest evidence, the specialists in this field of medicine developed a consensus that is that it is considered no longer safe to continue to prescribe these medicines without further evidence developed within the clinical trial settings that would normally apply to all other medicines. This decision was based on their concerns described in the evidence summary under recommendation 6.

In April 2024 NHS GGC and NHS Lothian issued a joint statement highlighting that both Health Boards would pause any new prescribing of puberty-suppressing hormones and gender-affirming hormones for young people under 18 years of age. Children and young people who were already receiving these medicines were not affected by the pause. This goes further than the most recent NHS England position for gender-affirming hormones. An exercise was undertaken to ensure that all young people in Scotland directly affected by this change were notified prior to the announcement.

Scottish Government commissioned research

The Scottish Government has previously awarded grant funding to the University of Glasgow to administer a wide programme of research on gender identity healthcare, including the long-term health outcomes of people accessing gender identity healthcare.

Following an open call to bid and a recommendation by an independent assessment panel, the University of Glasgow awarded research grants to six projects, each addressing an aspect of long-term health outcomes of people accessing gender identity healthcare. This includes both adults and young people, cardiovascular health, hypertension, sexual health, mental health and longer-term outcomes.

Research projects specific to young people that have been funded include research into the prevalence of hypertension (high blood pressure) in young people with gender dysphoria and research into young people’s experiences before and after accessing gender identity healthcare services including their emotional, social and physical wellbeing and development as well as educational or vocational progress.

The outputs of the programme will help to support and drive improvements in service provision and health outcomes for those accessing gender identity healthcare in Scotland.

In addition, the Scottish Government has commissioned Policy Scribe to carry out an independent evaluation of the impact of Scottish Government funding allocated to Health Boards. The overall aim of this work is to understand the potential impact of Scottish Government investment on waiting times and quality of care at each gender identity clinic including the Young Peoples Gender Service. This will include considering supportive factors or impediments to service improvement. This will help to support future development and service improvement work.