NHS England Stops Prescribing Puberty Blockers and Updates its Cross-Sex Hormones Policy for Minors

NHS England will no longer allow puberty blockers for gender dysphoria, while the updated cross-sex hormones policy suggests a move toward caution awaiting the final Cass report due April 2024.

Photo by Andy Holmes on Unsplash

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In March 2024, NHS England (NHSE) updated its puberty blockers and cross-sex hormones policies for gender-dysphoric youth. The release of these policies coincides with the launch of the new service model, which will replace the Gender Identity Development Service (GIDS) at Tavistock as of April 1, 2024. The goal of the new service model is to provide holistic care and support for gender-distressed youth, shifting away from the “gender clinic” model of care focused on gender transition of minors.

NHS England published a total of 11 documents in March 2024 explaining and supporting these changes (10 documents regarding the puberty blocker policy and 1 for the cross-sex hormone policy). Below, we summarize the most salient takeaways of these documents. Further changes are likely after the publication of the final Cass report expected in April 2024.

Puberty blockers (PB) as a treatment for gender dysphoria will no longer be prescribed by NHS England providers as of April 1, 2024.

This NHSE Puberty Blockers (PB) policy finalized an earlier draft published in August 2023, which went through a 90-day public consultation period and subsequently underwent further changes. The most salient change in the final document is the removal of the “exceptional circumstances” provision. Under the prior draft, some youth would have been allowed to start PBs if they were deemed “exceptional” cases. This option has been eliminated in the final policy. No child will be initiated on PBs for gender dysphoria outside of an approved clinical trial within the NHSE system.

Cross-sex hormones (CSH) can still be prescribed by the NHS England providers to youth at “around 16 years of age” but with a new safeguarding element.

Unlike the PB policy which underwent a lengthy and transparent update that reflected the recommendations of the draft Cass report, the revised CSH policy appears to be a much more hasty update of the 2016 policy, with a significant disconnect from the interim Cass report.

The update eliminated the prior requirement for patients to be on PBs for a year prior to commencing CSH treatment. This update was necessary to synchronise the two NHSE policies, as the prerequisite of PBs no longer makes sense given the NHSE decommissioning of PBs for gender dysphoria. This policy is likely an interim step in time for the launch of the new service on April 1, 2024. Further changes to the CSH policy will likely take place after the final Cass report, which is expected to come out later in April.

Under the current update, youth around age of 16 can still be prescribed cross-sex hormones, but a new guardrail provision has been added. The policy now explicitly requires that a multidisciplinary team of clinicians “not directly involved in the formation of the individual’s care plan” agree on the appropriateness of the CSH treatment.

Research into puberty blockers is being designed but there is no guarantee that it will gain ethics approval.

NHS England accepted the interim Cass report recommendation that young people seeking hormonal interventions should be entered into a research protocol. The NHS appointed a Clinical Trials Unit to develop the research protocol (including eligibility criteria) with the initial focus on puberty blockers for youth with prepubertal onset of gender dysphoria. The process will be overseen by a newly established National Research Oversight Programme Board.

However, the NHS cautioned that such a clinical trial must undergo ethics approval, which is not guaranteed. The NHS made it clear that unless and until the research trial is approved, no child will receive PBs for gender dysphoria from NHS England.

All references to WPATH have been removed from the PB and CSH policies.

During the consultation period for the PB policy, WPATH and EPATH issued a joint comment, noting that NHS England deviated from Standard of Care (SOC) 8 and urging it to keep puberty blockers for gender dysphoria available in general clinical use. In response, NHS England thoroughly evaluated the 200 citations in the relevant SOC chapter (i.e., Chapter 12 Hormone Therapy), but found them to be inconsequential.

Neither the PB nor the CSH updated policies contain references to WPATH. Notably, the revised CSH policy specifically removed the prior reference to the WPATH Standards of Care.

Private clinics and providers are exempt from the current policies.

While private healthcare is generally uncommon in the UK, this option does exist. Specific to gender services, there is only one private clinic approved by the UK Care Quality Commission (CQC) to provide endocrine interventions for gender dysphoric youth outside the NHS. The clinic, Gender Plus (not to be confused with Gender GP, which is based outside the UK and therefore beyond the reach of UK regulations), currently only sees patients aged 16+ and focuses on cross-sex hormone prescribing.

It is possible that the NHS restrictions on the provisions of PBs and CSHs will result in a proliferation of private gender clinics providing both puberty blockers and cross-sex hormones with far fewer restrictions, as private clinics are not covered by the NHS policies. However, even private clinics are under the purview of the CQC, which suggests at least some level of oversight in the private sector.

The final Cass report is due in April.

The interim Cass report has had a profound influence on the structure of gender services in England overall, and on the NHSE PB policy in particular. Thus far, however, it has had almost no influence on the CSH policy, which, despite the recent update, did not fundamentally change the conditions under which CSH are prescribed to gender-dysphoric youth. The final report from Dr. Hilary Cass is expected to be published in April 2024. The report should provide more clarity regarding a number of as yet unanswered questions and is likely to lead to additional policy changes and updates related to cross-sex hormones.

GIDS at the Tavistock will close its doors on March 31, 2024.

The initial plan to shut down GDS at the Tavistock in 2023 was delayed, but at this point, its closure on March 31 is imminent. GIDS will be replaced with a fundamentally new model of care for gender dysphoric youth, which will prioritize psychological and psychotherapeutic exploration and support. Two new service hubs will start operation on April 1, 2024, with several more hubs in the planning stages.

Background

On March 12 2024 NHS England published a new clinical policy for the use of puberty blockers (PBs) as a treatment for gender dysphoria. This was followed by an updated clinical policy for the use of cross-sex hormones (CSH), published on March 21 2024.

NHS England is the coordinating body that organizes healthcare for the 56 million residents of England. It sets policies and commissions services from hundreds of organizations known as NHS Trusts, including those relating to gender dysphoria. The new policy is part of wide-ranging reforms to gender dysphoria services in the UK and will be used in a new gender service for children and adolescents that opens in April 2024. It confirms that “The NHS in England will not prescribe Puberty Suppressing Hormones to children and young people with gender incongruence / dysphoria, from 1 April 2024.” However, cross-sex hormone prescriptions for those “around their 16th birthday” will still be allowed, pending the final Cass review, which is expected in April 2024.

In 2020, NHS England established an independent review of its approach to gender dysphoria in the under 18s, chaired by eminent pediatrician Dr Hilary Cass OBE, the former president of the Royal College of Paediatrics and Child Health. This was felt necessary due to the sharp rise in referrals over the previous decade, the marked changes in the types of patients being referred which were not well understood, the scarce and inconclusive evidence to inform clinical decision-making, and the failure of the existing service which had been rated ‘inadequate’ by its regulator, the Care Quality Commission.

In its interim report and subsequent recommendations, the independent Cass Review called for a fundamentally different approach to the treatment of gender dysphoria in young people, to better meet the holistic needs of young people distressed about their gender, rather than focusing on gender to the exclusion of other problems. In response, NHS England decided to permanently close the world’s largest pediatric gender clinic, GIDS (the Gender Identity Development Service), and to establish a new regional service based in children’s hospitals.

Two regional hubs will open on 1 April 2024, as “phase 1” in the implementation of this new plan. Both hubs are collaborations between several organizations: the southern hub, based in London (at Great Ormond Street Hospital, Evelina London Children’s Hospital and the South London and Maudsley NHS Foundation Trust); and the northern hub (at the Alder Hey Children’s NHS Foundation Trust in Liverpool and the Royal Manchester Children’s Hospital). Several additional hubs are expected to open in the coming years, including one based in Bristol, plans for which are already being developed.

NHS England’s Puberty Suppressing Hormones Policy, March 2024

On March 12, 2024, NHS England issued its puberty blockers (PB) clinical policy (Puberty Suppressing Hormones Policy), disallowing the use of puberty blockers as a treatment for youth gender dysphoria through the NHS. The policy finalized the earlier August 2023 interim clinical policy, which already stipulated that puberty blockers would not be available as routine treatment for gender dysphoria. It also made some additional changes. We highlight some of the more notable aspects of the policy below.

Is there anything new in the final version of this policy?

The August 2023 draft version of the policy was sent for a 90-day public consultation period. The policy published on 12 March is the final version of that draft, which incorporates all new evidence and feedback. Overall, the final policy confirms the draft proposal’s directive not to prescribe puberty-suppressing hormones to patients in the new service, however there are also various changes.

The most notable change between the draft and the final policy was the removal of the earlier clause that would allow the use of PBs in exceptional cases due to widely held concern that such a policy could not operate “appropriately, effectively and equitably.”

What will happen to patients already using puberty blockers?

The policy that disallows the use of puberty blockers for gender dysphoria applies only to newly referred patients to the new regional hubs, as well as those who are currently patients at GIDS but have not yet been referred for endocrine interventions.

Several groups are exempt from this policy, and will be allowed to be treated with puberty blockers related to their gender dysphoria diagnoses:

1. Patients currently receiving puberty blockers through GIDS

2. Patients who received their referral to the NHS endocrine clinics by March 31 2024

3. Natal male patients around ages 16-17. They will be allowed to receive puberty blockers in conjunction with cross-sex hormones.

The rationale for the first two exemptions from the policy was that the patients had a reasonable expectation of being prescribed puberty blockers and that withdrawing the option might be detrimental to the patient. The Equality and Health Inequalities Impact Assessment (EHIA) accompanying the new clinical policy estimated there are about 70 such patients.

The rationale for the third exemption was that estrogen alone does not sufficiently suppress testosterone levels in natal males, and thus, GnRHas (puberty blockers) will be allowed due to their anti-androgen properties.

What about private providers of puberty-suppressing hormones in the UK?

The NHS policy only covers services commissioned by NHS England and provided by the public health service and does not apply to private clinics. There is currently only one private clinic approved by the UK Care Quality Commission (CQC) to provide endocrine interventions for gender dysphoric youth outside the NHS—Gender Plus (not to be confused with GenderGP, which is operating outside the UK and is not subject to UK regulations). At the present time, Gender Plus only sees patients ages 16+ and does not provide puberty blockers as standalone treatment (it does, however, prescribe PBs in conjunction with CSH for natal males ages 16+ in order to enhance androgen suppression, which is still allowed under the new NHS PB policy).

Thus, currently, there are no private clinics within the UK offering puberty-suppressing hormones as a standalone treatment for gender dysphoria. It is, however, unknown whether the new NHS restrictions in the PB policy (and the possible restrictions to the CSH policy that may arise from the Cass review recommendations) will lead to growth in private-sector gender clinics in the UK. Should the UK experience a trend like the US, with a proliferation of private youth gender clinics that are not following the NHS guidance, it is currently unclear whether UK regulators such as the CQC will intervene.

The updates to the NICE evidence review

The documents published alongside the new PB clinical policy update the findings of a systematic evidence review published in October 2020 by the National Institute for Health and Care Excellence (NICE) of puberty-suppressing hormones (PBs). The review found that the evidence base for the use of these hormones was “subject to bias and confounding, and all the results are of very low certainty using modified GRADE.” There was also a “lack of clear, expected outcomes from treatment.” Studies “suggest little change” as a result of the intervention and where there were “differences in outcomes [these] could represent changes that are either of questionable clinical value, or the studies themselves are not reliable and changes could be due to confounding, bias or chance.”

NICE’s findings—and those in a second review, of gender-affirming (cross-sex) hormones—supported the decision to begin a wide-ranging independent review of gender dysphoria healthcare. In early 2020, NHS England convened a working group to review gender dysphoria services for the under 18s, which until that point were delivered exclusively by the Gender Identity Development Service (GIDS). This review was a routine matter, as the GIDS contract was due for renegotiation – such periodic reviews happen throughout the NHS – and the NICE evidence review was commissioned by this working group to help inform their deliberations. However, NICE’s findings raised fundamental questions about the viability of continuing the existing treatment protocols for gender dysphoria, given the lack of evidence of their safety and efficacy. It prompted NHS England to question whether it could re-commission its existing gender services for under 18s in their current form, and in response, it established the independent Cass Review to rebuild services from the ground up.

Now, NHS England has updated NICE’s findings, to account for newly-published studies and others brought to its attention by members of the public and stakeholders. Details are provided in three documents published alongside the new clinical policy: “Puberty suppressing hormones evidence report following stakeholder testing 7 July 2023,” “Puberty suppressing hormones evidence report following public consultation 5 Jan 2024,” and “Puberty suppressing hormones evidence report 15 Feb 2024.”

In July 2023, 19 studies were identified as having not previously been considered in the 2020 review, but the conclusion was that these “were not considered to materially impact on the conclusion of the review or the interim policy proposition.” In January 2024, an additional 251 references were identified by members of the public in response to the public consultation for the draft puberty-suppressing hormones policy. Of these, the great majority did not merit review as they did not meet the inclusion criteria set out in the 2020 review.

Three papers did meet the criteria for inclusion but, upon careful review “it was determined that these didn’t materially affect the proposition as written.” These three papers were:

• Kuper 2020: “a small number” (25/148) of participants were treated with puberty-suppressing hormones with “modest improvement” reported; however, 90% of the study’s participants were in a late stage of puberty.

• Lavender 2023: the study followed a cohort of youth before treatment, 1 year into PBs and 1 year into CSH treatment. The study suffered “considerable loss to follow-up.” From the 109 eligible participants, only 38 provided complete data, representing 65% non-participation rate.

• Ludvigsson 2023: a systematic review of evidence comprised of studies had either been previously identified, or were not relevant to the NICE review criteria.

Finally, the references cited in Chapter 12 (Hormone Therapy) of WPATH's Standard of Care 8 (SOC*) were examined. Of the 200 references, 189 fell outside the criteria established by NICE for review, 6 were not identifiable, and 5 had already been considered in the 2020 review. Thus, SOC8 was not deemed as a source of additional relevant evidence.

What about the research?

The NHS England confirmed its intention to design and launch a clinical trial of puberty blockers. Qualification criteria for the study have not been finalized, but NHS England has indicated that initially, the study would be “focused on children with early onset gender incongruence / dysphoria.” Such a study would need to pass the customary ethics and approvals process. The NHS stated that “should the approvals be granted, the study will begin to recruit eligible individuals in late 2024.”

One major question is whether the study will obtain clinical trial authorization from the UK’s regulator of medicines, the Medicines and Healthcare Products Regulatory Agency (MHRA). In 2010, when the NHS’s previous research into puberty blockers (the “Early Intervention Study”) was in the planning stages, the MHRA concluded that it did not require such authorization, waving it through swiftly when researchers characterized the study as “merely an extension downwards in age of a treatment we routinely use at age 16 years plus.” However, the efficacy and safety concerns about PBs that underpin NHS England’s change in policy also require the MHRA to look anew at the issue of clinical trial authorization. NHS England’s appointment of a Clinical Trial Unit to prepare a submission to the MHRA, suggests that it recognizes the MHRA made the wrong judgment last time around.

It appears that NHSE is anticipating the possibility that ethics approval may not be easily granted for a study of the use of puberty blockers as a treatment for youth gender dysphoria. This is reflected in a subtle language change between the draft and the final Equality and Health Inequalities Impact Assessment (EHIA) which accompanied the PB policy. While the draft referenced the “research framework,” the final EHIA report added a qualification, “should a research framework be feasible.” NHSE also now explicitly states that the decision to no longer offer puberty blockers as a treatment for gender dysphoria is “not contingent on the establishment of a clinical study” and that “unless and until a clinical study is established, no child or young person will have access to Puberty Suppressing Hormones for gender incongruence / dysphoria.”

NHS England’s Gender Affirming Hormones Policy, March 2024

The need to update the cross-sex hormones (CSH) policy was recognized both in the draft documents released last fall, and restated again in the Equality and Health Inequalities Impact Assessment (EHIA), which accompanied the PB policy published on 12 March 2024. Still, the release of the CSH policy update on March 21, 2024 (which replaced the earlier 2016 policy) appears to have caught the clinical community by surprise and drew significant criticism.

The concerns raised included both the questionable process (e.g., the update was not based on a systematic evidence review and it skipped a public consultation period), as well as the policy’s content. Specifically, the provision that 16-year-olds can have access to CSHs even if severe mental health problems are present appears wholly disconnected from the interim Cass report and its recommendations for a much more cautious approach to the management of gender incongruence in youth. The CSH policy update itself acknowledged that it “did not substantially change the access arrangements of the original policy.” However, it also noted that the policy may be revised again once new evidence becomes available, specifically referencing the final Cass review.

The update also contains errors. For example, under the heading “Governance arrangement,” the updated policy requires providers to adhere to a 2010 policy from the British Society for Paediatric Endocrinology and Diabetes, which is no longer in effect; the current version was implemented in 2019. It is a reminder of the importance of a slow and deliberate process, and the benefit of public scrutiny in matters of vital public health importance.

Having analyzed the situation, it is SEGM’s interpretation that the demonstrable problems in the CSH policy update are largely the result of an unfortunate disconnect in the timing of various key events (i.e., the release of the PB policy, the launch of the new service, and the publication of the final Cass report), and the haste with which the policy may have been prepared—rather than a deliberate intention to disregard the Cass review recommendations. Further, we believe following the publication of the Cass review, more restrictive updates to the CSH policy are likely. Our rationale follows:

The CSH update before April 1st was necessary since the PB policy created an “irrational” gap that had to be closed in time for the launch of the new gender services.

The existing CSH policy, issued in 2016, required prior use of PBs as a condition of eligibility for CSH treatment. Since the new 2024 PB policy no longer allows the use of PBs to treat gender dysphoria, keeping the old CSH policy with such a prerequisite in place would have been irrational. It would have also effectively constituted a ban on all new prescriptions of cross-sex hormones.

To be credible, any changes in the provision of CSH to youth should result from a careful examination of the practice and the evidence that supports it. Arriving at a “ban” for CSH as a mere side effect of inconsistencies between the two NHS policies is not credible and could also be easily challenged in court as being irrational.

The NHS did not have the complete information to do a comprehensive update to the CSH policy.

While NHSE had to act in order to close the gap between the PB and the CSH policies, at the same time, it lacked the necessary time and information to conduct a comprehensive CSH policy revaluation since the final Cass report has not yet come out (it is due to come out in April 2024).

The interim Cass report focused primarily on puberty blockers and informed the comprehensive PB policy update. It is expected that the final report will address the issue of older teens’ treatment with CSH in much more detail than the interim report did. Once the final Cass report is published, it will be appropriate for NSHE to re-engage with the urgent question of how to safely care for older gender-dysphoric teens in regard to CSH interventions.

The additional changes to the policy made by the NHS signal that more restrictive future updates may be expected.

The CSH policy update achieved the “minimum necessary” requirement to ensure the PB and the CSH policies are not in direct contradiction: it removed the PB prerequisite requirement from the CSH policy. However, the NHS went further, making several other changes that may foreshadow future changes after the publication of the Cass report. We briefly highlight some of the additional changes:

• There were significant language changes that signal a move away from activism and toward science. In an apparent shift toward depoliticized science-based language, the policy no longer refers to “assigned” sex/gender, instead using the term “natal.” Further, the 2016 footnote that discouraged the use of the terms “natal sex” or “biological sex” has been deleted in the 2024 update. (Of note, the term “assigned” in relation to sex and gender still appears in the “glossary” as a holdover from 2016, but it has been notably stripped from the body of the policy.) Other language changes may signal a shift away from the “on-demand” approach to gender reassignment—for example, the term “client” in the 2016 policy has been replaced with “individual” in the 2024 policy.

• References to WPATH have been deleted. The 2016 policy referenced WPATH SOC7. While the update appropriately deleted this reference (SOC7 is no longer the most recent version of WAPTH recommendations), it did not replace it with the current SOC8 version. (The policy did, however, add the 2017 Endocrine Society (ES) guideline reference, which apparently was discovered during the comment period. The 2017 ES guideline was heavily influenced by WPATH.)

• A new safeguarding provision has been added. The prior 2016 policy required approval of the plan to administer CSH to a young person by a multidisciplinary team directly involved in the formulation of the care plan, created a situation where the team “grades their own homework.” The new policy subtly but powerfully addresses this problem by explicitly requiring that approval for CSH is obtained from clinicians “not directly involved in the formation of the individual’s care plan.” How this will be implemented in practice remains to be seen.

In summary, it is SEGM’s assessment that the shortcomings and inconsistencies in the NHS CSH policy update are likely a result of a hasty process implemented in order to provide the newly launched gender services with a set of workable policies (PB and CSH) that are internally consistent, at least at a high level. The CSH’s policy’s lack of reference to the NICE systematic review of CSHs, and the deleted pages of discussions related to the treatment rationale, strongly signal that the CSH policy update represents a “stop-gap” measure—and that additional changes to the policy are likely after the final Cass review is published.

SEGM Take-Aways

The NHS England’s deliberate work to restructure the approach to treating gender-dysphoric youth, which was initiated circa 2019, will likely take several more years to implement. NHS England’s recognition that puberty blockers, hormones, and surgeries have profound irreversible consequences, unknown long-term effects, and are not based on reliable evidence is already evident in the current policy updates. More changes are likely to follow after the final Cass report.

The final policies will require a fundamental rethinking of the rationale for treating youth with irreversible interventions based on an identity-centered diagnosis. This was exemplified in CSH policy update issued in March 2024. The updated policy replaced the requirement of the DSM 5 diagnosis of “gender dysphoria” with the ICD-11 diagnosis of “Gender Incongruence.” This seemingly innocuous change goes to the heart of the question of gender transition of minors as a medical practice. Unlike the DSM 5 diagnosis, which requires the “distress” criterion to be present, the ICD-11 diagnosis removed the “distress” criterion, leaving clinicians with no treatment targets other than satisfaction with a more “congruent” appearance. Whether such a treatment target is justifiable given young people’s evolving identity development is a question that NHSE and other medical organizations will need to reckon with.

Further, the updated CSH policy’s stated rationale for the treatment puts the spotlight on the conundrum the field of youth gender medicine finds itself in. The policy states that the requirement of the ICD-11 diagnosis of “gender incongruence” is necessary “to ensure that the individual is highly likely to continue to identify in the experienced gender, meaning that GAH [gender-affirming hormone] therapy is an appropriate treatment in the long term.”

The primary goal of the introduction of the Gender Incongruence (GI) diagnosis, which was enacted in 2022, was to depathologize transgender identities, while ensuring insurance reimbursement for body modification procedures. However, this diagnosis has an unknown predictive validity: adolescents and young adults presenting with an “incongruent” identity and obtaining the ICD-11 diagnosis may or may not continue to experience feelings of incongruence in the future. This, in turn, suggests that the very rationale for the treatment of youth presented in the NHSE CSH policy is demonstrably invalid. The evolving nature of adolescent identity development, juxtaposed with the permanent and irreversible nature of gender-affirming interventions such as cross-sex hormones, is the very reason why the practice of gender transition of youth has come under scrutiny,

In the coming month of April 2024, three of the most profound events in youth gender medicine are taking place in the UK. First, the world’s biggest pediatric gender clinic (GIDS at the Tavistock) will shut down; second, England will launch its new gender services with 2 new hubs; and third, the final Cass report will be published. The UK, and indeed the entire world, eagerly await the final Cass report due in April 2024.

Change is never easy. Change to a medical practice that lost its claim of scientific credibility while still maintaining a strong political hold is infinitely harder. However, it is evident that the arc of history is bending in the direction of the reversal of the practice of youth gender transitions. This arc may be shorter in countries with strong centralized public health authorities who follow the principles of evidence-based medicine, and considerably longer in countries with a more consumeristic approach to medicine. But the notion that the ever-growing numbers of young people with significant mental health comorbidities should have on-demand access to body-modifying and fertility-threatening irreversible interventions based on adolescent declarations of identity is unlikely to withstand the test of time.

As the reversal of the practice of youth transitions is starting to take place in a growing number of countries, the medical community must re-commit to providing all patients with the highest quality, evidence-based, and compassionate care. This concerns both the growing numbers of patients who detransitioned and who may have profound but as yet poorly understood healthcare needs as well as those who persist with the medical gender-transition route, and who will depend on the healthcare system for the entirety of their life, with many as yet unanswered questions about their long-term health outcomes and needs.

This article was originally published on the Society for Evidence-Based Gender Medicine’s website on March 29, 2024.

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