Play it safe
An independent expert committee advising Australia’s federal Health Minister Mark Butler recommended that he not allow the hormone suppression drug Triptorelin to be used as taxpayer-subsidised puberty blockers for children.
Dr Ruth Griffiths, secretary of the Pharmaceutical Benefits Advisory Committee, said PBAC had suggested this restriction on the drug aimed chiefly at women’s health conditions, according to her letter sent earlier today to a mother whose daughter has autism and gender distress.
Dr Griffiths acknowledged “concerns raised in relation to the use of Triptorelin as a puberty blocker”.
Minors with autism are considered especially vulnerable to confusion about their sex and gender. Most children started on puberty blockers go on to cross-sex hormones meant to be taken lifelong, with potential effects including low bone density, cardiovascular disorders, sexual dysfunction and sterilisation. Deficits in cognitive development, caused by suppression of natural sex hormones during adolescence, have not been ruled out.
Triptorelin 3.75mg (sold as Diphereline) is to be listed on the Pharmaceutical Benefits Scheme from October 1, primarily to meet women’s health needs. It will serve as a substitute for another hormone-suppression drug, Goserelin 3.6mg (sold as Zoladex).
Zoladex is registered for use with hormone-driven cancers and women’s health conditions including endometriosis, but it is being withdrawn from the Australian market by its manufacturer.
In her letter to the mother, PBAC secretary Dr Griffiths also noted that doctors bear responsibility when writing a script for an “off-label” use, such as puberty suppression for children who reject their sex and identify as transgender or non-binary.
Off-label use means prescribing a drug for an indication—such as gender dysphoria—not listed with its registration by the Therapeutic Goods Administration. Safety data for a drug is specific to its registered indications.
Triptorelin’s registered uses include central precocious (or premature) puberty in girls before age 8 and in boys before 9. This use is distinct from the drug’s off-label use to suppress the naturally timed puberty of children under a diagnosis of gender dysphoria.
On September 17, Minister Butler cited women’s health conditions when announcing that Triptorelin 3.75mg would be listed on the taxpayer-funded PBS as unrestricted. Usually, that would be taken to mean that the subsidised use of the drug would not be limited to specified health conditions. (Mr Butler’s decision followed PBAC advice, although the public record of that recommendation said nothing about any exclusion from the unrestricted listing.)
The Australian Professional Association for Trans Health (AusPATH) seized on the term “unrestricted” to proclaim that PBS-subsidised Triptorelin could be prescribed at a sizeable discount on the cost now charged for a private prescription enabling off-label use of the drug as puberty blockers.
On Monday morning, AusPATH’s chief executive Eloise Brook emailed members of the association: “For trans and gender-diverse people, the significance of the word ‘unrestricted’ is important. Unlike a restricted PBS medicine, an unrestricted benefit is not limited by the PBS to particular clinical indications.”
During the day, AusPATH learned that gender dysphoria was in fact to be excluded from the “unrestricted” PBS listing.
At the moment, the mainstreaming of puberty blockers at scale is held back by the unsubsidised cost of more than $3,000 a year—10 times what the PBS-listed price would be. Widespread use of blockers is also thwarted by long queues at the limited capacity gender clinics of children’s hospitals, where state taxpayers pick up the bill for this chemical interruption of a minor’s normal sexual development.
Doctors put on notice
On Tuesday, a spokesperson for the federal Department of Health told GCN that the unrestricted listing of Triptorelin 3.75mg “is being implemented with an administrative note that says, ‘The listing of this medicine is not for the use in gender dysphoria in minors’.”
According to today’s letter from Dr Griffiths, it was PBAC that advised the addition of this administrative note excluding the puberty blocker use of Triptorelin.
“Noting concerns raised in relation to the use of Triptorelin as a puberty blocker, the PBAC advised that an administrative note should be included to prompt consideration of whether Triptorelin is appropriate for an individual patient, with prescribers responsible for applying their clinical judgement when making treatment decisions,” she said.
“Following this advice, an administrative note will be added to the Triptorelin PBS listing, indicating that the listing of this medicine is not for use in gender dysphoria in minors.
“Before a medicine is subsidised through the PBS for a particular condition it is assessed by the Pharmaceutical Benefits Advisory Committee. The PBAC assesses how well the medicine works and how safe it is compared to treatments that are already available in Australia.
“It also considers whether the benefits of the medicine are worth any additional cost [to taxpayers] above treatments that are already funded.”
The evidence for the use of hormone suppression drugs with gender-distressed minors is very weak and uncertain, according to “gold-standard” systematic reviews commissioned independently in several countries including England, Sweden and Finland.
Puberty blockers for minors are banned or restricted in multiple jurisdictions internationally on the grounds that the evidence for health outcomes is insufficient.
In January last year, Mr Butler asked the National Health and Medical Research Council to preside over the development of a new countrywide treatment guideline for youth gender dysphoria. The NHMRC interim advice on the safety and efficacy of puberty blockers is expected next month.
Mr Butler, from the Australian Labor Party, commissioned the NHMRC project soon after he was advised that his UK Labour counterpart, Wes Streeting, had banned prescription of puberty blockers outside a clinical trial, which has now begun to recruit minors aged 11-16.
In the House of Commons in December 2024, Mr Streeting said: “The Cass Review made it clear that there is not enough evidence about the long-term effects of using puberty blockers to treat gender incongruence to know whether they are safe or beneficial.
“That evidence should have been established before they were ever prescribed for that purpose. It is a scandal that medicine was given to vulnerable young children, without proof that it was safe or effective, or that it had gone through the rigorous safeguards of a clinical trial.”
Excellent work Experts.
I have just looked up Triptorelin on the PBS site and the administrative note is nowhere to be seen.
Maybe the PBS will allow an interval for all the kids to get their supply before adding the note!