Funding of GnRH analogues for indications not approved by Medsafe (children and adolescents)
Thank you for your request dated 2 March 2022 under the Official Information Act 1982 (OIA) for information relating to GnRH analogues/puberty blockers. You asked:
Why does Pharmac fund GnRH analogues (goserelin implants, or leuprorelin injections for children and adolescents who are unable to tolerate administration of goserelin) for this indication, despite it not being approved by Medsafe?
I am pleased to provide the information below in response to your request.
As you are likely aware, Pharmac is the government agency that decides which pharmaceuticals will be publicly funded. Medsafe is the business unit of the Ministry of Health which is responsible for the regulation of therapeutic products (eg medicines) in New Zealand.
Leuprorelin is Medsafe approved for use in the treatment of children with central precocious puberty.
Goserelin is open-listed. This means clinicians can prescribe goserelin when a patient and their doctor agree it’s a suitable treatment option. It is up to doctors to discuss the benefits and risks of each treatment with their patients and ensure the treatment is appropriate, whether or not it has been approved by Medsafe.
We fund a range of treatments. Some medicines are funded for indications not approved by Medsafe. These medicines need to be prescribed and used in accordance with section 25 of the Medicines Act 1981. This allows authorised prescribers to prescribe any medicine (approved or unapproved) for a particular patient in their care. You can read more about section 25 of the Medicines Act 1981, including the definition of authorised prescribers on the Medsafe website(external link)
Background to funding of GnRH analogues
In 2016, we ran a competitive process for the funding of GnRH analogues. This resulted in goserelin being fully funded and leuprorelin becoming part funded. As part of this process, we decided to fully fund leuprorelin for children and adolescents who are unable to tolerate administration of goserelin. This decision was informed by clinical advice, consultation feedback and the Medsafe-approved indications for the two chemicals.
You can read the discussion of the Endocrinology Advisory Committee [PDF, 1.2 MB] (formerly the Endocrinology Subcommittee of PTAC) meeting regarding the funding of GnRH analogues on the Pharmac website
Advice from our Specialist Advisory Committees is an important factor in considering the funding of treatments and any potential funding restrictions. Our clinical advisors consider the benefits and risks of treatments as part of their recommendations.
We trust that this information answers your queries. We are making our information more freely available, so we now publish selected OIA responses (excluding personal details) on our website. Please get in touch with us if you have any questions about this.