Programs & Initiatives
Pharmaceutical Benefits Scheme (PBS) Growth Hormone Program
This page contains downloadable PDF files of program guidelines, application forms and checklists for the Growth Hormone Program:
- News Update
- PBS Growth Hormone Program Guidelines
- Application form for initial growth hormone treatment
- Application form for continuing growth hormone treatment
- Data checklists for initial applications
- Data checklists for continuing treatment
Overview
Growth hormone (GH) is subsidised by the Australian Government through Pharmaceutical Benefits Scheme (PBS) special arrangements made under section 100 of the National Health Act 1953. The supply of GH under section 100 of the Act is set out in the program Guidelines.The program is administered by the Department of Health and Ageing with the assistance of the Growth Hormone Advisory Committee (GHAC), a panel of experienced paediatric endocrinologists.
Growth Hormone Advisory Committee Terms of Reference
News Update
Growth Hormone News Update - Saizen®SolutionIn July 2012 the Department ceased ordering Saizen® solution for injection (somatropin) through the Australian Government’s PBS Growth Hormone Program as the supplier had initiated a recall of short dated Saizen®.
The supplier has worked with the Department and the Therapeutic Goods Administration (TGA) to manage this situation and from 2 October 2012 the restriction was lifted.
The Department continues to monitor the situation and patients using Saizen® should ensure that their supply does not expire before the end of their treatment period. If it does, patients should contact their pharmacy and doctor as soon as possible to arrange replacement medicine.
Any questions regarding the current and future availability of Saizen® solution for injection can be addressed to the Growth Hormone Program via email (hgh@health.gov.au).
Information from the supplier and Frequently Asked Questions for affected patients, treating doctors and pharmacists are available from the links below:
PDF printable version of the Merck Serono Doctor Communique Signed (PDF 480 KB)
Microsoft Word printable version of the Merck Serono Doctor Communique Signed (Word 964 KB)
PDF printable version of the Merck Serono Patient Communique Signed (PDF 549 KB)
Microsoft Word printable version of the Merck Serono Patient Communique Signed (Word 1104 KB)
PDF printable version of the Merck Serono Pharmacist Communique Signed (PDF 791 KB)
Microsoft Word printable version of the Merck Serono Pharmacist Communique Signed (Word 1596 KB)
PDF printable version of the Frequently asked Questions (PDF 160 KB)
Microsoft Word printable version of the Frequently asked Questions (Word 119 KB)
Guidelines for the PBS Growth Hormone Program
Guidelines for the Pharmaceutical Benefits Scheme Growth Hormone Program (April 2012) (Word 665 KB)1st percentile height values - children 0-3 years
1st percentile height values - children ages 2-20 years
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Applications for growth hormone
Approved application forms available from this website must be used in all instances to submit applications for initial and continuing treatment. Please ensure that all sections of the forms are completed, with all mandatory information provided. The department will not consider an application until all the necessary information is submitted. Incomplete applications will be returned to sender.Applications for initial treatment
It is in the interest of medical practitioners submitting applications to familiarise themselves with the Guidelines and data checklists prior to submitting an application.Application for initial supply of growth hormone - May 2012 (PDF 979 KB)
Application for initial supply of growth hormone for treatment of Prader-Willi Syndrome - May 2012 (PDF 557 KB)
Supporting information for initial applications
Ozgrow diagnosis codes (PDF 104 KB)Data checklists for initial applications
Clinicians are encouraged to refer to application checklists relevant to each eligibility category, to identify the information required with the application.Short stature and slow growth
Initial application data checklist for short stature and slow growth (PDF 51 KB)Biochemical growth hormone deficiency (BGHD)
Initial application data checklist for biochemical growth hormone deficiency (PDF 52 KB)Growth retardation secondary to an intracranial lesion or cranial irradiation
Initial application data checklist for growth retardation secondary to an intracranial lesion or cranial irradiation (PDF 51 KB)Hypoglycaemia
Initial application data checklist for neonates/ infants at risk of hypoglycaemia secondary to growth hormone deficiency (PDF 48 KB)Turner Syndrome
Initial application data checklist for Turner Syndrome (PDF 42 KB)Short stature homeobox (SHOX) disorders
Initial application data checklist for short stature due to short stature homeobox (SHOX) gene disorders (PDF 53 KB)Chronic renal insufficiency
Initial application data checklist for chronic renal insufficiency (PDF 50 KB)BGHD and precocious puberty
Initial application data checklist for growth hormone deficiency and precocious puberty (PDF 53 KB)Prader-Willi Syndrome
Initial application data checklist for Prader – Willi Syndrome (PDF 45 KB)
Application for continued supply of growth hormone for the treatment of Prader –Willi Syndrome – May 2012 (PDF 627 KB)
Data checklists for continuing treatment
Continuing application data checklist for all categories (excluding Prader – Willi Syndrome) (PDF 33 KB)Continuing application data checklist for Prader – Willi Syndrome (PDF 38 KB)
Requirements when Growth Hormone is unusable
On rare occasions, Growth Hormone is not able to be used - due to expiry of the product, interruption of cold chain, or damage to the vials. In these instances, the Growth Hormone will need to be destroyed and the Department notified of this action.Where possible, families are requested to take the unusable Growth Hormone to their pharmacist for destruction.
The Pharmacist is then required to provide a completed Statutory Declaration to the Department regarding the destruction of the drug.
If the family is not able to take the Growth Hormone to a Pharmacist for disposal ie, the vial(s) is broken and the contents lost, then the family is required to provide the Statutory Declaration to the Department.
The attached Statutory Declaration form is provided for this use under the Growth Hormone Program.
Statutory Declaration Form (PDF 17 KB)
Statutory Declaration Form (Word 39 KB)
Departmental details
The Department’s contact details for all inquiries and applications are as follows:PBS Growth Hormone Program
Product Schemes Section
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health and Ageing
MDP 901
GPO Box 9848
Canberra ACT 2601
Phone: (02) 6289 7274
Fax: (02) 6289 3175
Email: hgh@health.gov.au
Other Links:
The Australasian Paediatric Endocrine Group (APEG)For any enquiries please contact the Human Growth Hormone (hGH) Treatment Program on (02) 6289 7274 or email HGH@health.gov.au Top of page
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