PBS updates

Genotropin GoQuick (Somatropin)

somatropin 5 mg injection [1 chamber] (&) inert substance diluent [1 mL chamber], 1 dual chamber pen device · INJECTION · PBS code 10443P

AUTHORITY_REQUIRED

What it costs

AU$151.51 PBS-determined price per 1 units

Most patients pay only the standard PBS co-payment, not the full price above — up to AU$25.00 per script (general) or AU$7.70 (concession/Safety Net) in 2026. The figure above is what the PBS pays the pharmacy; the Australian Government subsidises the rest. Always confirm the current amount with your pharmacist.

• First listed on the PBS: 2015-09-01.
• Repeats: 1.
• PBS program: GH.

Eligibility criteria for subsidised access

The following is the government's own wording from the PBS Schedule, shown unchanged.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Short stature and slow growth

Continuing treatment

Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND

Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or

Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or

Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or

Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or

Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND

Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND

Patient must not have an active tumour or evidence of tumour growth or activity; AND

Patient must be male and must not have a bone age of 15.5 years or more; or

Patient must be female and must not have a bone age of 13.5 years or more; AND

Patient must be male and must not have a height greater than or equal to 167.7cm; or

Patient must be female and must not have a height greater than or equal to 155.0cm; AND

Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.

The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2025 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).

The authority application must be in writing and must include:

1. Details of the proposed prescription; AND

2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND

3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND

4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND

5. The final adult height (in cm) of the patient's mother and father (where available); AND

6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).

Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.

In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Short stature associated with biochemical growth hormone deficiency

Continuing treatment

Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND

Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND

Patient must not have an active tumour or evidence of tumour growth or activity; AND

Patient must be male and must not have a bone age of 15.5 years or more; or

Patient must be female and must not have a bone age of 13.5 years or more; AND

Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.

The authority application must be in writing and must include:

1. Details of the proposed prescription; AND

2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND

4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND

5. The final adult height (in cm) of the patient's mother and father (where available); AND

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Growth retardation secondary to an intracranial lesion, or cranial irradiation

Continuing treatment

Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND

Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND

Patient must not have an active tumour or evidence of tumour growth or activity; AND

Patient must be male and must not have a bone age of 15.5 years or more; or

Patient must be female and must not have a bone age of 13.5 years or more.

The authority application must be in writing and must include:

1. Details of the proposed prescription; AND

2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND

4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND

5. The final adult height (in cm) of the patient's mother and father (where available); AND

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants

Continuing treatment

Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND

Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND

Patient must not have an active tumour or evidence of tumour growth or activity; AND

Patient must not have a chronological age of 5 years or greater.

The authority application must be in writing and must include:

1. Details of the proposed prescription; AND

2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND

4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND

5. The final adult height (in cm) of the patient's mother and father (where available); AND

When a patient receiving treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants reaches or surpasses 5 years of age (chronological), prescribers should seek reclassification to the indication 'short stature due to biochemical growth hormone deficiency'.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Biochemical growth hormone deficiency and precocious puberty

Continuing treatment

Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND

Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND

Patient must not have an active tumour or evidence of tumour growth or activity; AND

Patient must be male and must not have a bone age of 15.5 years or more; or

Patient must be female and must not have a bone age of 13.5 years or more.

The authority application must be in writing and must include:

1. Details of the proposed prescription; AND

2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND

4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND

5. The final adult height (in cm) of the patient's mother and father (where available); AND

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth

Continuing treatment

Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND

Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND

Patient must not have an active tumour or evidence of tumour growth or activity; AND

Patient must be male and must not have a bone age of 15.5 years or more; or

Patient must be female and must not have a bone age of 13.5 years or more.

The authority application must be in writing and must include:

1. Details of the proposed prescription; AND

2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND

4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND

5. The final adult height (in cm) of the patient's mother and father (where available); AND

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Short stature associated with Turner syndrome

Continuing treatment

Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND

Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or

Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or

Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or

Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or

Patient must have achieved an annualised growth velocity for bone age at or above the mean growth velocity for untreated Turner Syndrome girls (using the Turner Syndrome - Ranke growth velocity chart) while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND

Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND

Patient must not have an active tumour or evidence of tumour growth or activity; AND

Patient must not have a bone age of 13.5 years or greater; AND

Patient must not have a height greater than or equal to 155.0 cm.

The authority application must be in writing and must include:

1. Details of the proposed prescription; AND

2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND

4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND

5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Short stature due to short stature homeobox (SHOX) gene disorders

Continuing treatment

Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature due to short stature homeobox (SHOX) gene disorders category; AND

Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND

Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND

Patient must not have an active tumour or evidence of tumour growth or activity; AND

Patient must be male and must not have a height greater than or equal to 167.7 cm; or

Patient must be female and must not have a height greater than or equal to 155.0 cm; AND

Patient must be male and must not have a bone age of 15.5 years or more; or

Patient must be female and must not have a bone age of 13.5 years or more.

The authority application must be in writing and must include:

1. Details of the proposed prescription; AND

2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND

4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND

5. The final adult height (in cm) of the patient's mother and father (where available); AND

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Short stature associated with chronic renal insufficiency

Continuing treatment

Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND

Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND

Patient must not have an active tumour or evidence of tumour growth or activity; AND

Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND

Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND

Patient must be male and must not have a height greater than or equal to 167.7 cm; or

Patient must be female and must not have a height greater than or equal to 155.0 cm; AND

Patient must be male and must not have a bone age of 15.5 years or more; or

Patient must be female and must not have a bone age of 13.5 years or more.

The authority application must be in writing and must include:

1. Details of the proposed prescription; AND

2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND

4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND

5. The final adult height (in cm) of the patient's mother and father (where available); AND

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Short stature and poor body composition due to Prader-Willi syndrome

Continuing treatment

Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and poor body composition due to Prader-Willi syndrome category; AND

Patient must have been re-evaluated via polysomnography for airway obstruction and apnoea during the initial 32 week treatment period and any sleep disorders identified that required treatment must have been addressed; AND

Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; or

Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved height percentile for age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; or

Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved body mass index SDS for age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or

Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved waist circumference while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; or

Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved waist/height ratio (waist circumference in centimetres divided by height in centimetres) while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or

Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have achieved an increase in height percentile with reference to the untreated Prader-Willi syndrome standards for age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or

Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must not have been on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; or

Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved body mass index while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or

Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved body mass index SDS for age and sex while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or

Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved waist circumference while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; or

Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved waist/height ratio (waist circumference in centimetres divided by height in centimetres) while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or

Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved weight SDS for age and sex while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND

Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND

Patient must not have an active tumour or evidence of tumour growth or activity; AND

Patient must not have developed uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient's current height; AND

Patient must not have a chronological age of equal to or greater than 18 years.

The authority application must be in writing and must include:

1. Details of the proposed prescription; AND

2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND

3. Growth data (height, weight and waist circumference) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND

4. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND

5. Confirmation that during the initial 32 week treatment period, the patient was re-evaluated via polysomnography for airway obstruction and apnoea, and any sleep disorders that were identified have been addressed; AND

6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).

Maintenance is defined as a value within a 5% tolerance (this allows for seasonal and other measurement variations).

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Short stature and slow growth

Continuing treatment as a reclassified patient

Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature and slow growth; AND

The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or

Patient must have previously received treatment under the indication short stature associated with chronic renal insufficiency, have undergone a renal transplant and a 12 month period of observation following the transplant, and have an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; or

Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or

Patient must have had both: (i) a height no higher than the 1st percentile for age plus sex at the time of having commenced treatment with this drug, (ii) over the 12 month interval immediately prior to having commenced treatment, a growth velocity no greater than 8 cm/year where the patient had a bone/chronological age of no greater than 2.5 years; AND

Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND

Patient must not have an active tumour or evidence of tumour growth or activity; AND

Patient must be male and must not have a bone age of 15.5 years or more; or

Patient must be female and must not have a bone age of 13.5 years or more; AND

Patient must be male and must not have a height greater than or equal to 167.7cm; or

Patient must be female and must not have a height greater than or equal to 155.0cm; AND

Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or

Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND

Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.

An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.

The authority application must be in writing and must include:

1. Details of the proposed prescription; AND

2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND

3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (where the patient's chronological age was higher than 2.5 years); OR

(b) Confirmation that the patient has previously received treatment under the indication short stature associated with chronic renal insufficiency, has undergone a renal transplant and a 12 month period of observation following the transplant, and has an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m² measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; AND

4. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND

5. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Short stature associated with biochemical growth hormone deficiency

Continuing treatment as a reclassified patient

Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND

Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); or

Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or

Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or

Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or

Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND

Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or

Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or