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

Severe growth hormone deficiency

Initial treatment of late onset growth hormone deficiency

Must be treated by an endocrinologist; AND

Patient must have onset of growth hormone deficiency secondary to organic hypothalamic or pituitary disease diagnosed at chronological age of 18 years or older; or

Patient must have onset of growth hormone deficiency diagnosed after skeletal maturity (bone age greater than or equal to 15.5 years in males or 13.5 years in females) and before chronological age of 18 years; AND

Patient must have a diagnostic insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; or

Patient must have a diagnostic arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; or

Patient must have a diagnostic glucagon provocation test with maximum serum GH less than 3 micrograms per litre; or

Patient must have: (a) a chronological age of 18 years or older, (b) established hypothalamic-pituitary disease, (c) at least three documented pituitary hormone deficiencies, (d) an IGF-1 concentration lower than the sex- and age-specific lower limit of normal in a patient.

The authority application must be made in writing and must include:

1. Details of the proposed prescription, specifying the active ingredient name, form and strength of the medicine, followed by the brand name; AND

2. A completed Severe Growth Hormone Deficiency supporting information form; AND

3. If applicable, results of the growth hormone simulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender.

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

Severe growth hormone deficiency

Continuing treatment in a person with a mature skeleton or aged 18 years or older

Must be treated by an endocrinologist; AND

Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause in a patient with a mature skeleton; or

Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to late onset of growth hormone deficiency secondary to organic hypothalamic or pituitary disease in a patient with chronological age of 18 years or older; or

Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to late onset of growth hormone deficiency diagnosed after skeletal maturity (bone age greater than or equal to 15.5 years in males or 13.5 years in females) and before chronological age of 18 years.

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

Severe growth hormone deficiency

Initial treatment of childhood onset growth hormone deficiency in a patient who has received PBS-subsidised treatment as a child

Must be treated by an endocrinologist; AND

Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition as a child; AND

Patient must have a mature skeleton.

Somatropin is not PBS-subsidised for patients with Prader-Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency.

The authority application must be made in writing and must include:

1. Details of the proposed prescription, specifying the active ingredient name, form and strength of the medicine, followed by the brand name; AND

2. A completed Severe Growth Hormone Deficiency supporting information form.

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

Severe growth hormone deficiency

Initial treatment of childhood onset growth hormone deficiency in a patient who has received non-PBS subsidised treatment as a child

Must be treated by an endocrinologist; AND

Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND

Patient must have previously received non-PBS subsidised treatment with this drug for this condition as a child; AND

Patient must have current or historical evidence of an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; or

Patient must have current or historical evidence of an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; or

Patient must have current or historical evidence of a glucagon provocation test with maximum serum GH less than 3 micrograms per litre; AND

Patient must have a mature skeleton.

Somatropin is not PBS-subsidised for patients with Prader-Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency.

The authority application must be made in writing and must include:

1. Details of the proposed prescription, specifying the active ingredient name, form and strength of the medicine, followed by the brand name; AND

2. A completed Severe Growth Hormone Deficiency supporting information form; AND

3. Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender.