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

Acromegaly

Initial treatment

Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must have a mean growth hormone (GH) level greater than 1 microgram per litre or 3 mlU/L; or

Patient must have an age- and sex-adjusted insulin-like growth factor 1 (IGF-1) concentration greater than the upper limit of normal (ULN); AND

The treatment must be after failure to achieve biochemical control with a maximum indicated dose of either 30 mg octreotide LAR or 120 mg lanreotide ATG every 28 days for 24 weeks; unless contraindicated or not tolerated according to the TGA approved Product Information; AND

The treatment must not be given concomitantly with PBS-subsidised pegvisomant; AND

Patient must be aged 18 years or older.

If treatment with either octreotide or lanreotide is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of contraindication.

If intolerance to either octreotide or lanreotide treatment developed during the relevant period of use which is of a severity to necessitate withdrawal of the treatment, the application must provide details of the nature and severity of this intolerance.

Failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide is defined as:

1) Growth hormone level greater than 1 mcg/L or 3 mIU/L; OR

2) IGF-1 level is greater than the age- and sex-adjusted ULN.

In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.

Biochemical evidence of remission is defined as:

1) Growth hormone (GH) levels of less than 1 mcg/L or 3 mlU/L; OR

2) normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1)

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

a) a completed authority prescription form; and

b) a completed Acromegaly PBS Authority Application - Supporting Information Form; and

c) in a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy must be provided; the date and result of GH or IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided; and

d) a recent result of GH or IGF-1 levels must be provided.

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

Acromegaly

Continuing treatment

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

The treatment must not be given concomitantly with PBS-subsidised pegvisomant; AND

Patient must be aged 18 years or older.

In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.

Biochemical evidence of remission is defined as:

1) Growth hormone (GH) levels of less than 1 mcg/L or 3 mlU/L; OR

2) normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1)

In a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy and the GH and IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of approval.