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 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 a PBS-subsidised somatostatin analogue.

Somatostatin analogues include octreotide, lanreotide and pasireotide

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.

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.

In a patient treated with radiotherapy, pegvisomant should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pegvisomant should be withdrawn at least 8 weeks prior to the assessment of remission.

Biochemical evidence of remission is defined as normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1).

Two completed authority prescriptions should be submitted with the initial application for this drug. One prescription should be for the loading dose of 80 mg for a quantity of 4 vials of 20 mg with no repeats. The second prescription should be for subsequent doses, starting from 10 mg daily, and allowing dose adjustments in increments of 5 mg based on serum IGF-1 levels measured every 4 to 6 weeks in order to maintain the serum IGF-1 level within the age-adjusted normal range based on the dosage recommendations in the TGA-approved Product Information.

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

a) two completed authority prescription forms ; and

b) a completed Acromegaly Pegvisomant initial 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, the date and result of IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy; and

d) a recent result of the IGF-1 level and the date of assessment ; and

e) demonstration of failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2

No increase in the maximum quantity or number of units may be authorised for the loading dose.

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 a PBS-subsidised somatostatin analogue; AND

The treatment must cease if IGF-1 is not lower after 3 months of pegvisomant treatment at the maximum tolerated dose.

Somatostatin analogues include octreotide, lanreotide and pasireotide

In a patient treated with radiotherapy, pegvisomant should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pegvisomant should be withdrawn at least 8 weeks prior to the assessment of remission.

Biochemical evidence of remission is defined as 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 must be provided; and a copy of IGF-1 level taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of application.