Acromegaly

The Pharmaceutical Benefits Scheme subsidises pasireotide for patients with acromegaly.

For patients aged 18 years or older with acromegaly, treatment with pasireotide (Signifor LAR®) may be subsidised through the Pharmaceutical Benefits Scheme (PBS) under section 100 of the National Health Act 1953.

Section 100 arrangements

This item is only available to a patient who is attending:

  • an approved private hospital, or
  • public participating hospital, or
  • public hospital

and is either a

  • day admitted patient, or
  • non-admitted patient, or
  • patient on discharge.

This item is not available as a PBS benefit for in-patients of a hospital. The hospital provider name and number must be included on the application form.

Restriction details

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing pasireotide (Signifor LAR®).

Initial treatment

Applications for initial PBS subsidised treatment should be made where the patient:

  • had no prior PBS-subsidised pasireotide treatment, or
  • had pasireotide treatment before 1 September 2016.

If a patient was treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks before the assessment of remission.

Biochemical evidence of remission is defined as:

1) growth hormone (GH) levels of less than 2.5 mcg/L, and

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

Continuing treatment

If a patient was treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks before the assessment of remission.

Biochemical evidence of remission is defined as:

1) growth hormone (GH) levels of less than 2.5 mcg/L, and

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

Call us on the Complex Drugs Programs enquiry line to make an application for continuing treatment. The date of completion of radiotherapy and the GH and IGF-1 levels taken at the most recent 2 yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of approval.

Schedule item details

Dose - pasireotide (Signifor LAR®) is available as a 20 mg modified release injection, a 40 mg modified release injection, or a 60 mg modified release injection.

Pasireotide (Signifor LAR®) is administered by deep intramuscular injection every 4 weeks.

Dosing must be in accordance with the Therapeutic Goods Administration (TGA) approved product information.

Initial application

Prescriptions should be written for a maximum quantity of 2 syringes and up to 5 repeats.

Test requirements

Initial application must include a recent copy of GH and IGF-1 levels.

Lodging an application

All initial applications must be in writing and posted to the Complex Drugs Programs address on the contact us page.

Lodge the Acromegaly Initial PBS authority application and supporting information form (PB181) for a patient starting PBS subsidised treatment with pasireotide (Signifor LAR®).

The patient and prescriber acknowledgements must be completed.

Further information

For more information contact us on the Complex Drugs Programs enquiry line.

Page last updated: 8 November 2016

This information was printed Sunday 4 December 2016 from humanservices.gov.au/health-professionals/enablers/acromegaly It may not include all of the relevant information on this topic. Please consider any relevant site notices at humanservices.gov.au/siteinformation when using this material.