Gastrointestinal stromal tumour (GIST) - metastatic or unresectable

The Pharmaceutical Benefits Scheme subsidises imatinib mesylate for patients with metastatic or unresectable malignant gastrointestinal stromal tumour.

The Pharmaceutical Benefits Scheme subsidises imatinib mesylate for patients with metastatic or unresectable malignant gastrointestinal stromal tumour (GIST).

For patients with metastatic or unresectable malignant gastrointestinal stromal tumour, treatment with imatinib mesylate (Glivec®) may be authorised through the Pharmaceutical Benefits Scheme (PBS) under section 85 of the National Health Act 1953.

Restriction details

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing imatinib mesylate.

Initial treatment

Patients must start treatment at a dose of no more than 400 mg per day for at least 3 months. Authority prescriptions for a higher dose will not be approved during this initial 3-month treatment period.

Continuing treatment

Patients who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.

A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50 per cent or greater. Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.

Applications for continuing treatment may be requested by contacting us on the Complex Drug Enquiry line every 3 months.

Schedule item details

Dose - The maximum dose that can be prescribed for GIST – metastatic or unresectable - is 600 mg per day.

Glivec® is available in tablet form:

  • Glivec 100 mg tablets in a pack size of 60 and
  • Glivec 400 mg tablets in a pack size of 30

Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions and be eligible for the Pharmaceutical Benefits Scheme.

Reports

The following reports are required for initial PBS subsidised application:

  • a copy of a pathology report from an approved Australian pathology authority, supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining
  • a copy of the most recent, within two months of the application:
    • Computer Tomography (CT) scan or
    • Magnetic Resonance Imaging (MRI) or
    • Ultrasound of the tumour(s), confirming evidence of metastatic disease

Lodging an application

All initial application requests must be made in writing. Send all written applications to the Complex drugs address on the contact us page.

Further information

For more information contact us on the Complex Drug Enquiry line.

Page last updated: 27 January 2016

This information was printed Friday 9 December 2016 from humanservices.gov.au/health-professionals/enablers/gastrointestinal-stromal-tumour-gist-metastatic-or-unresectable 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.