Gastrointestinal stromal tumour (GIST) - metastatic or unresectable
The PBS subsidises imatinib mesilate for patients with metastatic or unresectable malignant gastrointestinal stromal tumour.
The Pharmaceutical Benefits Scheme subsidises imatinib mesilate for patients with metastatic or unresectable malignant gastrointestinal stromal tumour (GIST).
For patients with metastatic or unresectable malignant gastrointestinal stromal tumour, treatment with imatinib mesilate (Glivec®) may be authorised through the Pharmaceutical Benefits Scheme (PBS) under section 85 of the National Health Act 1953.
The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing imatinib mesilate.
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.
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
Patients must meet the relevant criteria as indicated in the restrictions and be eligible for the Pharmaceutical Benefits Scheme.
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.
- Lodge Gastrointestinal stromal tumour - metastatic or unresectable Initial PBS authority application and Supporting information form (PB095) for a patient starting initial PBS-subsidised treatment for GIST – metastatic or unresectable
For more information contact us on the Complex Drug Enquiry line.