Gastrointestinal stromal tumour (GIST), metastatic or unresectable - imatinib mesylate
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Through the Pharmaceutical Benefits Scheme (PBS), under Section 85 arrangements of the National Health Act 1953, authority to prescribe imatinib mesylate (Glivec®) is required for the treatment of metastatic or unresectable malignant gastrointestinal stromal tumour (GIST).
Restriction details
View a full transcript of the restriction details
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Initial treatment
Patients must start treatment at a dose no more than 400 mg per day for at least three months. Authority prescriptions for a higher dose will not be approved during this initial three 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 phone every three months. Call 1800 700 270* and select option 3 (8 am and 5 pm EST Monday to Friday).
* Call charges apply from mobile or pay phones only.
Item details
Dose
The maximum dose that can be prescribed for GIST – metastatic or unresectable - is 600 mg per day.
Glivec® is available in a 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 restrictions as per the criteria and be eligible to receive pharmaceutical benefits.
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.
Lodgement procedures
Applications for initial approvals must be in writing.
Send all written applications to:
Medicare Australia
Prior written approval of specialised drugs
Reply paid 9826
Hobart Tasmania 7001
(No stamp required if posted in Australia)
For more information call 1800 700 270* (option 3) Monday to Friday 8.00am to 5.00pm EST. Friday).
* Call charges apply from mobile or pay phones only
Application form
Lodge this form for a patient starting initial PBS subsidised treatment for GIST – metastatic or unresectable.
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Last updated: 4 April, 2012