Gastrointestinal stromal tumour
Authority to supply imatinib mesylate (Glivec®) for the treatment of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour (GIST) through the Pharmaceutical Benefits Scheme under the Section 85 arrangements of the National Health Act 1953.
Imatinib mesylate (Glivec®) is available for the treatment of patients with a metastatic or unresectable malignant gastrointestinal stromal tumour (GIST).
Important: Imatinib mesaylate is not PBS subsidised for the treatment of patients with resectable malignant gastrointestinal stromal tumours.
Schedule restriction details
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% 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 telephone every three months. Please 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.
Schedule item details
Dose
The maximum dose that can be prescribed for GIST 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 only 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)
- Magnetic Resonance Imaging (MRI) or Ultrasound assessment of the tumour(s), including whether or not there is evidence of metastatic disease.
Lodgment procedures
Applications for initial approvals must be in writing.
Please send all written applications to:
Medicare Australia
Prior written approval of specialised drugs
Reply paid 9826
GPO Box 9826
Hobart Tasmania 7001
Please ensure that all written applications for authorisation include:
- a completed authority prescription form
- a completed imatinib mesylate (Glivec®) supporting information form. Initial PBS-subsidised treatment only:
- a copy of a report(s) from one of the following—Computer Tomography (CT scan) or Magnetic Resonance Imaging (MRI) or ultrasound assessment
- a pathology report confirming eligibility for treatment (initial PBS-subsidised treatment only).
For more information please call 1800 700 270** and select option 3. (8 am to 5 pm EST Monday to Friday).
** Call charges apply from mobile or pay phones only.
Supporting information form
Initial PBS subsidised treatment for GIST - Imatinib mesylate (Glivec) PBS authority application supporting information form [PDF, 163Kb]
This document contains the form you must lodge for a patient commencing initial PBS subsidised treatment for GIST.
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Last updated: 15 September, 2008