Acute lymphoblastic leukaemia
Imatinib mesylate is available as Pharmaceutical Benefits Scheme (PBS) subsidised therapy, in combination with chemotherapy as induction or consolidation of a newly diagnosed patient with Acute Lymphoblastic Leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript BCR-ABL.
- View information on prescribing imatinib mesylat
Dasatinib, as monotherapy, is available as PBS subsidised therapy of a patient with ALL bearing the Philadelphia chromosome or expressing the transcript BCR-ABL, who has failed treatment with chemotherapy and imatinib mesylate and where appropriate, allogeneic haemopoietic stem cell transplantation.
- View information on prescribing dasatinib
Acute lymphoblastic leukaemia—imatinib mesylate
Authority to supply imatinib mesylate to eligible patients through the PBS under Section 85 arrangements of the National Health Act 1953.
Imatinib mesylate is available as PBS subsidised therapy in combination with chemotherapy, as induction or consolidation of a newly diagnosed patient with ALL bearing the Philadelphia chromosome or expressing the transcript BCR-ABL.
Patients are eligible to receive a lifetime maximum of 24 months of continuing treatment with imatinib mesylate reimbursed through the PBS.
Restriction details
There are three restrictions which apply. A patient must satisfy at least one restriction before approval will be granted to prescribe imatinib mesylate. The restrictions are:
- initial treatment in combination with chemotherapy as induction or consolidation of newly diagnosed patients with ALL
- initial PBS subsidised treatment in combination with chemotherapy for patients with ALL who have previously been treated with imatinib mesylate under the Imatinib Compassionate Program
- continuing treatment in combination with chemotherapy as maintenance of first complete remission of patients with ALL
The Schedule of Pharmaceutical Benefits
outlines the restrictions for prescribing imatinib mesylate to patients.
Item details
Dose
The maximum dose that can be prescribed is 600 mg per day.
Imatinib mesylate is available in tablet form as one of the following:.
- Imatinib mesylate 100 mg tablets are in a pack size of 60
- Imatinib mesylate 400 mg tablets are in a pack size of 30
| Daily dose | Tablet strength | Authority prescription | Quantity | Maximum number |
|---|---|---|---|---|
| 400 mg | 1 x 400 mg tablet | Imatinib mesylate 400 mg tablets | 30 | 2 |
| 4 x 100 mg tablets | Imatinib mesylate 100 mg tablets | 120 | 2 | |
| 600 mg | 6 x 100 mg tablets | Imatinib mesylate 100 mg tablets | 180 | 2 |
| or | ||||
| 1 x 400 mg tablet | Imatinib mesylate 400 mg tablets | 30 | 2 | |
| and | ||||
| 2 x 100 mg tablets | Imatinib mesylate 400 mg tablets | 60 | 2 | |
Important: it is essential that a separate authority prescription is written for each strength of imatinib mesylate.
Patient eligibility
Patients must meet the relevant criteria and be eligible to receive pharmaceutical benefits.
Pathology reports
All applicable pathology reports must be provided from an Approved Australian Pathology Authority.
For initial applications: a pathology report which confirms eligibility for treatment is required.
Lodgement
Applications for initial approvals must be in writing. Requests for continuing prescriptions can be submitted in writing or can be obtained by calling 1800 700 270** (option 3) between 8.00am to 5.00pm EST Monday to Friday.
Please send all written applications to:
Medicare Australia
Prior written approval of specialised drugs
Reply Paid 9826
Hobart TAS 7001
(No stamp required if posted in Australia)
Please ensure that all written applications for authorisation include:
- a completed authority prescription form
- a completed imatinib mesylate application form which includes signed patient and prescriber acknowledgements
- all relevant pathology reports to support current criteria.
If you require further information call 1800 700 270** (option 3) between 8.00am to 5.00pm EST Monday to Friday.
Application form
- Initial PBS subsidised treatment of acute lymphoblastic leukaemia—imatinib mesylate (Form 4206) [PDF, 147Kb]
Lodge this form for a patient starting initial PBS treatment for acute lymphoblastic leukaemia. The patient and prescriber acknowledgments must also be completed.
Important: information on this website will be updated regularly. Please check for regular updates.
Acute lymphoblastic leukaemia—dasatinib
Authority to supply dasatinib to eligible patients through the PBS under the Section 85 arrangements of the National Health Act 1953.
Dasatinib, as monotherapy, is available as PBS subsidised therapy of a patient with ALL bearing the Philadelphia chromosome or expressing the transcript BCR-ABL, who has failed treatment with chemotherapy and imatinib mesylate and where appropriate, allogeneic haemopoietic stem cell transplantation.
Restriction details
There are three restrictions which apply. A patient must satisfy at least one restriction before approval will be granted to prescribe dasatinib. These restrictions are:
- initial treatment for patients with ALL
- initial PBS subsidised treatment for patients with ALL who have previously been treated with dasatinib
- continuing treatment of patients with ALL who do not have progressive disease.
The Schedule of Pharmaceutical Benefits outlines the restrictions for prescribing dasatinib to patients.
Item details
Dose
The maximum dose that can be prescribed is 140 mg per day.
Dasatinib is available in a tablet form presented as one of the following:
- dasatinib 20 mg tablets are in a pack size of 60
- dasatinib 50 mg tablets are in a pack size of 60
- dasatinib 70 mg tablets are in a pack size of 60
Dasatinib prescriptions—a guide to quantity and repeats
| Daily dose | Tablet strength | Authority prescription | Quantity | Maximum number |
|---|---|---|---|---|
| 100 mg | 2 x 50 mg tablets | Dasatinib 50 mg tablets | 60 | 2 |
| 140 mg | 2 x 70 mg tablets | Dasatinib 70 mg tablets | 60 | 2 |
| or | ||||
| 2 x 50 mg tablet | Dasatinib 50 mg tablets | 60 | 2 | |
| and | ||||
| 2 x 20 mg tablets | Dasatinib 20 mg tablets | 60 | 2 | |
Patient eligibility
Patients must meet the relevant criteria and be eligible to receive pharmaceutical benefits.
Pathology reports
All applicable pathology reports must be provided from an Approved Australian Pathology Authority.
For initial applications:
- a pathology report which confirms that the patient has active disease and
- supporting pathology to demonstrate failure to an adequate trial of chemotherapy and imatinib mesylate
are required.
Lodgement
Applications for initial approvals must be in writing. Requests for continuing prescriptions can be submitted in writing or can be obtained by calling 1800 700 270** (option 3) between 8.00am to 5.00pm EST Monday to Friday.
Please send all written applications to:
Medicare Australia
Prior written approval of specialised drugs
Reply Paid 9826
Hobart TAS 7001
(No stamp required if posted in Australia)
Please ensure that all written applications for authorisation include:
- a completed authority prescription form
- a completed dasatinib application form which includes signed patient and prescriber acknowledgements
- all relevant pathology reports to support current criteria.
If you require further information call 1800 700 270** (option 3) between 8.00am to 5.00pm EST Monday to Friday.
Application form
- Initial PBS subsidised treatment of acute lymphoblastic leukaemia—dasatinib (Form 4207) [PDF, 200Kb] Lodge this form for a patient starting initial treatment of acute lymphoblastic leukaemia. The patient and prescriber acknowledgements must also be completed.
Important: information on this website will be updated regularly. Please check for regular updates.
** Call charges apply from mobile or pay phones only.
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Last updated: 21 August, 2009