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Medicare Australia - Australian Government
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September 2008
Forum and Bulletin Board

Acute lymphoblastic leukaemia

Imatinib mesylate is available as 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.

Dasatinib is available as PBS subsidised therapy, as monotherapy, of a patient with acute lymphoblastic leukaemia (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.

Acute lymphoblastic leukaemia (ALL)—imatinib mesylate

Authority to supply imatinib mesylate through the Pharmaceutical Benefits Scheme (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 acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR-ABL.

Imatinib mesylate is available as 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.

Patients are eligible to receive a maximum of 24 months treatment with imatinib mesylate; this includes both PBS subsidised and non PBS subsidised treatment.

Schedule restriction details

There are three restrictions, one of which a patient must satisfy before approval will be granted to prescribe imatinib mesylate. These restrictions are:

  • initial treatment for patients with newly diagnosed ALL
  • initial treatment for patients with ALL who have previously been treated with imatinib mesylate under the Imatinib Compassionate Program
  • continuing treatment as maintenance of first complete remission of patients with ALL

The Schedule of Pharmaceutical BenefitsExternal link outlines the restrictions for prescribing imatinib mesylate to patients.

Schedule item details

Dose

The maximum dose that can be prescribed is 600 mg per day.

Imatinib mesylate is available in tablet form.

  • Imatinib mesylate 100 mg tablets in a pack size of 60
  • Imatinib mesylate 400 mg tablets in a pack size of 30
Imatinib mesylate prescriptions—a guide to quantity and repeats
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

Please note: it is essential that a separate authority prescription is written for each strength of imatinib mesylate tablet.

Patient eligibility

Patients must meet the relevant restrictions as per the criteria and be eligible to receive pharmaceutical benefits.

Who is eligible for the PBS?

Pathology reports

All applicable pathology reports must be provided from an Approved Australian Pathology Authority.

Initial application: A pathology report which confirms eligibility for treatment.

Lodgment

Applications for initial approvals must be in writing. Requests for continuing prescriptions may be submitted in writing or may be obtained by calling 1800 700 270** and selecting option 3 (8 am to 5 pm EST Monday to Friday).

The postal address for all written applications is:

Medicare Australia
Prior written approval of specialised drugs
Reply Paid 9826
GPO Box 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 acknowledgments
  • all relevant pathology reports to support current criteria.

If you require further 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.

Application form

Important: information on this website will be updated regularly. Please keep checking this site for updates.

Acute lymphoblastic leukaemia (ALL)—dasatinib

Authority to supply dasatinib through the Pharmaceutical Benefits Scheme (PBS) under the Section 85 arrangements of the National Health Act 1953.

Dasatinib is available as PBS subsidised therapy, as monotherapy, of a patient with acute lymphoblastic leukaemia (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.

Schedule restriction details

There are three restrictions, one of which a patient must satisfy before approval will be granted to prescribe dasatinib. These restrictions are:

  • initial treatment for patients with ALL
  • initial 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 BenefitsExternal link outlines the restrictions for prescribing dasatinib to patients.

Schedule 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 in a pack size of 60
  • dasatinib 50 mg tablets in a pack size of 60
  • dasatinib 70 mg tablets 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 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 restrictions as per the criteria and be eligible to receive pharmaceutical benefits.

Who is eligible for the PBS?

Pathology reports

All applicable pathology reports must be provided from an Approved Australian Pathology Authority.

Initial application: 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.

Lodgment

Applications for initial approvals must be in writing. Requests for continuing prescriptions may be submitted in writing or may be obtained by calling 1800 700 270** and selecting option 3 (8 am to 5 pm EST Monday to Friday).

The postal address for all written applications is:

Medicare Australia
Prior written approval of specialised drugs
Reply Paid 9826
GPO Box 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 acknowledgments
  • all relevant pathology reports to support current criteria.

If you require further 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.

Application form

Important: information on this website will be updated regularly. Please keep checking this site for updates.

Some documents on this page may require the free Adobe PDF reader.

Last updated: 15 September, 2008

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