Early breast cancer
Authority to supply trastuzumab (Herceptin®) for treatment of human epidermal growth factor receptor 2 (HER2) positive early breast cancer or HER2 positive locally advanced breast cancer through the Pharmaceutical Benefit Scheme(PBS) is now available under Section 100 arrangements of the National Health Act 1953.
View information on late stage metastatic breast cancer.
Schedule restriction details
The schedule outlines restrictions for prescribing trastuzumab.
View a full transcript of the trastuzumab schedule restriction details
on the Department of Health and Aging website.
Initial treatment
All patients seeking initial treatment must meet the criteria and must:
- have had cardiac function tested by a suitable method and must have a left ventricular ejection fraction (LVEF) of ≥45 per cent and not have symptomatic heart failure
- start trastuzumab treatment while receiving chemotherapy
- demonstrate human epidermal growth factor receptor 2 (HER2) positivity by in-situ hybridisation (ISH).
Patients are eligible for 52 weeks of PBS subsidised treatment.
Continuing treatment
All patients for continuing treatment must have cardiac function tested every three months by a suitable method and must:
- have a left ventricular ejection fraction (LVEF) of ≥ 45 per cent and not have symptomatic heart failure.
Schedule item details
Dose
As of 1 December 2011 prescribing arrangements for intravenous chemotherapy have changed. The medical practitioner must specify on the prescription the dose to be administered in milligrams per infusion. The prescription must be written for one infusion plus the approved number of repeats (if applicable).
Initial application
The dose is dependent on the patient's weight and calculated as follows:
- once weekly dosing:
* loading dose: 4mg/kg - three weekly dosing:
* loading dose: 8mg/kg
Continuing treatment
The dose is dependent on the patient's weight and calculated as follows:
- once weekly dosing:
* continuing treatment: 2mg/kg. Up to 11 repeats may be requested. - three weekly dosing:
* continuing treatment: 6mg/kg. Up to 3 repeats may be requested.
Patient eligibility
Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.
Who is eligible for the Pharmaceutical Benefits Scheme
Test requirements
A copy of the pathology report confirming the presence of HER2 gene amplification by in-situ hybridisation (ISH) must be provided and must be from an approved pathology authority.
Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, before seeking the initial authority approval and then every three months during treatment.
Lodgement
All initial applications must be in writing and sent to:
Department of Human Services
Prior written approval of specialised drugs
GPO Box 9826
Hobart Tasmania 7001
(no stamp required if posted in Australia)
Please ensure that all written applications for initial PBS authorisations include:
- a completed authority prescription form
- a completed Early breast cancer PBS authority application supporting information form which includes the patient and prescriber acknowledgements
- a pathology report confirming HER2 gene amplification.
Applications for continuing treatment may be made in writing or may be obtained by calling Human Services on 1800 700 270** (select option 1) between 8:00 am to 5:00 pm Eastern Standard Time, Monday to Friday.
For more information please call 1800 700 270** (select option 1) between 8:00 am to 5:00 pm Eastern Standard Time, Monday to Friday.
For more information
Call 1800 700 270** (select option 1) Available Monday to Friday 8.00 am to 5.00 pm Eastern Standard Time.
** Call charges apply from mobile or pay phones only.
Application form
You must lodge this form for a patient starting PBS subsidised treatment with trastuzumab for HER2 positive early breast cancer.
Note: the patient and prescriber acknowledgements must be completed.
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Last updated: 6 March, 2013