Early breast cancer
Authority to supply trastuzumab (Herceptin®) for treatment of human epidermal growth factor receptor 2 (HER2) positive early 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.
Initial treatment
All patients for initial treatment must:
- have undergone surgery
- have had cardiac function tested by a suitable method and must:
- have a left ventricular ejection fraction (LVEF) of ≥45%
- not have symptomatic heart failure
- start trastuzumab treatment while receiving adjuvant 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 at three monthly intervals by a suitable method and must:
- have a left ventricular ejection fraction (LVEF) of ≥ 45%
- not have symptomatic heart failure.
Schedule item details
Dose
Trastuzumab is available in single vials containing 150 mg.
Initial application
The medical practitioner should request sufficient quantity based on the weight of the patient to provide for a maximum of three weeks treatment (equivalent to the loading dose for the three weekly dosing regimen or the loading dose and two weekly doses for the once weekly dosing regimen). Please refer to the chart below.
Dosage charts for weekly and three weekly dosing
Weekly dosing—three weeks therapy approved at each application
| Patient weight | Number of vials for three weeks treatment |
|---|---|
| 37 kg | 3 |
| 38-75 kg | 4 |
| 76-112 kg | 7 |
| 113-150 kg | 8 |
| 151-187 kg | 11 |
| Patient weight | Number of vials for three weeks treatment |
|---|---|
| 75 kg | 3 |
| 76-150 kg | 6 |
| > 150 kg | 9 |
Three weekly dosing—three weeks therapy approved at each application
| Patient weight | Number of vials for three weeks treatment |
|---|---|
| 37 kg | 2 |
| 38-56 kg | 3 |
| 57-75 kg | 4 |
| 76-93 kg | 5 |
| 94-112 kg | 6 |
| 113-131 kg | 7 |
| 132-150 kg | 8 |
| > 150 kg | 9 |
| Patient weight | Number of vials for three weeks treatment |
|---|---|
| 50 kg | 2 |
| 51-75 kg | 3 |
| 76-100 kg | 4 |
| 101-125 kg | 5 |
| 126-150 kg | 6 |
| > 150 kg | 7 |
Patient eligibility
Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.
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 at three monthly intervals during treatment.
Lodgment
All initial applications 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
(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
- a completed patient acknowledgement form
- a pathology report confirming HER2 gene amplification, where applicable.
Applications for continuing treatment may be made in writing or may be obtained by calling Medicare Australia on 1800 700 270** and select option 1 (8 am to 5 pm EST Monday to Friday).
For more information please call 1800 700 270** and select option 1 (8 am to 5 pm EST Monday to Friday).
** 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. The patient acknowledgment authority prescription and relevant attachments must also be included.
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Last updated: 15 September, 2008