Late stage metastatic breast cancer
Herceptin®
The Australian Government funds a program to make sure Herceptin® is available free of charge for late stage metastatic breast cancer. This program is not part of the Pharmaceutical Benefits Scheme (PBS).
There are separate arrangements for the treatment of early breast cancer with trastuzumab.
View information on prescribing trastuzumab for early breast cancer.
Herceptin® must only be ordered by prescribers for eligible patients. All orders of Herceptin® must be approved by Medicare Australia before supply, and no retrospective supplies of Herceptin® will be approved by Medicare Australia.
For the purpose of approving Herceptin® for late stage metastatic breast cancer, Medicare Australia uses the following classification:
- Metastatic breast cancer is considered present when the cancer has spread beyond the breast and axillary lymph nodes to a distant site such as bone, liver, brain or lungs. The presence of axillary node disease alone is not adequate.
Information indicating the presence of metastatic disease, such as diagnostic imaging reports, must be provided with the initial application for treatment.
Patient eligibility
Australian residents, and overseas visitors from countries with Reciprocal Health Care Agreements (RHCA) with Australia are eligible to receive treatment with Herceptin® provided they meet the restrictions for prescribing under this program.
To be eligible to receive treatment of human epidermal growth factor receptor 2 (HER-2) positive metastatic breast cancer with Herceptin® patients must have:
- immunohistological evidence of HER-2 protein at the 3+ level
- immunohistological evidence of HER-2 protein at the 2+ level, subsequently confirmed as exhibiting HER-2 gene amplification by in situ hybridisation (fluorescence or chromogenic)
or
- evidence of exhibiting HER-2 gene amplification by in situ hybridisation (fluorescence or chromogenic)
Patient registration and ordering
To obtain Herceptin® for late stage metastatic breast cancer, prescribers are required to register their patients on the Herceptin® program. Once patients are registered the prescriber should confirm ongoing registration every six months.
The prescriber is required to complete a Herceptin® authority application form. Consent will only be obtained once, and may be revoked, in writing at any time. Participation in the program will stop if consent is revoked by the patient or prescriber.
To enable patients to be registered on the Herceptin® program the prescriber is required to fax to Medicare Australia the completed Herceptin® authority application form, which has been signed by both the prescriber and the patient in the presence of a witness (over 18 years of age). Evidence of the patient’s HER-2 eligibility and the presence of metastatic disease must also be submitted.
Once eligibility has been established Medicare Australia will contact the prescriber to confirm the:
- starting date of treatment
- dosage regime
- treatment will be either
- in combination with taxanes for patients who have not received chemotherapy for metastatic disease or
- as monotherapy for treatment of patients who have received one or more chemotherapy regimen(s) for metastatic disease
- address to which the Herceptin® is to be delivered
(Note: if the drug is to be supplied through a hospital or pharmacy the hospital provider number or the pharmacy approval number is required in order to correctly identify the delivery site) - patient’s Herceptin® registration number.
Medicare Australia will then place an order with Roche Products. Roche Products is responsible for the delivery of the product to the address nominated by the prescriber.
The order will identify the patient with a unique Herceptin® registration number and the prescriber's name. The only patient information Roche Products will receive is the patient's Herceptin® registration number.
It is the responsibility of the prescriber to provide the patient’s details and Herceptin® registration number to the delivery site.
Note: Medicare Australia is unable to initiate drug orders until the patient’s eligibility has been assessed and confirmed.
The prescriber will determine the number of vials required for treatment. The dose is dependent on the patient's weight and can be calculated as 2 mg/kg for once weekly dosing and 6 mg/kg for three weekly dosing. Each vial contains 150 mg of Herceptin®. See dosage charts below for further details.
Prescribers may order further supplies no earlier than:
- 21 days from the date of the previous supply for weekly treatment
or - 18 days from the date of supply for three weekly treatment.
Dosage charts for weekly and three weekly dosing
Weekly dosing—four weeks therapy approved at each application
| Patient weight | No. vials for |
|---|---|
| < 75 kg | 5 |
| 75–150 kg | 9 |
| > 150 kg | 13 |
| Patient weight | No. vials for |
|---|---|
| < 75 kg | 4 |
| 75–150 kg | 8 |
| > 150 kg | 12 |
Three weekly dosing—three weeks therapy approved at each application
| Patient weight | No. vials for |
|---|---|
| Up to 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 |
| Patient weight | No. vials for |
|---|---|
| Up to 50 kg | 2 |
| 51–75 kg | 3 |
| 76–100 kg | 4 |
| 101–125 kg | 5 |
| 126–150 kg | 6 |
| > 150 kg | 7 |
Contact details and hours of service
Medicare Australia Specialised Drug program
Call: 1800 700 270* and select option 1 (8.00 am–5.00 pm EST Monday to Friday)
Fax: 03 6215 5640
*Call charges apply from mobile or pay phones
Herceptin® statistics
Below is a breakdown of Herceptin® information including:
Number of patients on taxane and monotherapy
| Month ending | Taxanes | Monotherapy | Total number |
|---|---|---|---|
| June 2008 | 1785 | 1287 | 3072 |
HER 3+ and ISH positive
| Month ending | HER 3+ | HER2+ and ISH positive | ISH positive |
|---|---|---|---|
| June 2008 | 2621 | 188 | 263 |
Age of patients taking Herceptin® (at start of treatment)
| Age range | Number of | Date |
|---|---|---|
| 20–29 | 17 | June 2008 |
| 30–39 | 271 | |
| 40–49 | 746 | |
| 50–59 | 955 | |
| 60–69 | 606 | |
| 70–79 | 332 | |
| 80–89 | 135 | |
| 90–100 | 10 | |
| Total | 3072 |
Deceased and withdrawn
| Month ending | Deceased | Withdrawn |
|---|---|---|
| June 2008 | 1109 | 971 |
Weight of patient
| Month | Patients | Patients | Total number |
|---|---|---|---|
| June 2008 | 2249 | 823 | 3072 |
Patients by state
| State | Patients | Date |
|---|---|---|
| NSW/ACT | 996 | June 2008 |
| Victoria | 859 | |
| Western Australia | 258 | |
| Queensland | 571 | |
| South Australia/NT | 295 | |
| Tasmania | 93 | |
| Total | 3072 |
New patients
| Date | Patients |
|---|---|
| June 2007 | 36 |
| July 2007 | 32 |
| August 2007 | 55 |
| September 2007 | 38 |
| October 2007 | 34 |
| November 2007 | 22 |
| December 2007 | 27 |
| January 2008 | 31 |
| February 2008 | 41 |
| March 2008 | 30 |
| April 2008 | 36 |
| May 2008 | 23 |
| June 2008 | 27 |
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Last updated: 7 August, 2008