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)

and must be treated:

• in combination with taxanes, for patients who have not received chemotherapy for metastatic disease

or

• as monotherapy, for the treatment of those patients who have received one or more chemotherapy regimen(s) for metastatic disease.

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.

• Supporting information page and authority application form for the Herceptin® program [PDF, 193Kb]

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

New patient (i.e. loading dose) 4 mg/kg

Patient weight	No. vials for
< 75 kg	5
75–150 kg	9
> 150 kg	13

Continuing applications 2 mg/kg

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

New patient (i.e. loading dose) 8 mg/kg

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

Continuing application 6 mg/kg

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: 1300 154 190

*Call charges apply from mobile or pay phones only

Herceptin® statistics

Below is a breakdown of Herceptin^® information including:

Number of patients on taxane and monotherapy

Month ending	Taxanes	Monotherapy	Total number
March 2009	1987	1395	3382

HER 3+ and ISH positive

Month ending	HER 3+	HER2+ and ISH positive	ISH positive
March 2009	2774	190	418

Age of patients taking Herceptin® (at start of treatment)

Age range	Number of	Date
20–29	19	March 2009
30–39	286
40–49	814
50–59	1051
60–69	679
70–79	371
80–89	150
90–100	12
Total	3382

Deceased and withdrawn

Month ending	Deceased	Withdrawn
March 2009	1725	669

Weight of patient

Month ending	Patients under 75kg	Patients over 75 kg	Total number of patients
March 2009	2462	920	3382

Patients by state

State	Patients	Date
NSW/ACT	1103	March 2009
Victoria	937
Western Australia	283
Queensland	626
South Australia/NT	328
Tasmania	105
Total	3382

New patients

Date	Patients
March 2008	30
April 2008	36
May 2008	29
June 2008	32
July 2008	40
August 2008	36
September 2008	33
October 2008	32
November 2008	26
December 2008	35
January 2009	33
February 2009	29
March 2009	33

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Last updated: 1 June, 2009