Late stage metastatic breast cancer

Trastuzumab (Herceptin®)

The Australian Government funds a program to make sure trastuzumab (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 before supply and no retrospective supplies of Herceptin® will be approved by Medicare.

Note: applications for retrospective supplies of Herceptin® will be rejected by Medicare.

For the purpose of approving Herceptin^® for late stage metastatic breast cancer, Medicare 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 at the time of primary diagnosis is not adequate.

Information indicating the presence of metastatic disease, such as diagnostic imaging reports, must be provided with the initial application for treatment.

From 1 August 2011, a new 60mg vial strength will be made available for the treatment of late stage breast cancer, along with the existing 150mg vial. When ordering Herceptin^® the most cost efficient combination of vials will be provided to reduce wastage.

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, prescribers are required to confirm ongoing registration every six months.

Prescribers are required to complete a Late stage breast cancer - Herceptin® Authority application [PDF, 193Kb] form. Consent will only be obtained once and can 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 has to fax to Medicare the completed Late stage breast cancer - Herceptin® Authority application [PDF, 193Kb] 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 will contact the prescriber to confirm:

• the starting date of treatment
• the patient's dosage regime
• whether the 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
• the 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 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 is unable to initiate drug orders until the patient’s eligibility has been assessed and confirmed.

From 1 August 2011, the most cost-efficient combination of vial sizes will be calculated by Medicare. The dose is dependent on the patient's weight and can be calculated as follows:

• once weekly dosing:
  * loading dose: 4mg/kg
  *continuing treatment: 2mg/kg
• three weekly dosing:
  * loading dose: 8mg/kg
  * continuing treatment: 6mg/kg

Note: there are now two vial sizes of Herceptin® available (60mg and 150mg vials). Patients must be dosed with the most cost effective combination of vials.

Orders for more supplies cannot be made 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.

Continuing treatment

Prescribers must contact Medicare on  1800 700 270** option 1, between 8.00 am and 5.00 pm Monday to Friday EST, to order each continuing Herceptin® treatment for each patient.

The Herceptin Fax reorder form (4624) may be completed by the prescriber for patient orders going to the same delivery address.  A separate form must be used for different delivery addresses. Incomplete reorder forms will be returned by fax for completion. Partial orders will not be placed. Confirmation of order will be provided by return fax.

Late stage breast cancer - Herceptin® Fax reorder form (Form 4624) [PDF, 121Kb]

For more information

Call Medicare Specialised Drug program
1800 700 270** (Option 1) Available Monday to Friday, between 8.00 am and 5.00 pm EST
Fax: 1300 154 190*

*Call charges apply.
**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

   HER 3+ and ISH positive

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

   Deceased and withdrawn

   Weight of patient

   Patients by state

   New patients

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Last updated: 8 January, 2013

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