Listing of Herceptin on the PBS

1 October 2006

What is the Government’s decision on Herceptin?

The Government has accepted a recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) to list the drug trastuzumab (Herceptin®) on the Pharmaceutical Benefits Scheme (PBS) for the treatment of patients with HER-2 positive early stage breast cancer.

The drug was listed on 1 October 2006. It will be used following surgery, commenced initially with adjuvant chemotherapy, and continued for a maximum period of 12 months. Adjuvant chemotherapy for breast cancer is anti-cancer drug treatment which is given following surgery to reduce the risk of recurrence of the cancer. The Government agreed with the PBAC recommendation that:

• Gene amplification testing to determine HER-2 positive status will be required prior to treatment. This will ensure that use of the drug is properly targeted to those able to benefit.
• Patients who have a particular vulnerability to heart damage should not receive the drug.

Who will qualify for the subsidised drug?

About 14,000 Australian women are diagnosed with breast cancer each year. Around 2,100 patients are expected to be treated with Herceptin each year.

From 1 October 2006, Herceptin has become available on the PBS for women who are diagnosed with HER-2 positive breast cancer, established by testing using a HER-2 gene amplification test. Herceptin will be administered concurrently with adjuvant chemotherapy.

Will women who have already been diagnosed with HER-2 positive breast cancer be eligible for PBS subsidy?

Women who are receiving treatment with adjuvant chemotherapy following surgery for early stage HER-2 positive breast cancer, and patients who are being treated with Herceptin on 1 October 2006, will qualify for access to PBS subsidised Herceptin from that date.

Will all the relevant chemotherapy drugs be available for the patients who are eligible for Herceptin?

Yes. Minor changes were made from 1 October 2006 to the PBS eligibility rules for the chemotherapy drugs, docetaxel and paclitaxel, to ensure that all early breast cancer patients who are eligible for Herceptin treatment can use these drugs as part of their chemotherapy regime.

Will any HER-2 positive patients not be able to receive Herceptin?

Herceptin will not be subsidised for patients at high risk of heart damage from Herceptin. Gene amplification testing, using an in-situ hybridisation test (known as ISH), will confirm a HER2 positive diagnosis so as to identify patients who are likely to benefit from use of the drug.

Will eligibility for Herceptin be restricted to patients with tumours greater than 20 mm in diameter for node negative patients?

No. The Government has accepted the PBAC recommendation that eligibility should not relate to tumour size as there is no clear link in the evidence to suggest that this is a relevant factor in identifying the group of patients who will benefit. There are also difficulties in measuring tumour size in pathology specimens.

What are the side effects of the drug?

There are a number of possible adverse effects from using this drug. The most significant is heart damage. The risk of permanent damage to the heart was carefully assessed by the PBAC in recommending which patients should access the drug on the PBS.

What is the success rate of Herceptin?

Herceptin does not cure breast cancer. Herceptin has been shown to reduce the risk of recurrence of disease in a portion of patients only. On the basis of the available evidence, the PBAC accepted that, for people with HER-2 gene amplification (which occurs in 15% to 25% of breast cancer cases) in early stage breast cancer, Herceptin would be expected, in the longer term, to reduce the rate of recurrence of disease by approximately 30%.

This assessment may change as more evidence becomes available.

What can be done for breast cancer patients who are not eligible?

The PBS already subsidises many medicines for the treatment of advanced and early stage breast cancer. These include anastrozole, paclitaxel, cyclophosphamide, epirubicin, doxorubicin, docetaxel and fluorouracil. New drugs used in the treatment of cancer are regularly added to the PBS. Patients should discuss their treatment options with their doctor.

What is the cost to the Government of subsidising Herceptin?

The cost of the 52 weeks of treatment is likely to be in the order of $50 000 per patient for eligible patients. The listing of Herceptin will add approximately $470 million to PBS and Repatriation Pharmaceutical Benefits Scheme expenditure between 2006-07 and 2009-10.

Will the funding for late stage breast cancer remain?

Yes. Since 2001 the Australian Government has funded trastuzumab for the treatment of late stage breast cancer under a special Herceptin Program, which Medicare Australia administers independently of the PBS.