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PBAC recommendation to list Herceptin on the PBS

The Pharmaceutical Benefits Advisory Committee has recommended that the Australian Government subsidise, under the Pharmaceutical Benefits Scheme (PBS), the drug, trastuzumab (Herceptin), for the treatment of patients with HER2 positive early stage breast cancer following surgery. Certain conditions apply.

PDF printable version of PBAC recommendation to list Herceptin on the PBS (PDF 47 KB)

14 July 2006

Fact Sheet

What has the PBAC recommended?

The Pharmaceutical Benefits Advisory Committee (PBAC) recommended that the Australian Government subsidise, under the Pharmaceutical Benefits Scheme (PBS), the drug, trastuzumab (Herceptin), for the treatment of patients with HER-2 positive early stage breast cancer following surgery, for a maximum period of 12 months to be commenced concurrently with adjuvant chemotherapy.

The committee also specified 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
• The sponsor company, Roche Pharmaceuticals would need to enter some commitments to ensure that the listing could go ahead.
• 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 would be expected to be treated with Herceptin each year. This is actually a larger number of patients than was proposed in the submission from Roche Products Pty Ltd seeking PBS listing.

Herceptin will only help women with HER-2 positive breast cancer. The PBAC recommendation applies to all patients with HER2 positive early stage breast cancer, established by testing for HER 2 gene amplification.

There are several drugs already listed on the PBS to treat breast cancer. At present, more than 85% of breast cancer patients who are diagnosed early and treated with surgery, radiation and/or chemotherapy survive for 10 years after treatment.

Who will not qualify for the drug?

Herceptin would not be subsidised for patients at high risk of heart damage from the drug. HER-2 gene amplification testing, using an in-situ hybridisation test (known as ISH), will be necessary 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 PBAC recommendation for eligibility does not specify a 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 HER2 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 percent. This assessment may change as more evidence becomes available.
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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 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 final cost of treatment is not currently known. It is likely to be in the order of $50 000 per patient for the recommended one year of treatment. This will be subject to price negotiations between Roche Products Pty Ltd and the Department of Health and Ageing.

How soon will funding be available through the PBS listing?

There are still several steps to be completed before listing can occur, including finalisation of the conditions for listing, and consideration by Cabinet.

Discussions will now occur with Roche Products Pty Ltd on the detail of the PBAC recommendation. The outcome of these discussions will inform further consideration by government, both as to whether this drug will be listed on the PBS and, if so, when this may occur. The Government will work as quickly as possible to make a decision on the PBS listing of Herceptin.

What still needs to be done before Herceptin can be listed?

The PBAC noted a number of outstanding issues:

• The optimal duration of the therapy remains unresolved, and Roche should monitor and report immediately to the PBAC on any new studies which might add to understanding of the optimal dose and duration of treatment therapy.
• Roche should fully fund appropriate gene amplification testing for any patient with early breast cancer to determine eligibility for the therapy, pending consideration of gene amplification testing by the Medical Services Advisory Committee (MSAC).
• Roche should take immediate steps to reduce wastage of the drug by having different vial sizes available.

The Department of Health and Ageing will consider each of these issues with the company before any listing can be finalised.

Will the funding for late state 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.