How breast cancer medicines are subsidised

The cost of your breast cancer medicines may have a significant financial impact on you and your family.

While many of the medicines used in breast cancer treatments are available at a government-subsidised price through the Pharmaceutical Benefits Scheme (PBS), not all are included.

The following information provides a simple overview of how breast cancer medicines are subsidised in Australia.

Testing and approval process

When a new breast cancer treatment is first discovered, it needs to be thoroughly evaluated through clinical trials to determine whether it is safe and effective for people to use.

If the results of the clinical trials are shown to be favourable, the manufacturer/pharmaceutical company will submit an application to the government’s Therapeutic Goods Administration (TGA) to have the treatment approved. Once a medicine has received approval, the medicine is considered safe and effective and it can be sold in Australia.

Following TGA approval, a sponsor (usually the pharmaceutical company) can make an application to have the medicine added to the PBS.

Applications are forwarded to the Pharmaceutical Benefits Advisory Committee (PBAC) which is responsible for making recommendations to the Federal Minister for Health about which medicines should be subsidised under the PBS.

The PBAC is an independent expert body of medical specialists, general practitioners, pharmacists, health economists and consumers that usually meets three times a year to consider applications. BCNA and professional groups such as the Medical Oncology Group of Australia (MOGA) sometimes work with the PBAC to speed up the process of approval for a subsidy for new breast cancer treatments that will provide major advances for women.

When assessing whether a medicine should be subsidised, the PBAC considers the overall clinical effectiveness of the medicine, as well as the cost effectiveness (value for money) of the medicine. In addition, the PBAC considers how the medicine compares with existing medicines used to treat the same condition.

The PBAC also considers community need or benefit through ‘non health’ outcomes, such as whether the medicine is more convenient to take, or whether there are other gains to the community apart from improved health.

If the PBAC considers that a medicine should be subsidised, the Pharmaceutical Benefits Pricing Authority (PBPA) will then negotiate with the sponsor regarding the proposed price of the medicine.

Once a price has been agreed, and following final consideration by the Federal Minister for Health, a medicine can then be added to the PBS. If a medicine is expected to cost more than $10 million per year, approval from the Federal Cabinet is also required before it can be added to the PBS.

While the PBAC considers applications for particular medicines to be added to the PBS, applications to have medical technologies and procedures (including diagnostic tests such as MRIs) subsidised under the Medicare Benefits Schedule (MBS) are instead considered by the Medical Services Advisory Committee (MSAC).

The MSAC is an independent scientific committee made up of individuals with expertise in clinical medicine, health economics and consumer matters, which advises the Federal Minister for Health. Broadly, the MSAC considers such factors as the safety, clinical effectiveness and cost-effectiveness when evaluating whether the procedure should be subsidised.

Sometimes, women are required to undergo a test to determine whether they would benefit from a particular breast cancer medicine. For example a ‘FISH’, ‘CISH’ or ‘SISH’ test is required to determine whether a woman’s breast cancer is HER2 positive, and whether she requires the treatment Herceptin or Tykerb. At present, reforms are attempting to improve the process for subsidising new tests to ensure that MSAC approval for the new test coincides with the PBAC approval for the related medicine.

Ways to access non-subsidised breast cancer medicines 

Some breast cancer medicines are not subsidised and, as a result, women may be required to pay the entire cost of the medicine. This can be very expensive for some medicines.

We know that it can be distressing for women if they are not able to afford expensive breast cancer medicines.

There are some other options available to access expensive breast cancer medicines, which are outlined below.

Patient access programs

Some breast cancer medicines that have been approved for use in Australia but are not subsidised under the PBS may be available through a patient access program, offered by the pharmaceutical company that produces the medicine.

These schemes are offered at the discretion of the pharmaceutical company and the medicines are provided on a case by case basis. In some cases the cost of the medicine is shared by the woman and the pharmaceutical company. You may like to ask your medical oncologist about medicines available through these schemes.

Private health insurance

Some private health insurance policies may allow you to claim benefits towards the cost of your prescription medicines, which means that you may have lower out-of-pocket expenses.

If you have private health insurance you may like to ask your insurer if you are able to claim benefits towards the cost of your prescriptions.

Other options to access breast cancer medicines

In some circumstances, your medical oncologist may be able to access breast cancer medicines that are not available for purchase in Australia. However it is always advisable to discuss any options such as this very carefully with your oncologist. Your oncologist is required to document your informed consent to the use of an unapproved medicine and to notify the TGA of any unexpected side effects.