Removal of Herceptin from PBS

From October 2021, there will be some changes to Herceptin, one of the drug therapies that is available for people with HER-2 positive breast cancer. Herceptin is currently available in two forms: intravenous (an injection into your veins via a drip) and subcutaneous (injection into the skin).

Intravenous Herceptin will no longer be made available by its manufacturer, Roche Australia, for subsidy by the Australian Government’s Pharmaceutical Benefits Scheme (PBS). However, there will continue to be subsidised access to equivalent medicines.

Breast Cancer Network Australia (BCNA) does not consider there to be any significant impacts to consumers currently receiving intravenous Herceptin as part of their breast cancer treatment, but we would like to explain what this change means.

What are the changes?

Herceptin, manufactured by Roche Australia, is one of the brand names for trastuzumab and is a targeted therapy for HER-2 positive breast cancer.

Herceptin is expensive to manufacture. Prior to it being subsidised by the government, many people could not afford to access it as part of their breast cancer treatment. In 2001 and again in 2006, BCNA ran successful campaigns for the Australian Government to subsidise Herceptin by adding it to the PBS to ensure equal access for all Australians.

Several equivalent brands of trastuzumab have since been approved for use in Australia (these are referred to as ‘biosimilar’ medicines). These medicines will continue to be subsidised through the PBS and will remain available to people undergoing treatment for HER2-positive breast cancer instead of Herceptin. 

Roche Australia has decided to remove Herceptin from the PBS as a result of local price reductions that make is unsustainable for Herceptin to remain on the PBS with other biosimilars in the market.

What does this mean for my treatment?

If you are currently receiving intravenous Herceptin as part of your breast cancer treatment, your clinician will discuss the change to one of the biosimilar medicines currently on the PBS with you.

A biosimilar medicine is a very similar version of an existing drug or medicine. While they do not contain the exact same ingredients as the original, they have been proven to work in the same way and have the same benefits as well as potential side effects (see Dept of Health and Aged Care - Biosimilar medicines).

In Australia, the Therapeutic Goods Administration (TGA) regulates the use of biosimilar medicines according to strict guidelines and other international standards to ensure they are safe and effective.

There are currently five biosimilar versions of Herceptin approved in Australia (see Dept of Health and Aged Care - What we're doing about medicines), including:

• Herzuma (also known as Ritemvia, Rituzena, Tuxella)
• Ogivri
• Ontruzant
• Kanjinti
• Trazimera.

These drugs are subsidised by the PBS and are in supply. This means there should be no impact to your treatment schedule when you switch to one of the biosimilar medicines. BCNA recommends raising any concerns or questions you may have with your treatment team.

Are there any changes to subcutaneous Herceptin?

Subcutaneous Herceptin, which is administered under the skin rather than intravenously, will remain on the PBS for now. Roche will update health professionals and consumers about any future changes to the subcutaneous Herceptin subsidy.

When will the changes come into effect?

The removal of intravenous Herceptin from the list of subsidised medicines on the PBS comes into effect on 1 October 2021.

What is BCNA doing?

BCNA is proud of the part it has played to ensure access to this life-saving medicine for thousands of people with breast cancer in Australia over the past 20 years. BCNA will continue to advocate for faster, more flexible processes for new medicines to be approved for use in Australia and listed on the PBS to ensure the best treatment possible for people living with breast cancer. We will also continue to monitor the implications of any changes in the supply of drugs and advise our consumers of any changes that may affect their breast cancer treatment. Feel free to get in touch with any questions or concerns.