The Royal College of Pathologists of Australasia (RCPA) supports the move to add Braftovi, a targeted therapy for metastatic colorectal cancer (mCRC) to the Pharmaceutical Benefits Schedule (PBS) this year, improving health outcomes for potentially thousands of patients in Australia.

RCPA Fellow, Prof Anthony Gill explains that the addition of Braftovi to the PBS is an encouraging step forward that will offer significant improvements in health outcomes for patients.

“Used in combination with the PBS-listed anti-cancer medicine Cetuximab, Braftovi has the potential to slow down or stop the growth of the cancer and can help some patients with advanced mCRC survive longer and have a better quality of life. 

This addition of Braftovi to the PBS vastly improves access for patients and means that rather than costing around AUD$33,600 per course of treatment, as it did previously, it now costs AUD$42.50 per script or AUD$6.80 for concession cardholders,” said Prof Gill.

In order to determine eligibility for PBS access to Braftovi, patients must first have their cancer tested for mutations in the RAS genes (KRAS and NRAS) and the BRAF gene. Following an application to the Medical Services Advisory Committee (MSAC) by the RCPA, this testing is now available on the Medicare Benefits Schedule (MBS) for patients with mCRC.

“For many years, patients with mCRC have been eligible for MBS access to a drug called Cetuximab, but only if their tumours do not have a mutation in the KRAS or NRAS genes. 

This is because we know Cetuximab will not work against tumours that have these mutations. What we have known for a while now is that patients with mCRC who have the BRAF mutation in their tumours, do not respond well to Cetuximab, even if they do not have RAS mutations. 

However, we now know that these patients will respond to Cetuximab when it is combined with Braftovi (which is a BRAF inhibitor).

“In order to access this treatment, patients must have their colon cancers tested for both RAS and BRAF mutations. Testing for RAS mutations was already funded on the PBS for mCRC, but this has now been extended to include the addition of BRAF mutation testing, significantly improving accessibility for those who need it.

“This is yet another example of how accurate and accessible pathology testing guides treatment for so many conditions.

Not only will it allow us to provide the right treatment, to the right patient at the right time, equally importantly it will also allow us to advise against treating patients with therapies that would not work for them. For example, we know that this treatment will not help if the tumour has RAS mutations or lacks BRAF mutations,” said Prof Gill.

Since the mid-1990s, the number of new mCRC cases has been increasing among people under the age of 50. Now, mCRC is the deadliest cancer and the fifth leading cause of death overall for Australians aged 25-44.  Over 15,000 Australians are diagnosed with CRC each year and this number continues to rise.

The BRAF gene mutation makes mCRC more aggressive and more resistant to chemotherapy and treatment options for these patients are extremely limited.

The mutation affects about one in 10 Australians with advanced mCRC, resulting in a poor prognosis, with an average survival rate of just four to six months after failure of initial therapy.  Braftovi offers patients a significantly better option in their disease management.