Anger at lifesaving $10,000 breast cancer test
Terminal cancer patients are being denied new treatments because Australia's regulator is too slow approving drugs, while thousands of seriously ill people are unable to afford a test that could save their life.
The Therapeutic Drugs Administration (TGA) has been criticised for failing to recognise overseas approvals for innovative drugs, while advanced cancer patients are begging for access to molecular testing that could alert them to possible new treatments earlier.
A special investigation by The Daily Telegraph has found Australian women suffering advanced, late-stage breast cancers are desperate for more affordable options to improve their often dire prognoses.
More than 20,000 people have already signed a petition calling on the federal government to make molecular testing - which costs about $10,000 through private companies - more affordable to anyone with an advanced or rare cancer.
Triple-negative breast cancer sufferer Meagan Monk has just finished one year of surgeries, chemo and radiation, and is now waiting to find out if they worked.
"Hopefully I'll be okay, but there's still a 30 per cent chance it will come back," she said.
Ms Monk said she wished she had known about the test earlier, as it can match a patient with more targeted treatments.
"When you're first told you have cancer your head is spinning, I didn't even know there were different types of breast cancer," she said.
Ms Monk has the BRCA1 gene, which meant she had a 70 per cent chance of getting breast cancer.
"My daughter has a 50/50 chance of getting the gene," she said.
The government has committed $50 million to a molecular testing program called Omico, but limited resources mean it can only help about one in 20 advanced stage cancer sufferers
The life expectancy of people who have been matched to a treatment through Omico has been extended by about 50 per cent.
Those who can't qualify for the test can turn to a private provider, but many find the results recommend a drug not yet approved for use by the TGA, such as Troldevy.
The TGA has to date not approved Trodelvy, a drug that can extend a terminal cancer patient's life, or treat and cure an earlier stage the aggressive breast cancer, even though the FDA in the US has.
A TGA spokeswoman said Trodelvy was a "priority submission currently under evaluation," but the regulator must make a "sovereign" decision regarding the drug's safety, efficacy and quality,
A spokeswoman for Trodelvy manufacturer, Gilead, said the company "recognises" there were Australians who could benefit from the new treatment.
"Gilead has already initiated expedited registration pathways … via the … TGA in Australia," she said.
If Gilead gets registration, it will then need to go through the Pharmaceutical Benefits Scheme (PBS) process, which patient advocates warn could take years.
Rare Cancers Australia director Richard Vines said molecular testing was the "great hope" for cancer patients.
"No patient should go to their grave without this genomic testing," he said.
Mr Vines said grouping rare cancers by genomics, would allow faster drug approvals.
"It takes eight months to get a drug approved by the TGA, and the PBS is another 18 months on top of that," he said.
"People with aggressive, advanced cancers, don't have that time."
PATIENTS WANT TEST
Alison Day was last year told her triple negative breast cancer was terminal, has launched a petition calling on the federal government to make molecular testing available at a lower cost for people with a rare or advanced stage cancer.
"Cancer patients and their medical teams need to have the most advanced, personalised data available when making decisions about their treatment," she said.
Ms Day, who is an employee at NewsCorp, is also calling for a more "efficient" and "fast track" TGA approval process for cancer drugs and technology with high clinical need.
Sydney woman Louise was diagnosed with early-stage cancer in 2019 and had the tumour removed through surgery before commencing a "one size fits all" treatment of chemotherapy and radiation.
She later learned her cancer had the P53 mutation, which often indicates a resistance to radiotherapy and a relative resistance to chemotherapy.
About 50 per cent of invasive tumours have this mutation and Louise said this meant patients were going through chemo for "no" or "minimal" benefit.
"The cost of a molecular test is significantly less than the costs the government pays for chemotherapy and radiotherapy, which often won't work for P53 patients," she said.
Originally published as Anger at lifesaving $10,000 breast cancer test