29 April 2022
Australian men with early-stage prostate cancer that no longer responds to traditional hormone therapy will now be able to access a new form of treatment rather than wait for their cancer to spread.1,2
Erlyand® (apalutamide) is being listed on the Pharmaceutical Benefits Scheme from 1 May for approximately 1,000 men with non-metastatic prostate cancer who despite treatment with testosterone-lowering medication experience a rapid rise in prostate specific antigen (PSA) levels, signalling the imminent spread of cancer. Erlyand will be prescribed in combination with androgen deprivation therapy.1,2
Prostate Cancer Foundation of Australia welcomed the news that the life-extending drug would be made available to men with high-risk forms of prostate cancer.
“This PBS listing is an important development, and our message is clear – early diagnosis, early treatment and early identification of changes in cancer activity are key to containing and combatting prostate cancer,” said CEO Anne Savage.
The PBS listing means that eligible patients will pay just $42.50 (general patients) or $6.90 (concessional patients) for each cycle of treatment with Erlyand.7
Without listing on the PBS, the precision medicine would cost consumers around $40,000 a year.
Associate Professor Arun Azad from Peter MacCallum Cancer Centre said that the PBS listing meant eligible Australian patients would have affordable access to Erlyand, an oral therapy which was made available overseas more than four years ago as the first approved medicine to treat non-metastatic prostate cancer.3
He said the PBS listing heralds “a new era in the treatment of prostate cancer where doctors pre-empt the spread of cancer”.
“Stopping cancer before it spreads represents a shift in how we treat prostate cancer. It’s akin to identifying and dowsing flames before they form and spread as a bushfire.”
Associate Professor Azad explained that while there were treatments for advanced prostate cancer, suppressing the cancer at an earlier stage is a more effective strategy which avoids “fighting the cancer on multiple fronts”.
“Wherever possible we want to stop the spread of cancer. We now have treatment options that can be used earlier with the aim of preventing further spread of disease,” he said.
A rapid doubling of PSA levels in the blood indicates that men with non-metastatic prostate cancer are at heightened risk of their cancer spreading.4 “This is a red flag that signals a need for change in treatment,” Associate Professor Azad explained.
Associate Professor Azad said that a decline in men participating in PSA testing due to COVID-195 had been concerning and would undoubtedly mean more men being diagnosed with advanced prostate cancer.
“It’s vital that men undergo regular prostate health checks, so they are diagnosed at an earlier stage of the disease and don’t miss out on this critical window to treat the cancer before it spreads.
“For men living with prostate cancer, regular monitoring is essential to detect changes in PSA levels, which can be a warning signal that cancer is on the move,” he said.
Each year, more than 18,000 Australian men are diagnosed with prostate cancer and over 3,300 men lose their lives to the disease.
Erlyand works by blocking the action of testosterone in prostate cancer cells and prevents the hormone androgen, which plays a role in prostate cancer growth, from binding to the androgen receptor.2 The therapy is taken as a tablet once a day, with or without food.2
The PBS listing means that eligible patients will pay just $42.50 (general patients) or $6.90 (concessional patients) for each cycle of treatment with Erlyand.7
Janssen Australia and New Zealand Managing Director, Biljana Naumovic said the company had been “working to secure a PBS listing since 2018”.
“It’s been a long wait and the implications on the health of men with non-metastatic prostate cancer cannot be underestimated,” she said.
“This is why the Federal Government’s review of National Medicines Policy must remove the barriers to timely and equitable access to innovative medicines.”
Ms Naumovic confirmed that Janssen continues to explore the use of Erlyand at different stages in the prostate cancer treatment journey. “We are hopeful that Erlyand will play an important role in combatting various forms of prostate cancer.”
All medicines have side-effects. The most common side-effects that occurred with Erlyand in the clinical trials were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea and fracture.2
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References:
1. PBS Schedule of Pharmaceutical Benefits. 2022. Available at: https://www.pbs.gov.au/pbs/home
2. ERLYAND® Product Information. 21 July 2021. Available at: janssen.com.au/erlyand_pi
3. New Non-Metastatic, Castration-Resistant Prostate Cancer Treatment Oncology Times: March 20, 2018 - Volume 40 - Issue 6 - p 17
4. Smith M et al. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer N Engl J Med 2018;378:1408–1418.
5. Impacts of the COVID-19 pandemic on early detection of prostate cancer in Australia BJU Int 2021;128 Supplement 3: 6–8 doi:10.1111/bju.15631
6. PBS: Fees, Patient Contributions and Safety Net Thresholds. 2021. Available at: https://www.pbs.gov.au/info/healthpro/explanatory-notes/front/fee
Janssen-Cilag Pty Ltd, ABN 47 000 129 975, 1-5 Khartoum Road, Macquarie Park NSW 2113. Ph: 1800 226 334. Prepared March 2022. CP-307899
