16 November 2023
New PBS drug listing for men with prostate cancer
A new government medicine subsidy will allow thousands of Australian men battling an advanced form of prostate cancer to launch a three-pronged attack against their disease.1,2
Medical experts are welcoming Pharmaceutical Benefits Scheme (PBS) access to the first and only medicine specifically registered by the Therapeutic Goods Administration for use in triple therapy to fight cancer in a number of different and complementary ways as soon as it has escaped the prostate.1,2
From 1 December, men with metastatic hormone-sensitive prostate cancer (cancer that has spread beyond the prostate to organs such as the lymph nodes, bone, lung and liver) will receive subsidised access to NUBEQA® (darolutamide) for the first time. It will form part of a three-pronged treatment, used alongside chemotherapy and hormone therapy (androgen deprivation therapy or ADT).1,2
Genesis Care Medical Oncologist Dr Laurence Krieger explained that NUBEQA works to starve cancer cells of the hormones they need to grow and divide,2 while androgen deprivation therapy blocks production of the cancer-stimulating hormones,3 and chemotherapy works to destroy cancer cells.4
“Sadly, prostate cancer remains the second greatest cancer killer of Australian men.5 New treatment options are desperately needed,” he said.
Through the PBS, around 2,8006 eligible men will pay just $7.30 (on concession) or $30.00 (general patients) each month for NUBEQA.7 Without the PBS subsidy, these tablets could cost more than $42,0006 each year in addition to the cost of other anti-cancer medicines.
“Every year nearly 4,000 Australian men will be diagnosed with incurable Stage 3 or 4 prostate cancers,”5 said PCFA CEO Anne Savage.
“The listing of medicines such as NUBEQA for more men is an important development for thousands of Australian fathers and sons,” she said. “However, we need to continue raising awareness so that all Australian men get a fair chance of detecting prostate cancer early, so that we can beat it.”
“We are tremendously grateful to Health Minister Mark Butler for supporting men and families in our community with this new listing,” Ms Savage added.
Ashraf Al-Ouf, CEO of Bayer Australia and New Zealand Group and Country Division Head for Pharmaceuticals, stated: “Timely access to additional treatment options could be a key moment for someone living with prostate cancer – potentially impacting their ability to live well alongside family and friends”.
“Bayer is proud to deliver NUBEQA as an additional treatment option for men with this form of advanced prostate cancer, as well as stand behind PCFA in its efforts to raise awareness of the disease and address barriers to early diagnosis,” he said.
About prostate cancer
Prostate cancer is the most common cancer in Australia and the second-leading cause of cancer deaths among Australian men.5 It is projected that this year alone, 25,487 Australian men will be diagnosed with prostate cancer and 3,743 will lose their lives to the disease8 – a 25% increase in the number of deaths from prostate cancer since 2007.9
When prostate cancer spreads outside of the prostate to other parts of the body (such as the lymph nodes or bones) it is classified as advanced or metastatic prostate cancer.4 Five-year survival rates for prostate cancer diagnosed at Stage 1 is 100%; this drops to just 36% for men with Stage 4 (advanced) disease.5
About NUBEQA in metastatic hormone sensitive prostate cancer (mHSPC)
NUBEQA is an oral treatment option for metastatic hormone sensitive prostate cancer that is registered by the TGA for use in conjunction with androgen deprivation therapy and chemotherapy (docetaxel). It belongs to a class of medicines known as androgen receptor inhibitors.2
As with all medicines, NUBEQA is associated with some side-effects. While uncommon, the most frequent adverse drug reactions are fatigue, rash, or pain in an extremity. The most frequently observed adverse drug reactions in patients with mHSPC receiving NUBEQA in combination with docetaxel were constipation, decreased appetite, rash and hypertension.2
NUBEQA is not suitable for patients with hypersensitivity to the medicine or other substances in the tablet, or in women who are or may become pregnant. Caution is required in patients who have recently suffered a cardiovascular event, or who have impaired liver or kidney function, and in those under 18 years of age. The following medicines may influence the effect of NUBEQA, or NUBEQA may influence the effect of these medicines: rifampicin (antibiotic), carbamazepine and phenobarbital (epilepsy), St. John's Wort (anxiety or low mood), rosuvastatin, fluvastatin and atorvastatin (high cholesterol), methotrexate (joint and/or skin inflammation, or cancer), sulfasalazine (inflammatory bowel disease) and itraconazole (fungal infections). Seizures and hepatotoxicity have occurred in patients treated with NUBEQA.2
Individuals with further questions or concerns should consult their doctor who is best placed to advise on their condition and suitable treatment options.
About Bayer in Australia
Bayer is a global enterprise with core competencies in the life science fields of health care, nutrition and agriculture. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. The company has operated in Australia since 1925 and has a long-term commitment to the health and nutrition of all Australians. Locally, Bayer employs almost 900 people across the country and is dedicated to servicing the needs of rural and remote communities. Bayer embraces and encourages its employees’ unique identities and advances a culture of inclusion and diversity across gender, LGBTQI+, generations, disability and race. For more information, go to www.bayer.com.au.
This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems
Product and Consumer Medicine Information for NUBEQA® is available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2020-PI-01276-1&d
PBS Information: PBS listed from 1 December 2023.
Authority Required. Refer to PBS schedule for full information when available at www.pbs.gov.au.
References:
- Australia Government Department of Health. Schedule of Pharmaceutical Benefits. 2023.
- Bayer Australia. NUBEQA Product Information. 2023.
- Prostate Cancer Foundation of Australia. Understanding Hormone Therapy for Prostate Cancer. 2023.
- Cancer Council NSW. Advanced Prostate Cancer. 2023
- Prostate Cancer Foundation of Australia. Prostate cancer in Australia – what do the numbers tell us?
- Bayer Australia. Data on File – NUBEQA Access Details: Cost and Patient Eligibility. 2023.
- Australia Government Department of Health. Pharmaceutical Benefits Scheme (PBS) | Fees & Patient Contributions. 2023.
- Prostate Cancer Foundation of Australia. Prostate Cancer in Australia – Key Statistics. August 2023.
- Prostate Cancer Foundation of Australia. Death count climbs while survival improves. August 2023.
