29 June 2023 – Thousands of Australians with type 2 diabetes who face the prospect of kidney failure will soon be able to access a first-of-its-kind medicine2,3 to help slow the worsening of kidney damage.2-4
From 1 July, Kerendia® (finerenone) will be funded through the Pharmaceutical Benefits Scheme (PBS) to delay the progressive decline of kidney function in adults with chronic kidney disease associated with type 2 diabetes (with albuminuria, which means protein is found in the urine).4 It is used in addition to standard medicines for the condition.4
According to Professor Richard MacIsaac, Director of Endocrinology at St Vincent’s Hospital Melbourne and co lead of diabetes kidney disease research at the Australian Centre for Accelerating Diabetes Innovations at the University of Melbourne, who was involved in clinical trials of Kerendia, “the availability of Kerendia through the PBS is very welcome news for the large number of Australians living with the ‘deadly duo’ of type 2 diabetes and progressive kidney disease”.
The listing comes as a new report from Diabetes Australia reveals the full extent of the diabetes-related kidney disease crisis in Australia, warns the problem will compound with time, and calls for the introduction of a national screening program to enable early detection and treatment in order to slow the progression of the disease and help mitigate the impact on the health system.5
“Kidney disease is one of the most common and dangerous complications of type 2 diabetes6 and affects around one in every four Australians living with the condition,”7,8 said Professor MacIsaac.
“Rising rates of type 2 diabetes have seen diabetes-induced kidney disease reach epidemic levels.1 We need to do more to turn the tide on this serious and often silent disease,” he said.
Kidney disease occurs when the kidneys are damaged and become progressively less effective at cleaning the blood.9 Diabetes is the most common cause of kidney disease in Australia, accounting for almost 40 per cent of cases.1 Over time, diabetes damages the kidneys' delicate filtering system. Eventually, the condition may progress to ‘kidney failure‘, where the kidneys become so ineffective that the body is overloaded with toxins and requires either regular dialysis (a blood filtering procedure) or a kidney transplant for survival.7
Kerendia works to block hormones (such as aldosterone and cortisol) from attaching to their receptors (known as mineralocorticoid receptors) in the kidney and blood vessels. Blocking the overactivity of these receptors may prevent the inflammation and scarring that cause kidney disease to progress.2,10
With the new PBS subsidy, around 26,000 eligible patients11 will pay just $7.30 (on concession) or $30.00 (general patients) each month for Kerendia.12 Without the subsidy, this medicine would cost more than $1,000 each year,13 often in addition to the cost of multiple other medicines.
The number of Australians with diabetes requiring treatment for kidney failure has tripled in the last 20 years,1 and dialysis is now the leading cause of hospital admission in Australia.5
Each year, more than 12,000 Australians with diabetes-induced kidney failure receive dialysis and almost 475 receive kidney transplants.5 Additionally, chronic kidney disease contributes to more than 17,700 deaths (or 11 per cent of all deaths) in Australia.14
According to Professor MacIsaac, “We cannot underestimate the impact of chronic kidney disease in Australia, with this problem largely driven by type 2 diabetes”.1
He explained that the higher a person’s blood glucose levels, the more damage done to the kidneys. However, as kidney disease is usually progressive, kidney function will continue to decline even when a person’s diabetes is well controlled.15
“Controlling blood glucose is very important, but it‘s not enough to stop the slippery slope of diabetic kidney disease,”15 he said. “Adopting a healthy lifestyle, having good metabolic and blood pressure control and using medications that slow the progression of kidney function loss are the keys to managing kidney disease in people with diabetes.”
“Despite making progress in the area, we need to do more to slow the progression of the disease, with the goal of avoiding or at least delaying, life-altering dialysis treatment,” concluded Professor MacIsaac.
“We commend the Federal Government for addressing the growing tide of diabetes-induced kidney disease and providing equitable access to Kerendia for Australians living with this potentially life-threatening condition,” said CEO of Bayer ANZ Group and Country Head for Pharmaceuticals, Ashraf Al-Ouf.
“Bayer is proud to play a role in addressing some of the biggest health challenges being faced by everyday Australians and in helping to strengthen our communities. We feel passionately about meeting the unmet needs of patients to help them have better lives, and remain committed to delivering medical innovations that improve the standard of care for Australians living with complex chronic conditions, including kidney and cardiovascular diseases,” said Mr Al-Ouf.
About Kerendia
Kerendia is the first in a class of medicines known as nonsteroidal mineralocorticoid receptor antagonists (MRA) for adults with chronic kidney disease associated with type 2 diabetes.2,3 It is used to delay the progressive decline of kidney function in adults with chronic kidney disease associated with type 2 diabetes (with albuminuria [protein in the urine]) in addition of care.2-4
Kerendia works to block certain hormones (such as aldosterone and cortisol) from attaching to their receptors in the kidney and blood vessels. Blocking the overactivity of these receptors may prevent the inflammation and scarring that cause kidney disease to progress.2,10
As with all medicines, Kerendia can cause some side-effects. The most frequent adverse events include high potassium levels, low sodium levels, and low blood pressure.2,10
Appropriate treatment for each patient is for their healthcare professional to decide in consultation with the patient.
Consumer Medicine Information for Kerendia® is available here.
PBS Information: PBS listed from 1 July 2023.
Media Contacts:
Amy Ma (0497 863 707) at Bayer; or Rebecca Anable (0404 019 323) or John Morton (0416 184 044) at Ethical Strategies.
References:
1. Australian Institute of Health and Welfare. Chronic Kidney Disease: Australian Facts – Data Tables. Available at: https://www.aihw.gov.au/reports/chronic-kidney-disease/chronic-kidney-disease/data
2. Bayer Australia. Kerendia Product Information. 2021. Available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2021-PI-02408-1&d=20230403172310101
3. Agarwal, R. et. Al. Investigating new treatment opportunities for patients with chronic kidney disease in type 2 diabetes: the role of finerenone, Nephrology Dialysis Transplantation, 37(6): 2022:1014–1023.
4. Australia Government Department of Health. Schedule of Pharmaceutical Benefits. 2023. Available at: https://www.pbs.gov.au/pbs/home, July 2023.
5. Diabetes Australia. Shine a Light: Saving Lives by Better Detecting Diabetes-Related Kidney Disease. 2023
6. National Kidney Foundation (US). Does Type 2 Diabetes Increase Your Risk for Kidney Disease? Yes. Available at: https://www.kidney.org/atoz/content/does-type-2-diabetes-increase-your-risk-kidney-disease-yes
7. Diabetes Australia. Diabetes in Australia. https://www.diabetesaustralia.com.au/about-diabetes/diabetes-in-australia/
8. Diabetes Australia. Media release: The bush records troubling kidney rankings, 2023.
9. Mayo Clinic. Diabetic Nephropathy. 2021. Available at: https://www.mayoclinic.org/diseases-conditions/diabetic-nephropathy/symptoms-causes/syc-20354556
10. Bayer Australia. Kerendia Consumer Medicine Information. 2021. Available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2021-CMI-02413-1&d=20230515172310101
11. Bayer Australia. Data on File – Kerendia Patient Population.
12. Australia Government Department of Health. Pharmaceutical Benefits Scheme (PBS) | Fees & Patient Contributions. 2023. Available at: https://www.pbs.gov.au/info/healthpro/explanatory-notes/front/fee
13. Bayer Australia. Data on File – Kerendia Private Prescription Price.
14. Australian Institute of Health and Welfare. Chronic Kidney Disease: Australian Facts. 2023. Available at: https://www.aihw.gov.au/reports/chronic-kidney-disease/chronic-kidney-disease/contents/about
15. Perkovic, V. et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med, 2019;380:2295-2306.
About Bayer in Australia
Bayer is a global life science company with expertise in healthcare and agriculture. The company has had a presence in Australia since 1925 and has a long-term commitment to the health and nutrition of all Australians and New Zealanders. As people live longer and the population continues to grow locally and beyond, Bayer is one of the few companies that takes a comprehensive view of these issues. Guided by our purpose – Science for a better life – we apply our global scientific expertise in healthcare and agriculture to deliver innovations locally to help people and the planet thrive.
For further information visit www.bayer.com.au.
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Bayer Australia Ltd, ABN 22 000 1 38 714, 875 Pacific Highway, Pymble NSW 2073.
Ph: (02) 9391 6000. Date of Preparation: June / COR-M_FIN-AU-0009-2.