First New Treatment In More Than 20 Years Added To The PBS For People Living With Proteinuric Chronic Kidney Disease (CKD)^1,2,3,4

1 in 3 Australians have risk factors for chronic kidney disease⁵

Fewer than 10% of the people with CKD are aware they have this condition^5,6

First Nations Australians are approximately twice as likely as non-First Nations Australians to have any stage of chronic kidney disease⁶

Forxiga® (dapagliflozin) can be used to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease who meet the specific criteria of the PBS listing²

Chronic kidney disease is estimated to cost the Australian health system approximately $5.1 billion per year⁵
 

31^st August 2022: AstraZeneca welcomes the announcement about the listing of oral therapy Forxiga® (dapagliflozin) on the Pharmaceutical Benefits Scheme (PBS) in Australia from 1 September 2022 to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease who meet the specific criteria of the PBS listing.^1,2

Kidney disease results in the loss of normal kidney function over time. The most common form of kidney disease is chronic kidney disease.⁷

Based on most recent estimates, chronic kidney disease affects approximately 10% of the Australian adult population.⁶ First Nations Australians are approximately twice as likely as non-First Nations Australians to have any stage of chronic kidney disease.⁶  

Forxiga is an oral medicine and is the first new treatment in more than two decades to be listed on the PBS for proteinuric chronic kidney disease.^2,3,4

Professor Carol Pollock OA – Professor of Medicine at the University of Sydney, Kolling Institute, Royal North Shore Hospital, Chair of Kidney Health Australia, Chair of NSW Bureau Health Information and Deputy Chair of Australian Organ Tissue and Transplant Authority – said the reimbursement of a new effective treatment gives clinicians more options to help manage proteinuric chronic kidney disease.

“Patients diagnosed with proteinuric chronic kidney disease currently have few treatment options. The priority is to slow the progression to dialysis and kidney transplantation. This medicine has been used to manage type 2 diabetes and heart failure with reduced ejection fraction, and it is pleasing to see that it will now be available as an accessible option supporting the treatment of patients diagnosed with proteinuric chronic kidney disease.” said Professor Pollock. 

Chris Forbes, CEO of Kidney Health Australia – the peak body for kidney health in Australia – welcomed the availability of a new treatment option for Australians living with chronic kidney disease.

“Chronic kidney disease is a silent condition, which means that people who are affected can lose up to 90% of their kidney function before noticeable symptoms appear.⁵ It is essential that Australians living with chronic kidney disease have access to innovative treatments so they can better manage their condition. More broadly we need to encourage Australians to understand if they are at risk of chronic kidney disease and if so, speak with their GP to get diagnosed early. Early diagnosis together with education, treatment and support will improve the health of the many Australians affected by the disease,” said Mr Forbes.

Chronic kidney disease frequently occurs alongside diabetes and cardiovascular disease.⁶ An estimated 29% of Australian adults have one or more of chronic kidney disease, diabetes, and/or cardiovascular disease; of this number approximately one quarter have at least two of these conditions.⁶ Data shows that up to 40% of chronic kidney disease is caused by diabetes.⁵

According to Dr Kean-Seng Lim – Sydney-based general practitioner (GP) – GPs are well positioned to play a key role in detecting and treating patients with chronic kidney disease, especially in areas where specialist services are limited.

“Availability of treatment for proteinuric chronic kidney disease will not only help manage patients who have been diagnosed with the condition but improves awareness and leads to enhanced vigilance in monitoring at-risk patients. We know that chronic kidney disease often goes undetected until it has advanced to later stages,⁵ and is more prevalent in people living outside of metropolitan areas due to issues with accessing health services.⁶ GPs are uniquely placed to monitor patients during regular visits and, if needed, can act quickly when the need arises,” said Dr Lim.

Benjamin McDonald– Country President at AstraZeneca Australia and New Zealand – says the latest reimbursement of Forxiga demonstrates the need for new treatment options for people living with proteinuric chronic kidney disease.

“AstraZeneca welcomes the PBS listing of Forxiga. Forxiga provides Australians with proteinuric chronic kidney disease access to a new treatment option for the first time in over 20 years.⁴ We commend the Australian Government for their commitment to Australians living with chronic kidney disease through the PBS listing of Forxiga. The PBS is critical to ensuring Australians have access to the latest innovative medicines,” said Mr McDonald.  

Forxiga contains the active ingredient dapagliflozin.² All medicines can have side effects. Sometimes they are serious, most of the time they are not. Some side effects may require medical treatment. Side effects of Forxiga include:²

• hypoglycaemia (low blood sugar),
• genital infections as suggested by irritation of the genitals,
• urinary tract infections (UTI),
• back pain,
• changes in the amount of cholesterol or fats in your blood,
• headache.

For information on Forxiga please speak to your doctor. The Forxiga Consumer Medicine Information (CMI) brochure may be obtained from your health care professional or viewed online – https://www.guildlink.com.au/gc/ws/astra/cmi.cfm?product=apcforxi10921

For more information about chronic kidney disease, please visit the Kidney Health Australia website: https://kidney.org.au/your-kidneys/what-is-kidney-disease/types-of-kidney-disease

– ENDS –

This media release has been distributed by Palin Communications on behalf of AstraZeneca Australia.

Professor Pollock and Dr Lim have served on advisory boards sponsored by AstraZeneca for which compensation was received. In relation to this AstraZeneca media announcement, no compensation was provided to Professor Pollock or Dr Lim, and the opinions expressed are their own. Both have been briefed by AstraZeneca on the PBS reimbursement of this product.

AstraZeneca proudly supports Kidney Health Australia through sponsorship of healthcare professional education, disease awareness, patient education and activities supporting patients with chronic kidney disease.

MEDIA CONTACTS

• Joni Thomes / joni@palin.com.au / M: 0421 967 709
• Juliette Bagwell / juliette@palin.com.au / M: 0433 336 487

Additional notes for media

About chronic kidney disease
For more information about chronic kidney disease, please visit the Kidney Health Australia website: http://www.kidney.org.au

About Forxiga²
Forxiga is a prescription medicine used to slow the progression of kidney disease in adults.        

Forxiga is a prescription medicine used with diet, exercise and sometimes other medicines to control the levels of blood sugar (glucose) in adults with type 2 diabetes mellitus. It can also reduce hospitalisation for heart failure in adults with type 2 diabetes. Forxiga is also used with other medicines to treat heart failure.

About AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology; Cardiovascular, Renal & Metabolism; and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information, please visit www.astrazeneca.com and www.astrazeneca.com.au

AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com or email Medical Information enquiries to medinfo.australia@astrazeneca.com

References

1. The Pharmaceutical Benefits Scheme. Australian Government Department of Health and Aged Care. 2022. Available at: https://www.pbs.gov.au/pbs/home (accessed September 2022)

2. Forxiga Consumer Medicine Information. Available at http://www.guildlink.com.au/gc/ws/astra/cmi.cfm?product=apcforxi10921

3. Tuttle KR. SGLT2 inhibition and chronic kidney disease outcomes: in diabetes and beyond. Lancet Diabetes Endocrinol. 2021 Jan;9(1):3-5. doi: 10.1016/S2213-8587(20)30374-0. PMID: 33338414.

4. Breyer MD, Susztak K. Nat Rev Drug Discov. 2016 Aug;15(8):568-88. doi: 10.1038/nrd.2016.67

5. Kidney Health Australia, Chronic Kidney Disease (CKD) Management in Primary Care: Guidance and clinical tips to help detect, manage and refer patients in your practice with CKD, 4^th ed. 2020. Available at: https://kidney.org.au/health-professionals/ckd-management-handbook (accessed July 2022)

6. Kidney Health Australia, Make the link: Kidney, diabetes and heart evidence report 2021. Available at https://kidney.org.au/get-involved/advocacy/make-the-link-kidneys-diabetes-and-heart (accessed July 2022)  

7. Kidney Health Australia, What is Kidney Disease? About kidney disease. Available at: https://kidney.org.au/your-kidneys/what-is-kidney-disease  (accessed July 2022)