Australians living with type 2 diabetes and high cardiovascular risk can receive earlier access to AstraZeneca’s FORXIGA® (dapagliflozin) and XIGDUO® XR (dapagliflozin/metformin) following a broadening of the Pharmaceutical Benefits Scheme (PBS) listing from 1 December 2024.
This PBS listing for FORXIGA® and XIGDUO® XR will now enable broader prescribing options to treat people living with type 2 diabetes in combination with metformin earlier and where the person has cardiovascular disease, or is at high risk of a cardiovascular event, or the person identifies as Aboriginal or Torres Strait Islander.1
- Type 2 diabetes is a chronic disease when the body becomes resistant to the normal effects of insulin and loses capacity to produce enough insulin in the pancreas.2
- Almost 1.2 million people were living with type 2 diabetes in Australia in 20213, and up to 500,000 people are estimated to have undiagnosed type 2 diabetes.4
- Cardiovascular disease is the biggest cause of death among people with diabetes, and around 30 per cent of people with type 2 diabetes also have cardiovascular disease.5
Ben McDonald, Country President of AstraZeneca Australia and New Zealand, which has delivered innovative medicines for chronic diseases to Australian patients for more than 60 years, said:
“Hundreds of thousands of Australians with type 2 diabetes may now benefit from earlier access to FORXIGA® and XIGDUO® XR treatments.
“This PBS listing is a major shift in diabetes management in Australia.
“People living with diabetes can now get these treatments earlier from their GP or specialist without having to wait for their blood sugar to increase to a certain point,” Mr McDonald said.
Professor Jonathan Shaw, Deputy Director (Clinical and Population Health), and Head of Clinical Diabetes and Epidemiology, at the Baker Heart and Diabetes Institute said:
“Currently people living with type 2 diabetes typically have to wait for their blood glucose levels to reach an HbA1c measurement greater than 7% before a GP or a specialist can prescribe FORXIGA® or XIGDUO® XR.
“These PBS changes mean doctors can now act earlier and not wait to prescribe these treatments when their patient also has cardiovascular disease or high cardiovascular risk, which is defined as an estimated risk of a cardiovascular event of at least 10 per cent over 5 years.
“The new listing also addresses the need for Aboriginal and Torres Strait Islander people living with type 2 diabetes as they are 2.9 times6 as likely to have the disease, and 2.4 times7 more likely to have cardiovascular disease compared with non-indigenous Australians,” Professor Shaw said.
ABOUT FORXIGA®
FORXIGA® is a member of a class of oral medicines called SGLT-2 (Sodium Glucose Cotransporter-2) inhibitors. FORXIGA® is used with diet, exercise and other medicines (which may include metformin; insulin; a sulfonylurea medicine such as gliclazide, glimepiride and glibenclamide; or a dipeptidyl peptidase-4 inhibitor [DPP 4 inhibitor] such as sitagliptin or saxagliptin or a glucagon like peptide 1 [GLP-1] receptor agonist) 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 and to slow the progression of kidney disease in adults.
Precautions: Patients should inform their doctor if they: have allergies to any other medicines, foods, dyes or preservatives; have or have had type 1 diabetes mellitus, kidney liver or pancreas problems, frequently get genital or urinary tract infections, illnesses that make you dehydrated or diabetic ketoacidosis; take medicines for high blood pressure or take a water pill; take any other medicines; are lactose intolerant. Patients should inform their doctor if they are pregnant or intend to become pregnant or are breastfeeding or intend to breastfeed.
Interactions: Patients should inform their doctor if they are taking any other medicines, including any medicines, vitamins or supplements without a prescription from a pharmacy, supermarket or health food shop. Patients should inform their doctor or pharmacist if they are taking lithium because FORXIGA® can lower the amount of lithium in your blood.
Side Effects: Less serious side effects include irritation of the genitals caused by genital infection; back pain; headache. Serious side effects include: allergic reaction; hypoglycaemia; dehydration; genital or urinary tract infections.
ABOUT XIGDUO® XR
XIGDUO® XR contains two active ingredients dapagliflozin and metformin hydrochloride. Dapagliflozin is a member of a class of medicines you take by mouth called SGLT-2 (Sodium Glucose Cotransporter-2) inhibitors and metformin belongs to a class of medicines called biguanides. XIGDUO® XR is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure. XIGDUO® XR is used with diet, exercise and sometimes other medicines such as insulin, a sulfonylurea, or a dipeptidyl peptidase (DPP-4) inhibitor, or a glucagon like peptide 1 (GLP-1) receptor agonist such as exenatide to control the levels of blood sugar (glucose) in patients with type 2 diabetes mellitus.
Precautions: Patients should inform their doctor if they: have allergies to any other medicines, foods, dyes or preservatives; have or have had type 1 diabetes mellitus, kidney liver or pancreas problems, frequently get genital or urinary tract infections, illnesses that make you dehydrated or diabetic ketoacidosis; take medicines for high blood pressure or take a water pill; take any other medicines; are lactose intolerant. Patients should inform their doctor if they are pregnant or intend to become pregnant or are breastfeeding or intend to breastfeed.
Interactions: XIGDUO® XR contains dapagliflozin and metformin. If you have more than one medicine containing dapagliflozin or metformin in your possession, you may accidentally take too much. XIGDUO® XR may affect how well other medicines work and some medicines can affect how well XIGDUO® XR works.
Serious Side Effects: In rare cases metformin, one of the medicines in XIGDUO® XR, can cause a serious side effect called lactic acidosis. Lactic acidosis is a medical emergency that can cause death and must be treated in the hospital. Lactic acidosis is caused by a build-up of lactic acid in your blood.
More information can be found in the FORXIGA® Consumer Medicine Information and the XIGDUO® XR Consumer Medicine Information.
Patients should discuss their treatment options with their clinician.
PBS Information: FORXIGA®: Authority required (STREAMLINED) 16220. Diabetes mellitus
type 2. Clinical criteria: The treatment must be in combination with metformin; unless contraindicated/intolerant, AND Patient must have cardiovascular disease; OR Patient must be at high risk of a cardiovascular event; OR Patient must identify as Aboriginal or Torres Strait Islander. Treatment criteria: Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor. Note: The Australian Absolute Cardiovascular Disease Risk Calculator is available at www.cvdcheck.org.au. High cardiovascular risk is defined as an estimated risk of a cardiovascular event of at least 10% over 5 years. Refer to PBS Schedule for full Authority Required Information.
XIGDUO® XR: Authority required (STREAMLINED) 16158, Diabetes mellitus type 2 Clinical criteria: Patient must have cardiovascular disease; OR Patient must be at high risk of a cardiovascular event; OR Patient must identify as Aboriginal or Torres Strait Islander. Treatment criteria: Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor. Note: The Australian Absolute Cardiovascular Disease Risk Calculator is available at www.cvdcheck.org.au. High cardiovascular risk is defined as an estimated risk of a cardiovascular event of at least 10% over 5 years. Refer to PBS Schedule for full Authority Required Information.
- ENDS-
Professor Shaw has been involved in medical education and speaker activities sponsored by AstraZeneca for which compensation was received. In relation to this AstraZeneca media announcement, no compensation was provided to Professor Shaw, and the opinions expressed are his own. Professor Shaw has been briefed by AstraZeneca on the approved use of this product.
Media Contacts
AstraZeneca Australia and New Zealand
FORXIGA® and XIGDUO® XR are trademarks of AstraZeneca. 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
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.au
References
1. PBS Schedule https://www.pbs.gov.au/pbs/search?term=dapagliflozin, viewed 27 November 2024
2. Diabetes Australia, Type 2 Diabetes, https://www.diabetesaustralia.com.au/about-diabetes/type-2-diabetes/, viewed 27 November 2024
3. Australian Institute of Health and Welfare, ‘Diabetes Australian Facts’, https://www.aihw.gov.au/reports/diabetes/diabetes/contents/how-common-is-diabetes/type-2-diabetes, viewed 27 November 2024
4. Diabetes Australia, Facts about Diabetes, https://www.diabetesaustralia.com.au/about-diabetes/, viewed 21 October 2024
5. Heart Foundation of Australia, Diabetes and Heart Disease, https://www.heartfoundation.org.au/your-heart/diabetes-and-heart-disease, viewed 15 November 2024
6. Australian Institute of Health and Welfare, ‘Diabetes Australian Facts’, https://www.aihw.gov.au/reports/diabetes/diabetes/contents/how-common-is-diabetes/type-2-diabetes, viewed 27 November 2024
7. Australian Institute of Health and Welfare, ‘Aboriginal and Torres Strait Islander Health Performance Framework, 1.05 Cardiovascular disease’, https://www.indigenoushpf.gov.au/measures/1-05-cardiovascular-disease, viewed 27 November 2024
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