AstraZeneca announces new treatment will be listed on the PBS from November 1st, 2021 to help manage COPD, Australia’s fifth leading cause of death

  • Chronic obstructive pulmonary disease (COPD) is the fifth leading cause of death and the leading cause of preventable hospitalisations in Australia.3 Around one in five people with COPD die within one year of their first hospitalisation for an exacerbation (flare up).4,5,6
  • Breztri Aerosphere® (budesonide/glycopyrronium/formoterol fumarate), which combines three medications in the same device, will be listed on the Pharmaceutical Benefits Scheme (PBS) from November 1, 2021 for patients with COPD.*1,2
  • The reimbursement of a new triple therapy represents a new treatment option for patients living with this devastating disease.

SYDNEY AUSTRALIA, 30 OCTOBER 2021 – Australians with chronic obstructive pulmonary disease (COPD) now have access to a new treatment option which combines three medications in the same device, following the announcement that Breztri Aerosphere® (budesonide/glycopyrronium/formoterol fumarate) will be listed on the Pharmaceutical Benefits Scheme (PBS) as of November 1, 2021.1

Breztri Aerosphere® is registered by the TGA for maintenance treatment to prevent exacerbations and relieve symptoms in adults with moderate, severe, or very severe chronic obstructive pulmonary disease (COPD) who require treatment with a combination of an inhaled corticosteroid (ICS), a long-acting β2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA).1 Breztri Aerosphere® is not indicated for the initiation therapy in COPD. Breztri Aerosphere® is reimbursed for those have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months, as well as those who have been stabilised on a combination of a LAMA, LABA and an ICS for this condition.*2

COPD, a progressive and debilitating disease that restricts airflow in the lungs,7,8,9 is the fifth leading cause of death and the leading cause of preventable hospitalisations in Australia.3 Approximately 8.3% Australians aged 40 years and over have some form of COPD.10 People living with COPD may have varied symptoms including breathlessness, fatigue and coughing. They can experience flare-ups, which are known as exacerbations, that lead to poor outcomes.11

Mark Brooke, CEO Lung Foundation Australia said: “A flare-up or an exacerbation is the worsening of COPD symptoms and recovery can take some time. That’s why it’s important to recognise the symptoms and have an action plan in place. However, what we have recently seen in our patient community is that people who experience an exacerbation do not visit a medical professional, and the majority do not have a management plan in place. With such a high prevalence of COPD in Australia and being one of our top five killers, raising awareness of the long-term impact of the disease has never been more critical. This announcement will provide clinicians caring for these patients with an opportunity to explore treatment options for their patients with COPD”

A COPD exacerbation can be caused by an infection (often due to a virus) or triggered by air pollutants or irritants.11 Exacerbations are more common during the winter months and can make everyday activities more difficult.11 Studies have shown that the risk of death within one year of hospitalisation for an exacerbation could be as high as 22% and 26% of patients with COPD.4,5,6

Professor Christine Jenkins, Head of the Respiratory Group for The George Institute for Global Health Sydney and Professor of Respiratory Medicine at UNSW Sydney said: “Even a single COPD flare up (exacerbation) can have a negative impact on lung function and increase the risk of hospitalisation and death. Despite the known burden of exacerbations, many symptomatic patients with a history of exacerbations do not have their therapy reviewed and optimized. It is important for people living with COPD to speak with their GP or respiratory specialist about managing exacerbations. The availability of a new treatment option provides another option to support the management of people living with COPD.”

People living with lung conditions including COPD are often misunderstood and stigmatised in the community.12 The response of others to noticeable respiratory symptoms that are distinguishing characteristics of COPD, such as cough, expectoration (spitting or expelling phlegm) and wheeze, can add to patients feeling devalued and have a lasting impact on their quality of life.13 For some patients, stigma can contribute to lack of support, delayed presentation and poorer outcomes.12 Educating the community about COPD is critical to improving the mental health and wellbeing, quality of life and social participation for people with living with COPD.12

Liz Chatwin Country President, AstraZeneca Australia and New Zealand said: “AstraZeneca has been committed to improving the lives of Australians living with chronic conditions for more than 64 years. The reimbursement of Breztri Aerosphere® on the PBS for eligible Australian patients with COPD reinforces AstraZeneca’s commitment to supporting patients with chronic respiratory conditions to access new and innovative treatment options.”

Breztri Aerosphere® is an inhaled fixed-dose combination medication in a pressurised metered dose inhaler (pMDI) or puffer, which contains three active ingredients, budesonide, glycopyrronium and formoterol fumarate.1,14 These work together in different ways to reduce and prevent inflammation in the lungs, and stop the tightening of the muscles in the lungs, making it easier for air to get in and out of the lungs.14

Breztri Aerosphere® should not be used if you are allergic to any of the ingredients. Patients should inform their doctor if they have allergies to any other medicines or foods or have any other medical conditions such as asthma, high blood pressure or heart problems, thyroid problems, low potassium in your blood, diabetes or high blood glucose, prostate problems, problems passing urine, eye problems, severe kidney or liver problems, or if they take any medicines for any other condition.14

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need treatment if you get some of the side effects. Ask your doctor to answer any questions you may have. The most common side effects for Breztri Aerosphere® include: headache, painful and/or frequent urination, muscle cramps/spasms, thrush, feeling anxious, problems sleeping, cough and/or hoarse voice, and feeling sick.14

Full Consumer Medicine Information can be accessed at:
http://www.guildlink.com.au/gc/ws/astra/cmi.cfm?product=apcbrezt10721

PBS Information: This product is not listed on the PBS

Breztri Aerosphere® is a registered trademark of the AstraZeneca group of companies. Registered user 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

Notes to editors

About COPD

COPD is a progressive disease, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness.6,9,15 Around 8.3% of Australians aged 40 years and over have some form of COPD.10 COPD is the fifth leading cause of death and the leading cause of preventable hospitalisations in Australia3 and the third leading cause of death worldwide.16

Improving lung function, reducing exacerbations and managing daily symptoms such as breathlessness are important treatment goals in the management of COPD.15,16  A single COPD exacerbation can have a negative impact on lung function,17,18 quality of life19 and increase the risk of hospitalisation.9 Additionally, studies have shown that the risk of death within one year of hospitalisation for a severe exacerbation could be as high as 22% and 26% for patients with COPD.4,5 

About Breztri Aerosphere®

Breztri Aerosphere® (budesonide/glycopyrronium/formoterol fumarate) is an inhaled fixed-dose combination medication which contains three active ingredients, budesonide, glycopyrronium and formoterol fumarate.1,14 Breztri is delivered via a pressurised metered dose inhaler (pMDI).1

Budesonide, an inhaled corticosteroid, works by reducing and preventing inflammation in the lungs.14 

Glycopyrronium, a long-acting muscarinic antagonist (or LAMA), and formoterol, a long-acting beta-2-agonist (or LABA), belongs to a group of medicines called bronchodilators. These work together in different ways to stop the tightening of the muscles in the lungs, making it easier for air to get in and out of the lungs.14

AstraZeneca in Respiratory & Immunology

Respiratory & Immunology is one of AstraZeneca’s three key therapy areas. For over 50 years, AstraZeneca has been dedicated to innovation in respiratory care.

AstraZeneca is an established leader in respiratory care in Australia and Globally. Our inhaled treatments are the core of our business and the foundation of asthma and COPD care around the world. In 2019, our inhaled and biologic medicines reached more than 53 million patients.20

AstraZeneca recognises the impact of COPD and other respiratory diseases on Australian lives. We are committed to continuing to unlock the power of what science can do in respiratory disease. Our ongoing respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction.

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, visit www.astrazeneca.com.au

References

1. Breztri Aerosphere Australian Product information. Available at: http://www.guildlink.com.au/gc/ws/astra/pi.cfm?product=appbrezt10721 [Last accessed: October 2021]

2. PBS – Available at: https://www.pbs.gov.au

3. AIHW. Chronic obstructive pulmonary disease (COPD). Available at: https://www.aihw.gov.au/reports/chronic-respiratory-conditions/copd/contents/deaths [Last accessed: September 2021].

4.  Suissa S, Dell’Aniello S, Ernst P. Long-term natural history of chronic obstructive pulmonary disease: severe exacerbations and mortality. Thorax. 2012; 67 (11): 957-63.

5. Ho TW, Tsai YJ, Ruan SY, et al. In-Hospital and One-Year Mortality and Their Predictors in Patients Hospitalized for First-Ever Chronic Obstructive Pulmonary Disease Exacerbations: A Nationwide Population-Based Study. PLOS ONE. 2014; 9 (12): e114866.

6. Lindenauer PK, Dharmarajan K, Qin L, et al. Risk Trajectories of Readmission and Death in the First Year After Hospitalization for Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2018 Apr 15;197(8):1009-1017.

7. Laviolette L, Laveneziana P; ERS Research Seminar Faculty. Dyspnoea: a multidimensional and multidisciplinary approach. Eur Respir J. 2014; 43 (6): 1750-1762.

8. May SM, Li JT. Burden of chronic obstructive pulmonary disease: healthcare costs and beyond. Allergy Asthma Proc. 2015; 36 (1): 4-10.

9. Exacerbations in a General Practice-based Population with Chronic Obstructive Pulmonary Disease. Am Jour of Resp Crit Care Med. 2018; 198 (4): 464-471.

10. Toelle, B. G., Ampon, R. D., Abramson, M. J., James, A. L., Maguire, G. P., Wood‐Baker, R., Johns, D. P., & Marks, G. B. (2021). Prevalence of chronic obstructive pulmonary disease with breathlessness in Australia: weighted using the 2016 Australian census. Internal Medicine Journal, 51(5), 784–787. https://doi.org/10.1111/imj.15325

11. Lung Foundation Australia. COPD Factsheet. https://lungfoundation.com.au/resources/copd-fact-sheet/ [Last accessed: September 2021]

12. Department of Health. National Strategic Action Plan for Lung Conditions. 2019. Available at: https://www.health.gov.au/resources/publications/national-strategic-action-plan-for-lung-conditions. [Last accessed: October 2021]

13. Mathioudakis AG, Ananth S, Vestbo J. Stigma: an unmet public health priority in COPD. Lancet Respir Med. 2021 Sep;9(9):955-956. doi: 10.1016/S2213-2600(21)00316-7. Epub 2021 Jun 28. PMID: 34197813.

14. Breztri Aerosphere Australian Consumer Medicines Information. Available at: http://www.guildlink.com.au/gc/ws/astra/cmi.cfm?product=apcbrezt10721 [Last accessed: September 2021]

15. GOLD. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2020. [Online]. Available at: http://goldcopd.org. [Last accessed: September 2021].

16. Quaderi SA, Hurst JR. The unmet global burden of COPD. Glob Health Epidemiol Genom. 2018; 3: e4. Published 2018 Apr 6.

17. Kerkhof M, Voorham J, Dorinsky P, et al. Association between COPD exacerbations and lung function decline during maintenance therapy. Thorax. 2020; 75 (9): 744-753.

18. Halpin DMG, Decramer M, Celli BR, et al. Effect of a single exacerbation on decline in lung function in COPD. Respiratory Medicine 2017; 128: 85-91.

19. Roche N, Wedzicha JA, Patalano F, et al. COPD exacerbations significantly impact quality of life as measured by SGRQ-C total score: results from the FLAME study. Eur Resp J. 2017; 50 (Suppl 61): OA1487.

20. AstraZeneca plc. Annual Report 2019. Available at: https://www.astrazeneca.com/investor-relations/annual-reports.html [Last accessed: September 2021].

AU-12142 | Date of Preparation: October 2021