27 November 2022 – With Australian hospitals under unprecedented strain,⁴ medical experts say Federal Government funding for a first-of-its-kind treatment for worsening heart failure could not have come soon enough.¹ 

A medicine known as Verquvo® (vericiguat) will become available through the Pharmaceutical Benefits Scheme (PBS) for Australians with a common form of chronic heart failure, who have recently required emergency medical attention (often hospitalisation) for their worsening condition. It will be used in addition to standard of care treatments.^1*

*For use in addition to standard of care therapy for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF) less than 45%, who are stabilised after a recent heart failure decompensation event requiring hospital admission and/or intravenous diuretic therapy^.1
 

From 1 December, an estimated 35,000 eligible patients⁵ will pay just $6.80 (on concession) or $42.50 (general patients) each month for Verquvo.6 Without a PBS subsidy, the medicine would cost more than $1,850 each year.⁵

Verquvo treats worsening cases of what is known as heart failure with reduced ejection fraction2 which occurs when the heart is no longer able to pump a sufficient volume of blood around the body due to an injury or damage to the heart muscle. This can occur following a heart attack or other illness affecting the heart, or as a result of poorly controlled diabetes, obesity, high blood pressure or coronary artery disease.⁷  

Verquvo works to relax and widen blood vessels in the heart, making it easier for the heart to pump more oxygenated blood around the body.^2,8

Professor Andrew Sindone, a leading cardiologist and heart failure expert from Sydney who was involved in clinical trials of Verquvo, welcomed the subsidy for the medicine, noting that each day 179 Australians are hospitalised due to heart failure.⁹

“With each heart failure hospitalisation, a person’s risk of dying increases by 30 per cent,“¹⁰ he said.

“Heart failure is very serious and very common. One-in-four people die within a year of being diagnosed with heart failure with reduced ejection fraction.”¹¹

Professor Sindone explained that while the term ‘heart failure‘ may sound as though the heart suddenly fails and stops beating, it is generally a chronic condition where the heart becomes progressively weak and fails to work as well as it should.¹²

Over time, patients with heart failure become short of breath, fatigued, experience swollen ankles, and everyday activities like dressing or walking to the mail box become an ordeal.¹³ Those whose condition is worsening are at high risk of requiring hospitalisation or even death^.8

“When the body is no longer able to compensate for the weakened heart, the condition worsens and patients can find themselves in a cycle of being hospitalised time and time again,“he said. 

“The reality is that after hospitalisation, a patient’s heart is never the same again and their condition continues to progress. 

“One-in-five will be back in hospital within a month and most will be re-hospitalised within 12 months,“¹⁴ said Professor Sindone. “By this stage, heart failure has a huge impact on the life of the patient, their family and also on our hospital and healthcare system.“

Ashraf Al-Ouf, CEO of the Bayer Group in Australia and New Zealand, commended the Albanese Government for its commitment to invest in innovative medicines for heart failure.

“The downward spiral of heart failure is one of the greatest public health challenges facing our ageing population,” said Mr Al-Ouf.

“Affordable access to Verquvo will come as good news for Australians with heart failure with reduced ejection fraction who face the high risk of repeat hospitalisation or losing their lives to this insidious disease,” he said. 

“Bayer is proud to remain at the forefront of scientific advances in the treatment of cardiovascular diseases.”

About VERQUVO
Verquvo is the first in a new class of medicines for heart failure known as soluble guanylate cyclase stimulators^.2,3

Verquvo is indicated and PBS listed in addition to standard of care therapy for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction less than 45% (HFrEF) who are stabilised after a recent heart failure decompensation event requiring hospitalisation and/or intravenous diuretic therapy^.1,2

As with all medicines, Verquvo is associated with some side-effects. The most frequent adverse events include hypotension, headache, dizziness and gastrointestinal disorders including nausea or vomitting^.2 

Verquvo is not suitable for patients with hypersensitivity to the medicine or other substances in the formulation, or for those taking other soluble guanylate cyclase (sGC) stimulators, such as riociguat. Caution is required in relation to patients with vascular disorders, including low blood pressure (hypertension).² 

About Heart Failure
Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot supply adequate circulation to meet the body’s demands for oxygenated blood.

 
Symptoms associated with the condition, such as breathlessness and fatigue, can significantly impact a patient’s quality of life.¹² Heart failure is classified according to left ventrivular ejection fraction (LVEF), a measurement of the percentage of blood the left ventricle of the heart pumps out with each contraction.¹⁵ Heart failure with reduced ejection fraction occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared with a normally functioning heart.¹⁵ 

Approximately half-a-million Australians currently live with heart failure with reduced ejection fraction; it accounts for around half of all heart failure cases.¹⁶ Each year approximately 67,000 new cases are diagnosed and 61,000 Australians lose their lives to the disease.¹⁶

About Bayer in Australia
Bayer is a global enterprise with core competencies in the Life Science fields of healthcare and agriculture. Its products and services are designed to benefit people and improve their quality of life. It has operated in Australia since 1925 and has a long-term commitment to the health of Australians. Locally, Bayer currently employs almost 900 people across the country and is dedicated to servicing the needs of rural Australia and the local community. Bayer is deeply committed to research and development and has a strong tradition of innovation. The company’s focus on people, partnerships and innovation underpins all aspects of its operations, consistent with its mission, “Bayer: Science For A Better Life.” www.bayer.com.au

Consumer Medicine Information for Verquvo^® is available here. 

Full Product Information for Verquvo^® is available here.

Media Contacts:
Amy Ma (0497 863 707) at Bayer; or
Rebecca Anable (0404 019 323) at Ethical Strategies.

^References:

1. ^{Schedule of Pharmaceutical Benefits. Available at: https://www.pbs.gov.au/pbs/ From 1 December 2022.}

2. ^{Bayer Australia. VERQUVO Product Information, 2021.}

3. ^{Australian Government. Australian Register of Therapeutic Goods.2022. Available at: https://www.tga.gov.au/resources/artg}

4. ^{Australian Medical Association. Ambulance Ramping Report Card. 2022. Available at: https://www.ama.com.au/articles/ama-ambulance-ramping-report-card}

5. ^{Bayer Australia. Data on File. September 2022.}

6. ^{Pharmaceutical Benefits Scheme: Fees, Patient Contributions and Safety Net Thresholds. 2022. Available at: https://www.pbs.gov.au/info/healthpro/explanatory-notes/front/fee. Last accessed February 2022}

7. ^{Mostert A et al. Clinical epidemiology of heart failure, Heart. 2007;93:1137-1146}

8. ^{Armstrong, P et al. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med 2020; 382:1883-1893.}

9. ^{Heart Foundation. Key Statistics: Heart Failure. 2021. Available at: https://www.heartfoundation.org.au/activities-finding-or-opinion/key-statistics-heart-failure.}

10. ^{S. Solomon, J. et al., Influence of Nonfatal Hospitalization for Heart Failure on Subsequent Mortality in Patients With Chronic Heart Failure, Circulation, vol.116, issue.13, pp.1482-1487, 2007. Available at: https://www.ahajournals.org/doi/10.1161/circulationaha.107.696906}

11. ^{Levy D et al. Long-term trends in the incidence of and survival with heart failure. N Engl J Med. 2002; 347:1397-402}

12. ^{Australian Institute of Health and Welfare. Heart Failure and Cardiomyopathy. 2021/ Available at: https://www.aihw.gov.au/reports/heart-stroke-vascular-diseases/hsvd-facts/contents/heart-stroke-and-vascular-disease-and-subtypes/heart-failure-and-cardiomyopathy}

13. ^{Calvert MJ et al. The impact of chronic heart failure on health-related quality of life data acquired in the baseline phase of the CARE-HF study. Eur J Heart Fail. 2005;7:243-51.}

14. ^{Al-Omary, M. Et al. Mortality and Readmission Following Hospitalisation for Heart Failure in Australia: A Systematic Review and Meta-Analysis, Heart, Lung and Circulation, 2018; 27(8):917-927.orta}

15. ^{Atherton, J. et al. National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand Guidelines for the Prevention, Detection and Management of Heart Failure in Australia, Heart, Lung and Circulation, 2018; 27:1123–1208.}

16. ^{Chen, L. et al. Snapshot of heart failure in Australia. May 2017. Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia.}

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 Pty Ltd, ABN 22 000 1 38 714, 875 Pacific Highway, Pymble NSW 2073. 
Ph: (02) 9391 6000. Date of Preparation: October 2022 / COR-VER-AU-0012-1