VYNDAMAX® (tafamidis) PBS-listed for adult patients with wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM) with New York Heart Association (NYHA) Class I-II heart failure

  • VYNDAMAX has been listed on the Pharmaceutical Benefits Scheme (PBS) for adult patients with wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM) with New York Heart Association (NYHA) Class I-II heart failure.[1]
  • ATTR-CM is a debilitating and often fatal condition that leads to heart failure.[2],[3]
  • The availability of VYNDAMAX on the PBS provides subsidised access to a once-daily oral single-capsule treatment for ATTR-CM for adults with New York Heart Association (NYHA) Class I-II heart failure.[1]

SYDNEY, May 4, 2024 /PRNewswire/ — Pfizer Australia has welcomed the announcement that VYNDAMAX® (tafamidis), which is approved in Australia for adult patients with wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM), will be listed on Australia’s Pharmaceutical Benefits Scheme (PBS) for adults with New York Heart Association (NYHA) Class I-II heart failure from 1 May 2024.[4]

ATTR-CM is an underdiagnosed disease affecting the heart,[5] of which there are two types – hereditary ATTR-CM (hATTR) and wild-type ATTR-CM (wtATTR).[2] hATTR-CM is caused by a gene mutation and can run in families. Symptoms can start as early as 20 years of age or as late as age 80.[2],[3] wtATTR-CM is most common in men aged 65 or older but occurs rarely in women.[2],[3] ATTR-CM occurs due to genetic mutation or aging where the transthyretin protein doesn’t assemble normally, then clumps together into amyloid fibrils, and travels through the bloodstream where it is then deposited in the heart.[2],[3]

People with ATTR-CM display symptoms of heart failure, with a thicker ventricular heart wall being a key feature in both types.[3] A group of international experts suggested a way to identify the disease by looking out for certain symptoms and signs.[3] These include a history of carpal tunnel syndrome in both hands and a slightly higher level of troponin, a protein found in the heart muscle cells and specific changes in heart function. Other symptoms affecting the eye, nerves, and stomach problems can also point to this condition, especially in hATTR.[3]

“On average, people with ATTR-CM who do not receive treatment live for approximately three to five years after their diagnosis, so proactive identification and early intervention are critical to slow disease progression. The availability of VYNDAMAX on the PBS offers subsidised access to Australians living with ATTR-CM” said Professor Liza Thomas, Conjoint Professor at Sydney University and University of New South Wales and current Chair of the cardiac subcommittee of the Australian Amyloidosis Network.

“With the availability of this listing, specialists now have an option for patients based on factors such as disease stage, symptoms, and individual patient characteristics,” Professor Thomas said.

The reimbursement of VYNDAMAX reflects Pfizer’s ongoing effort to bring innovative treatments to Australian patients.

Anne Harris, Pfizer Australia and New Zealand Managing Director, said: “Pfizer’s purpose is to deliver breakthrough medicines that change patients’ lives.

“We thank the Australian Government for providing patients living with this rare, debilitating and often fatal disease with this treatment option. We are committed to working with healthcare professionals to raise awareness and enhance early detection and diagnosis of this condition,” Ms Harris said.  

For more information about ATTR-CM visit the Australia Amyloidosis Network (AAN) website: https://aan.org.au/

 

PBS Information: Authority Required. Refer to the PBS Schedule for full authority information.

 

 

To monitor outcomes of pregnant women exposed to VYNDAMAX, a Tafamidis Enhanced Surveillance for Pregnancy Outcomes (TESPO) program has been established. If a pregnancy occurs in a woman being treated with VYNDAMAX, medical or healthcare professionals are encouraged to report the pregnancy to Pfizer Australia.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reportingproblems.

See Consumer Medicine Information for details.

About Pfizer: Breakthroughs That Change Patients’ LivesTM

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development, and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time.

Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments, and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. For more information, visit: www.pfizer.com.au.

References

[1] Pharmaceutical Benefits Scheme. Listing of Vyndamax® (tafamidis) for the treatment of adult patients with wild-type or hereditary transthyretin amyloid cardiomyopathy.

[2] American Heart Association. (2021, December 8) What is Transthyretin Amyloid Cardiomyopathy (ATTR-CM). Available at: https://www.heart.org/en/health-topics/cardiomyopathy/what-is-cardiomyopathy-in-adults/transthyretin-amyloid-cardiomyopathy-attr-cm. Accessed April 2024. 

[3] Witteles, R. M., Bokhari, S., Damy, T., Elliot, P. M., Falk, R. H., Fine, N. M., Gospodinova, M., Obici, L., Rapezzi, C., & Garcia-Pavia, P. (2019). Screening for Transthyretin Amyloid Cardiomyopathy in Everyday Practice, JACC Heart Failure, 7(8): 709-16.

[4] VYNDAMAX Product Information.

[5] Australian Amyloidosis Network. (n.d) What is Amyloidosis? Available at: https://amyloidosis.net.au/patients-and-carers/what-is-amyloidosis/. Accessed April 2024.

 

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