Dupixent® PBS listed for severe atopic dermatitis
First-in-class medicine subsidised for debilitating skin condition
Department of Health Announcement
Sydney – 27 February 2021 – Australians battling severe uncontrolled atopic dermatitis, commonly known as eczema and characterised by relentless itching and painful rashes, will now have an affordable new treatment option.1
From 1 March, a first-in-class biologic therapy known as Dupixent® (dupilumab) will be listed on the Pharmaceutical Benefits Scheme for the treatment of patients 12 years or older with severe atopic dermatitis, who have failed to respond to optimally prescribed topical treatments.1
Dermatologist, Associate Professor Peter Foley, Director of Research, Skin Health Institute, said, “Severe atopic dermatitis is more than just a skin condition. It affects every aspect of life, disrupting sleep, impacting work and relationships, and has been linked to an increased frequency of anxiety and depression.”
“Many people think of eczema as a relatively mild skin condition which resolves after the early years of life, but for some people it can be debilitating and lifelong,” he said.
In a recent Australian study, atopic dermatitis has been found to increase the risk of insomnia, anxiety, and depression by 79 per cent, 44 per cent and 41 per cent respectively,2 while another study found suicidal thoughts and suicide attempts by 44 per cent and 36 per cent more likely, respectively, compared to people without the condition.3
Approximately 100,000 Australians are living with severe atopic dermatitis4 and can experience flare-ups that are frequent, extensive and may require hospitalisation to prevent or treat severe skin infections.5
Professor Connie Katelaris, from the Department of Immunology and Allergy at Campbelltown Hospital said, “Until now, atopic dermatitis treatment has focused on reducing inflammation through a combination of intensive topical treatments and through broad based systemic therapies that may have widespread effects on the body.
“While this may be effective in some patients, many others struggle with uncontrolled disease and experience a constant battle to control symptoms because the underlying type 2 inflammation remains unchecked,” Professor Katelaris said.
“Dupixent is the first and only dual-acting targeted therapy that simultaneously inhibits two signaling proteins, IL-4 and IL-13, which are key culprits responsible for the type 2 inflammation that causes severe inflamed and itchy skin, often associated with atopic dermatitis,6” she said.
“This marks the first time that a biologic therapy has been subsidised through the PBS to treat atopic dermatitis.
“It also represents a new treatment era, as it is the first time a therapy has been available for severe atopic dermatitis that targets the underlying type 2 inflammation,” she said.
Type 2 inflammation is the common denominator behind a range of lifelong diseases, including atopic dermatitis, asthma, and other allergic or atopic disorders which appear to be disparate conditions but occur when the immune system overreacts to an allergen or pathogen.
The medicine is injected once every two weeks and is not intended for episodic use.6 Without a subsidy, Dupixent will cost approximately $22,800 per year. With the PBS subsidy, eligible patients will only need to pay $41 per prescription, or $6.60 with a concession card.
Sanofi Genzyme Australia and New Zealand General Manager, Fiona Clark said the company was committed to working with clinicians to help Australians affected by atopic dermatitis.
“I would like to acknowledge the many clinicians, patients and patient organisations who advocated for both greater understanding of the impacts of severe atopic dermatitis and access to new treatment options,” she said.
“Access to new treatments on the PBS is fundamental to Australia having the best health system in the world.
“We are pleased that we have been able to reach agreement with the Australian Government to list Dupixent on the PBS,” Ms Clark said.
Dupixent is generally well tolerated and does not require regular blood tests. In clinical trials the most common side effects included injection site reactions, conjunctivitis, blepharitis, eye pruritus, and oral herpes.6
Care should be taken in patients with helminth (worm) infestation and in patients who have recently received certain types of vaccines (check with your Doctor). Patients
should be reminded to report any changes in their vision to their doctor. Use in pregnancy or breastfeeding needs to be discussed with the treating doctor.6
Australians with moderate-to-severe atopic dermatitis who do not meet PBS criteria will continue to be able to access the medicine on private prescription.
Dupixent is jointly developed by Sanofi and Regeneron under a global collaboration agreement.
- Federal Health Minister’s announcement, 27 February 2021
- Chidwick K, et al. Prevalence, incidence and management of atopic dermatitis in Australian general practice using routinely collected data from MedicineInsight Australasian Journal of Dermatology 2020
- Sandhu, JK et al. Association Between Atopic Dermatitis and Suicidality: A Systematic Review and Meta-analysis JAMA Dermatology 2019 155(2):178-187
- METIS Healthcare Research. Dupilumab Patient Tracker, prepared August 2019.
- Smith S, et al. Atopic dermatitis in adults: An Australian management consensus Australasian Journal of Dermatology 2020, 61, 23-32
- Dupixent TGA Approved Product Information 6 October 2020
© Sanofi Australia and New Zealand. Talavera Corporate Centre, Building D, 12-24 Talavera Road, Macquarie Park, NSW 2113. MAT-AU-2100132.
First issued February 2021