Australians with severe systemic lupus erythematosus (SLE) will now be able to access a new treatment on the Pharmaceutical Benefits Scheme (PBS) from 1 July 2024 following the PBS listing of SAPHNELO® (anifrolumab) for eligible patients.
The PBS reimbursement of SAPHNELO® is for the treatment of severe systemic lupus erythematosus (SLE) with high disease activity, despite standard of care.
This is the first time a targeted treatment for severe SLE has been reimbursed on the PBS.
- Lupus is a disease in which the immune system attacks its own cells and tissues, causing inflammation and organ damage. It can affect almost any organ in the body, including skin, joints, kidneys, brain and other organs, and can cause pain, rashes, fatigue, swelling in joints, and fevers.1
- It is estimated that SLE affects approximately 20,000 Australians. 90% are women who are diagnosed between the ages of 15 and 45.2-4
- The prevalence of SLE in Aboriginal Australians is two times higher compared with non-Aboriginal Australians.5
- More than 50% of patients with SLE develop permanent organ damage, caused by the disease or existing treatments, which exacerbates symptoms and increases the risk of mortality.6-8
Ben McDonald, Country President of AstraZeneca Australia and New Zealand, which aims to deliver new therapies in diseases with high unmet need like SLE, said:
“We welcome the news that Australians may now access SAPHNELO® on the PBS for the treatment of severe SLE with high disease activity, despite standard of care.
“SAPHNELO® is the first targeted treatment for severe SLE to be listed on the PBS, which may benefit hundreds of patients every year.
“I would like to thank the Australian researchers, clinicians and patients for their tireless efforts to ensure this treatment is available on the PBS.” Mr McDonald said.
Professor Eric Morand, Director of Rheumatology at Monash Health and Dean of the Sub-Faculty of Clinical and Molecular Medicine at Monash University, a global leading expert in SLE, said:
“SLE is a debilitating disease with no cure and limited treatments. No new therapy has been reimbursed for SLE in Australia for 60 years and the unmet need for new targeted medicines is urgent.
“Many with severe SLE live with ongoing disease symptoms which can lead to a reduced quality of life and potential damage to their organs. The goal of treatment is to move beyond simply managing symptoms to targeting the cause of disease.”
“This listing provides a much-needed treatment option to a complex and chronic disease.” Prof Morand said.
Vu Nguyen, Secretary and Founder of Lupus Victoria, who support people living with lupus and fundraise to advance lupus research said:
“There has been no significant advancement in lupus treatments for many years. It’s important that treatments like SAPHNELO® are listed on the PBS so that they are affordable and accessible for eligible Australians living with severe SLE.
“Lupus Victoria is dedicated to making a difference in the fight against lupus and works to raise funds for vital research to build a brighter future for those affected by this chronic disease.”
Susan Hughes, Lupus Support Series, Dragon Claw charity, who support people living with autoimmune diseases including lupus, said:
“SLE is a complex and often debilitating autoimmune condition affecting organs and joints and can significantly impact quality of life. People living with severe SLE tell us about the need for new targeted treatments.
“This is the first reimbursed medication that is specifically directed to SLE. As an organisation supporting people living with SLE, we see the importance of new treatment options being listed on the PBS to provide access to those who may benefit.”
ABOUT SAPHNELO®
SAPHNELO® is a monoclonal antibody (a type of specialised protein) that blocks the action of a group of proteins called Type I Interferons (IFN). Type I interferons are found at high levels in people with lupus and blocking them can reduce the inflammation in your body that causes the signs and symptoms of lupus. SAPHNELO® is used to treat moderate to severe lupus (systemic lupus erythematosus or SLE) in adults whose disease is not well controlled by standard treatment. You will be given SAPHNELO® as well as your usual treatment for lupus.
Precautions: Patients should inform their doctor if they: have any other medical conditions; take any medicines for any other conditions; have a long term infection or if you have an infection that keeps coming back; get an infection or have symptoms of an infection. Symptoms may include fever or flu-like symptoms, muscle or joint aches, cough, shortness of breath, stinging or burning while urinating, diarrhoea or stomach pain, shingles (a red skin rash that can cause pain and burning); think you have had an allergic reaction. Symptoms may include swelling of your face, tongue or mouth, breathing difficulties, feeling faint, dizzy or lightheaded; have recently had or plan to have an immunisation (vaccine); have, or have had, cancer; if your lupus affects your kidneys or nervous system; if you are receiving another biologic medicinal product. Patients should inform their doctor if they are pregnant or intend to become pregnant or are breastfeeding or intend to breastfeed.
Interactions: Patient should inform their doctor or pharmacist if they are taking any other medicines, including any medicines, vitamins or supplements without a prescription from a pharmacy, supermarket or health food shop.
Side Effects: Less serious side effects include: rash, redness, itching or swelling of the skin where you have received SAPHNELO® as they may be symptoms of a less severe allergic reaction (hypersensitivity); headache, feeling sick (nausea), being sick (vomiting), feeling tired or weak (fatigue) and dizziness as they may be symptoms of an infusion-related reaction. Serious side effects include: swelling of your face, tongue or mouth, breathing difficulties, feeling faint, dizzy or lightheaded as these may be symptoms of a serious allergic reaction (anaphylaxis); fever or flu-like symptoms, body aches, cough, chest pain, shortness of breath, wheezing or sore throat as they may be symptoms of an infection of the nose, throat, airways or chest (bronchitis), sinuses (sinusitis) or lungs; red skin rash that can cause pain and burning as this may be a symptom of shingles (herpes zoster).
More information can be found in the SAPHNELO® Consumer Medicine Information here: Saphnelo CMI
Patients should discuss their treatment options with their clinician.
PBS Information: SAPHNELO® is listed on the PBS as a Section 100 item. Refer to PBS Schedule for full authority information. |
- ENDS-
Prof Morand has been involved in research, 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 Prof Morand, and the opinions expressed are his own. Prof Morand has been briefed by AstraZeneca on the approved use of this product.
Media Contacts
AstraZeneca Australia
SAPHNELO® is a trademark 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. Saphnelo Consumer Medicine Information. Available at https://www.astrazeneca.com.au/medicines/consumer-medicine-information.html
2. Garvan Institute of Medical Research. https://www.garvan.org.au/research/diseases/lupus Accessed May 2024
3. Nikpour M, Bridge JA, Richter S.A systematic review of prevalence, disease characteristics and management of systemic lupus erythematosus in Australia: identifying areas of unmet need. Intern Med J. 2014;44(12a):1170-1179.
4. Carter EE, Barr SG, Clarke AE. The global burden of SLE: prevalence, health disparities and socioeconomic impact. Nat Rev Rheumatol. 2016;12(10):605-620.
5. Raymond WD, Lester S, Preen DB, et al. Hospitalisation for systemic lupus erythematosus associates with an increased risk of mortality in Australian patients from 1980 to 2014: a longitudinal, population-level, data linkage, cohort study. Lupus Sci Med. 2021;8(1):e000539.
6. American College of Rheumatology. Guidelines for referral and management of systemic lupus erythematosus in adults. Arthritis Rheum. 1999; 42:1785-1796.
7. Bruce IN, et al. Factors associated with damage accrual in patients with systemic lupus erythematosus: results from the systemic lupus international collaborating Clinics (SLICC) inception cohort. Ann Rheum Dis. 2015; 74:1706-1713.
8. Segura BT, et al. Damage accrual and mortality over long-term follow-up in 300 patients with systemic lupus erythematosus in a multi-ethnic British cohort. Rheumatol. 2020;59(3):524-533.
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