- Korsuva® (difelikefalin) is the first approved treatment available on the PBS for moderate-to-severe pruritus associated with chronic kidney disease (CKD) in adults undergoing haemodialysis.1,2
- CKD-associated pruritus, often known as uremic pruritus or CKD-associated itch, is defined as relentless itching directly related to CKD, without another explainable cause.3,4
- The condition impacts a patient's quality of life, often causing sleep disturbances, depression and decreased mental and physical functioning.4,5,6
- In Australia, it is estimated that up to 43% of patients undergoing haemodialysis are moderately to extremely affected by CKD-associated itch.5
MELBOURNE, 13 May 2024
CSL Seqirus welcomes the announcement that Korsuva (difelikefalin) will be available on the Pharmaceutical Benefits Scheme (PBS) from 1 May 2024. Korsuva is the first approved and reimbursed treatment for moderate-to-severe pruritus associated with chronic kidney disease (CKD) in adults undergoing haemodialysis.1,2
CKD-associated pruritus, also referred to as CKD-associated itch, is a persistent itch related to chronic kidney disease – a common condition that results in the loss of normal kidney function over time.3 It particularly impacts those undergoing haemodialysis, a treatment for managing kidney disease that filters out toxins, wastes and extra fluid.4,8
Australians living with CKD-associated itch often experience negative impacts on their quality of life. The condition often leads to sleep disturbances, depression and decreased mental and physical functioning.4,5,6 It has also been associated with an increase in missed haemodialysis sessions, higher rates of hospitalisation and an increase in mortality.4,5
More than two thirds (67%) of haemodialysis patients suffer with itch, however, it is estimated that 43% of patients undergoing haemodialysis are moderately to extremely affected by CKD-associated itch.5 With over 12,000 Australians living with chronic kidney disease currently undergoing haemodialysis, the burden of associated conditions remains high.7
Professor Carol Pollock AO – Nephrologist and Chair of Kidney Health Australia, said the availability of a reimbursed option for CKD–associated pruritus will help clinicians to better manage this condition in their haemodialysis patients and may improve quality of life for those with moderate-to-severe symptoms.
“CKD-associated pruritis is a relentless itch, and up until this point we have had very few options to help manage this condition. The PBS listing of Korsuva is welcome news as it means people whose quality of life is impacted by moderate-to-severe symptoms have a specific and accessible option to help reduce the burden of this condition,” said Professor Pollock.
“CKD-associated itch is often underdiagnosed and undertreated. With the burden of chronic kidney disease remaining high in Australia, it is important we do what we can to improve quality of life for people living with associated conditions.”
Chris Forbes, CEO of Kidney Health Australia – the peak body for kidney health in Australia – welcomed the availability of Australia’s first approved treatment option for CKD-associated itch.
“When we talk about CKD, we don’t often think about the associated conditions, like CKD-associated itch, that can severely impact a person’s life. Experiencing consistent itching because of CKD can affect all facets of a person’s work and social life, including sleep and overall mood. Having a specifically designed treatment option for haemodialysis patients experiencing CKD-associated itch is a significant step forward to reduce the burden of these symptoms in patients with the greatest need,” said Mr Forbes.
Claire Morgan, CSL Seqirus Medical Director for Pharmaceuticals, said the PBS listing is an important milestone for the treatment of CKD-associated itch, and CSL Seqirus is proud to bring to market Australia’s first approved treatment option for this condition.
“This reimbursement provides haemodialysis patients living with moderate-to-severe itch associated with CKD, access to a first-of-its-kind treatment to help manage a condition which can further burden the lives of people living with significant chronic disease. We are committed to improving quality of life for patients living with chronic kidney disease and this listing is evidence of that,” said Ms Morgan.
About KORSUVA®
Korsuva is a medicine used to treat itchy skin in adults with chronic kidney disease who need haemodialysis to clean their blood. Korsuva is given as an injection and works by activating kappa-opioid receptors outside of the brain.
Precautions: Patients should inform their doctor if they: have any other medical conditions; take any medicines for any other condition; have a reduced function of the blood-brain barrier; are 65 years of age or older; are using medicines that could increase the risk of drowsiness or dizziness. Patients should inform their doctor is they are pregnant or intend to become pregnant or are breastfeeding or intend to breastfeed.
Interactions: Patients should inform their doctor 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: headache; dizziness; confusion and mental status changes; drowsiness; nausea; diarrhoea.
More information can be found in the KORSUVA® Consumer Medicine Information available at https://www.cslseqirus.com.au/products
Patients should discuss their treatment options with their clinician.
ENDS
Media Contact
For further information or to request an interview, please contact:
|
Karina Durham Chief Executive Officer Palin Communications 0402 307 056 |
Hamish Walsh Senior Communications Business Partner CSL Seqirus 0422 424 338 |
Consumer Medicine Information available at https://www.cslseqirus.com.au/products
Professor Pollock has been involved in medical education and speaker activities sponsored by CSL Seqirus for which compensation was received. In relation to this CSL Seqirus media announcement, no compensation was provided to Prof. Pollock, and the opinions expressed are her own. Prof. Pollock has been briefed by CSL Seqirus on the approved use of this product.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
In Australia, CSL Seqirus operates the only local manufacturing facility for seasonal and pandemic influenza vaccine and produces a range of unique medicines in the national interest including antivenoms and the world’s only human vaccine for Q fever. The company also in-licenses a broad range of paediatric and adult vaccines and specialty pharmaceutical products.
About CSL
CSL (ASX: CSL; USOTC: CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 30,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL.
For more information about CSL, visit www.csl.com.
References:
- Korsuva Product Information. Available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2024-PI-01565-1
- The Pharmaceutical Benefits Scheme, PBAC Meeting Outcomes November 2023. Available at https://www.pbs.gov.au/info/news
- Verduzco HA, Shirazian S. CKD-Associated Pruritus: New Insights Into Diagnosis, Pathogenesis, and Management. Kidney Int Rep. 2020;5(9):1387-1402. Published 2020 May 8. doi:10.1016/j.ekir.2020.04.027
- Topf J, Wooldridge T, McCafferty K, et al. Efficacy of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis of KALM-1 and KALM-2 Phase 3 Studies. Kidney Med. 2022;4(8):100512. Published 2022 Jun 28. doi:10.1016/j.xkme.2022.100512
- Sukul N, Karaboyas A, Csomor PA, et al. Self-reported Pruritus and Clinical, Dialysis-Related, and Patient-Reported Outcomes in Hemodialysis Patients. Kidney Med. 2020;3(1):42-53.e1. Published 2020 Nov 21. doi:10.1016/j.xkme.2020.08.011
- Weiner DE, Schaufler T, McCafferty K, et al. Difelikefalin improves itch-related sleep disruption in patients undergoing haemodialysis. Nephrol Dial Transplant. Published online November 15, 2023. doi:10.1093/ndt/gfad245
- Australia and New Zealand Dialysis and Transplant Registry. ANZDATA. 2022. Available at: https://www.anzdata.org.au/wp-content/uploads/2023/09/ANZDATA_AR-2022-23_Chapter-4_F5.pdf
- Kidney Health Australia, Dialysis: Key Facts. Available at https://kidney.org.au/your-kidneys/treatment/dialysis-key-facts
Korsuva® is a registered trademark. Seqirus (Australia) Pty Ltd. Melbourne, Victoria, Australia. ABN 66 120 398 067. Medical Information: 1800 642 865. Date of Preparation: May 2024. AU-OTH-24-0009.
