Nucala® (mepolizumab) is now listed on the PBS for Australians with chronic rhinosinusitis with nasal polyps
- Nucala is the first biologic treatment to be PBS-subsidised for the treatment of severe chronic rhinosinusitis with nasal polyps1,2
- Chronic rhinosinusitis is a common chronic respiratory disease that affects one in ten Australians.3 An estimated 25-30% of people living with chronic rhinosinusitis also have nasal polyps (soft jelly-like tissue growths within the nasal cavity)4,5
- The availability of Nucala on the PBS for CRSwNP provides subsidised access to a new treatment option for these patients
GSK Australia welcomes the announcement that Nucala (mepolizumab), will be subsidised by the Pharmaceutical Benefits Scheme (PBS) from 1 April 2023 as an add-on treatment for adult patients (18 years and above) with chronic rhinosinusitis with nasal polyps (CRSwNP) that is severe, eosinophilic and recurrent post-surgery.2
Chronic rhinosinusitis is a common chronic respiratory disease that affects one in ten Australians.3 An estimated 25-30% of people living with chronic rhinosinusitis also have nasal polyps (soft jelly-like tissue growths in the nasal cavity), termed chronic rhinosinusitis with nasal polyps (CRSwNP).4,5
Nucala is the first monoclonal antibody to be PBS-subsidised for CRSwNP.1 Clinical trials have shown effectiveness in improving recurring CRSwNP symptoms.1,6 It is an additional option for CRSwNP patients who have had previous nasal polyps surgery and continue to experience severe, chronic inflammation and symptoms after treatment.1,2
Monoclonal antibodies are a type of biological medicine, or medicines made from living cell cultures.7 They can be tailored to target a part of the immune system that is not functioning as it should.8
CRSwNP is associated with increased inflammation, including high numbers of eosinophils (a type of white blood cell) in the blood and tissues of the nose – which can cause nasal polyps to form inside the nose.9 Nucala works by reducing the number of eosinophils in the blood and can reduce the size of nasal polyps.1
People living with CRSwNP experience symptoms that impact their day-to-day life. Symptoms of CRSwNP include nasal blockage and discharge, congestion, loss of smell and facial pressure, which can have a significant impact on quality of life by affecting mental wellbeing, sleep, and productivity.10-12 It is estimated that 40% of people living with CRSwNP struggle with recurring nasal polyps within 1.5 years of surgery.13
According to Professor Richard Harvey, a leading Otolaryngology Head and Neck Surgeon and researcher, CRSwNP has a significant impact on quality of life and the PBS subsidisation of Nucala for CRSwNP is an important step forward in helping patients who live with persistent, recurring symptoms.
“The treatment journey for CRSwNP patients can be long and complex. The PBS listing of Nucala means affordable access for Australian patients to a monoclonal antibody treatment for the first time. This is welcome news as it means patients, who have not had an adequate response to other treatments, have a new option that can improve their quality of life and potentially reduce the number of future surgical procedures for this group of patients,” said Professor Harvey.
Maria Said, CEO of Allergy & Anaphylaxis Australia, said the PBS subsidisation is significant in reducing the burden of CRSwNP on patients, and the healthcare system.
“The impact on the quality of life of Australians living with CRSwNP can be profound. Debilitating symptoms negatively impact those affected across different facets of their life. New treatment options for chronic rhinosinusitis with nasal polyps are important, as they give Australians living with this chronic condition the opportunity to more effectively manage the severe and persistent symptoms that characterise this disease,” said Ms Said.
Dr Alan Paul, Country Medical Director at GSK Australia, said the PBS listing is an important milestone for the treatment of CRSwNP, and GSK is proud to bring this option to patients.
“GSK is pleased that Australians living with chronic rhinosinusitis with nasal polyps can now access Nucala via the PBS. This subsidisation provides appropriate patients with access to a biologic treatment option to help reduce both the chronic symptoms and the burden of disease,” said Dr Paul.
“GSK is committed to ongoing research and innovation to help address unmet patient needs and today’s announcement is evidence of that.”
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About chronic rhinosinusitis with nasal polyps and eosinophilic inflammation
CRSwNP is characterised by chronic eosinophilic inflammation, with an inflammatory protein, interleukin-5 (IL-5) playing a key role in the disease process.9 Symptoms of CRSwNP include nasal obstruction and discharge, loss of smell and facial pressure, which can have an impact on the patient's quality of life.10,11
Mepolizumab is a monoclonal antibody that blocks a specific protein called interleukin-5 (IL-5). By blocking the action of IL-5, Nucala limits the production of more eosinophils (a type of white blood cell) from the bone marrow and lowers the number of eosinophils in the bloodstream and the lungs.1
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com/company
In relation to this GSK media announcement, no honorarium was provided to Professor Richard Harvey and Maria Said AM. They have been briefed by GSK on the approved use of the product.
For information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109.
Consumer Medicines Information can be accessed at www.gsk.com.au/nucala
1. Nucala Consumer Medicines Information.
2. The Pharmaceutical Benefits Scheme (PBS). Recommendations made by the PBAC – November 2022 [updated 2022 Dec 16, accessed 2023 Jan 31]. Available from: pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes/recommendations-made-by-the-pbac-november-2022
3. Habib A-R et al. Aust J Otolaryngol 2019;2:28. Available from: theajo.com/article/view/4232/html
4. Chen S et al. Curr Med Res Opin 2020;36(11):1897–1911. Available from: https://pubmed.ncbi.nlm.nih.gov/32847417/
5. Takabayashi T et al. J Allergy Clin Immunol 2020;145(3):740–50. Available from: https://pubmed.ncbi.nlm.nih.gov/32145873/
6. Han JK et al. Lancet Respir Med 2021;9(10):1141–53. Available from: https://pubmed.ncbi.nlm.nih.gov/33872587/
7. World Health Organization (WHO). Biologicals [accessed 2023 March 8]. Available from: who.int/health-topics/biologicals#tab=tab_1
8. The University of Queensland. What are biologics? [accessed 2023 Feb 23]. Available from: https://aibn.uq.edu.au/what-are-biologics
9. Gevaert P et al. Int Forum Allergy Rhinol 2022;12(11):1413–23. Available from: https://pubmed.ncbi.nlm.nih.gov/35243803/
10. Mullol J et al. J Allergy Clin Immunol Pract 2022;10(6):1434–53.e9. Available from: pubmed.ncbi.nlm.nih.gov/35306180/
11. Khan A et al. Rhinology 2019;57(5):343–51. Available from: https://pubmed.ncbi.nlm.nih.gov/35306180/
12. Bachert C et al. J Asthma Allergy 2021;14:127–134. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7886239/
13. DeConde AS et al. Laryngoscope 2017;127(3):550–5. Available from: https://pubmed.ncbi.nlm.nih.gov/27859303/
NP-AU-MPL-PRSR-230001. Date of Approval: March 2023
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