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First biologic treatment on the PBS for uncontrolled chronic obstructive pulmonary disease (COPD)

GSK

• NUCALA (mepolizumab) is now listed on the Pharmaceutical Benefits Scheme (PBS) for adults with uncontrolled COPD and raised blood eosinophils as an add-on to inhaler triple therapy. [1,2]
• In 2022, approximately 496,000 Australians aged 45 and over were estimated to be living with COPD, a progressive lung disease that can make breathing difficult. [3]
• COPD patients with raised blood eosinophils have an increased risk of flare-ups of symptoms. [4,5,6]

                                            

NUCALA (mepolizumab) has become the first biologic treatment to be added to the Pharmaceutical Benefits Scheme (PBS) for adults living with uncontrolled chronic obstructive pulmonary disease (COPD).[1,2]

 

The PBS listing subsidises the cost of NUCALA for eligible adults with uncontrolled COPD and raised blood eosinophils (a type of white blood cell), who continue to experience flare-ups despite optimised inhaler triple therapy.[1,2]

 

In 2022, approximately 496,000 Australians aged 45 and over were estimated to be living with COPD, a progressive lung disease that can cause breathing difficulties, cough, chest discomfort and excess mucus.[2,3] These symptoms may affect daily activities and can lead to reduced physical activity, impaired sleep and increased anxiety and depression, and reduce quality of life.[7]

 

It is estimated from studies that 20–35% of people with COPD have a high number of eosinophils in the blood, which can increase the risk of flare-ups (exacerbations) of COPD symptoms.[4,5]

 

Mark Brooke, Chief Executive Officer of Lung Foundation Australia, commented: "Living with uncontrolled COPD can be incredibly challenging. Managing breathlessness, infections and repeated flare-ups can be a source of ongoing anxiety and make everyday life harder.”

 

Dr Gregory King, Head of Respiratory Medicine at the Royal North Shore Hospital and Research Leader at The Woolcock Institute of Medical Research, said the PBS listing of Nucala for uncontrolled COPD with raised eosinophils is welcome news for Australians living with the condition: “One of the challenges in COPD management is that many people with uncontrolled COPD continue to experience flare-ups despite inhaler triple therapy. Some people with COPD have raised eosinophils, which are associated with an increased risk of flare-ups. The PBS listing provides subsidised access to an additional treatment option for eligible patients who meet the PBS criteria."

 

COPD exacerbations can worsen breathing difficulties, increase progression of the disease and lead to hospitalisations.[8] In 2023-2024 there were 68,000 potentially preventable hospitalisations for COPD, highlighting the burden uncontrolled COPD can place on individuals, families and the wider healthcare system. [9,10]

 

NUCALA contains mepolizumab, a monoclonal antibody that blocks a specific protein called interleukin-5 (IL-5). By blocking the action of IL-5, NUCALA reduces the number of eosinophils in the blood lung tissue and can reduce the flare-ups of COPD symptoms. [2]

 

Andrew Thomas, Vice President and General Manager, GSK Australia, said: “We are delighted that eligible Australians with uncontrolled COPD and raised eosinophils will now have access to Nucala on the PBS. GSK is committed to improving outcomes for people living with respiratory diseases.”

 

Less serious side effects that can occur with Nucala include headache, injection-site reaction, fatigue, fever, eczema, back pain, pharyngitis, nasal congestion, lower respiratory tract infection, chest infection, upper abdominal pain, vomiting, diarrhoea and urinary tract infection.[2] Serious side effects include allergic or allergic-like events and shingles infection. In the COPD clinical trials, these serious side effects occurred in 1% of patients receiving Nucala.[2]

 

Patients should speak to their healthcare professional if they have questions about the treatment or management of COPD.

-Ends-

About NUCALA (mepolizumab) [2]

Indication

NUCALA is indicated as an add-on maintenance treatment for adult patients with uncontrolled COPD with raised blood eosinophils on stable inhaler triple therapy (or, where clinically required, an equivalent regimen).

Safety Information

Less serious effects that may occur after receiving NUCALA include: Headache, injection-site reaction, fatigue, fever, eczema, back pain, pain in extremities, sore throat, nasal congestion, lower respiratory tract infection, chest infection, upper abdominal pain, vomiting, diarrhoea and urinary tract infection.

Serious side effects may occur, including shingles (herpes zoster) and allergic or allergic-like reactions. Allergic or allergic-like reactions often occur within minutes to hours after the medicine is administered, but in some instances, symptoms can have a delayed onset of up to several days. If patients think they are having an allergic reaction to NUCALA, they should stop using the medicine and tell their doctor or a nurse immediately or go straight to the emergency department at their nearest hospital. If patients have less serious side effects or notice anything else that may be making them feel unwell, they should tell their doctor.

 

Precautions

NUCALA should not be used to treat acute COPD-related symptoms, such as a sudden COPD flare-up (exacerbation). Patients should not stop injections of Nucala unless their doctor tells them to. Patients should be careful driving or operating machinery until they know how NUCALA affects them.

Patients should be told to seek medical advice if their COPD symptoms don't improve or worsen after starting treatment with NUCALA.

If patients are taking corticosteroids, they should not abruptly stop them after starting treatment with Nucala. Doses of corticosteroids should be reduced gradually, if required, and must be done under the supervision of their doctor.

Acute and delayed reactions, including allergic (hypersensitivity) reactions (symptoms may include: chest tightness, cough, wheezing or difficulty breathing, fainting, dizziness, felling lightheaded, swelling of the face, lips, tongue or other parts of the body, rash, itching, hives or redness on the skin, stomach pain or discomfort and vomiting), have occurred after the injection of NUCALA. These reactions generally occur within hours of administration, but in some instances can occur days after the injection. Sometimes these reactions can occur for the first time even after treatment with Nucala for a long time. If a patient experiences a hypersensitivity reaction, NUCALA should be discontinued.

If patients have a worm infection, they should be treated before treatment with Nucala.

Warnings

Patients should tell their doctor if they have any other medical conditions, take any medicines, have had an allergic reaction to any other medicine before, have an existing parasitic infection or they are travelling to or live in an area where infections caused by parasites are common are pregnant or plan to become pregnant, or are breastfeeding.

Contraindications

Nucala should not be used in patients who are allergic (hypersensitive) to mepolizumab or any of the ingredients in NUCALA.

Interactions

No formal drug interaction studies have been done with Nucala. Patients should tell their doctor or pharmacist about any other medicines, vitamins or supplements they take.

 

About chronic obstructive pulmonary disease (COPD)

COPD is a progressive lung condition that causes narrowing of the bronchial tubes in the lungs (sometimes called bronchi or airways), making it difficult to breathe. Sometimes air gets trapped in the lungs causing the feeling of breathlessness. COPD is an umbrella term for a group of lung conditions including emphysema and chronic bronchitis.[10]

 

Around one in seven Australians aged 40 years and over have some form of COPD.[10] In 2022, approximately 496,000 (4.8%) of people aged 45 and over were estimated to have COPD, however around half of people living with COPD symptoms do not know they have the condition.[3,10] In 2023-24, the rate of hospitalisations for COPD among First Nations people was 5.8 times the rate of non-Indigenous Australians.[3] In 2023, COPD was the fifth leading cause of death in Australia, accounting for approximately 7,400 deaths annually.[3]

 

 Depending on the severity, flare up of COPD symptoms (exacerbations) can lead to ED presentations and hospitalisations. In 2024-2025 there were 61,500 ED presentations for COPD in Australia, and 71,000 potentially preventable hospitalisations for COPD.[3,12] It is estimated that COPD is responsible for $1.8 billion in healthcare system costs in Australia in 2023-2024, and a $4.85 billion loss in patient and carer productivity in 2024.[3,9]

 

About GSK

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 https://au.gsk.com.  

 

Additional Information

 

In relation to this GSK media announcement, no honorarium was provided to Dr Gregory King. They have been briefed by GSK on the use of this product.

Media contacts

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0489 209 033	0466 514 894

 

For further information, please refer to the Consumer Medicine Information at www.gsk.com/nucala.  For information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109. GlaxoSmithKline Australia Pty Ltd. ABN 47 100 162 481. Melbourne, VIC. Trademarks are owned by or licensed to the GSK group of companies. Date of approval: August 2026 NP-AU-MPL-PRSR-260001

 

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