New once-daily treatment option reimbursed for patients with asthma

ARNUITY ELLIPTA (fluticasone furoate), once-daily maintenance therapy for asthma reimbursed by the PBS in Australia

Thursday 1^st August 2019 – Melbourne, Australia - GSK Australia is announcing that ARNUITY ELLIPTA will be reimbursed by the Pharmaceutical Benefits Scheme (PBS) for suitable Australian patients aged 12 years and over with asthma, from August 1^st 2019.¹

People living with asthma are more likely to report a poorer quality of life.² This reimbursement provides affordable access to another treatment option for asthma patients which is positive news for Australians living with asthma. Providing additional treatment options is one way to help reduce the burden of asthma.  

Professor Greg King, Respiratory physician at the Royal North Shore Hospital and The Woolcock Institute of Medical Research welcomed the availability of another reimbursed treatment on the PBS and a new option in treating asthma.

“The introduction of a new once-daily, regular preventer therapy will help healthcare professionals provide their patients with a suitable treatment for their condition. Even those with mild asthma can benefit from regular preventer treatment.”

“It’s important for all patients to have a thorough assessment of their asthma, so that the most appropriate medication regime can be given. This new once-daily inhaler adds to the treatment options available to patients, which will be welcomed by patients and carers,” said Professor King.

Siobhan Brophy, CEO of The National Asthma Council (NAC), said the reimbursement represented additional treatment options that can help improve the quality of life for Australians affected by asthma.

“Asthma can prevent people from fully participating in the activities that make life enjoyable. And mild asthma is still asthma – it needs to be actively managed to keep you feeling well.”

“Having access to additional therapy options is welcome news for patients,” said Ms Brophy.

Andrew Weekes, Medical Director, GSK Australia said the announcement was part of GSK’s ongoing commitment to help ease the burden of a condition that affects many Australians.

“While there are still people with uncontrolled asthma symptoms, GSK will continue our research and development efforts globally and in Australia to expand the range of available treatment options for them. We are proud to add Arnuity to our portfolio of reimbursed medicines today.”

About Arnuity Ellipta¹

ARNUITY ELLIPTA is registered for use in patients with asthma.  Patients use ARNUITY ELLIPTA by breathing it into their lungs through their mouth using the Ellipta inhaler.

In the management of conditions, healthcare professionals in consultation with their patients consider both the potential risks (eg. side effects) and benefits (eg. effectiveness) of each medicine.  Information is available from the Consumer Medicine Information (CMI) and Product Information.  A summary of this information is provided below, please review the CMI for further information.

Important safety information¹ 

ARNUITY ELLIPTA contains the active ingredient fluticasone furoate.

Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids. Corticosteroids are used to reduce inflammation. They reduce the swelling and irritation in the small air passages in the lungs and so ease breathing problems. Corticosteroids also help to prevent attacks of asthma.

ARNUITY ELLIPTA should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting inhaler (such as VENTOLIN).

ARNUITY ELLIPTA 100 microgram and ARNUITY ELLIPTA 200 microgram should not be used in children under the age of 12.

Don’t use ARNUITY ELLIPTA:

• you are allergic (hypersensitive) to lactose or milk protein
• if you are allergic (hypersensitive) to fluticasone furoate or any other ingredients in ARNUITY ELLIPTA

Some medicines and ARNUITY ELLIPTA may interfere with each other. These include:

• ketoconazole, to treat fungal infections
• ritonavir, to treat viral infections

Very common side effects

These may affect more than 1 in 10 people:

• headache
• runny nose

Common side effects

These may affect up to 1 in 10 people:

• sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis)
• inflammation of the lungs (bronchitis)
• infection of the nose sinuses or throat
• flu (influenza)
• pain and irritation in the back of the mouth and throat
• inflammation of the sinuses
• itchy, runny or blocked nose
• cough
• high temperature (fever)
• back pain

The dose of ARNUITY ELLIPTA for adults and adolescents aged 12 and over is one inhalation of 100 micrograms of fluticasone furoate once daily at the same time each day. Don’t use more than your doctor tells you to.

The dose of ARNUITY ELLIPTA for children aged 5 to less than 12 is one inhalation of 50 micrograms of fluticasone furoate once daily at the same time each day. ARNUITY ELLIPTA 50 microgram strength is not available in Australia. Don’t use more than your doctor tells you to.

ARNUITY ELLIPTA needs to be used with caution (ie. care) in patients with: liver disease; are being or have been treated with tuberculosis (TB) or pneumonia; have eye problems (glaucoma or cataracts); have weak bones (osteoporosis); have long standing or untreated infections. Talk to your doctor before you use ARNUITY ELLIPTA.

About Asthma

Asthma is when the muscles surrounding the smaller airways become tight (bronchoconstriction), swollen and irritated (inflammation). Symptoms come and go and can include shortness of breath, wheezing, chest tightness and cough.¹

Asthma affects one in nine Australians, irrespective of age.² The rate of asthma among Indigenous Australians is almost two times as high as that of non-Indigenous Australians. This is even more marked in the older adult age group.²

For information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109.

About GSK

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit au.gsk.com.

If you are an Australian healthcare professional please visit au.gsk.com for more information on GSK products.

You can follow GSK on Twitter for more Australian updates @GSK_AU.

Additional information:

The information contained within this media release does not contain all the available information.  It does not take the place of talking to healthcare professionals. Please speak to your healthcare professional for further information about asthma or Arnuity Ellipta.  For a copy of the Consumer Medicine Information, please ask your healthcare professional or visit: www.gsk.com.au

In relation to this GSK media announcement, no compensation was provided to Associate Professor Greg King and the opinions expressed are their own. Associate Professor Greg King has been briefed by GSK on the approved use of this product.

GlaxoSmithKline Australia Pty Ltd. Melbourne, VIC. ABN 47 100 162 481. Trademarks are owned by or licensed to the GSK group of companies. ©2019 GSK group of companies or its licensor. PM-AU-FLF-PRSR-190001 Date of Approval: July 2019.

Arnuity^™ and Ellipta^® are registered trademarks of the GSK group of companies.

For more information or interviews please contact:

References

1. Arnuity Ellipta Consumer Medicine Information. Dated January 2019. Available at: https://au.gsk.com/media/424747/arnuity-ellipta_cmi.pdf [Accessed 26 July 2019]
2. Asthma Australia. “Statistics” Available at: https://www.asthmaaustralia.org.au/national/about-asthma/what-is-asthma/statistics [Accessed 19 July 2019]