New treatment reimbursed for major breathing disorder

Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol) - first, once-daily triple therapy for COPD reimbursed by the PBS in Australia

GSK Australia has today announced Trelegy Ellipta will be reimbursed by the Pharmaceutical Benefits Scheme (PBS) for suitable Australian adults with moderate to severe chronic obstructive pulmonary disease (COPD) from 1st June 2018.1

There is an estimated one in twenty Australians (5%) aged 55 and over2 who are affected by the disease.

COPD is a serious, progressive condition that limits airflow in the lungs. Patients with COPD may require hospitalisation for severe exacerbations, which people with the condition may describe as ‘flare ups’.2 These are often caused by infections of the respiratory tract or the tracheobronchial tree.2

People describe COPD as “like breathing through a straw”3 and those affected experience a range of unpleasant symptoms such as shortness of breath, wheezing, coughing and increased phlegm production. In its advanced stages, a person’s ability to perform everyday tasks like walking up stairs, showering, dressing, cooking and shopping are significantly impacted.3

Trelegy Ellipta will be reimbursed for the long-term, once-daily, maintenance treatment for appropriate adult patients with moderate to severe COPD. Clinical criteria apply*.

Trelegy Ellipta is the first and only once-daily, single inhaler triple therapy for COPD to be reimbursed in Australia.1

COPD-related exacerbations are the second leading cause of hospitalisations in Australia, causing 66,250 potentially preventable hospitalisations in 2014-2015 and 355,000 bed days in 2013–14.2

Respiratory Specialist Professor Philip Bardin, Director of Respiratory Medicine at Monash Health, said increased access to affordable treatment options for COPD patients was a positive step forward in reducing the burden of the disease.

“Uncontrolled COPD has a significant impact on the daily lives of people affected. Triple therapy is an emerging option for COPD and we’re always looking at new ways to reduce exacerbations for our patients. We want to keep our COPD patients out of hospital so new options with good evidence behind them are always of interest,” said Professor Bardin.

Heather Allan, CEO of The Lung Foundation Australia, said the reimbursement represented additional options for Australians affected by the condition.

“Not only does COPD have a serious impact on our public health system, but its impact on the quality of life of those affected is particularly marked. Symptom burden prevents people from fully participating in activities that make life meaningful and the risk of exacerbations (a sudden worsening of symptoms) can often result in hospitalisation and can be life-threatening. Medications are a critical element of the treatment of COPD aimed at managing symptoms and reducing the risk of exacerbation,” said Ms Allan.

Andrew Weekes, Pharmaceutical Medical Director, GSK Australia said the announcement was part of GSK’s ongoing commitment to improving the lung health of Australians.

“While people are struggling with breathlessness and having their lives negatively impacted by COPD, GSK will continue to research and develop new treatment options. GSK is committed to bringing our innovative medicines to the people that need them most and today’s announcement provides evidence of that,” said Dr Weekes.

Important safety information4

Trelegy Ellipta contains three active ingredients: fluticasone furoate, umeclidinium (as bromide) and vilanterol (as trifenatate).

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.

Umeclidinium and vilanterol belong to a group of medicines called bronchodilators. They work together to help open the airways and make it easier for air to get in and out of the lungs.

When Trelegy Ellipta is used regularly, it can help to control the breathing difficulties related to your disease and help with the effects of the disease on your everyday life.

Trelegy 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).

Trelegy Ellipta should not be used in children or adolescents under the age of 18 years.

Don’t use Trelegy Ellipta:

  • if you are allergic (hypersensitive) to lactose or milk protein
  • if you are allergic (hypersensitive) to fluticasone furoate, umeclidinium, vilanterol or any other ingredients of Trelegy Ellipta

Some medicines and Trelegy Ellipta may interfere with each other. These include:

  • medicines called beta blockers, to treat high blood pressure or other heart problems
  • ketoconazole, to treat fungal infections
  • ritonavir, to treat HIV
  • other long acting medicines similar to this medicine that are used to treat breathing problems (i.e. inhalers used as maintenance or preventer therapy)
  • medicines to treat depression or mood/mental disorders (such as monoamine oxidase inhibitors or tricyclics antidepressants).

Common side effects

These may affect up to 1 in 10 people:

  • common cold
  • headache
  • cough
  • joint pain
  • back pain
  • itchy, runny or blocked nose
  • flu (influenza)
  • infection of the nose, sinuses or throat
  • infection of the upper airways
  • infection of the lungs (pneumonia)*

*Affected approximately 1 in 50 people in clinical trials. In general, risk factors for pneumonia in people with COPD receiving inhaled medicines containing a corticosteroid include smoking, prior pneumonia, low body weight and severe COPD.

The dose of Trelegy Ellipta is one inhalation once daily at the same time each day. Rinse mouth after use. Don’t use more than your doctor tells you to use.

About COPD

COPD is a serious, progressive condition that limits airflow in the lungs. Symptoms of COPD include shortness of breath with little or no exertion, coughing, phlegm production and wheezing.2 Patients with COPD may require hospitalisation for severe exacerbations, which are often caused by infections of the respiratory tract or the tracheobronchial tree.2

COPD affects an estimated one in twenty Australians (5%) aged 55 and over, with this rising to nearly one in 10 (9%) aged 85 years and over.2 Aboriginal and Torres Strait Islander Australians have approximately 2.5 times the rate of COPD as other Australians.2,5

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

Additional information

Professor Bardin has served on advisory boards and been involved in clinical trials sponsored by GSK for which compensation was received. In relation to this GSK media announcement, no compensation was provided to Professor Bardin, and the opinions expressed are their own. Professor Bardin has been briefed by GSK on the approved use of this product.

References

  1. Trelegy Ellipta Consumer Medicine Information. Dated January 2018.
  2. Australian Commission on Safety and Quality in Health Care - The Second Australian Atlas of Healthcare Variation: Chronic disease and infection (2017) [Accessed 26 February 2018] Available at: https://safetyandquality.gov.au/atlas-assets/The%20Second%20Australian%20Atlas%20of%20Healthcare%20Variation.pdf
  3. St. Joseph's Healthcare Hamilton Careers. (2013). “Like breathing through a straw”: Anxiety faced with COPD | News & Events. [online] Available at: http://www.joinstjoes.ca/our-people-culture/news-events/~1701--Like-breathing-through-astraw-Anxiety-faced-with-COPD [Accessed 26 Feb. 2018].
  4. Trelegy Ellipta Consumer Medicine Information. Dated 16 January 2018. Available at: https://au.gsk.com/en-au/products/our-prescription-medicines-and-vaccines/medicines/trelegy-ellipta/  [Accessed 26 February 2018]
  5. Australian Institute of Health and Welfare (AIHW) COPD (Chronic Obstructive Pulmonary Disease) December 2017. Available here: https://www.aihw.gov. [Accessed 26 February 2018]

 

*Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy.

AND

Patient must have a history of repeated exacerbations with significant symptoms despite regular bronchodilator therapy with a long acting muscarinic antagonist (LAMA) and a long acting beta-2 agonist (LABA) or an inhaled corticosteroid (ICS) and a LABA.

OR

Patient must have been stabilised on a combination of a LAMA, a LABA and an ICS for this condition.