Access to Breo Ellipta for respiratory patients on the PBS is unchanged

Breo Ellipta PBS listing updated to recognise fluticasone furoate as a distinct medicine from fluticasone propionate from 1 June 2017

GSK’s respiratory medicine Breo Ellipta (fluticasone furoate/vilanterol trifenatate 100/25mcg and 200/25mcg) continues to be available to appropriate patients with asthma and COPD on the PBS.

Breo Ellipta is a once-daily combination treatment of an inhaled corticosteroid (ICS) and a long-acting bronchodilator administered using the Ellipta dry powder inhaler (DPI). Breo Ellipta is listed on the PBS for the treatment of moderate to severe asthma in patients aged 12 years and older.1

Breo Ellipta is also listed on the PBS for the treatment of chronic obstructive pulmonary disease (COPD) which is also known as chronic bronchitis, “smoker’s cough” or emphysema.1

The Breo Ellipta PBS listing has been updated to recognise fluticasone furoate (a component of Breo formulated in combination with vilanterol trifenatate) as a separate and distinct medicine from fluticasone propionate. 

The administrative process undertaken by the PBS has resulted in the delisting and relisting of Breo Ellipta under different item codes.  Reports of this change have led to confusion about the continued listing of Breo Ellipta.  The new PBS codes are:

11124L

FLUTICASONE FUROATE + VILANTEROL, fluticasone furoate 100   microgram/actuation + vilanterol 25 microgram/actuation powder for   inhalation, 30 actuations (Breo Ellipta 100/25)

 

11129R

FLUTICASONE FUROATE + VILANTEROL, fluticasone furoate 200   microgram/actuation + vilanterol 25 microgram/actuation powder for   inhalation, 30 actuations (Breo Ellipta 200/25)

 

Important Safety Information for Breo Ellipta in Australia

Breo Ellipta is listed on the PBS for use in patients with asthma and/or COPD.  Patients use Breo Ellipta by breathing it into their lungs through their mouth using the Ellipta inhaler.1

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.1

Breo Ellipta should not be used to relieve sudden attack of breathlessness or wheezing.  Breo Ellipta should not be used in patients with an allergy to lactose or milk protein or an allergy to any of the ingredients within the medicine.1

Breo Ellipta needs to be used with caution (ie. care) in specific patients, including those with: liver disease; heart or blood pressure problems; being or have been treated with tuberculosis (TB) or pneumonia; eye problems (glaucoma or cataracts); weak bones (osteoporosis); diabetes; thyroid problems; seizures; long standing or untreated infections; immune system problems.1

Like all medicines, Breo Ellipta can cause side effects, although not everybody gets them.  Common side effects oral thrush, mouth pain or irritation; voice disorder and cough.  Some of these side effects can be reduced by rinsing the mouth out with water immediately after using Breo Ellipta.  Other side effects include: infection or inflammation of the lungs; infection or inflammation of the nose sinuses; itchy, runny or blocked nose; weakening of the bones; stomach pain; high temperature; joint and back pain.1

Some medicines may affect how Breo Ellipta works or increase the likelihood of side effects, these include: beta-blockers (used to treat high blood pressure and heart conditions); ketoconazole (used to treat fungal infections); ritonavir (used to treat viral infections); and medicines to treat depression or mood/mental disorders (such as monoamine oxidase inhibitors or tricyclics antidepressants).1

References:

  1. Breo® Ellipta® Product information

Patients concerned about their health or medicine should speak to their healthcare professional for advice. For information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109.

To access the consumer medicine leaflet: http://au.gsk.com/media/363989/breo-ellipta_cmi_au_007_approved.pdf

For media: Contact Bernadette Murdoch 0449 950 745

GlaxoSmithKline - is a global research-based pharmaceutical and healthcare company. Since 1886 we have delivered the highest quality medicines, vaccines and over-the-counter healthcare products to Australians while investing in local research and providing skilled jobs. For further information please visit www.au.gsk.com.

GSK has two manufacturing facilities in Australia. Pharmaceutical products are manufactured in Boronia on the outskirts of Melbourne. It is one of GSK’s largest sterile facilities globally and includes two Relenza lines and innovative blow-fill-seal technology.  The GSK site at Ermington, in north-western Sydney, manufactures consumer products.

AUS/FFT/0041/17a Date of Approval June 2017