From 1 December 2015 two new fixed-dose combination (FDC) bronchodilators are PBS listed for adults with COPD:1, 2
- eformoterol fumarate dihydrate with aclidinium bromide (Brimica Genuair)
- olodaterol hydrochloride with tiotropium bromide (Spiolto Respimat).
Both bronchodilators consist of an FDC of a long-acting beta-2 agonist (LABA) and a long-acting anticholinergic (or long-acting muscarinic antagonist [LAMA]).3, 4
They join two other LABA/LAMA FDC bronchodilators currently listed on the PBS – vilanterol trifenatate/umeclidinium bromide (Anoro Ellipta) and indacaterol maleate/glycopronium bromide (Ultibro Breezhaler).5
PBS listing
Eformoterol/aclidinum and olodaterol/tiotropium both have an Authority Required (STREAMLINED) listing for patients with COPD.1, 2 As with the other LABA/LAMA FDC bronchodilators, eformoterol/aclidinum and olodaterol/tiotropium are not PBS-subsidised for first-line treatment of COPD; patients must have been stabilised on a combination of a LABA and a LAMA taken with separate inhalers.1, 2
The Pharmaceutical Benefits Advisory Committee recommended the listings on a cost-minimisation basis compared with the two LABA/LAMA FDC bronchodilators that were already listed on the PBS.6
Eformoterol/aclidinum and olodaterol/tiotropium may be prescribed by nurse practitioners.1, 2
Place in therapy
LABA/LAMA combination therapy is an option for maintenance treatment of moderate to severe stable COPD.7 When combination therapy is indicated, an FDC bronchodilator can simplify the treatment regimen by combining two medicines in a single device.7
As with any LABA/LAMA combination therapy, only a short-acting beta-2 agonist can be used concurrently with eformoterol/aclidinum and olodaterol/tiotropium.8 Stepwise Management of Stable COPD, by the Lung Foundation of Australia, offers a visual guide to addition of therapies in COPD.8
For more information on the use of LABA/LAMA FDC bronchodilators in COPD, refer to the December 2014 NPS RADAR review ‘Indacaterol with glycopyrronium (Ultibro Breezhaler) for chronic obstructive pulmonary disease’.9
Comparison of LABA/LAMA FDC bronchodilators
No head-to-head trials have been conducted comparing the LABA/LAMA FDC bronchodilators available in Australia.
Refer to the respective Australian approved Product Information documents for efficacy and safety data comparing these FDC bronchodilators with their chosen comparators.
Table 1 PBS-listed LABA/LAMA FDC bronchodilators1, 2, 5
|
Active ingredients (LABA/LAMA) |
Brand name |
Dosage |
|---|---|---|
|
Eformoterol fumarate dehydrate/ |
Brimica Genuair |
Twice daily (one inhalation) |
|
Indacaterol maleate/ |
Ultibro Breezhaler |
Once daily (inhalation of content of one capsule) |
|
Olodaterol hydrochloride/ |
Spiolto Respimat |
Once daily (two inhalations) |
|
Vilanterol trifenatate/ |
Anoro Ellipta |
Once daily (one inhalation) |
References
- Australian Government Department of Health. Public Summary Document \u2013 Aclidinium bromide and eformoterol fumarate dihydrate. 2015. [PBS] (accessed 3 November 2015).
- Australian Government Department of Health. Public Summary Document \u2013 tiotropium bromide and olodaterol hydrochloride. 2015. [PBS] (accessed 3 November 2015).
- A. Menarini Australia Pty Ltd. Product Information \u2013 Brimica Genuair. 2015. http://www.menarini.com.au/wp-content/uploads/2015/06/pi-brimica.pdf (accessed 7 October 2015).
- Boehringer Ingelheim Pty Limited. Product Information \u2013 Spiolto Respimat 2015. http://files.boehringer.com.au/files/PI/Spiolto Respimat PI.pdf (accessed 7 October 2015).
- Australian Government Department of Health. Pharmaceutical Benefits Scheme. 2015. [PBS] (accessed 7 October 2015).
- Australian Government Department of Health. July 2015 PBAC Outcomes \u2013 Positive Recommendations, 2015. [PBS] (accessed 7 October 2015).
- Therapeutic Guidelines Limited. eTG complete [Internet]. Melbourne, 2015. [TG Online] (accessed 7 August 2015).
- Lung Foundation of Australia. Stepwise management of stable COPD. 2015. [Lung Foundation] (accessed 7 October 2015).
- NPS MedicineWise. Indacaterol with glycopyrronium (Ultibro Breezhaler) for chronic obstructive pulmonary disease. NPS RADAR (December 2014). 2014. [NPS RADAR] (accessed 7 October 2015).