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/
aclidinium bromide

Brimica Genuair

Twice daily (one inhalation)

Indacaterol maleate/
glycopyrronium bromide

Ultibro Breezhaler

Once daily (inhalation of content of one capsule)

Olodaterol hydrochloride/
tiotropium bromide

Spiolto Respimat

Once daily (two inhalations)

Vilanterol trifenatate/
umeclidinium bromide

Anoro Ellipta

Once daily (one inhalation)