Limited coverage drugs – budesonide in combination with glycopyrronium and formoterol

Generic name



budesonide 182 mcg/glycopyrronium (as bromide) 8.2 mcg/formoterol fumarate dihydrate 5.8 mcg


suspension for oral inhalation  

Special Authority criteria

Approval period

Diagnosis of moderate to very severe1 chronic obstructive pulmonary disease (COPD) where spirometry measures are as follows:

  • A post-bronchodilator fixed ratio of forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 0.70


  • A post-bronchodilator FEV1 < 80% predicted 


Who have a history of exacerbations as follows:

  • History of ≥ 2 moderate exacerbations defined as requiring a prescribed antibiotic and/or using systemic glucocorticoids in the previous 12 months


  • History of ≥ 1 severe exacerbation defined as requiring a hospital admission or emergency department visit in the previous 12 months


Inadequate response after a minimum 6-month trial of either

  • a combination of long-acting muscarinic receptor antagonist (LAMA) and long-acting beta agonist (LABA)


  • a combination of inhaled corticosteroids (ICS) and LABA



  • Moderate to very severe COPD is defined as follows:
    • Moderate COPD is defined as 50% ≤ FEV1 < 80% predicted
    • Severe COPD is defined as 30% ≤ FEV1 < 50% predicted 
    • Very severe COPD is defined as FEV1 < 30% predicted

Practitioner exemptions

  • Respirologists are invited to apply for a Collaborative Prescribing Agreement (CPA).
  • Respirologists who already have a CPA for fluticasone furoate-umeclidinium-vilanterol (Trelegy Ellipta) automatically have a CPA for Breztri Aerosphere. 

Special notes

  • In remote areas, where spirometry access is limited, spirometry measurements are to be provided within 6 months.

Special Authority request form(s)