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Limited coverage drugs – budesonide in combination with glycopyrronium and formoterol

Last updated on September 27, 2024

Generic name

budesonide-gylcopyrronium-formoterol

Strength

budesonide 160 mcg / glycopyrronium (as bromide) 7.2 mcg /  formoterol fumarate dihydrate 5 mcg

Form

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

AND

  • A post-bronchodilator FEV1 < 80% predicted 

AND

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

OR

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

AND

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)

OR

  • a combination of inhaled corticosteroids (ICS) and LABA

Indefinite

Notes

  • 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)