Limited coverage drugs – budesonide in combination with glycopyrronium and formoterol

Last updated on April 5, 2024

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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 severe¹chronic 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

Special Authority criteria

Approval period

Diagnosis of moderate to very severe¹chronic 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

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)

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)

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Limited coverage drugs – budesonide in combination with glycopyrronium and formoterol

Notes

Practitioner exemptions

Special notes

Special Authority request form(s)