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Limited coverage criteria – glycopyrronium-indacaterol

Last updated on March 18, 2025

 

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Generic name

glycopyrronium-indacaterol

Strength & form

glycopyrronium 50 mcg/indacaterol 110 mcg dry powder 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

Inadequate response after a minimum 6-month trial of either:

  • a long-acting muscarinic receptor antagonist (LAMA)

OR

  • a long-acting beta agonist (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 not required to submit a Special Authority request form for coverage

Special notes

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

Special Authority request form(s)