Limited Coverage Drugs - glycopyrronium in combination with indacaterol

Generic Name

glycopyrronium-indacaterol

Strength

glycopyrronium 50 mcg/indacaterol 110 mcg

Form

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)

Notes:

1Moderate 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

Indefinite

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