Limited Coverage Drugs - Indacaterol in combination with glycopyrronium

Generic Name / Strength / Form

Indacaterol in combination with glycopyrronium / indacaterol 110 mcg/glycopyrronium 50 mcg / capsule for oral inhalation via inhaler

Special Authority Criteria

Approval Period

Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), where spirometry measures are:

  • FEV1 as a percentage of predicted value (less than or equal to 65%)

AND

  • Ratio of actual FEV1/FVC (less than 0.7)

AND

  • Inadequate response after a 3 month trial of either:
  • ipratropium at a dose of 12 puffs daily

    OR
  • ipratropium and salbutamol combination inhaler (Combivent Respimat) at a dose of 6 puffs daily1

Notes:

12 puffs of ipratropium via inhaler is equivalent to 6 puffs of Combivent Respimat via inhaler.

Indefinite

Practitioner Exemptions

  • Practitioners in the following specialty are not required to submit a Special Authority request form for coverage: Respirology

Special Notes

  • In remote areas, where spirometry access is limited, spirometry measurements are to be provided within 6 months.
  • Patients who meet Special Authority criteria for aclidinium/glycopyrronium/tiotropium will automatically receive coverage for the indacaterol with glycopyrronium combination product.
  • Patients should only be initiated on the indacaterol with glycopyrronium combination product after an inadequate response to monotherapy with either a single-entity long-acting beta agonist (LABA, e.g., formoterol, indacaterol, salmeterol) or a single-entity long-acting muscarinic receptor antagonist (LAMA, e.g., aclidinium, glycopyrronium, tiotropium).
  • The doses of indacaterol should not exceed 110 mcg per day and glycopyrronium should not exceed 50 mcg per day. 

Special Authority Request Form