Limited Coverage Drugs - Glycopyrronium

Generic Name                                                 

glycopyrronium

Strength

50 µg / capsule for inhalation

Form

inhaler

Special Authority Criteria

Approval Period

Diagnosis of 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 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
     puffs daily.1

Notes:

  1. 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

  • The dose of glycopyrronium should not exceed 50 mcg per day.

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

Special Authority Request Form(s)