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Limited coverage drugs – aclidinium bromide in combination with formoterol

Last updated on October 19, 2022

Generic name

aclidinium bromide-formoterol

Strength

aclidinium bromide 400 mcg/formoterol 12 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 fixed 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)