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Limited coverage drugs – aclidinium bromide in combination with formoterol

Last updated on May 1, 2024

 

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Generic name

aclidinium bromide-formoterol

Strength & form

aclidinium bromide 400 mcg/formoterol 12 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 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

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
  • 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

Special Authority request form(s)