Limited Coverage Drugs – aclidinium bromide in combination with formoterol

Generic Name

aclidinium bromide-formoterol


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


  • A post-bronchodilator FEV1 < 80% predicted


Inadequate response after a minimum 6-month trial of either:

  • a long-acting muscarinic receptor antagonist (LAMA)


  • a long-acting beta agonist (LABA)


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


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)