Limited Coverage Drugs – Aclidinium in combination with formoterol

Generic Name

 aclidinium in combination with formoterol                                                                                                                                        
Strength aclidinium bromide 400 mcg / formoterol 12 mcg

Form

 dry powder for oral inhalation via inhaler

Special Authority Criteria

Approval Period

Diagnosis of chronic obstructive pulmonary disease (COPD) where spirometry measures are:

  • Forced expiratory volume in 1 second (FEV1) as a percentage of predicted value (less than or equal to 65%)

AND

  • Ratio of actual FEV1/forced vital capacity (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 6 puffs daily1.

Notes:

  1. 12 puffs of ipratropium via metered dose inhaler is equivalent to 6 puffs of ipratropium via Combivent Respimat 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 should be initiated on the aclidinium with formoterol combination product only after an inadequate response to monotherapy with either a single-entity long-acting beta agonist (LABA) or a single-entity long-acting muscarinic receptor antagonist (LAMA).

Special Authority Request Form(s)