Limited Coverage Drugs – fluticasone furoate in combination with umeclidinium and vilanterol

fluticasone furoate-umeclidinium-vilanterol

fluticasone furoate 100 mcg/umeclidinium 62.5 mcg/vilanterol 25 mcg

dry powder for oral inhalation

Diagnosis of moderate to very severe¹ chronic obstructive pulmonary disease (COPD) where spirometry measures are as follows:

• A post-bronchodilator fixed ratio of forced expiratory volume in 1 second (FEV₁)/forced vital capacity (FVC) < 0.70

AND

• A post-bronchodilator FEV₁ < 80% predicted

AND

Who have a history of exacerbations as follows:

• History of ≥ 2 moderate exacerbations defined as requiring a prescribed antibiotic and/or using systemic glucocorticoids in the previous 12 months

OR

• History of ≥ 1 severe exacerbation defined as requiring a hospital admission or emergency department visit in the previous 12 months

AND

Inadequate response after a minimum 6-month trial of either

• a combination of long-acting muscarinic receptor antagonist (LAMA) and long-acting beta agonist (LABA)

OR

• a combination of inhaled corticosteroids (ICS) and LABA

Notes:

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

Indefinite