Limited coverage criteria – fluticasone furoate in combination with vilanterol

Last updated on March 17, 2025

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Generic name	fluticasone furoate-vilanterol
Strength & form	fluticasone furoate 100 mcg / vilanterol 25 mcg dry powder for oral inhalation, for asthma and COPD
Strength & form	fluticasone furoate 200 mcg / vilanterol 25 mcg dry powder for oral inhalation, for asthma

Special Authority criteria	Approval period
Diagnosis of asthma AND inadequate response on optimal dose of inhaled corticosteroid.	Indefinite
Diagnosis of moderate to very severe chronic obstructive pulmonary disease (COPD)^1,2 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 long-acting muscarinic receptor antagonist (LAMA) OR A long-acting beta agonist (LABA)	Indefinite

Special Authority criteria

Approval period

Diagnosis of asthma

AND

inadequate response on optimal dose of inhaled corticosteroid.

Indefinite

Diagnosis of moderate to very severe chronic obstructive pulmonary disease (COPD)^1,2 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

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 long-acting muscarinic receptor antagonist (LAMA)

A long-acting beta agonist (LABA)

Indefinite

Notes

Fluticasone furoate-vilanterol 100 mcg/25 mcg once daily is the only strength indicated for the treatment of COPD. Fluticasone furoate-vilanterol 200 mcg/25 mcg is not indicated for treatment of COPD
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

The following practitioners are not required to submit a Special Authority request form for coverage:

Respirologists for asthma and COPD
Allergists for asthma

Special notes

In remote areas, where spirometry access is limited, spirometry measurements are to be provided within 6 months

Special Authority request form(s)

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