Limited Coverage Drugs – fluticasone furoate in combination with vilanterol

Generic Name

fluticasone furoate-vilanterol

Strength

fluticasone furoate 100 mcg/vilanterol 25 mcg for asthma and COPD

fluticasone furoate 200 mcg/vilanterol 25 mcg for asthma

Form

dry powder for oral inhalation

Special Authority Criteria

Approval Period

  1. Diagnosis of asthma

AND

inadequate response on optimal dose of inhaled corticosteroid.

Indefinite

  1. 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)

Notes:

  • 1Fluticasone 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.
  • 2Moderate 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

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)