Limited coverage drugs – fluticasone propionate in combination with salmeterol

Generic name

fluticasone propionate-salmeterol

Strengths

fluticasone propionate 100 mcg or 250 mcg or 500 mcg/salmeterol 50 mcg

fluticasone propionate 125 mcg or 250 mcg/salmeterol 25 mcg

Forms

dry powder for oral inhalation

suspension 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 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 long-acting muscarinic receptor antagonist (LAMA)

OR

  • a long-acting beta agonist (LABA)

Indefinite

Notes

  • 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 forms