More topics

Limited coverage drugs – tiotropium in combination with olodaterol

Last updated on September 27, 2024

Generic name

tiotropium-olodaterol

Strength

tiotropium 2.5 mcg/olodaterol 2.5 mcg

Form

solution for oral inhalation

Special Authority criteria

Approval period

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

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

  • 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

Practitioner exemptions

  • Respirologists are not required to submit a Special Authority request form for coverage.

Special notes

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

Special Authority request form(s)