Limited Coverage Drugs – Tiotropium in combination with olodaterol

Generic Name

Tiotropium in combination with olodaterol                                                                                                                                               
Strength Tiotropium 2.5 mcg / 2.5 mcg olodaterol

Form

Solution for oral inhalation via inhaler

Special Authority Criteria

Approval Period

Diagnosis of COPD where spirometry measures are:

  • FEV1 as a percentage of predicted value (less than or equal to 65%)

AND

  • Ratio of actual FEV1 / FVC (less than 0.7)

AND

  • Inadequate response after 3 month trial of either:
    • Ipratropium at a dose of 12 puffs daily

                    OR​

  • Ipratropium and salbutamol combination inhaler (Combivent Respimat) at a dose of 6 puffs daily1.

Notes:

  1. 12 puffs of ipratropium via metered dose inhaler is equivalent to 6 puffs of ipratropium via Combivent Respimat inhaler.

Indefinite

 

Practitioner Exemptions

  • Practitioners in the following specialty are not required to submit a Special Authority request form for coverage: Respirology.

Special Notes

  • In remote areas, where spirometry access is limited, spirometry measurements are to be provided within 6 months.
  • Patients who meet Special Authority criteria for aclidinium/glycopyrronium/tiotropium/umeclidinium will automatically receive coverage of the tiotropium with olodaterol combination product.
  • Patients should be initiated on the tiotropium with olodaterol combination product only after an inadequate response to monotherapy with either a single-entity long-acting beta agonist (LABA, e.g., formoterol, indacaterol, salmeterol) or a single-entity long-acting muscarinic receptor antagonist (LAMA, e.g., aclidinium, glycopyrronium, tiotropium).

Special Authority Request Form(s)