Limited Coverage Drugs - Umeclidinium in combination with vilanterol

Generic Name

umeclidinium in combination with vilanterol
Strength

umeclidinium 62.5 mcg /vilanterol 25 mcg

Form dry powder for oral inhalation via inhaler
Criteria Approval Period

Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), where spirometry measures are:

  • Forced expiratory volume in 1 second (FEV1) as a percentage of predicted value (less than or equal to 65%)
    AND
  • Ratio of actual FEV1/forced vital capacity (FVC) (less than 0.7)
    AND
  • Inadequate response after a 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 inhaler is equivalent to 6 puffs of Combivent Respimat via 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 will automatically receive coverage of the umeclidinium with vilanterol combination product.
  • Patients should be initiated on the umeclidinium with vilanterol 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).
  • Daily dose of vilanterol should not exceed 25 mcg; daily dose of umeclidinium should not exceed 62.5 mcg.

Additional Information

  • None

Special Authority Request Form