Limited Use Note(s)

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TIOTROPIUM BROMIDE MONOHYDRATE & OLODATEROL HYDROCHLORIDE2.5mcg & 2.5mcg/Actuation Inh Sol-60 Actuation Pk
Reason For Use CodeClinical Criteria
459For the long-term treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD-see notes below) who have had an inadequate response to a long-acting bronchodilator (i.e., long-acting beta-2 agonist (LABA), or long-acting muscarinic antagonist (LAMA)).
LU Authorization Period: Indefinite.
NOTE: COPD disease severity is based on spirometry, symptoms and disability (see classification tables below). Classification COPD Stages - Symptoms and disability: Mild: Shortness of breath from COPD when hurrying on the level or walking up a slight hill. Moderate: Shortness of breath from COPD causing the patient to stop after walking approximately 100m (or after a few minutes) on the level Severe: Shortness of breath from COPD resulting in the patient being too breathless to leave the house, breathless when dressing or undressing (MRC 5), or the presence of chronic respiratory failure or clinical signs of right heart failure Classification by impairment of lung function: COPD stage and spirometry (post bronchodilator) FEV1 predicted: Mild: Greater than or equal to 80 percent Moderate: 50 to 79 percent Severe: 30 to 49 percent Very severe: Less than 30 percent