ROFLUMILAST TAB
Clinical Criteria Summary
Exclusion Criteria
- Asthma without Chronic Obstructive Pulmonary Disease (COPD)
- Moderate-severe hepatic impairment (Child-Pugh B or C)
- Coadministration of strong CYP450 inducers
- Treatment of acute bronchospasm
- History of depression, anxiety, suicidal thoughts or behavior, unless determined with mental health specialist consultation that roflumilast can be used
- Pregnant or nursing status
- Co-administration of CYP3A4 or dual CYP3A4/CYP1A2 inhibitors or oral contraceptives containing gestodene and ethinyl estradiol (consider risk versus benefit)
- Patients with anxiety, insomnia, depression, or suicidal ideation/behavior (use cautiously, if at all)
- Patients with other mental health disorders (e.g., psychotic disorder, bipolar disorder, PTSD), especially if not fully controlled
Inclusion Criteria
- Care provided by a VA/VA Community Care pulmonologist (or designated expert)
- COPD associated with chronic bronchitis (daily cough with production of sputum for 3 months, two years in a row)
- FEV1 less than or equal to 50% predicted
- At least 1 recorded COPD exacerbation requiring systemic steroids, unscheduled healthcare contact, or hospitalization in the previous year
- Maintenance bronchodilator therapy optimized (inhaled anticholinergics, long-acting beta-agonists)
- Inhaled corticosteroid therapy optimized unless use determined to be medically inappropriate