ENSIFENTRINE SUSP,INHL
Clinical Criteria Summary
Disease Diagnosis & Severity
- Diagnosis of asthma (Exclusion)
- Treatment of acute bronchospasm or an acute exacerbation of chronic obstructive pulmonary disease (COPD) (Exclusion)
- Moderate to severe COPD (e.g., post-bronchodilator FEV1 30-70% predicted and FEV1/FVC <0.7, confirmed by pulmonary function testing) (Inclusion)
- Inadequate symptom control (e.g., dyspnea score of at least 2 on Medical Research Council dyspnea scale) (Inclusion)
Prior Therapy & Exacerbation History
- Receiving maintenance bronchodilator therapy with a long-acting beta-agonist (LABA) AND a long-acting anticholinergic (LAMA) AND an inhaled corticosteroid (unless inhaled corticosteroid is contraindicated) for at least 3 months (Inclusion)
- Had at least 2 moderate COPD exacerbations (requiring systemic steroids and/or antibiotics) or at least 1 severe COPD exacerbation (requiring hospitalization) in the previous 12 months (Inclusion)
- Patient is unable to tolerate or had an inadequate response to roflumilast and/or azithromycin after therapeutic trial (e.g., continued exacerbations after at least 6 months) or is clinically not appropriate for either agent (e.g., risks outweigh benefits) (Inclusion)
Psychiatric Considerations
- History of depression (e.g., major depressive disorder [MDD]), suicidal thoughts or behaviors, unless determined in consultation with a mental health specialist or primary care provider that ensifentrine can be used (Exclusion/Caution)
- Other psychiatric adverse events including insomnia and anxiety; use with caution in patients with these or other mental health disorders (e.g., psychotic disorder, bipolar disorder, PTSD), especially if not fully controlled (Exclusion/Caution)
- Potential for psychiatric events with ensifentrine such as mood changes, depression, anxiety and suicidal thoughts and/or behaviors have been discussed with the patient and documented in medical record (Inclusion)
Hepatic Function
- Moderate to severe hepatic impairment as exposure to ensifentrine may increase up to 2.3-fold (Exclusion/Caution)
Smoking Status
- Patient is non-smoking or, if not, he/she is enrolled in a quit smoking program or on medications to assist with smoking cessation; current smokers may be considered if unable or refuse to quit (Additional Guidance/Inclusion)
Reproductive Potential
- For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy (Additional Inclusion Criteria)
Provider & Administrative Requirements
- Provider is a VA or VA Community Care pulmonologist or designated expert (Inclusion)
- Adherent to COPD medications as evidenced by a review of prescription refill history (Inclusion)
- Patient has demonstrated correct inhaler technique (documented in medical record) (Inclusion)