Ohtuvayre (ensifentrine) inhalation suspension 3 mg/2.5 mL — Blue Cross Blue Shield of Montana

Initial criteria

• 1. BOTH of the following: A. ONE of the following: 1. The patient has a diagnosis of COPD AND ALL of the following: A. Diagnosis confirmed by spirometry with post-bronchodilator FEV1/FVC < 0.7 AND B. Post-bronchodilator FEV1 between 30%–70% predicted AND C. ONE of the following: 1. Modified Medical Research Council dyspnea (mMRC) score ≥ 2 OR 2. COPD Assessment Test (CAT) score ≥ 10 AND D. ONE of the following: 1. Patient currently treated with LABA + LAMA combination with or without ICS OR 2. Patient has intolerance or hypersensitivity to LABA + LAMA combination OR 3. Patient has FDA labeled contraindication to all LABA + LAMA combinations OR 2. The patient has another FDA labeled indication for the requested agent AND B. If the patient has an FDA labeled indication, ONE of the following: A. Patient’s age is within FDA labeling for the indication OR B. Support for use at the patient’s age for the indication AND 2. If COPD, the patient will continue COPD control therapy (LABA, LAMA, ICS) in combination with the requested agent AND 3. Prescriber is a specialist (e.g., allergist, immunologist, pulmonologist) or has consulted with one AND 4. Patient has no FDA labeled contraindications to the requested agent
• Also approved when the member resides in Ohio AND the plan is Fully Insured or HIM Shop (SG) AND BOTH: A. Patient has no FDA labeled contraindications AND B. ONE of the following: 1. Patient has another FDA labeled indication for the agent and route OR 2. Patient has another compendia supported indication for the agent and route OR 3. Prescriber submitted two peer-reviewed journal articles supporting proposed use as safe and effective

Reauthorization criteria

• 1. Patient previously approved through plan’s Prior Authorization process AND 2. ONE of the following: A. Patient has diagnosis of COPD AND BOTH: 1. Decrease in exacerbations and/or dyspnea with the requested agent AND 2. Will continue COPD control therapy (LABA, LAMA, ICS) in combination with the requested agent OR B. Patient has a diagnosis other than COPD AND has had clinical benefit with the requested agent AND 3. Prescriber is a specialist (allergist, immunologist, pulmonologist) or has consulted with a specialist AND 4. Patient does not have any FDA labeled contraindications to the requested agent

Approval duration

Initial 6 months (BCBSIL 12 months); Renewal 12 months