ensifentrine — Blue Cross Blue Shield of Kansas

Initial criteria

• ONE of the following: (A) The requested agent is eligible for continuation of therapy AND ONE of the following: (1) The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR (2) The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR (B) BOTH of the following:
• 1. ONE of the following: (A) The patient has a diagnosis of chronic obstructive pulmonary disease (COPD) AND ALL of the following: (1) The patient's diagnosis was confirmed by spirometry with a post‑bronchodilator FEV1/FVC ratio < 0.7 AND (2) The patient has a post‑bronchodilator FEV1 between 30%–70% predicted AND (3) ONE of the following: (A) The patient has a Medical Research Council dyspnea (mMRC) score ≥ 2 OR (B) The patient has a COPD Assessment Test (CAT) score ≥ 10 AND (4) ONE of the following: (A) The patient is currently being treated with a long‑acting beta‑2 agonist (LABA) + long‑acting muscarinic antagonist (LAMA) combination with or without an inhaled corticosteroid (ICS) OR (B) The patient has an intolerance or hypersensitivity to a LABA + LAMA combination OR (C) The patient has an FDA labeled contraindication to all LABA + LAMA combinations OR (B) The patient has another FDA labeled indication for the requested agent;
• 2. If the patient has an FDA labeled indication, then ONE of the following: (A) The patient's age is within FDA labeling for the requested indication OR (B) There is support for use for this age and indication;
• 3. If the patient has a diagnosis of COPD, the patient will continue COPD controller therapy (e.g., LABA, LAMA, ICS) in combination with the requested agent;
• 4. The prescriber is a specialist in or consulted with a specialist in the area of the patient's diagnosis (e.g., pulmonologist, allergist, immunologist);
• 5. The patient does NOT have any FDA labeled contraindications to the requested agent.

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s prior‑authorization process;
• 2. ONE of the following: (A) The patient has a diagnosis of COPD AND BOTH of the following: (1) The patient has had a decrease in exacerbations and/or dyspnea with the requested agent AND (2) The patient will continue COPD controller therapy (e.g., LABA, LAMA, ICS) in combination with the requested agent OR (B) The patient has a diagnosis other than COPD AND has had clinical benefit with the requested agent;
• 3. The prescriber is a specialist in or consulted with a specialist in the area of the patient's diagnosis (e.g., pulmonologist, allergist, immunologist);
• 4. The patient does NOT have any FDA labeled contraindications to the requested agent.

Approval duration

initial 6 months; renewal 12 months