Ohtuvayre (ensifentrine) — Blue Cross Blue Shield of New Mexico

Initial criteria

• 1. BOTH of the following: A. ONE of the following: 1. The patient has a diagnosis of chronic obstructive pulmonary disease (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% to 70% predicted AND C. ONE of the following: 1. Modified Medical Research Council (mMRC) dyspnea score ≥ 2 OR 2. COPD Assessment Test (CAT) score ≥ 10 AND D. ONE of the following: 1. 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 2. The patient has intolerance or hypersensitivity to a LABA + LAMA combination OR 3. The patient has an 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, 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 in the patient’s age for that indication 2. If the patient has a diagnosis of COPD, the patient will continue COPD control therapy (e.g., LABA, LAMA, ICS) in combination with the requested agent 3. The prescriber is a specialist in the area of the diagnosis (e.g., allergist, immunologist, pulmonologist) or has consulted a specialist 4. The patient does NOT have any FDA labeled contraindications to the requested agent
• For members residing in Ohio and enrolled in Fully Insured or HIM Shop (SG) plans: 1. The member resides in Ohio AND 2. The plan is Fully Insured or HIM Shop (SG) AND BOTH of the following: A. The patient does NOT have any FDA labeled contraindications to the requested agent AND B. ONE of the following: 1. The patient has another FDA labeled indication for the requested agent and route of administration OR 2. The patient has another indication supported in compendia for the requested agent and route of administration OR 3. The prescriber has submitted TWO peer-reviewed articles from major medical journals (e.g., JAMA, NEJM, Lancet) demonstrating safety and efficacy (case studies not accepted). Accepted study designs include randomized, double-blind, placebo-controlled trials.

Reauthorization criteria

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

Approval duration

initial 6 months (BCBSIL 12 months); renewal 12 months